Subchapter C—Federal Hazardous Substances Act Regulations

SUBCHAPTER C—FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS

PART 1500—HAZARDOUS SUB- for use by children over 18 but not over 36 months of age. STANCES AND ARTICLES: ADMIN- 1500.53 Test methods for simulating use and ISTRATION AND ENFORCEMENT abuse of toys and other articles intended REGULATIONS for use by children over 36 but not over 96 months of age. Sec. 1500.81 Exemptions for food, drugs, cos- 1500.1 Scope of subchapter. metics, and fuels. 1500.2 Authority. 1500.82 Exemption from full labeling and 1500.3 Definitions. other requirements. 1500.4 Human experience with hazardous 1500.83 Exemptions for small packages, substances. minor hazards, and special cir- 1500.5 Hazardous mixtures. cumstances. 1500.12 Products declared to be hazardous 1500.85 Exemptions from classification as substances under section 3(a) of the act. banned hazardous substances. 1500.13 Listing of ‘‘strong sensitizer’’ sub- 1500.86 Exemptions from classification as a stances. banned toy or other banned article for 1500.14 Products requiring special labeling use by children. under section 3(b) of the act. 1500.87 Children’s products containing lead: 1500.15 Labeling of fire extinguishers. inaccessible component parts. 1500.17 Banned hazardous substances. 1500.88 Exemptions from lead limits under 1500.18 Banned toys and other banned arti- section 101 of the Consumer Product cles intended for use by children. Safety Improvement Act for certain elec- 1500.19 Misbranded toys and other articles tronic devices. intended for use by children. 1500.89 Procedures and requirements for de- 1500.20 Labeling requirement for advertising terminations regarding lead content of toys and games. materials or products under section 1500.40 Method of testing toxic substances. 101(a) of the Consumer Product Safety 1500.41 Method of testing primary irritant Improvement Act. substances. 1500.90 Procedures and requirements for ex- 1500.42 Test for eye irritants. clusions from lead limits under section 1500.43 Method of test for flashpoint of vola- 101(b) of the Consumer Product Safety tile flammable materials by Tagliabue Improvement Act. open-cup apparatus. 1500.91 Determinations regarding lead con- 1500.43a Method of test for flashpoint of tent for certain materials or products volatile flammable materials. under section 101 of the Consumer Prod- 1500.44 Method for determining extremely uct Safety Improvement Act. flammable and flammable solids. 1500.121 Labeling requirements; prominence, 1500.45 Method for determining extremely placement, and conspicuousness. flammable and flammable contents of 1500.122 Deceptive use of disclaimers. self-pressurized containers. 1500.123 Condensation of label information. 1500.46 Method for determining flashpoint of 1500.125 Labeling requirements for accom- extremely flammable contents of self- panying literature. pressurized containers. 1500.126 Substances determined to be ‘‘spe- 1500.48 Technical requirements for deter- cial hazards.’’ mining a sharp point in toys and other 1500.127 Substances with multiple hazards. articles intended for use by children 1500.128 Label comment. under 8 years of age. 1500.129 Substances named in the Federal 1500.49 Technical requirements for deter- Caustic Poison Act. mining a sharp metal or glass edge in 1500.130 Self-pressurized containers: label- toys and other articles intended for use ing. by children under 8 years of age. 1500.133 Extremely flammable contact adhe- 1500.50 Test methods for simulating use and sives; labeling. abuse of toys and other articles intended 1500.134 Policy on first aid labeling for sa- for use by children. line emesis. 1500.51 Test methods for simulating use and 1500.135 Summary of guidelines for deter- abuse of toys and other articles intended mining chronic toxicity. for use by children 18 months of age or 1500.210 Responsibility. less. 1500.211 Guaranty. 1500.52 Test methods for simulating use and 1500.212 Definition of guaranty; suggested abuse of toys and other articles intended forms.

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1500.213 Presentation of views under section Act (Pub. L. 92–573, 86 Stat. 1207–33 (15 7 of the act. U.S.C. 2051–81)). 1500.214 Examinations and investigations; (b) Statutory definitions. Except for samples. the definitions given in section 2 (c) 1500.230 Guidance for lead (Pb) in consumer products. and (d) of the act, which are obsolete, 1500.231 Guidance for hazardous liquid the definitions set forth in section 2 of chemicals in children’s products. the act are applicable to this part and 1500.232 Statement on animal testing pol- are repeated for convenience as follows icy. (some of these statutory definitions are interpreted, supplemented, or provided IMPORTS with alternatives in paragraph (c) of 1500.265 Imports; definitions. this section): 1500.266 Notice of sampling. (1) Territory means any territory or 1500.267 Payment for samples. possession of the United States, includ- 1500.268 Hearing. ing the District of Columbia and the 1500.269 Application for authorization. 1500.270 Granting of authorization. Commonwealth of Puerto Rico but ex- 1500.271 Bonds. cluding the Canal Zone. 1500.272 Costs chargeable in connection with (2) Interstate commerce means (i) com- relabeling and reconditioning inadmis- merce between any State or territory sible imports. and any place outside thereof and (ii) AUTHORITY: 15 U.S.C. 1261–1278. commerce within the District of Co- lumbia or within any territory not or- SOURCE: 38 FR 27012, Sept. 27, 1973, unless ganized with a legislative body. otherwise noted. (3) Person includes an individual, § 1500.1 Scope of subchapter. partnership, corporation, and association. Set forth in this subchapter C are the (4)(i) Hazardous substance means: regulations of the Consumer Product (A) Any substance or mixture of sub- Safety Commission issued pursuant to stances which is toxic, corrosive, an ir- and for the implementation of the Fed- ritant, a strong sensitizer, flammable eral Hazardous Substances Act as or combustible, or generates pressure amended (see § 1500.3(a)(1)). through decomposition, heat, or other means, if such substance or mixture of § 1500.2 Authority. substances may cause substantial per- Authority under the Federal Haz- sonal injury or substantial illness dur- ardous Substances Act is vested in the ing or as a proximate result of any cus- Consumer Product Safety Commission tomary or reasonably foreseeable han- by section 30(a) of the Consumer Prod- dling or use, including reasonably fore- uct Safety Act (15 U.S.C. 2079(a)). seeable ingestion by children. (B) Any substance which the Com- § 1500.3 Definitions. mission by regulation finds, pursuant (a) Certain terms used in this part. As to the provisions of section 3(a) of the used in this part: act, meet the requirements of section (1) Act means the Federal Hazardous 2(f)(1)(A) of the act (restated in (A) Substances Act (Pub. L. 86–613, 74 Stat. above). 372–81 (15 U.S.C. 1261–74)) as amended (C) Any radioactive substance if, by: with respect to such substance as used (i) The Child Protection Act of 1966 in a particular class of article or as (Pub. L. 89–756, 80 Stat. 1303–05). packaged, the Commission determines (ii) The Child Protection and Toy by regulation that the substance is suf- Safety Act of 1969 (Pub. L. 91–113, 83 ficiently hazardous to require labeling Stat. 187–90). in accordance with the act in order to (iii) The Poison Prevention Pack- protect the public health. aging Act of 1970 (Pub. L. 91–601, 84 (D) Any toy or other article intended Stat. 1670–74). for use by children which the Commis- (2) Commission means the Consumer sion by regulation determines, in ac- Product Safety Commission estab- cordance with section 3(e) of the act, lished May 14, 1973, pursuant to provi- presents an electrical, mechanical, or sions of the Consumer Product Safety thermal hazard.

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(ii) Hazardous substance shall not 200 milligrams or less per kilogram of apply to pesticides subject to the Fed- body weight, when administered by eral Insecticide, Fungicide, and continuous contact with the bare skin Rodenticide Act, to foods, drugs, and for 24 hours or less. cosmetics subject to the Federal Food, (ii) If the Commission finds that Drug, and Cosmetic Act, nor to sub- available data on human experience stances intended for use as fuels when with any substance indicate results dif- stored in containers and used in the ferent from those obtained on animals heating, cooking, or refrigeration sys- in the dosages and concentrations spec- tem of a house. ‘‘Hazardous substance’’ ified in paragraph (b)(6)(i) of this sec- shall apply, however, to any article tion, the human data shall take prece- which is not itself a pesticide within dence. the meaning of the Federal Insecticide, (7) Corrosive means any substance Fungicide, and Rodenticide Act but which in contact with living tissue will which is a hazardous substance within cause destruction of tissue by chemical the meaning of section 2(f)(1) of the action, but shall not refer to action on Federal Hazardous Substances Act (re- inanimate surfaces. stated in paragraph (b)(4)(i) of this sec- (8) Irritant means any substance not tion) by reason of bearing or con- corrosive within the meaning of sec- taining such a pesticide. tion 2(i) of the act (restated in para- (iii) Hazardous substance shall not in- graph (b)(7) of this section) which on clude any source material, special nu- immediate, prolonged, or repeated con- clear material, or byproduct material tact with normal living tissue will in- as defined in the Atomic Energy Act of duce a local inflammatory reaction. 1954, as amended, and regulations (9) Strong sensitizer means a substance issued pursuant thereto by the Atomic which will cause on normal living tis- Energy Commission. sue through an allergic or (5) Toxic shall apply to any substance photodynamic process a hyper- (other than a radioactive substance) sensitivity which becomes evident on which has the capacity to produce per- reapplication of the same substance sonal injury or illness to man through and which is designated as such by the ingestion, inhalation, or absorption Commission. Before designating any through any body surface. substance as a strong sensitizer, the (6)(i) Highly toxic means any sub- Commission, upon consideration of the stance which falls within any of the frequency of occurrence and severity of following categories: the reaction, shall find that the sub- (A) Produces death within 14 days in stance has a significant potential for half or more than half of a group of 10 causing hypersensitivity. or more laboratory white rats each (10) The terms extremely flammable, weighing between 200 and 300 grams, at flammable, and combustible as they a single dose of 50 milligrams or less apply to any substances, liquid, solid, per kilogram of body weight, when or the contents of any self-pressurized orally administered; or container, are defined by regulations (B) Produces death within 14 days in issued by the Commission and pub- half or more than half of a group of 10 lished at § 1500.3(c)(6). or more laboratory white rats each (11) Radioactive substance means a weighing between 200 and 300 grams, substance which emits ionizing radi- when inhaled continuously for a period ation. of 1 hour or less at an atmospheric con- (12) Label means a display of written, centration of 200 parts per million by printed, or graphic matter upon the volume or less of gas or vapor or 2 mil- immediate container of any substance ligrams per liter by volume or less of or, in the cases of an article which is mist or dust, provided such concentra- unpackaged or is not packaged in an tion is likely to be encountered by man immediate container intended or suit- when the substance is used in any rea- able for delivery to the ultimate con- sonably foreseeable manner; or sumer, a display of such matter di- (C) Produces death within 14 days in rectly upon the article involved or half or more than half of a group of 10 upon a tag or other suitable material or more rabbits tested in a dosage of affixed thereto. A requirement made by

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or under authority of the act that any ed, except when modified by regulation word, statement, or other information of the Commission pursuant to section appear on the label shall not be consid- 3 of the act; ered to be complied with unless such (G) Instruction, when necessary or word, statement, or other information appropriate, for first-aid treatment; also appears (i) on the outside con- (H) The word Poison for any haz- tainer or wrapper, if any there be, un- ardous substance which is defined as less it is easily legible through the out- ‘‘highly toxic’’ by section 2(h) of the side container or wrapper and (ii) on all act (restated in paragraph (b)(6) of this accompanying literature where there section); are directions for use, written or other- (I) Instructions for handling and stor- wise. age of packages which require special (13) Immediate container does not in- care in handling or storage; and clude package liners. (J) The statement (1) ‘‘Keep out of (14) Misbranded hazardous substance the reach of children’’ or its practical means a hazardous substance (includ- equivalent, or, (2) if the article is in- ing a toy, or other article intended for tended for use by children and is not a use by children, which is a hazardous banned hazardous substance, adequate substance, or which bears or contains a directions for the protection of chil- hazardous substance in such manner as dren from the hazard; and to be susceptible of access by a child to (ii) On which any statements re- whom such toy or other article is en- quired under section 2(p)(1) of the act trusted) intended, or packaged in a (restated in paragraph (b)(14)(i) of this form suitable, for use in the household section) are located prominently and or by children, if the packaging or la- are in the English language in con- beling of such substance is in violation spicuous and legible type in contrast of an applicable regulation issued pur- by typography, layout, or color with suant to section 3 or 4 of the Poison other printed matter on the label. Prevention Packaging Act of 1970 or if Misbranded hazardous substance also such substance, except as otherwise means a household substance as de- provided by or pursuant to section 3 of fined in section 2(2)(D) of the Poison the act (Federal Hazardous Substances Prevention Packaging Act of 1970 if it Act), fails to bear a label: is a substance described in section (i) Which states conspicuously: 2(f)(1) of the Federal Hazardous Sub- (A) The name and place of business of stances Act (restated in paragraph the manufacturer, packer, distributor, (b)(4)(i)(A) of this section) and its pack- or seller; aging or labeling is in violation of an (B) The common or usual name or applicable regulation issued pursuant the chemical name (if there be no com- to section 3 or 4 of the Poison Preven- mon or usual name) of the hazardous tion Packaging Act of 1970. substance or of each component which (15)(i) Banned hazardous substance contributes substantially to its hazard, means: unless the Commission by regulation (A) Any toy, or other article intended permits or requires the use of a recog- for use by children, which is a haz- nized generic name; ardous substance, or which bears or (C) The signal word ‘‘DANGER’’ on contains a hazardous substance in such substances which are extremely flam- manner as to be susceptible of access mable, corrosive, or highly toxic; by a child to whom such toy or other (D) The signal word ‘‘WARNING’’ or article is entrusted; or ‘‘CAUTION’’ on all other hazardous (B) Any hazardous substance in- substances; tended, or packaged in a form suitable, (E) An affirmative statement of the for use in the household, which the principal hazard or hazards, such as Commission by regulation classifies as ‘‘Flammable,’’ ‘‘Combustible,’’ ‘‘Vapor a ‘‘banned hazardous substance’’ on the Harmful,’’ ‘‘Causes Burns,’’ ‘‘Absorbed basis of a finding that, notwith- Through Skin,’’ or similar wording de- standing such cautionary labeling as is scriptive of the hazard; or may be required under the act for (F) Precautionary measures describ- that substance, the degree or nature of ing the action to be followed or avoid- the hazard involved in the presence or

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use of such substance in households is subjected to reasonably foreseeable such that the objective of the protec- damage or abuse, its design or manu- tion of the public health and safety can facture may cause personal injury or be adequately served only by keeping illness by electric shock. such substance, when so intended or (17) ‘‘Mechanical hazard’’—an article packaged, out of the channels of inter- may be determined to present a me- state commerce; Provided, That the chanical hazard if, in normal use or Commission by regulation (1) shall ex- when subjected to reasonably foresee- empt from section 2(q)(1)(A) of the act able damage or abuse, its design or (restated in paragraph (b)(15)(i)(A) of manufacture presents an unreasonable this section) articles, such as chem- risk of personal injury or illness: istry sets, which by reason of their (i) From fracture, fragmentation, or functional purpose require the inclu- disassembly of the article; sion of the hazardous substance in- (ii) From propulsion of the article (or volved, or necessarily present an elec- any part or accessory thereof); trical, mechanical, or thermal hazard, (iii) From points or other protru- and which bear labeling giving ade- sions, surfaces, edges, openings, or clo- quate directions and warnings for safe sures; use and are intended for use by chil- (iv) From moving parts; dren who have attained sufficient ma- (v) From lack or insufficiency of con- turity, and may reasonably be ex- trols to reduce or stop motion; pected, to read and heed such direc- (vi) As a result of self-adhering char- tions and warnings, and (2) shall ex- acteristics of the article; empt from section 2(q)(1)(A) of the act (vii) Because the article (or any part (restated in paragraph (b)(15)(i)(A) of or accessory thereof) may be aspirated this section), and provide for the label- or ingested; ing of, common fireworks (including toy paper caps, cone fountains, cyl- (viii) Because of instability; or inder fountains, whistles without re- (ix) Because of any other aspect of port, and sparklers) to the extent that the article’s design or manufacture. the Commission determines that such (18) ‘‘Thermal hazard’’—an article articles can be adequately labeled to may be determined to present a ther- protect the purchasers and users there- mal hazard if, in normal use or when of. subjected to reasonably foreseeable (ii) Proceedings for the issuance, damage or abuse, its design or manu- amendment, or repeal of regulations facture presents an unreasonable risk pursuant to section 2(q)(1)(B) of the act of personal injury or illness because of (restated in paragraph (b)(15)(i)(B) of heat as from heated parts, substances, this section) shall be governed by the or surfaces. provisions of section 701 (e), (f), and (g) (c) Certain statutory definitions inter- of the Federal Food, Drug, and Cos- preted, supplemented, or provided with al- metic Act: Provided, That if the Com- ternatives. The following items inter- mission finds that the distribution for pret, supplement, or provide alter- household use of the hazardous sub- natives to definitions set forth in sec- stance involved presents an imminent tion 2 of the act (and restated in para- hazard to the public health, the Com- graph (b) of this section): mission may by order published in the (1) To provide flexibility as to the FEDERAL REGISTER give notice of such number of animals tested, and to em- finding, and thereupon such substance phasize in vitro testing methods, the when intended or offered for household following is an alternative to the defi- use, or when so packaged as to be suit- nition of ‘‘highly toxic’’ in section 2(h) able for such use, shall be deemed to be of the act (and paragraph (b)(6) of this a ‘‘banned hazardous substance’’ pend- section); Highly toxic means: ing the completion of proceedings re- (i) A substance determined by the lating to the issuance of such regula- Commission to be highly toxic on the tions. basis of human experience; and/or (16) ‘‘Electrical hazard’’—an article (ii) A substance that produces death may be determined to present an elec- within 14 days in half or more than half trical hazard if, in normal use or when of a group of:

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(A) White rats (each weighing be- and 5 grams per kilogram of body tween 200 and 300 grams) when a single weight will be considered for exemp- dose of 50 milligrams or less per kilo- tion from some or all of the labeling gram of body weight is administered requirements of the act, under § 1500.82, orally; upon a showing that such labeling is (B) White rats (each weighing be- not needed because of the physical tween 200 and 300 grams) when a conform of the substances (solid, a thick centration of 200 parts per million by plastic, emulsion, etc.), the size or clo- volume or less of gas or vapor, or 2 mil- sure of the container, human experi- ligrams per liter by volume or less of ence with the article, or any other rel- mist or dust, is inhaled continuously evant factors; for 1 hour or less, if such concentration (B) White rats (each weighing be- is likely to be encountered by man tween 200 and 300 grams) when an at- when the substance is used in any rea- mospheric concentration of more than sonably foreseeable manner; and/or 200 parts per million but not more than (C) Rabbits (each weighing between 20,000 parts per million by volume of 2.3 and 3.0 kilograms) when a dosage of gas or vapor, or more than 2 but not 200 milligrams or less per kilogram of more than 200 milligrams per liter by body weight is administered by contin- volume of mist or dust, is inhaled con- uous contact with the bare skin for 24 tinuously for 1 hour or less, if such hours or less by the method described in § 1500.40. concentration is likely to be encountered by man when the substance is The number of animals tested shall be used in any reasonably foreseeable sufficient to give a statistically signifi- manner; and/or cant result and shall be in conformity (C) Rabbits (each weighing between with good pharmacological practices. 2.3 and 3.0 kilograms) when a dosage of (iii) A substance that produces a re- more than 200 milligrams but not more sult of ‘highly toxic’ in any of the ap- than 2 grams per kilogram of body proved test methods described in the weight is administered by continuous CPSC’s animal testing policy set forth contact with the bare skin for 24 hours in 16 CFR 1500.232, including data from by the method described in § 1500.40. in vitro or in silico test methods that (D) The number of animals tested the Commission has approved; or a shall be sufficient to give a statis- validated weight-of-evidence analysis tically significant result and shall be comprising all of the following that are in conformity with good pharma- available: existing human and animal data, structure activity relationships, cological practices. Toxic also applies physicochemical properties, and chem- to any substance that can be labeled as ical reactivity data. such, based on the outcome of any of (2) To give specificity to the defini- the approved test methods described in tion of ‘‘toxic’’ in section 2(g) of the the CPSC’s animal testing policy set act (and restated in paragraph (b)(5) of forth in § 1500.232, including data from this section), the following supple- in vitro or in silico test methods that ments that definition. ‘‘Toxic’’ applies the Commission has approved; or a to any substance that is ‘‘toxic’’ (but validated weight-of-evidence analysis not ‘‘highly toxic’’) on the basis of comprising all of the following that are human experience. The following cat- available: Existing human and animal egories are not intended to be inclu- data, structure activity relationships, sive. physicochemical properties, and chem- (i) Acute toxicity. Toxic means any ical reactivity data. substance that produces death within (ii) Chronic toxicity. A substance is 14 days in half or more than half of a toxic because it presents a chronic haz- group of: ard if it falls into one of the following (A) White rats (each weighing be- categories. (For additional information tween 200 and 300 grams) when a single see the chronic toxicity guidelines at dose of from 50 milligrams to 5 grams 16 CFR 1500.135.) per kilogram of body weight is admin- (A) For Carcinogens. A substance is istered orally. Substances falling in the toxic if it is or contains a known or toxicity range between 500 milligrams probable human carcinogen.

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(B) For Neurotoxicological Toxicants. A the outcome of any of the approved substance is toxic if it is or contains a test methods described in the CPSC’s known or probable human neurotoxin. animal testing policy set forth in 16 (C) For Developmental or Reproductive CFR 1500.232, including data from in Toxicants. A substance is toxic if it is vitro or in silico test methods that the or contains a known or probable Commission has approved; or a vali- human developmental or reproductive dated weight-of-evidence analysis com- toxicant. prising all of the following that are (3) The definition of corrosive in sec- available: existing human and animal tion 2(i) of the act (restated in para- data, structure activity relationships, graph (b)(7) of this section) is inter- physicochemical properties, and chem- preted to also mean the following: Cor- ical reactivity data. Eye irritant means rosive means a substance that causes a substance that human experience visible destruction or irreversible al- data indicate is an irritant to the eye; terations in the tissue at the site of and/or means a substance for which a contact. A test for a corrosive sub- positive test is obtained when tested by stance is whether, by human experi- the method described in 1500.42; and/or ence, such tissue destruction occurs at means a substance that can be consid- the site of application. A substance ered an eye irritant based on the out- would be considered corrosive to the come of any of the approved test meth- skin if a weight-of-evidence analysis ods described in the CPSC’s animal suggests that it is corrosive, or vali- testing policy set forth in 16 CFR dated in vitro test method suggests that 1500.232, including data from in vitro or it is corrosive, or if, when tested by the in silico test methods that the Commis- in vivo technique described in § 1500.41, sion has approved; or a validated the structure of the tissue at the site weight-of-evidence analysis comprising of contact is destroyed or changed irre- all of the following that are available: versibly in 24 hours or less. Other ap- existing human and animal data, struc- propriate tests should be applied when ture activity relationships, physico- contact of the substance with other chemical properties, and chemical re- than skin tissue is being considered. A activity data. substance could also be labeled corrosive based on the outcome of any of the (5) The definition of strong sensitizer approved test methods described in the in section 2(k) of the Federal Haz- CPSC’s animal testing policy set forth ardous Substances Act (restated in in 16 CFR 1500.232, including data from paragraph (b)(9) of this section) is sup- in vitro or in silico test methods that plemented by the following definitions: the Commission has approved; or a (i) Sensitizer. A sensitizer is a sub- validated weight-of-evidence analysis stance that is capable of inducing a comprising all of the following that are state of immunologically mediated available: Existing human and animal hypersensitivity (including allergic data, structure activity relationships, photosensitivity) following a variable physicochemical properties, and chem- period of exposure to that substance. ical reactivity data. Hypersensitivity to a substance will (4) The definition of irritant in sec- become evident by an allergic reaction tion 2(j) of the act (restated in para- elicited upon reexposure to the same graph (b)(8) of this section) is supple- substance. mented by the following: Irritant in- (ii) Significant potential for causing cludes primary irritant to the skin, as hypersensitivity. (A) Before designating well as substances irritant to the eye any substance a ‘‘strong sensitizer,’’ or to mucous membranes. Primary irri- the Commission shall find that the sub- tant means a substance that is not cor- stance has significant potential for rosive and that human experience data causing hypersensitivity. Significant indicate is a primary irritant; and/or potential for causing hypersensitivity is a means a substance that results in an relative determination that must be empirical score of five or more when made separately for each substance. tested by the method described in The determination may be based on 1500.41; and/or a substance that can be documented medical evidence of hyper- considered a primary irritant based on sensitivity reactions upon subsequent

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exposure to the same substance ob- tant reaction would be considered one tained from epidemiological surveys or with a significant impact on quality of case histories; controlled in vivo or in life. Consideration should be given to vitro experimental studies; suscepti- the location of the hypersensitivity re- bility profiles (e.g., genetics, age, gen- sponse, such as the face, hands, and der, atopic status) in non-sensitized or feet as well as persistence of clinical allergic subjects; and chemical or func- manifestations. For example, strong tional properties of the substance. sensitizers may produce substantial ill- (B) In determining whether a sub- ness, including any or all of the fol- stance is a ‘‘strong’’ sensitizer, the lowing: substantial physiological ef- Commission shall consider the avail- fects, such as discomfort and distress, able data for a number of factors, fol- substantial hardship, functional or lowing a weight-of-evidence approach. structural impairment, persistent mor- The following factors (if available), bidity, or in rare cases, mortality. ranked in descending order of impor- (iii) Normal living tissue. The allergic tance, should be considered: well-con- hypersensitivity reaction occurs in ducted clinical and diagnostic studies, normal living tissues, including the epidemiological studies, with a pref- skin, mucous membranes (e.g., ocular, erence for general population studies oral), and other organ systems, such as over occupational studies, well-con- the respiratory tract and gastro- ducted animal studies, well-conducted intestinal tract, either singularly or in in vitro test studies, cross-reactivity combination, following sensitization data, and case histories. by contact, ingestion, or inhalation. (C) Additional consideration may be (6) The Consumer Product Safety given to Quantitative Structure-Activ- Commission, by the regulations pub- ity Relationships (QSARs), in silico lished in this section, defines the terms data, specific human sensitization extremely flammable, flammable, and com- threshold values, other data on po- bustible, appearing in section 2(1) of the tency and sensitizer bioavailability, if Federal Hazardous Substances Act, as data are available and the methods follows: validated. Bioavailability is the dose of (i) The term extremely flammable shall the allergen available to interact with apply to any substance which has a a tissue. Bioavailability is a reflection flashpoint at or below 20 °F (¥6.7 °C) as of how well the skin or another organ determined by the test method de- can absorb the allergen and the actual scribed at § 1500.43a, except that, any penetrating ability of the allergen, in- mixture having one component or more cluding factors such as size and com- with a flashpoint higher than 20 °F position of the chemical. (¥6.7 °C) which comprises at least 99 (D) Criteria for a ‘‘well-conducted’’ percent of the total volume of the mix- study would include: validated out- ture is not considered to be an ex- comes, relevant dosing, route of admin- tremely flammable substance. istration, and use of appropriate con- (ii) The term flammable shall apply to trols. Studies should be carried out ac- any substance having a flashpoint cording to national and/or inter- above 20 °F (¥6.7 °C) and below 100 °F national test guidelines and according (37.8 °C), as determined by the method to good laboratory practice (GLP), described at § 1500.43a, except that: compliance with good clinical practice (A) Any mixture having one compo- (GCP), and good epidemiological prac- nent or more with a flashpoint at or tice (GEP). above 100 °F (37.8 °C) which comprises (E) Before the Commission des- at least 99 percent of the total volume ignates any substance as a ‘‘strong’’ of the mixture is not considered to be sensitizer, frequency of occurrence and a flammable substance; and range of severity of reactions in ex- (B) Any mixture containing 24 per- posed subpopulations having average or cent or less of water miscible alcohols, high susceptibility will be considered. by volume, in aqueous solution is not The minimal severity of a reaction for considered to be flammable if the mix- the purpose of designating a material ture does not present a significant as a ‘‘strong sensitizer’’ is a clinically flammability hazard when used by con- important reaction. A clinically impor- sumers.

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(iii) The term combustible shall apply less when subjected to friction, percus- to any substance having a flashpoint at sion, or electrical spark. or above 100 °F (37.8 °C) to and includ- (vi) Flammable solid means a solid ing 150 °F (65.6 °C) as determined by the substance that, when tested by the test method described at § 1500.43a, ex- method described in § 1500.44, ignites cept that: and burns with a self-sustained flame (A) Any mixture having one compo- at a rate greater than one-tenth of an nent or more with a flashpoint higher inch per second along its major axis. than 150 °F (65.6 °C) which comprises at (vii) Extremely flammable contents of least 99 percent of the total volume of self-pressurized container means con- the mixture is not considered to be a tents of a self-pressurized container combustible hazardous substance; and that, when tested by the method de- (B) Any mixture containing 24 per- scribed in § 1500.45, a flashback (a flame cent or less of water miscible alcohols, extending back to the dispenser) is ob- by volume, in aqueous solution is not tained at any degree of valve opening considered to be combustible if the and the flashpoint, when tested by the mixture does not present a significant method described in § 1500.43a is less flammability hazard when used by con- than 20 °F (¥6.7 °C). sumers. (viii) Flammable contents of self-pres- (iv) To determine flashpoint tem- surized container means contents of a peratures for purposes of enforcing and self-pressurized container that, when administering requirements of the Fed- tested by the method described in eral Hazardous Substances Act applica- § 1500.45, a flame projection exceeding ble to ‘‘extremely flammable,’’ ‘‘flam- 18 inches is obtained at full valve open- mable,’’ and ‘‘combustible’’ hazardous ing, or flashback (a flame extending substances, the Commission will follow back to the dispenser) is obtained at the procedures set forth in § 1500.43a. any degree of valve opening. However, the Commission will allow (7) The definition of hazardous sub- manufacturers and labelers of substance in section 2(f)(1)(A) of the act stances and products subject to those (restated in paragraph (b)(4)(i)(A) of requirements to rely on properly con- this section) is supplemented by the ducted tests using the Tagliabue open- following definitions or interpretations cup method which was in effect prior to or terms used therein: the issuance of § 1500.43a (as published at 38 FR 27012, September 27, 1973, and (i) A substance or mixture of subset forth below), and the defintions of stances that ‘‘generates pressure the terms ‘‘extremely flammable,’’ through decomposition, heat, or other ‘‘flammable,’’ and ‘‘combustible’’ in means’’ is a hazardous substance: this section before its amendment (as (A) If it explodes when subjected to published at 38 FR 27012, September 27, an electrical spark, percussion, or the 1983, and amended 38 FR 30105, Novem- flame of a burning paraffin candle for 5 ber 1, 1973, set forth in the note fol- seconds or less. lowing this section) if all of the fol- (B) If it expels the closure of its con- lowing conditions are met: tainer, or bursts its container, when (A) The substance or product was held at or below 130 °F. for 2 days or subject to and complied with the re- less. quirements of the Federal Hazardous (C) If it erupts from its opened con- Substances Act for ‘‘extremely flam- tainer at a temperature of 130 °F. or mable,’’ ‘‘flammable,’’ or ‘‘combus- less after having been held in the tible’’ hazardous substances before the closed container at 130 °F. for 2 days. effective date of § 1500.43a; and (D) If it comprises the contents of a (B) No change has been made to the self-pressurized container. formulation or labeling of such sub- (ii) Substantial personal injury or ill- stance or product after the effective ness means any injury or illness of a date of § 1500.43a, prescribing a closed- significant nature. It need not be se- cup test apparatus and procedure. vere or serious. What is excluded by (v) Extremely flammable solid means a the word ‘‘substantial’’ is a wholly in- solid substance that ignites and burns significant or negligible injury or ill- at an ambient temperature of 80 °F or ness.

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(iii) Proximate result means a result cluding, but not limited to, a garage, that follows in the course of events carport, barn, or storage shed. The without an unforeseeable, intervening, term includes articles, such as polishes independent cause. or cleaners, designed primarily for pro- (iv) Reasonably foreseeable handling or fessional use but which are available in use includes the reasonably foreseeable retail stores, such as hobby shops, for accidental handling or use, not only by nonprofessional use. Also included are the purchaser or intended user of the items, such as antifreeze and radiator product, but by all others in a house- cleaners, that although principally for hold, especially children. car use may be stored in or around (8) The definition of ‘‘radioactive dwelling places. The term does not in- substance’’ in section 2(m) of the act clude industrial supplies that might be (restated in paragraph (b)(11) of this taken into a home by a serviceman. An section) is supplemented by the fol- article labeled as, and marketed solely lowing: Radioactive substance means a for, industrial use does not become sub- substance which, because of nuclear in- ject to this act because of the possi- stability, emits electromagnetic and/or bility that an industrial worker may particulate radiation capable of pro- take a supply for his own use. Size of ducing ions in its passage through mat- unit or container is not the only index ter. Source materials, special nuclear of whether the article is suitable for material, and byproduct materials de- use in or around the household; the scribed in section 2(f)(3) of the act are test shall be whether under any reason- exempt. ably foreseeable condition of purchase, (9) In the definition of ‘‘label’’ in sec- storage, or use the article may be tion 2(n) of the act (restated in para- found in or around a dwelling. graph (b)(12) of this section), a provi- (ii) Conspicuously in section 2(p)(1) of sion stipulates that words, statements, the act and prominently and conspicuous or other information required to be on in section 2(p)(2) of the act mean that, the label must also appear on all ac- under customary conditions of pur- companying literature where there are chase, storage, and use, the required directions for use, written or other- information shall be visible, notice- wise. To make this provision more spe- able, and in clear and legible English. cific, ‘‘accompanying literature’’ is in- Some factors affecting a warning’s terpreted to mean any placard, pam- prominence and conspicuousness are: phlet, booklet, book, sign, or other Location, size of type, and contrast of written, printed, or graphic matter or printing against background. Also visual device that provides directions bearing on the effectiveness of a warn- for use, written or otherwise, and that ing might be the effect of the package is used in connection with the display, contents if spilled on the label. sale, demonstration, or merchandising of a hazardous substance intended for NOTE: The definitions of extremely flam- or packaged in a form suitable for use mable, flammable, and combustible hazardous in the household or by children. substances set forth above in paragraphs (10) The definition of ‘‘misbranded (b)(10) and (c)(6) are effective August 10, 1987. hazardous substance’’ in section 2(p) of The definitions remaining in effect until Au- this act (restated in paragraph (b)(14) gust 10, 1987, as published at 38 FR 27012, Sept. 27, 1973, and amended at 38 FR 30105, of this section) is supplemented by the Nov. 1, 1973, are set forth below. Manufactur- following definitions or interpretations ers and labelers of products subject to the of terms used therein: Federal Hazardous Substances Act may con- (i) Hazardous substances intended, or tinue to use these definitions for labeling of packaged in a form suitable, for use in the those products under the conditions set forth household means any hazardous sub- in § 1500.3(c)(6)(iv), as amended. stance, whether or not packaged, that (b)(10) Extremely flammable shall apply to under any customary or reasonably any substance which has a flashpoint at or ° foreseeable condition of purchase, stor- below 20 F. as determined by the Tagliabue Open Cup Tester; flammable shall apply to age, or use may be brought into or any substance which has a flashpoint of around a house, apartment, or other above 20 °F., to and including 80 °F., as deter- place where people dwell, or in or mined by the Tagliabue Open Cup Tester; around any related building or shed in- and combustible shall apply to any substance

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which has a flashpoint above 80 °F. to and in- § 1500.5 Hazardous mixtures. cluding 150 °F., as determined by the Tagliabue Open Cup Tester; except that the For a mixture of substances, the de- flammability or combustibility of solids and termination of whether the mixture is of the contents of self-pressurized containers a ‘‘hazardous substance’’ as defined by shall be determined by methods found by the section 2(f) of the act (repeated in Commission to be generally applicable to § 1500.3(b)(4)) should be based on the such materials or containers, respectively, physical, chemical, and pharma- and established by regulations issued by the cological characteristics of the mix- Commission, which regulations shall also de- ture. A mixture of substances may fine the terms flammable, combustible, and ex- therefore be less hazardous or more tremely flammable in accord with such hazardous than its components because methods. of synergistic or antagonistic reactions. It may not be possible to reach a * * * * * fully satisfactory decision concerning the toxic, irritant, corrosive, flam- (c)(6)(i) Extremely flammable means any substance that has a flashpoint at or below 20 mable, sensitizing, or pressure-gener- °F. as determined by the method described in ating properties of a substance from § 1500.43. what is known about its components or (ii) Flammable means any substance that ingredients. The mixture itself should has a flashpoint of above 20 °F., to and in- be tested. cluding 80 °F., as determined by the method described in § 1500.43. § 1500.12 Products declared to be hazardous substances under section [38 FR 27012, Sept. 27, 1973, as amended at 38 3(a) of the act. FR 30105, Nov. 1, 1973; 49 FR 22465, May 30, (a) The Commission finds that the 1984; 51 FR 28536, Aug. 8, 1986; 51 FR 29096, Aug. 14, 1986; 51 FR 30209, Aug. 25, 1986; 57 FR following articles are hazardous sub- 46669, Oct. 9, 1992; 77 FR 73293, Dec. 10, 2012; stances within the meaning of the act 79 FR 8831, Feb. 14, 2014; 83 FR 8341, Feb. 27, because they are capable of causing 2018] substantial personal injury or substantial illness during or as a proximate re- § 1500.4 Human experience with haz- sult of any customary or reasonably ardous substances. foreseeable handling or use: (a) Reliable data on human experi- (1) Charcoal briquettes and other forms of charcoal in containers for re- ence with any substance should be tail sale and intended for cooking or taken into account in determining heating. whether an article is a ‘‘hazardous sub- (2) Metal-cored candlewicks that stance’’ within the meaning of the act. have a lead content of more than 0.06 When such data give reliable results percent of the total weight of the different from results with animal metal core, and candles made with data, the human experience takes prec- such wicks. edence. (b) [Reserved] (b) Experience may show that an article is more or less toxic, irritant, or [38 FR 27012, Sept. 27, 1973, as amended at 68 FR 19147, Apr. 18, 2003] corrosive to man than to test animals. It may show other factors that are im- § 1500.13 Listing of ‘‘strong sensitizer’’ portant in determining the degree of substances. hazard to humans represented by the On the basis of frequency of occur- substance. For example, experience rence and severity of reaction informa- shows that radiator antifreeze is likely tion, the Commission finds that the to be stored in the household or garage following substances have a significant and likely to be ingested in significant potential for causing hypersensitivity quantities by some persons. It also and therefore meet the definition for shows that a particular substance in ‘‘strong sensitizer’’ in section 2(k) of liquid form is more likely to be in- the act (repeated in § 1500.3(b)(9)): gested than the same substance in a (a) Paraphenylenediamine and prod- paste or a solid and that an aerosol is ucts containing it. more likely to get into the eyes and (b) Powdered orris root and products the nasal passages than a liquid. containing it.

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(c) Epoxy resins systems containing (1) Diethylene glycol. Because in any concentration ethylenediamine, diethylene glycol and mixtures con- diethylenetriamine, and diglycidyl taining 10 percent or more by weight of ethers of molecular weight of less than diethylene glycol are commonly mar- 200. keted, stored, and used in a manner in- (d) Formaldehyde and products con- creasing the possibility of accidental taining 1 percent or more of formalde- ingestion, such products shall be la- hyde. beled with the signal word ‘‘warning’’ (e) Oil of bergamot and products con- and the statement ‘‘Harmful if swal- taining 2 percent or more of oil of ber- lowed.’’ gamot. (2) Ethylene glycol. Because ethylene glycol and mixtures containing 10 per- § 1500.14 Products requiring special cent or more by weight of ethylene gly- labeling under section 3(b) of the col are commonly marketed, stored, act. and used in a manner increasing the (a) Human experience, as reported in possibility of accidental ingestion, the scientific literature and to the Poi- such products shall be labeled with the son Control Centers and the National signal word ‘‘warning’’ and the state- Clearing House for Poison Control Cen- ment ‘‘Harmful or fatal if swallowed.’’ ters, and opinions of informed medical (3) Benzene, toluene, xylene, petroleum experts establish that the following distillates. (i) Because inhalation of the substances are hazardous: vapors of products containing 5 percent (1) Diethylene glycol and mixtures or more by weight of benzene may containing 10 percent or more by cause blood dyscrasias, such products weight of diethylene glycol. shall be labeled with the signal word (2) Ethylene glycol and mixtures con- ‘‘danger,’’ the statement of hazard taining 10 percent or more by weight of ‘‘Vapor harmful,’’ the word ‘‘poison,’’ ethylene glycol. and the skull and crossbones symbol. If (3) Products containing 5 percent or the product contains 10 percent or more by weight of benzene (also known more by weight of benzene, it shall as benzol) and products containing 10 bear the additional statement of haz- percent or more by weight of toluene ard ‘‘Harmful or fatal if swallowed’’ (also known as toluol), xylene (also and the additional statement ‘‘Call known as xylol), or petroleum dis- physician immediately.’’ tillates such as kerosine, mineral seal (ii) Because products containing 10 oil, naphtha, gasoline, mineral spirits, percent or more by weight of toluene, stoddard solvent, and related petro- xylene, or any of the other substances leum distillates. listed in paragraph (a)(3) of this section (4) Methyl alcohol (methanol) and may be aspirated into the lungs, with mixtures containing 4 percent or more resulting chemical pneumonitis, pneu- by weight of methyl alcohol (meth- monia, and pulmonary edema, such anol). products shall be labeled with the sig- (5) Turpentine (including gum tur- nal word ‘‘danger,’’ the statement or pentine, gum spirits of turpentine, hazard ‘‘Harmful or fatal if swal- steam-distilled wood turpentine, sul- lowed,’’ and the statement ‘‘Call physi- fate wood turpentine, and destructively cian immediately.’’ distilled wood turpentine) and mix- (iii) Because inhalation of the vapor tures containing 10 percent or more by of products containing 10 percent or weight of such turpentine. more by weight of toluene or xylene (b) The Commission finds that the may cause systemic injury, such prod- following substances present special ucts shall bear the statement of hazard hazards and that, for these substances, ‘‘Vapor harmful’’ in addition to the the labeling required by section 2(p)(1) statements prescribed in paragraph of the act is not adequate for the pro- (b)(3)(ii) of this section. tection of the public health. Under sec- (4) Methyl alcohol (methanol). Because tion 3(b) of the act, the following spe- death and blindness can result from the cific label statements are deemed nec- ingestion of methyl alcohol, the label essary to supplement the labeling re- for this substance and for mixtures quired by section 2(p)(1) of the act: containing 4 percent or more by weight

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of this substance shall include the sig- tainers of such products packaged be- nal word ‘‘danger,’’ the additional word fore November 3, 1997, shall bear the ‘‘poison,’’ and the skull and crossbones following borderlined statement: symbol. The statement of hazard shall WARNING: Do Not Use for Indoor Heating include ‘‘Vapor harmful’’ and ‘‘May be or Cooking Unless Ventilation Is Provided fatal or cause blindness if swallowed.’’ for Exhausting Fumes to Outside. Toxic The label shall also bear the statement Fumes May Accumulate and Cause Death ‘‘Cannot be made nonpoisonous.’’ (B) For bags of charcoal packaged be- (5) Turpentine. Because turpentine fore November 3, 1997, the statement (including gum turpentine, gum spirits specified in paragraph (b)(6)(i) of this of turpentine, steam-distilled wood tur- section shall appear within a heavy pentine, sulfate wood turpentine, and borderline in a color sharply con- destructively distilled wood turpen- trasting to that of the background, on tine) and products containing 10 per- both front and back panels in the upper cent or more by weight of such turpen- 25 percent of the panels of the bag at tine, in addition to oral toxicity result- least 2 inches below the seam, and at ing in systemic poisoning, may be aspi- least 1 inch above any reading material rated into the lungs with resulting or design elements in type size as fol- chemical pneumonitis, pneumonia, and lows: The signal word ‘‘WARNING’’ pulmonary edema, such products shall shall appear in capital letters at least be labeled with the signal word ‘‘dan- three-eighths inch in height; the re- ger’’ and the statement of hazard maining text of the warning statement ‘‘Harmful or fatal if swallowed.’’ shall be printed in letters at least (6) Charcoal. Charcoal briquettes and three-sixteenths inch in height. other forms of charcoal in containers (ii)(A) Because inhalation of the car- for retail sale and intended for cooking bon monoxide produced by burning or heating. charcoal indoors or in confined areas (i)(A) Because inhalation of the car- can cause serious injury or death, con- bon monoxide produced by burning tainers of such products packaged on charcoal indoors or in confined areas or after November 3, 1997, shall bear may cause serious injury or death, con- the following borderlined label.

(B) Except as provided in paragraph on both the front and back panels in (b)(6)(ii)(C) of this section, the fol- the upper 25 percent of the panels of lowing requirements apply to bags of the bag, and with the outer edge of the charcoal subject to paragraph borderline at least 2.54 cm (1 inch) (b)(6)(ii)(A) of this section. The label below the seam and at least 2.54 cm (1 specified in paragraph (b)(6)(ii)(A) of inch) above any other reading material this section shall appear within a or design elements. The signal word heavy borderline, in a color sharply ‘‘WARNING’’ shall be in bold capital contrasting to that of the background, letters in at least 7.14 mm (9⁄32 inch)

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type. The remaining text of the warn- WARNING (OR CAUTION) EMITS SHOWERS OF ing statement shall be in at least 4.763 SPARKS mm (3⁄16 inch) type. The phrase ‘‘CAR- Use only under [close] adult supervision. BON MONOXIDE HAZARD’’ shall be in (Use of the word close is optional.) bold. This phrase and the word For outdoor use only. ‘‘NEVER’’ shall be in all capital let- Stick firmly in ground in an upright posi- ters. The lettering shall have a tion. strokewidth-to-height ratio of 1:6 to Do not hold in hand. 1:8. The label shall be at least 50.8 mm Light fuse and get away. (2 inches) high and 147.5 mm (513⁄16 (B) Handle fountains. inches) wide. The label’s lettering, spacing between the bottom of the let- WARNING (OR CAUTION) EMITS SHOWERS OF SPARKS ters of one line and the top of the letter of the next line, and pictogram Use only under [close] adult supervision. shall have the size relation to each (Use of the word close is optional.) other and to the remainder of the label For outdoor use only. Hold in hand—point away from body. shown in paragraph (b)(6)(ii)(A) of this Light fuse. section. (C) For bags of charcoal subject to (iv) Roman Candles. paragraph (b)(6)(ii)(A) of this section WARNING (OR CAUTION) SHOOTS FLAMING that are 6 inches or less wide, the min- BALLS imum label height may be reduced to 38 mm (1.5 inches) and the minimum Use only under [close] adult supervision. width may be reduced to 139.7 mm (5.5 (Use of the word close is optional.) For outdoor use only. inches). The signal word ‘‘WARNING’’ Stick butt end in ground. shall be in capital letters in at least Do not hold in hand. 6.32 mm (0.249 inch) type. The remain- Light fuse and get away. ing text of the warning shall be in at least 4.23 mm (0.166 inch) type. All (v) Rockets with sticks. other requirements of paragraphs WARNING (OR CAUTION) FLAMMABLE 6(b)(ii) (A) and (B) of this section shall apply to these bags. Use only under [close] adult supervision. (Use of the word close is optional.) (7) Fireworks devices. Because of the For outdoor use only. special hazards presented by fireworks Place in wooden trough or iron pipe at 75° devices if not used in a certain manner, angle, pointing away from people or flam- the following listed fireworks devices mable material. shall be labeled as indicated: Do not hold in hand. (i) Fountains. Light fuse and get away.

WARNING (OR CAUTION) (vi) Wheels.

FLAMMABLE (or EMITS SHOWERS OF WARNING (OR CAUTION) FLAMMABLE (OR EMITS SPARKS, if more descriptive). SHOWERS OF SPARKS, IF MORE DESCRIPTIVE) Use only under [close] adult supervision. Use only under [close] adult supervision. (Use of the word close is optional.) For outdoor use only. (Use of the word close is optional.) Place on level surface. For outdoor use only. Light fuse and get away. Attach securely by means of a nail through the hole (or place on hard flat surface, for (ii) California candles. ground spinners). Light fuse and get away. WARNING (OR CAUTION) EMITS SHOWERS OF SPARKS (vii) Illuminating torches.

Use only under [close] adult supervision. WARNING (OR CAUTION) FLAMMABLE (OR EMITS (Use of the word close is optional.) SHOWERS OF SPARKS, IF MORE DESCRIPTIVE) For outdoor use only. Hold in hand at bottom of tube. Use only under [close] adult supervision. Point away from body so that neither end (Use of the word close is optional.) points toward body. For outdoor use only. Hold in hand—point away from body, cloth- (iii) Spike and handle cylindrical foun- ing, or other flammable material (or place tains. upright on level ground. Do not hold in (A) Spike fountains. hand, if more descriptive).

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Light fuse (or light fuse and get away, if WARNING (OR CAUTION) FLAMMABLE more descriptive). Use only under [close] adult supervision. (viii) Sparklers. (Use of the word close is optional.) Do not point either end toward face or other On the front and back panels: person. Hold in hand—jerk string. WARNING (OR CAUTION) FLAMMABLE (xiv) Missile-type rockets. On the side, front, back, top, or bottom panel. WARNING (OR CAUTION) FLAMMABLE (OR EMITS SHOWERS OF SPARKS, IF MORE DESCRIPTIVE) CAUTION Use only under [close] adult supervision. Use only under [close] adult supervision. (Use of the word close is optional.) (Use of the word close is optional.) For outdoor use only. For outdoor use only. Place on hard, open surface. Do not touch glowing wire (or do not touch Light fuse and get away. hot plastic, wood, etc., if more descriptive). Hold in hand with arm extended away from (xv) Labeling—General. Any fireworks body. device not required to have a specific Keep burning end or sparks away from wear- label as indicated above shall carry a ing apparel or other flammable material. warning label indicating to the user (ix) Mines and shells. where and how the item is to be used and necessary safety precautions to be WARNING (OR CAUTION) EMITS SHOWERS OF observed. All labels required under this SPARKS (OR SHOOTS FLAMING BALLS, IF section shall comply with the require- MORE DESCRIPTIVE) ments of § 1500.121 of these regulations. Use only under [close] adult supervision. (See also § 1500.17(a) (3), (8) and (9); (Use of the word close is optional.) § 1500.83(a)(27); § 1500.85(a)(2); and part For outdoor use only. 1507). Place on hard smooth surface (or place up- (8) Art materials. right on level ground, if more descriptive). Do not hold in hand. NOTE: The Labeling of Hazardous Art Ma- Light fuse and get away. terials Act (‘‘LHAMA’’), 15 U.S.C. 1277 (Pub. L. 100–695, enacted November 18, 1988) pro- (x) Whistles without report. vides that, as of November 18, 1990, ‘‘the requirements for the labeling of art materials WARNING (OR CAUTION) FLAMMABLE set forth in the version of the standard of the SHOOTS WHISTLE IN AIR (if applicable) American Society for Testing and Materials Use only under [close] adult supervision. [‘‘ASTM’’] designated D–4236 that is in effect (Use of the word close is optional.) on [November 18, 1988] * * * shall be deemed For outdoor use only. to be a regulation issued by the Commission Do not hold in hand. under section 3(b)’’ of the Federal Hazardous Light fuse and get away. Substances Act, 15 U.S.C. 1262(b). For the convenience of interested persons, the Com- (xi) Toy smoke devices and flitter de- mission is including the requirements of vices. ASTM D–4236 in paragraph (b)(8)(i) of this section, along with other requirements (stat- WARNING (OR CAUTION) FLAMMABLE (OR EMITS ed in paragraph (b)(8)(ii) of this section) SHOWERS OF SPARKS, IF MORE DESCRIPTIVE) made applicable to art materials by the Use only under [close] adult supervision. LHAMA. The substance of the requirements (Use of the word close is optional.) specified in LHAMA became effective on No- vember 18, 1990, as mandated by Congress. For outdoor use only. Do not hold in hand. (i) ASTM D–4236—(A) Scope—(1) This Light fuse and get away. section describes a procedure for devel- (xii) Helicopter-type rockets. oping precautionary labels for art materials and provides hazard and pre- WARNING (OR CAUTION) FLAMMABLE (OR EMITS cautionary statements based upon SHOWERS OF SPARKS, IF MORE DESCRIPTIVE) knowledge that exists in the scientific Use only under [close] adult supervision. and medical communities. This section (Use of the word close is optional.) concerns those chronic health hazards For outdoor use only. known to be associated with a product Place on hard, open surface. or product component(s), when the Light fuse and get away. component(s) is present in a physical (xiii) Party poppers. form, volume, or concentration that in

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the opinion of a toxicologist (see para- immediate container intended or suit- graph (b)(8)(i)(B)(11) of this section) has able for delivery to users, the label can the potential to produce a chronic ad- be a display of such matter directly verse health effect(s). upon the article involved or upon a tag (2) This section applies exclusively to or other suitable labeling device at- art materials packaged in sizes in- tached to the art material. tended for individual users of any age (7) Producer—the person or entity or those participating in a small group. who manufactures, processes, or im- (3) Labeling determinations shall ports an art material. consider reasonably foreseeable use or (8) Repackager—the person or entity misuse. who obtains materials from producers (4) Manufacturers or repackagers and without making changes in such may wish to have compliance certified materials puts them in containers in- by a certifying organization. Guide- tended for sale as art materials to lines for a certifying organization are users. given in paragraph (b)(8)(i)(H) of this (9) Sensitizer—a substance known to section. cause, through an allergic process, a (B) Descriptions of Terms Specific to chronic adverse health effect which be- This Standard. (1) Art material or art comes evident in a significant number material product—any raw or proc- of people on re-exposure to the same essed material, or manufactured prod- substance. uct, marketed or represented by the (10) Toxic—applies to any substance producer or repackager as intended for that is likely to produce personal in- and suitable for users as defined herein. jury or illness to humans through in- (2) Users—artists or crafts people of gestion, inhalation, or skin contact. any age who create, or recreate in a (11) Toxicologist—an individual who limited number, largely by hand, works through education, training, and expe- which may or may not have a practical rience has expertise in the field of toxi- use, but in which aesthetic consider- cology, as it relates to human expo- ations are paramount. sure, and is either a toxicologist or (3) Chronic adverse health effect(s)— physician certified by a nationally rec- a persistent toxic effect(s) that devel- ognized certification board. ops over time from a single, prolonged, (12) Bioavailability—the extent that or repeated exposure to a substance. a substance can be absorbed in a bio- This effect may result from exposure(s) logically active form. to a substance that can, in humans, (C) Requirements. (1) The producer or cause sterility, birth defects, harm to a repackager of art materials shall sub- developing fetus or to a nursing infant, mit art material product formula- cancer, allergenic sensitization, dam- tion(s) or reformulation(s) to a toxi- age to the nervous system, or a per- cologist for review, such review to be sistent adverse effect to any other in accordance with paragraph organ system. (b)(8)(l)(D) of this section. The toxi- (4) chronic health hazard(s) (here- cologist shall be required to keep prod- after referred to as ‘‘chronic hazard’’)— uct formulation(s) confidential. a health risk to humans, resultant (2) Unless otherwise agreed in writing from exposure to a substance that may by the producer or repackager, no one cause a chronic adverse health effect. other than the toxicologists shall have (5) Analytical laboratory—a labora- access to the formulation(s); except tory having personnel and apparatus that the toxicologists shall furnish a capable of performing quantitative or patient’s physician, on a confidential qualitative analyses of art materials, basis, the information necessary to di- which may yield information that is agnose or treat cases of exposure or ac- used by a toxicologist for evaluation of cidental ingestion. potentially hazardous materials. (3) The producer or repackager, upon (6) Label—a display of written, print- advice given by a toxicologist in ac- ed, or graphic matter upon the imme- cordance with paragraph (b)(8)(i)(D) of diate container of any art material this section and based upon generally product. When the product is accepted, well-established evidence unpackaged, or is not packaged in an that a component substance(s) is

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known to cause chronic adverse health chronic toxic potential of each compo- effects adopt precautionary labeling in nent and the total formulation. accordance with paragraph (b)(8)(i)(E) (iii) Specific physical and chemical of this section. form of the art material product, bio- (4) Labeling shall conform to any la- availability, concentration, and the beling practices prescribed by federal amount of each potentially chronic and state statutes or regulations and toxic component found in the formula- shall not diminish the effect of re- tion. quired acute toxicity warnings. (iv) Reasonably foreseeable uses of (5) The producer or repackager shall the art material product as determined supply a poison exposure management by consultation with users and other information source the generic formu- individuals who are experienced in use lation information required for dis- of the material(s), such as teachers, or semination to poison control centers or by market studies, unless such use in- shall provide a 24-hour cost-free tele- formation has previously been deter- phone number to poison control cen- mined with respect to the specific art ters. material(s) under review. (6) The producer or repackager shall (v) Potential for known synergism have a toxicologist review as nec- and antagonism of the various compo- essary, but at least every 5 years, art nents of the formulation. material product formulation(s) and (vi) Potentially chronic adverse associated label(s) based upon the then- health effects of decomposition or com- current, generally accepted, well-estab- bustion products, if known, from any lished scientific knowledge. reasonably foreseeable use of the haz- (7) Statement of Conformance— ardous art material product. ‘‘Conforms to ASTM Practice D–4236,’’ (vii) Opinions of various regulatory or ‘‘Conforms to ASTM D–4236,’’ or agencies and scientific bodies, includ- ‘‘Conforms to the health requirements ing the International Agency for Re- of ASTM D–4236.’’ This statement may search on Cancer and the National Can- be combined with other conformance cer Institute, on the potential for statements. The conformance state- chronic adverse health effects of the ment should appear whenever practical various components of the formulation. on the product; however, it shall also (3) Based upon the conclusion be acceptable to place the statement reached in conformance with review on one or more of the following: determinations set forth herein, the (i) The individual product package, toxicologist(s) shall recommend pre- (ii) a display or sign at the point of cautionary labeling consistent with purchase, paragraph (b)(8)(i)(E) of this section. (iii) separate explanatory literature (E) Labeling Practices—(1) Signal available on requirements at the point Word. (i) When a signal word for an of purchase, acute hazard(s) is mandated and a (iv) a response to a formal request for chronic hazard(s) exists, the signal bid or proposal. word shall be that for the acute hazard. (D) Determination of Labeling. (1) An (ii) When only a chronic hazard(s) ex- art material is considered to have the ists, the signal word WARNING shall potential for producing chronic adverse be used. health effects if any customary or rea- (iii) The signal word shall be promi- sonably foreseeable use can result in a nently visible and set in bold capitals chronic hazard. in a size equal to or greater than the (2) In making the determination, a statement of potential chronic hazards. toxicologist(s) shall take into account (2) List of Potentially Chronic Haz- the following: ards—Potentially chronic hazards, as (i) Current chemical composition of determined under the procedures of the art material, supplied by an ana- paragraph (b)(8)(i)(D) of this section, lytical laboratory or by an industrial shall be stated substantially in accord- chemist on behalf of a manufacturer or ance with the statements listed in repackager. paragraph (b)(8)(i)(F) of this section. (ii) Current generally accepted, well- Potentially chronic hazards noted shall established scientific knowledge of the be those that are clinically significant

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and that might be expected with any shall have a label that includes a signal reasonably foreseeable use of the art word in conformance with paragraph material. The hazards should be (b)(8)(i)(E)(1) of this section and a list grouped in the order of relative de- of potentially harmful or sensitizing scending severity. components in conformance with para- (3) Name of Chronically Hazardous graphs (b)(8)(i)(E) (3) and (5) of this sec- Component(s)—All components and tion. known decomposition products of the (9) The information described in formulation with a potential for chron- paragraph (b)(8)(i)(E) of this section ic hazards, as determined under the must appear on: procedures of paragraph (b)(8)(i)(D) of (i) The outside container or wrapper, this section, shall be listed promi- if any, unless it is easily legible nently. Generically equivalent names through the outside container or wrap- may be used. per and (4) Safe Handling Instructions—Ap- (ii) All accompanying literature propriate precautionary statements as where there are directions for use, to work practices, personal protection, written or otherwise. Where a product and ventilation requirements shall be that requires warning labels under used substantially conforming with paragraphs (b)(8)(i) (D) and (E) of this those listed in paragraph (b)(8)(i)(G) of section is packed within a point-of-sale this section. package that obscures the warning (5) List of Sensitizing Components— statement(s), the point-of-sale package To protect users from known sensi- shall carry the signal word conforming tizers found within art materials, each to paragraph (b)(8)(i)(E)(1) and the fol- label shall contain a list of those sensi- lowing wording: ‘‘Contains: (list haz- tizers present in sufficient amounts to ardous product(s)) that may be harmful contribute significantly to a known if misused. Read cautions on individual skin or respiratory sensitization. containers carefully. Keep out of the (6) Combined Statement—If an art reach of children.’’ material contains more than one com- (10) Statements required under para- ponent capable of causing a chronic ad- graphs (b)(8)(i) (D) and (E) of this sec- verse health effect, or if a single chem- tion must be in the English language ical can cause several different chronic and located prominently in con- adverse health effects, the potential ef- spicuous and legible type in contrast fects may be combined into one state- by topography, layout, or color with ment. other printed matter on the label. (7) Information Sources—The pre- (11) Supplemental Information— cautionary label shall contain a state- Where appropriate, more detailed in- ment identifying a source for addi- formation that relates to chronic haz- tional health information substantially ard(s), such as physical properties, de- in conformance with one of the phrases composition products, detailed safety listed below: instructions, or disposal recommenda- (i) For more health information—(24 tions, shall be included in supple- hour cost-free U.S. telephone number), mental documents, such as Material (ii) Contact a physician for more Safety Data Sheets, technical bro- health information, or chures, technical data sheets etc. (iii) Call your local poison control (F) chronic Hazard Statements center for more health information. MAY CAUSE STERILITY. (8) Labeling Content, Product Size— CONTACT MAY CAUSE PERMANENT Any art material product in a con- EYE DAMAGE. tainer larger in size than one fluid MAY BE HARMFUL BY BREATHING ounce (30 ml) (if the product is sold by VAPORS/DUSTS. volume) or one ounce net weight (28 g) MAY BE HARMFUL IF SWALLOWED. (if the product is sold by weight) shall MAY BE HARMFUL BY SKIN CON- have full precautionary labeling, as de- TACT. scribed in paragraph (b)(8)(i) (E) of this MAY PRODUCE BIRTH DEFECTS IN section. Any art material product in a THE DEVELOPING FETUS. container equal to or smaller than one MAY BE EXCRETED IN HUMAN fluid ounce or one ounce net weight MILK.

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MAY CAUSE HARM TO THE NURS- eral Insecticide, Fungicide, and ING INFANT. Rodenticide Act or drugs, devices, or CANCER AGENT! EXPOSURE MAY cosmetics subject to the Federal Food, PRODUCE CANCER. Drug, and Cosmetics Act. CANCER AGENT BASED ON TESTS (B) The standard referred to in para- WITH LABORATORY ANIMALS. graph (b)(8)(i) of this section applies to POSSIBLE CANCER AGENT BASED art materials intended for users of any ON TESTS WITH LABORATORY age. ANIMALS. (C) Each producer or repackager of MAY PRODUCE ALLERGIC REAC- art materials shall describe in writing TION BY INGESTION/INHALATION/ the criteria used to determine whether SKIN CONTACT. an art material has the potential for MAY PRODUCE NUMBNESS OR producing chronic adverse health ef- WEAKNESS IN THE EXTREMITIES. fects. Each producer or repackager EXPOSURE MAY CAUSE (SPECIFY shall submit, to the Commission’s Divi- THE ORGAN(S)) DAMAGE. sion of Regulatory Management, Con- HEATING/COMBUSTION MAY CAUSE sumer Product Safety Commission, HAZARDOUS DECOMPOSITION Washington, DC 20207, the written de- PRODUCTS. scription of the criteria described (G) Precautionary Statements above and a list of art materials that Keep out of reach of children. require hazard warning labels under When using do not eat, drink, or this section. Upon request of the Com- smoke. mission, a producer or repackager shall Wash hands immediately after use. submit to the Commission product for- Avoid inhalation/ingestion/skin con- mulations. tact. (D) All art materials that require Avoid fumes from combustion. chronic hazard labeling pursuant to Keep container tightly closed when not this section must include on the label in use. the name and United States address of Store in well-ventilated area. the producer or repackager of the art Wear protective clothing (specify materials, an appropriate United type). States telephone number that can be Wear protective goggles/face shield. contacted for more information on the Wear NIOSH-certified mask for dusts/ hazards requiring warning labels under mists/fumes. this section, and a statement that such Wear NIOSH-certified respirator with art materials are inappropriate for use an appropriate cartridge for (specify). by children. Wear NIOSH-certified supplied-air res- (E) If an art material producer or re- pirator. packager becomes newly aware of any Use window exhaust fan to remove va- significant information regarding the pors and ensure adequate cross ven- hazards of an art material or ways to tilation. (Specify explosion-proof if protect against the hazard, this new in- necessary.) formation must be incorporated into Do not heat above (specify tempera- the labels of such art materials that ture) without adequate ventilation. are manufactured after 12 months from Use (specify type) local exhausting the date of discovery. If a producer or hood. repackager reformulates an art mate- Do not use/mix with (specify material). rial, the new formulation must be eval- (ii) The following shall apply with re- uated and labeled in accordance with spect to the standard for art materials the standard set forth § 1500.14(b)(8)(i). set forth in § 1500.14(b)(8)(i). (F) In determining whether an art (A) The term art material or art mate- material has the potential for pro- rial product shall mean any substance ducing chronic adverse health effects, marketed or represented by the pro- including carcinogenicity and poten- ducer or repackager as suitable for use tial carcinogenicity, the toxicologist in any phase of the creation of any to whom the substance is referred work of visual or graphic art of any under the standard described above medium. The term does not include shall take into account opinions of var- economic poisons subject to the Fed- ious regulatory agencies and scientific

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bodies, including the U.S. Consumer how it is marketed and promoted (e.g., Product Safety Commission (CPSC), pencils and pens intended specifically the U.S. Environmental Protection for sketching and drawing are likely to Agency (EPA), and the International be art materials), and where it is sold Agency for Research on Cancer (IARC). (e.g., products sold in an art supply (iii) Pursuant to the LHAMA, the store are likely to be art materials). Commission has issued guidelines The products described in this para- which, where possible, specify criteria graph do not meet the statutory defini- for determining when any customary tion of ‘‘art material.’’ or reasonably foreseeable use of an art (2) Tools, implements, and furniture material can result in a chronic haz- used in the creation of a work of art ard. These guidelines include criteria such as brushes, chisels, easels, picture for determining when art materials frames, drafting tables and chairs, can- may produce chronic adverse effects in vas stretchers, potter’s wheels, ham- children and adults, criteria for deter- mers, air pumps for air brushes, kilns, mining which substances contained in and molds. art materials have the potential for (3) Surface materials upon which an producing chronic adverse effects and art material is applied, such as color- what those effects are, criteria for de- ing books and canvas, unless, as a re- termining the bioavailability of chron- sult of processing or handling, the con- ically hazardous substances contained sumer is likely to be exposed to a in art materials when the products are chemical in or on the surface material used in a customary or reasonably fore- in a manner which makes that chem- seeable manner, and criteria for deter- ical susceptible to being ingested, ab- mining acceptable daily intake levels sorbed, or inhaled. for chronically hazardous substances (4) The following materials whether contained in art materials. Because used as a surface or applied to one, un- these guidelines apply to hazardous less, as a result of processing or han- substances in general as well as to haz- dling, the consumer is likely to be ex- ardous substances in art materials, the posed to a chemical in or on the sur- guidelines are set forth in § 1500.135 and face material in a manner which makes a definition of ‘‘chronic toxicity’’ is that chemical susceptible to being in- provided in § 1500.3(c)(2)(ii) as part of gested, absorbed, or inhaled: paper, supplementation of the term ‘‘toxic’’ in cloth, plastics, films, yarn, threads, section 2(q) of the FHSA. rubber, sand, wood, stone, tile, ma- (iv) Policies and interpretations. (A) sonry, and metal. For purposes of enforcement policy, (B) For purposes of LHAMA enforce- the Commission will not consider as ment policy, the Commission will en- sufficient grounds for bringing an enforce against materials including, but forcement action under the Labeling of not limited to, paints, crayons, colored Hazardous Art Materials Act pencils, glues, adhesives, and putties, if (‘‘LHAMA’’) the failure of the following such materials are sold as part of an types of products to meet the require- art, craft, model, or hobby kit. The ments of § 1500.14(b)(8) (i) through (iii). Commission will enforce the LHAMA (1) Products whose intended general requirements against paints or other use is not to create art (e.g., common materials sold separately which are in- wood pencils, and single colored pens, tended to decorate art, craft, model, markers, and chalk), unless the par- and hobby items. Adhesives, glues, and ticular product is specifically pack- putties intended for general repair or aged, promoted, or marketed in a man- construction uses are not subject to ner that would lead a reasonable per- LHAMA. However, the Commission will son to conclude that it is intended for enforce the LHAMA requirements use as an art material. Factors the against adhesives, glues, and putties Commission would consider in making sold separately (not part of a kit) if this determination are how an item is they are intended for art and craft and packaged (e.g., packages of multiple model construction uses. This para- colored pencils, chalks, or markers un- graph (b)(8)(iv)(B) applies to products less promoted for non-art materials introduced into interstate commerce uses are likely to be art materials), on or after August 14, 1995.

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(C) Commission regulations at § 1500.15 Labeling of fire extin- § 1500.14(b)(8)(i)(C)(7) require that a guishers. statement of conformance appear with When a substance or mixture of sub- art materials that have been reviewed stances labeled for use in or as a fire in accordance with the Commission extinguisher produces substances that standard. The Commission interprets this provision to require a conformance are toxic within the meaning of statement regardless of the presence of § 1500.3(c) (1) and (2) when used accord- any chronic hazard warnings. ing to label directions to extinguish a (D) Nothing in this enforcement fire, the containers for such substances statement should be deemed to alter shall bear the following labeling: any of the requirements of the Federal (a) When substances are produced Hazardous Substances Act (‘‘FHSA’’), that meet the definition of highly toxic such as, but not limited to, the require- in § 1500.3(c)(1), the signal word ‘‘Dan- ment that any hazardous substance in- ger’’ and the statement of hazard tended or packaged in a form suitable ‘‘Poisonous gases formed when used to for household use must be labeled in extinguish flame or on contact with accordance with section 2(p) of the heat’’ are required labeling. FHSA. (b) When substances are produced that meet the definition of toxic in APPENDIX A TO § 1500.14(b)(8)—GUIDELINES FOR A CERTIFYING ORGANIZATION (NOT MAN- § 1500.3(c)(2), the signal word ‘‘Caution’’ DATORY) or ‘‘Warning’’ and the statement of (a) The term ‘‘certifying organization,’’ as hazard ‘‘Dangerous gas formed when used in this paragraph, refers to an organiza- used to extinguish flame or on contact tion or an institute that, after assuring that with heat’’ are required labeling. all provisions are met, certifies that an art (c) Regardless of whether paragraph material does conform to the labeling re- (a) or (b) of this section applies, any quirements of this practice. substance or mixture of substances la- (b) The certifying body may be funded by member manufacturers, but should include beled for use as a fire extinguisher users or their representatives, as well as that, if applied to an electrical fire, manufacturers’ chemists, on its technical would subject the user to the likeli- and certifying committees. hood of electrical shock shall be con- (c) Representative samples of art mate- spicuously labeled ‘‘Caution: Do not rials, labeled as conforming to this section use on electrical wires.’’ and bought at retail, should be analyzed at random and from time to time by an analyt- (d) The statements specified in para- ical laboratory to ensure they are the same graphs (a), (b), and (c) of this section as the formulation used by the toxi- shall be in addition to any other that cologist(s) for determining labeling require- may be required under the act. All such ments. substances or mixtures of substances (d) The methods used by the toxicologist(s) in review and determination of the need and shall also bear the additional state- content of precautionary labeling for poten- ments ‘‘Use in an enclosed place may tially chronic adverse health effects should be fatal’’ and ‘‘Do not enter area until be periodically reviewed by an advisory well ventilated and all odor of chem- board composed of not less than three or ical has disappeared.’’ more than five toxicologists, at least one of whom is certified in toxicology by a nation- § 1500.17 Banned hazardous sub- ally recognized certification board. stances. (e) In cases where there is disagreement by participating producers or participating (a) Under the authority of section users, with the determination of the toxi- 2(q)(1)(B) of the act, the Commission cologist(s), there should be a method where- declares as banned hazardous sub- by the toxicologist’s decision can be pre- stances the following articles because sented to the advisory board of toxicologists for arbitration. they possess such a degree or nature of hazard that adequate cautionary label- [38 FR 27012, Sept. 27, 1973, as amended at 41 ing cannot be written and the public FR 22934, June 8, 1976; 48 FR 16, Jan. 3, 1983; 53 FR 3018, Feb. 3, 1988; 57 FR 46669, Oct. 9, health and safety can be served only by 1992; 60 FR 8193, Feb. 27, 1995; 61 FR 19829, keeping such articles out of interstate May 3, 1996; 61 FR 33175, June 26, 1996] commerce:

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(1) Mixtures that are intended pri- Packaging Act of 1970 (Pub. L. 91–601, marily for application to interior ma- 84 Stat. 1670–74 (15 U.S.C. 1471–76)). sonry walls, floors, etc., as a water re- (5) Products containing soluble cya- pellant treatment and that are ‘‘ex- nide salts, excluding unavoidable man- tremely flammable’’ within the mean- ufacturing residues of cyanide salts in ing of section 2(1) of the act (repeated other chemicals that under reasonable in § 1500.3(b)(10)). and foreseeable conditions of use will (2) Carbon tetrachloride and mixtures not result in a concentration of cya- containing it (including carbon tetra- nide greater than 25 parts per million. chloride and mixtures containing it (6)(i) Any paint or other similar sur- used in fire extinguishers), excluding face-coating material intended, or unavoidable manufacturing residues of packaged in a form suitable, for use in carbon tetrachloride in other chemi- or around the household that: cals that under reasonably foreseeable (A) Is shipped in interstate commerce conditions of use do not result in an at- after December 31, 1973, and contains mospheric concentration of carbon tet- lead compounds of which the lead con- rachloride greater than 10 parts per tent (calculated as the metal) is in ex- million. cess of 0.06 percent of the total weight (3) Fireworks devices intended to of the contained solids or dried paint produce audible effects (including but film; or not limited to cherry bombs, M–80 sa- (B) Is shipped in interstate commerce lutes, silver salutes, and other large after December 31, 1972, and contains firecrackers, aerial bombs, and other lead compounds of which the lead con- fireworks designed to produce audible tent (calculated as the metal) is in ex- effects, and including kits and compo- cess of 0.5 percent of the total weight nents intended to produce such fire- of the contained solids or dried paint works) if the audible effect is produced film. (C) [Reserved] by a charge of more than 2 grains of (D) The provisions of paragraph pyrotechnic composition; except that (a)(6)(i) of this section do not apply to this provision shall not apply to such artists’ paints and related materials. fireworks devices if all of the following (ii) Any toy or other article intended conditions are met: for use by children that: (i) Such fireworks devices are distrib- (A) Is shipped in interstate commerce uted to farmers, ranchers, or growers after December 31, 1973, and bears any through a wildlife management pro- paint or other similar surface-coating gram administered by the U.S. Depart- material containing lead compounds of ment of the Interior (or by equivalent which the lead content (calculated as State or local government agencies); the metal) is in excess of 0.06 percent of and the total weight of the contained solids (ii) Such distribution is in response or dried paint film; or to a written application describing the (B) Is shipped in interstate commerce wildlife management problem that re- after December 31, 1972, and bears any quires use of such devices, is of a quan- paint or other similar surface-coating tity no greater than required to con- material containing lead compounds of trol the problem described, and is which the lead content (calculated as where other means of control are un- the metal) is in excess of 0.5 percent of available or inadequate. (See also the total weight of the contained solids § 1500.14(b)(7); § 1500.17(a) (8) and (9); or dried paint film. § 1500.83(a)(27); § 1500.85(a)(2); and part (iii) Since the Commission has issued 1507). comprehensive regulations for lead- (4) Liquid drain cleaners containing containing paint and certain consumer 10 percent or more by weight of sodium products bearing such paint at the 0.06 and/or potassium hydroxide; except percent level under the Consumer that this subparagraph shall not apply Product Safety Act (see 16 CFR part to such liquid drain cleaners if pack- 1303), paragraphs (i) and (ii) of aged in accordance with a standard for § 1500.17(a)(6) are revoked as to the sub- special packaging of such articles pro- ject products manufactured after Feb- mulgated under the Poison Prevention ruary 27, 1978.

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NOTE: The effective date of paragraphs wildlife management problem that re- (a)(6)(i)(A) and (a)(6)(ii)(A) was stayed by an quires use of such devices, is of a quan- order published in the FEDERAL REGISTER of tity no greater than required to con- August 10, 1972 (37 FR 16078). trol the problem described, and is (7) General-use garments containing where other means of control is un- asbestos (other than garments having a available or inadequate. (See also bona fide application for personal pro- § 1500.17(a) (3) and (8)). tection against thermal injury and so (10) Self-pressurized products in- constructed that the asbestos fibers tended or suitable for household use will not become airborne under reason- that contain vinyl chloride monomer ably foreseeable conditions of use). as an ingredient or in the propellant (8) Firecrackers designed to produce manufactured or imported on or after audible effects, if the audible effect is October 7, 1974. (See also § 1500.17(a) (3) produced by a charge of more than 50 and (8)). milligrams (.772 grains) of pyrotechnic (11)(i) Reloadable tube aerial shell composition (not including fire- fireworks devices that use shells larger crackers included as components of a than 1.75 inches in outer diameter and rocket), aerial bombs, and devices that that are imported on or after October may be confused with candy or other 8, 1991. foods, such as ‘‘dragon eggs,’’ and (ii) Findings. (A) General. In order to ‘‘cracker balls’’ (also known as ‘‘ball- issue a rule under section 2(q)(1) of the type caps’’), and including kits and Federal Hazardous Substances Act components intended to produce such (‘‘FHSA’’), 15 U.S.C. 1261(q)(1), fireworks except such devices which classifying a substance or article as a meet all of the following conditions: banned hazardous substance, the FHSA (i) The fireworks devices are distrib- requires the Commission to make cer- uted to farmers, ranchers, or growers tain findings and to include these find- through a wildlife management pro- ings in the regulation. These findings gram administered by the U.S. Depart- are discussed below. ment of Interior (or by equivalent State or local governmental agencies); (B) Voluntary standard. Although a and voluntary standard relating to the risk (ii) Such distribution is in response of injury associated with reloadable to a written application describing the tube aerial shells has been adopted, it wildlife management problem that re- has not been implemented. Thus, the quires use of such devices, is of a quan- Commission is not required to make tity no greater than required to con- findings covering the likelihood that trol the problem described, and is the voluntary standard would result in where other means of control is un- elimination or adequate reduction of available or inadequate. (See also the risk of injury or that there would § 1500.17(a) (3) and (9)). be substantial compliance with the vol- (9) All fireworks devices, other than untary standard. firecrackers, including kits and compo- (C) Relationship of benefits to costs. nents intended to produce such fire- The Commission estimates that the re- works, not otherwise banned under the moval of large reloadable shells from act, that do not comply with the appli- the market is likely to virtually elimi- cable requirements of part 1507 of this nate the number of associated injuries, chapter, except fireworks devices with only a slight offsetting increase in which meet all the following condi- the number of injuries due to the use of tions: substitute Class C fireworks products (i) The fireworks devices are distrib- available to consumers. The estimated uted to farmers, ranchers, or growers net benefits range from essentially zero through a wildlife management pro- to close to $1 million annually. The an- gram administered by the U.S. Depart- nual costs of a ban are estimated to be ment of the Interior (or by equivalent very low. Included are potential costs State or local government agencies); to foreign manufacturers and U.S. im- and porters from sales losses, production (ii) Such distribution is in response changes, and inventory retrofitting, to a written application describing the and slightly reduced market choices

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for consumers who purchase aerial dis- jury potential could not be established. play fireworks. Costs to each of these Also, costs could be slightly higher. sectors are estimated to be slight, and (4) The Commission also considered are reduced to the extent that alter- imposing no mandatory requirements native products are perceived as ade- on large reloadable shells and relying quate substitutes for large reloadable instead on the AFSL voluntary stand- shells. Thus, the Commission finds that ard. However, it is uncertain whether the benefits expected from the regula- any net benefits to consumers would tion bear a reasonable relationship to result from this alternative, since the its costs. level of injury reduction could be near (D) Least burdensome requirement. The zero if, as is probable, some firms chose Commission considered several alter- not to conform with some or all of the natives to the ban. These included: De- AFSL standard. sign or performance criteria; addi- (12)(i) Large multiple-tube devices. Mul- tional or alternative labeling; inclu- tiple-tube mine and shell fireworks de- sion of some reloadable shells 1.75 vices that first enter commerce or are inches or smaller in the ban; and no ac- imported on or after March 26, 1997, tion in reliance on the voluntary that have any tube measuring 1.5 standard. The Commission determined inches (3.8 cm) or more in inner diame- that a ban of reloadable shells larger ter, and that have a minimum tip angle than 1.75 inches in outer diameter is less than 60 degrees when tested in ac- the least burdensome alternative that cordance with the procedure of § 1507.12 would prevent or adequately reduce the of this part. risk of injury. (ii) Findings—(A) General. In order to issue a rule under the section 2(q)(1) of (1) Regarding design or performance the FHSA, 15 U.S.C. 1261(q)(1), criteria, the Commission considered re- classifying a substance or article as a quirements similar to those stated in banned hazardous substance, the FHSA the voluntary standard of the Amer- requires the Commission to make cer- ican Fireworks Standards Laboratory tain findings and to include these in (‘‘AFSL’’). However, such criteria may the regulation. These findings are dis- increase the cost of the product and cussed in paragraphs (a)(12)(ii) (B) would not address all factors involved through (D) of this section. in the incidents. Further, concerns (B) Voluntary standard. (1) One alter- exist about the feasibility of criteria native to the tip-angle requirement and quality control. that the Commission considered is to (2) Regarding additional or alter- take no mandatory action, and to de- native labeling, the users’ perception pend on a voluntary standard. The and experience concerning the amount American Fireworks Safety Labora- of time available to get away may lead tory (AFSL) has a standard for mines them to disregard an inconsistent and shells intended to address the po- warning. There are no data to suggest tential tip-over hazard associated with that a significant number, if any, inci- multiple-tube fireworks devices. dents would be avoided if large AFSL’s Voluntary Standard for Mines reloadable shells carried more detailed and Shells—Single or Multiple Shot re- labels or instructions than they cur- quires that large multiple-tube devices rently do. It cannot be concluded that not tip over (except as the result of the potential benefits would be greater last shot) when shot on a 2-inch thick than zero. medium-density foam pad. The Com- (3) The Commission considered in- mission cannot conclude that AFSL’s cluding reloadable shells that are 1.75 existing voluntary standard adequately inches or less in outer diameter and reduces the risk of injury from large have the ‘‘equivalent explosive power’’ devices that tip over while functioning. of larger shells. A kinetic energy level The Commission’s tests using poly- of 70 joules was considered to evaluate urethane foam did not find sufficient explosive power. However, any poten- agreement between performance on tial benefits are uncertain since the foam and on grass. No other data are Commission concluded that a clear re- available to show that this dynamic lation between kinetic energy and in- test is reliable.

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(2) In addition, even if the AFSL (13)(i) Candles made with metal-cored standard is effective, the Commission wicks. Candles manufactured or im- does not believe that compliance with ported on or after October 15, 2003, the standard will be adequate. AFSL made with metal-cored candlewicks, reports that it has been testing in ac- unless: cordance with its standard since Janu- (A) The metal core of each ary 1994. However, the results of candlewick has a lead content (cal- CPSC’s compliance testing indicate culated as the metal) of not more than that multiple-tube devices still tip 0.06 percent of the total weight of the over while functioning. In fiscal year metal core; and 1994, all 24 imported devices the Com- (B) Each outer container or wrapper mission tested, and 1 of 8 domestic de- in which candles subject to paragraph vices, tipped over while functioning. In (a)(13)(i)(A) of this section are shipped, fiscal year 1995, 22 of 27 imported de- including each outer container or vices and 1 of 5 domestic devices tipped wrapper in which such candles are dis- over during Commission testing. The tributed to a retail outlet, is labeled Commission finds that there is un- ‘‘Conforms to 16 CFR 1500.17(a)(13).’’ likely to be substantial compliance For purposes of this paragraph (B), the with the voluntary standard applicable term ‘‘outer container or wrapper’’ to multiple-tube devices. does not include the immediate con- (C) Relationship of benefits to costs. tainer in which candle(s) is/are in- The Commission estimates that the 60- tended to be displayed at retail or dur- degree tip-angle standard will elimi- ing use in the home, unless that con- nate the unreasonable tip-over risk tainer or wrapper is also the only con- posed by these devices. This will pro- tainer or wrapper in which the can- vide benefits of saving one life about dle(s) is/are shipped to a retailer. every 3 years, and preventing an un- (ii) Metal-cored candlewicks. Metal- known number of nonfatal injuries. cored candlewicks manufactured or im- The annual cost of modifying affected ported on or after October 15, 2003, un- devices is estimated to be between $1.5 less: million and $2.7 million. The Commis- sion finds that the benefits from the (A) The metal core of each regulation bear a reasonable relation- candlewick has a lead content (cal- ship to its costs. culated as the metal) of not more than (D) Least burdensome requirement. The 0.06 percent of the total weight of the Commission considered the following metal core; and alternatives: a ban of all multiple-tube (B) Each outer container or wrapper devices with inner tube diameters 1.5 in which candlewicks subject to para- inches or greater; a dynamic perform- graph (a)(13)(ii)(A) of this section is ance standard; additional labeling re- shipped, including each outer container quirements; and relying on the vol- or wrapper of a shipment distributed to untary standard. Although a ban of all a retail outlet, is labeled ‘‘Conforms to large multiple-tube devices would ad- 16 CFR 1500.17(a)(13).’’ For purposes of dress the risk of injury, it would be this paragraph (B), the term ‘‘outer more burdensome than the tip-angle container or wrapper’’ does not include standard. The Commission was unable the immediate container in which to develop a satisfactory dynamic candlewick(s) is/are intended to be dis- standard that would reduce the risk of played or sold at retail, unless that injury. Neither additional labeling re- container or wrapper is also the only quirements nor reliance on the vol- container or wrapper in which the untary standard would adequately re- candlewick(s) is/are shipped to a reduce the risk of injury. Thus, the Com- tailer. mission finds that a standard requiring (iii) Findings—(A) General. To issue a large multiple-tube devices to have a rule under section 2(q)(1) of the FHSA, minimum tip angle greater than 60 de- 15 U.S.C. 1261(q)(1), classifying a sub- grees is the least burdensome require- stance or article as a banned hazardous ment that would prevent or adequately substance, the Commission must make reduce the risk of injury. certain findings and include them in

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the regulation. These findings are dis- (b) [Reserved] cussed in paragraphs (a)(13)(iii)(B) through (D) of this section. (Secs. 2(f)(1), (A), (B), (g), (q)(1)(B), 3(a), 74 Stat. 372, 374, as amended 80 Stat. 1304–05, 83 (B) Voluntary standard. One alter- Stat. 187–189, 90 Stat. 503 (15 U.S.C. 1261, native to the ban that the Commission 1262); sec. 701 (e), (f), (g), 52 Stat. 1055–56, as considered is to take no mandatory ac- amended 70 Stat. 919, 72 Stat. 948 (21 U.S.C. tion, and to depend on a voluntary 371 (e), (f), (g)), sec. 30(a), 86 Stat. 1231 (15 standard. One organization has a U.S.C. 2079(a))) standard for candlewicks intended to [38 FR 27012, Sept. 27, 1973, as amended at 38 address the potential for substantial FR 27514, Oct. 4, 1973; 38 FR 31520, Nov. 15, illness posed by such wicks and candles 1973; 39 FR 30114, Aug. 21, 1974; 39 FR 42903, with such wicks. The Commission has Dec. 9, 1974; 41 FR 22935, June 8, 1976; 42 FR found that the standard is technically 44202, Sept. 1, 1977; 43 FR 12310, Mar. 24, 1978; unsound and that substantial compli- 48 FR 16, Jan. 3, 1983; 56 FR 37837, Aug. 9, ance with it is unlikely. Furthermore, 1991; 61 FR 13095, Mar. 26, 1996; 61 FR 18245, there is no evidence that the standard Apr. 25, 1996; 68 FR 19147, Apr. 18, 2003] has been adopted and implemented by § 1500.18 Banned toys and other candlewick or candle manufacturers. banned articles intended for use by (C) Relationship of benefits to costs. children. The Commission estimates that the ban will reduce the potential for expo- (a) Toys and other articles presenting sure to lead and resulting lead poi- mechanical hazards. Under the author- soning because there is no ‘‘safe’’ level ity of sections 2(f)(1)(D) and 24 of the of lead in the blood. The annual cost to act and pursuant to the provisions of the candle/wick industry of the ban is section 3(e) of the act, the Commission estimated by the Commission to be in has determined that the following the range of $100,000 to $300,000. On a types of toys or other articles intended percentage basis these costs represent for use by children present a mechan- only 0.005 to 0.015 percent of the overall ical hazard within the meaning of sec- value of candle shipments in 2000, tion 2(s) of the act because in normal which was approximately $2 billion. use, or when subjected to reasonably Accordingly, the Commission finds foreseeable damage or abuse, the de- that the benefits from the regulation sign or manufacture presents an unrea- bear a reasonable relationship to its sonable risk of personal injury or ill- costs. ness: (D) Least burdensome requirement. The (1) Any toy rattle containing, either Commission considered the following internally or externally, rigid wires, alternatives: no action; labeling all sharp protrusions, or loose small ob- metal-cored candles with wicks con- jects that have the potential for caus- taining more than 0.06 percent lead by ing lacerations, puncture wound in- weight of the metal; recordkeeping for jury, aspiration, ingestion, or other in- shipments of wicks containing 0.06 per- jury. (But see § 1500.86(a)(1)). cent or less lead by weight of the metal (2) Any toy having noisemaking com- and of candles with such wicks; and re- ponents or attachments capable of lying on the voluntary standard. Nei- being dislodged by the operating feather no action, nor labeling, nor reli- tures of the toy or capable of being de- ance on the voluntary standard would liberately removed by a child, which adequately reduce the risk of illness. toy has the potential for causing lac- Recordkeeping for shipments of wicks eration, puncture wound injury, aspira- and of candles was not the least bur- tion, ingestion, or other injury. densome requirement that would pre- (3) Any doll, stuffed animal, or other vent or adequately reduce the risk of similar toy having internal or external illness. Therefore the Commission finds components that have the potential for that a ban on candlewicks containing causing laceration, puncture wound in- more than 0.06 percent lead by weight jury, or other similar injury. (But see of the metal and candles with such § 1500.86(a)(2)); (See also §§ 1500.48 and wicks is the least burdensome require- 1500.49). ment that would prevent or adequately (4) Lawn darts and other similar reduce the risk of illness. sharp-pointed toys usually intended for

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outdoor use and having the potential semicircles thus causing a ‘‘clacking’’ for causing puncture wound injury. sound, which toys present a mechan- (5) [Reserved] ical hazard because their design or (6) Any article known as a ‘‘baby- manufacture presents an unreasonable bouncer’’ or ‘‘walker-jumper’’ and any risk of personal injury from fracture, other similar article (referred to in fragmentations, or disassembly of the this paragraph as ‘‘article(s)’’), except toy and from propulsion of the toy or an infant walker subject to part 1216, its part(s). (But see § 1500.86(a)(5).) This which is intended to support very does not include products that are con- young children while sitting, bouncing, structed so that the connecting mem- jumping, and/or reclining, and which bers consist of plastic rods integrally because of its design has any exposed molded to the balls and are mounted on parts capable of causing amputation, a pivot so that movement of the balls crushing, lacerations, fractures, is essentially limited to a single plane. hematomas, bruises, or other injuries (8) Any pacifier that does not meet to fingers, toes, or other parts of the the requirements of 16 CFR part 1511 anatomy of young children. Included and that is introduced into interstate among, but not limited to, the design commerce after February 26, 1978. features of such articles which classify (9) Any toy or other article intended the articles as banned hazardous sub- for use by children under 3 years of age stances are: which presents a choking, aspiration, (i) The areas about the point on each or ingestion hazard because of small side of the article where the frame parts as determined by part 1501 of this components are joined together to chapter and which is introduced into form an ‘‘X’’ shape capable of pro- interstate commerce after January 1, ducing a scissoring, shearing, or pinch- 1980. For purposes of this regulation, ing effect. introduction into interstate commerce (ii) Other areas where two or more is defined as follows: A toy or chil- parts are joined in such a manner as to dren’s article manufactured outside the permit a rotational movement capable United States is introduced into inter- of exerting a scissoring, shearing, or state commerce when it is first pinching effect. (iii) Exposed coil springs which may brought within a U.S. port of entry. A expand sufficiently to allow an infant’s toy or children’s article manufactured finger, toe, or any other part of the in the United States is introduced into anatomy to be inserted, in whole or in interstate commerce (1) at the time of part, and injured by being caught be- its first interstate sale, or (2) at the tween the coils of the spring or be- time of its first intrastate sale if one or tween the spring and another part of more of its components and/or raw ma- the article. terials were received interstate, which- (iv) Holes in plates or tubes which ever occurs earlier. Part 1501 defines provide the possibility of insertion, in the term ‘‘toy or other article intended whole or in part, of a finger, toe, or any for use by children under 3,’’ as used in part of the anatomy that could then be this regulation, and exempts certain injured by the movement of another products from banning under this regu- part of the article. lation. (v) Design and construction that per- (10)–(11) [Reserved] mits accidental collapse while in use. (12) Any bicycle as defined in (But see § 1500.86(a)(4)). § 1512.2(a) of this chapter (except a bicy- (7) Toys usually known as clacker cle that is a ‘‘track bicycle’’ or a ‘‘one- balls and consisting of two balls of of-a-kind bicycle’’ as defined in § 1512.2 plastic or another material connected (d) and (e) of this chapter) that is in- by a length of line or cord or similar troduced into interstate commerce on connector (referred to as ‘‘cord’’ in or after May 11, 1976, and that does not § 1500.86(a)(5)), intended to be operated comply with the requirements of part in a rhythmic manner by an upward 1512 of this chapter, except for and downward motion of the hand so §§ 1512.5(c)(3), 1512.9(a), 1512.18(e) and that the two balls will meet forcefully 1512.18(f) which become effective No- at the top and bottom of two vember 13, 1976.

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(15) Any rattle (as defined in § 1510.2 The potential costs to businesses are of this chapter) that is introduced into expected to be offset by production of interstate commerce on or after Au- other products, and the potential costs gust 21, 1978, and that does not comply to consumers are likely to be offset by with the requirements of part 1510 of the availability of substitutes for a this chapter. For purposes of the regu- comparable price. lation, introduction into interstate (D) Least burdensome requirement. The commerce is defined as follows: A rat- Commission considered labeling and a tle manufactured outside the United design or performance standard as al- States is introduced into interstate ternatives to the ban. The Commission commerce when it is first brought does not believe that any form of label- within a U.S. port of entry. A rattle ing would have a significant effect in manufactured in the United States is preventing the hazard associated with introduced into interstate commerce infant cushions. The Commission also (a) at the time of its first interstate concluded that no feasible standard ex- sale, or (b) at the time of its first intra- ists that would address the hazard. state sale if one or more of its compo- Thus, the Commission determined that nents and/or raw materials were re- a ban of infant cushions is the least ceived interstate. burdensome alternative that would (16) (i) Any article known as an ‘‘in- prevent or adequately reduce the risk fant cushion’’ or ‘‘infant pillow,’’ and of injury. any other similar article, which has all (17) Any ball intended for children of the following characteristics (But under three years of age that, under see § 1500.86(a)(9)): the influence of its own weight, passes, (A) Has a flexible fabric covering. in any orientation, entirely through a The term fabric includes those mate- circular hole with a diameter of 1.75 rials covered by the definition of ‘‘fab- inches (44.4 mm.) in a rigid template 1⁄4 ric’’ in section 2(f) of the Flammable inches (6 mm.) thick. In testing to Fabrics Act, 15 U.S.C. 1191(f). evaluate compliance with this para- (B) Is loosely filled with a granular graph, the diameter of opening in the material, including but not limited to, Commission’s test template shall be no polystyrene beads or pellets. greater than 1.75 inches (44.4 mm.). (C) Is easily flattened. (D) Is capable of conforming to the (i) For the purposes of this para- body or face of an infant. graph, the term ‘‘ball’’ includes any (E) Is intended or promoted for use spherical, ovoid, or ellipsoidal object by children under one year of age. that is designed or intended to be (ii) Findings—(A) General. In order to thrown, hit, kicked, rolled, dropped, or issue a rule under section 2(q)(1) of the bounced. The term ‘‘ball’’ includes any Federal Hazardous Substance Act spherical, ovoid, or ellipsoidal object (FHSA), 15 U.S.C. 1261(q)(1), classifying that is attached to a toy or article by a substance or article as a banned haz- means of a string, elastic cord, or simi- ardous substance, the FHSA requires lar tether. The term ‘‘ball’’ also in- the Commission to make certain find- cludes any multi-sided object formed ings and to include these findings in by connecting planes into a generally the regulation. These findings are dis- spherical, ovoid, or ellipsoidal shape cussed in paragraphs (a)(16)(ii) (B) that is designated or intended to be through (D) of this section. used as a ball, and any novelty item of (B) Voluntary standard. No findings a generally spherical, ovoid, or ellip- concerning compliance with or ade- soidal shape that is designated or in- quacy of a voluntary standard are nec- tended to be used as a ball. essary since no voluntary standard ad- (ii) The term ‘‘ball’’ does not include dressing infant cushions has been dice, or balls permanently enclosed in- adopted or implemented. side pinball machines, mazes, or simi- (C) Relationship of benefits to costs. lar outer containers. A ball is perma- The Commission estimates that the re- nently enclosed if, when tested in ac- moval of infant cushions from the mar- cordance with 16 CFR 1500.52, the ball ket will result in total annual benefits is not removed from the outer con- of approximately five million dollars. tainer.

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(iii) In determining whether such a shape, such as dive rings and dive disks ball is intended for use by children are also exempt. under three years of age, the criteria (ii)(A) Findings. In order for the Com- specified in 16 CFR 1501.2(b) and the en- mission to issue a rule under section forcement procedure established by 16 2(q)(1) of the FHSA classifying a sub- CFR 1501.5 shall apply. stance or article as a banned hazardous (18)(i) Any bunk bed (as defined in substance, the Commission must make § 1513.2(c) of this chapter) that does not certain findings and include these find- comply with the requirements of part ings in the regulation. 15 U.S.C. 1513 of this chapter. 1262(i)(2). These findings are discussed (ii) Findings. In order to issue a rule in paragraphs (a)(18)(ii)(B) through (D) under Section 3(e) of the Federal Haz- of this section. ardous Substances Act (FHSA), 15 (B) Voluntary standard. No findings U.S.C. 1262(e), classifying a toy or concerning compliance with and ade- other article intended for use by chil- quacy of a voluntary standard are nec- dren as a hazardous substance on the essary because no relevant voluntary basis that it presents a mechanical standard addressing the risk of injury hazard (as defined in Section 2(s) of the posed by dive sticks has been adopted FHSA), the FHSA requires the Com- and implemented. mission to make the following findings (C) Relationship of benefits to costs. and to include these findings in the The Commission estimates the poten- regulation: Bunk beds present a me- tial benefits of removing hazardous chanical hazard; Where a voluntary dive sticks from the market to be 2 to standard has been adopted and imple- 4 cents per dive stick. With the avail- mented by the affected industry, that ability of substitutes and the expected compliance with such voluntary stand- low cost of modifying dive sticks to ard is not likely to result in the elimi- conform to the rule, the Commission nation or adequate reduction of the anticipates that necessary changes will risk of injury, or it is unlikely that be minimal. The Commission estimates there will be substantial compliance that the costs of the rule will be no with such voluntary standard; The ben- more than 2 to 4 cents per dive stick. efits expected from the rule bear a rea- Thus, the Commission finds that there sonable relationship to its costs; and is a reasonable relationship between The rule imposes the least burdensome the expected benefits of the rule and its requirement that prevents or ade- costs. quately reduces the risk of injury for (D) Least burdensome requirement. The which the rule is being promulgated. Commission considered pursuing vol- These findings are made in the appen- untary recalls, following a voluntary dix to Part 1513. standard, requiring labeling or chang- (19)(i) Dive sticks, and other similar ing the scope of the rule. A banning articles, that are used in swimming rule would be more effective than case- pools or other water environments for by-case recalls because the impalement such activities as underwater retrieval hazard affects all dive sticks, not a spe- games or swimming instruction, and cific brand or model. Awaiting recalls which, when placed in the water, sub- would allow these hazardous items on merge and rest at the bottom of the the market until the Commission ob- pool. This includes products that are tained recalls. No applicable voluntary pre-weighted to sink to the bottom and standard exists, and compliance may products that are designed to allow the be low if one did. Although labeling user to adjust the weight. Dive sticks could help reduce the risk of injuries and similar articles that come to rest from dive sticks, it would be less effec- underwater at an angle greater than 45 tive than a banning rule. It may be dif- degrees from vertical when measured ficult for a label to convey the nec- under the test at § 1500.86(a)(7) and dive essary information at the time of use. sticks and similar articles that main- Modifying the scope so that the rule tain a compressive force of less than 5- would only apply to pre-weighted dive lbf under the test at § 1500.86(a)(8) are sticks would continue to permit haz- exempt from this banning rule. Arti- ardous items because the unweighted cles that have a continuous circular dive sticks can easily be weighted to

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stand vertically at the bottom of the and is a banned hazardous substance water. Thus, the Commission finds that because its design (specifically its size a ban of dive sticks with the hazardous and electrical conductivity) presents a characteristics it has identified is the risk of personal injury from electric least burdensome alternative that shock due to its ability to conduct would adequately reduce the risk of in- electricity and to become entangled in jury. or otherwise contact high voltage elec- (b) Electrically operated toys and other tric power lines. electrical operated children’s articles pre- (2) [Reserved] senting electrical, thermal, and/or certain mechanical hazards. Under the author- (15 U.S.C. 1261 (f)(1)(D), (g)(1)(A), (r); 15 U.S.C. ity of section 2(f)(1)(D) of the act and 1262(e)(1); 15 U.S.C. 2079(a)) pursuant to provisions of section 3(e) of [38 FR 27012, Sept. 27, 1973] the act, the Commission has deter- EDITORIAL NOTE: For FEDERAL REGISTER ci- mined that the following types of elec- tations affecting § 1500.18, see the List of CFR trically operated toys or other elec- Sections Affected, which appears in the trically operated articles intended for Finding Aids section of the printed volume use by children present electrical, ther- and at www.govinfo.gov. mal, and/or certain mechanical hazards within the meaning of section 2 (r), (s), § 1500.19 Misbranded toys and other and/or (t) of the act because in normal articles intended for use by chil- use or when subjected to reasonably dren. foreseeable damage or abuse, the de- (a) Definitions. For the purposes of sign or manufacture may cause per- this section, the following definitions sonal injury or illness by electric shock shall apply. and/or presents an unreasonable risk of (1) Ball means a spherical, ovoid, or personal injury or illness because of ellipsoidal object that is designed or heat as from heated parts, substances, intended to be thrown, hit, kicked, or surfaces, or because of certain me- rolled, dropped, or bounced. The term chanical hazards. ‘‘ball’’ includes any spherical, ovoid, or (1) Any electrically operated toy or ellipsoidal object that is attached to a other electrically operated article in- toy or article by means of a string, tended for use by children (as defined elastic cord, or similar tether. The in § 1505.1(a)(1)) that is introduced into term ‘‘ball’’ also includes any multi- interstate commerce and which does sided object formed by connecting not comply with the requirements of planes into a generally, spherical, part 1505 of this chapter. ovoid, or ellipsoidal shape that is des- NOTE: Paragraph (b)(1) was originally pro- ignated or intended to be used as a mulgated as 21 CFR 191.9a(b)(1) with an effec- ball, and any novelty item of a gen- tive date of September 3, 1973 (38 FR 6138). erally spherical, ovoid, or ellipsoidal (2) [Reserved] shape that is designated or intended to (c) Toys and other articles (not elec- be used as a ball. The term ‘‘ball’’ does trically operated) presenting electric haz- not include dice, or balls permanently ards. Under the authority of section enclosed inside pinball machines, 2(f)(1)(D) of the act and pursuant to mazes, or similar outer containers. A provisions of section 3(e) of the act, the ball is permanently enclosed if, when Commission has determined that the tested in accordance with 16 CFR following types of toys or other arti- 1500.53, it is not removed from the cles intended for use by children (not outer container. electrically operated) present an elec- (2) Small ball means a ball that, under trical hazard within the meaning of the influence of its own weight, passes, section 2(r) of the act. in any orientation, entirely through a (1) Any kite 10 inches or greater in circular hole with a diameter of 1.75 any dimension constructed of alu- inches (44.4 mm.) in a rigid template 1⁄4 minized polyester film or any kite hav- inches (6 mm.) thick. In testing to ing a tail or other component con- evaluate compliance with this regula- sisting of a piece of aluminized poly- tion, the diameter of opening in the ester film 10 inches or greater in any Commission’s test template shall be no dimension presents an electrical hazard greater than 1.75 inches (44.4 mm.).

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(3) Latex balloon means a toy or deco- chaser’s attention on the product. De- rative item consisting of a latex bag scriptive material ‘‘accompanies’’ a that is designed to be inflated by air or product subject to the labeling require- gas. The term does not include inflat- ments when it is packaged with the able children’s toys that are used in product or when it is intended to be aquatic activities such as rafts, water distributed with the product at the wings, swim rings, or other similar time of sale or delivery to the pur- items. chaser. ‘‘Descriptive material’’ does (4) Marble means a ball made of a not include statements that appear on hard material, such as glass, agate, the package of a product subject to the marble or plastic, that is used in var- labeling requirements. ‘‘Descriptive ious children’s games, generally as a material’’ does not include material in- playing piece or marker. The term tended solely for use by children if the ‘‘marble’’ does not include a marble package it accompanies contains a sep- permanently enclosed in a toy or game. arate package insert prominently iden- A marble is permanently enclosed if, tified as a warning for parents that when tested in accordance with 16 CFR contains the required precautionary 1500.53, it is not removed from the toy statements. or game. (8) Bin and container for retail display (5) Small part means any object mean containers in which multiple which, when tested in accordance with unpackaged and unlabeled items are the procedures contained in 16 CFR held for direct selection by and sale to 1501.4(a) and 1501.4(b)(1), fits entirely consumers. within the cylinder shown in Figure 1 (b) Misbranded toys and children’s arti- appended to 16 CFR part 1501. The use cles. Pursuant to sections 2(p) and 24 of and abuse testing provisions of 16 CFR the FHSA, the following articles are 1500.51 through 1500.53 and 1501.4(b)(2) misbranded hazardous substances if do not apply to this definition. their packaging, any descriptive mate- (6) Package or packaging refers to the rial that accompanies them, and, if immediate package in which a product unpackaged and unlabeled, any bin in subject to labeling under section 24 of which they are held for sale, any con- the act is sold, as well as to any outer tainer in which they are held for retail container or wrapping for that pack- display, or any vending machine from age. which they are dispensed, fails to bear (7) Descriptive material means any dis- the labeling statements required in crete piece of written material sepa- paragraphs (b) (1) through (4) and para- rate from the label of the package that graph (f)(3) of this section, or if such contains an instruction (whether writ- labeling statements fail to comply ten or otherwise) for the use of a prod- with the prominence and conspicuous- uct subject to these labeling require- ness requirements of paragraph (d) of ments, any depiction of the product, this section. and any written material that specifi- (1) With the exception of books and cally describes any function, use, warn- other articles made of paper, writing ings, user population, design or mate- materials such as crayons, chalk, pen- rial specification, or other char- cils, and pens, modeling clay and simi- acteristic of the product. A catalog or lar products, fingerpaints, watercolors, other marketing material or advertise- and other paint sets, and any other ar- ment that depicts other products in ad- ticle identified in 16 CFR 1501.3 (other dition to the product it accompanies is than balloons), any article that is a toy not ‘‘descriptive material’’ unless it or game intended for use by children contains additional information, such who are at least three years old but as instructions for use of the product it less than six years of age shall bear or accompanies or lists of accessories ex- contain the following cautionary state- clusively for use with that product, ment if the toy or game includes a that are designed to focus the pur- small part:

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(2) Any latex balloon, or toy or game bear the following cautionary state- that contains a latex balloon, shall ment:

(3)(i) Any small ball intended for shall bear the following cautionary children three years of age or older statement:

(ii) Any toy or game intended for that contains a small ball shall bear children who are at least three years the following cautionary statement: old but less than eight years of age

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(4)(i) Any marble intended for chil- bear the following cautionary state- dren three years of age or older shall ment:

(ii) Any toy or game intended for that contains a marble shall bear the children who are at least three years following cautionary statement: old but less than eight years of age

(c) Age of intended user. In deter- quired by 16 CFR 1500.19(b) and (f) shall mining the ages of the children for be blocked together within a square or which any toy or article subject to this rectangular area, with or without a section is intended, the following fac- border. This means that the state- tors are relevant: the manufacturer’s ments must appear on at least two stated intent (such as the age stated on lines. The statements shall be sepa- a label) if it is reasonable; the adver- rated from all other graphic material tising, marketing, and promotion of by a space no smaller than the min- the article; and whether the article is imum allowable height of the type size commonly recognized as being infor other cautionary material (e.g., the tended for children in this age group. phrase ‘‘Not for children under 3 yrs.’’). In enforcing this provision, the Com- If not separated by that distance, the mission will follow the procedures set labeling statements must be sur- forth in 16 CFR 1501.5. rounded by a border line. Label design, (d) Prominence and conspicuousness of the use of vignettes, or the proximity labeling statements. The requirements of of other labeling or lettering shall not 16 CFR 1500.121 relating to the promi- obscure or render inconspicuous any la- nence and conspicuousness of pre- beling statement required under cautionary labeling statements for haz- § 1500.19(b) and (f). This means that ardous substances shall apply to any such statements shall appear on a solid labeling statement required under background, which need not differ from § 1500.19(b) and (f), with the following the background color or any other clarifications and modifications. color on the package label. (1) All labeling statements required (2) The words ‘‘WARNING’’ or by § 1500.19(b) and (f) shall be in the ‘‘SAFETY WARNING’’ required by sec- English language. The statements re- tion 24 of the FHSA shall be regarded quired by paragraph (b) need not ap- as signal words. pear in the format and layout depicted (3) The statement ‘‘CHOKING HAZ- in paragraph (b). The statements re- ARD’’ shall be regarded as a statement

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of the principal hazard associated with from which items are dispensed, exclu- the products subject to this section. sive of the area of metal attachments, (4) All other remaining statements coin inserts, bases, etc. Any other side required by this section shall be re- or surface of such a bin, container for garded as ‘‘other cautionary material’’ retail sale, or vending machine that as that term is defined in 16 CFR bears information, such as price or 1500.121(a)(2)(viii). product description, for examination (5) The principal display panel for a by purchasers shall be deemed to be a bin, container for retail display, or principal display panel, excluding any vending machine shall be the side or side or surface with information that surface designed to be most promi- only identifies the company that owns nently displayed, shown, or presented or operates a vending machine. to, or examined by, prospective pur- (6) All of the labeling statements re- chasers. In the case of bins or con- quired by this section, including those tainers for retail display, the cau- classified as ‘‘other cautionary mate- tionary material may be placed on a rial,’’ must appear on the principal dis- display card of a reasonable size in re- play panel of the product, except as lationship to the surface area of the provided for by § 1500.19(f). Any signal bin or container. The area of the dis- word shall appear on the same line and play card shall constitute the area of in close proximity to the triangle re- the principal display panel. In the case quired by section 24 of the act. Mul- of vending machines that contain a dis- tiple messages should be provided with play card, the cautionary label may be sufficient space between them, when placed either on the display card, on feasible, to prevent them from visually the coinage indicator decal, or on the blending together. glass or clear plastic of the machine. If (7) All labeling statements required there is no display card inside a vend- by this section shall comply with the ing machine, the size of the principal following type size requirements. 16 display panel will be calculated in ac- CFR 1500.121(c)(1) explains how to com- cordance with 16 CFR 1500.121(c) based pute the area of the principal display on the size of the front of the container panel and letter height.

Area sq. in ...... 0–2 + 2–5 + 5–10 + 10–15 + 15–30 + 30–100 + 100–400 + 400 Type 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 section cautionary labeling shall be in reason- that appears on a bin, container for re- able proximity to such instructions or tail display, or vending machine shall directions and shall be placed together be in reasonable proximity to any pric- within the same general area (see 16 ing or product information contained CFR 1500.121(c)(6)). on the principal display panel, or, if (10) In the case of any alternative la- such information is not present, in beling statement permitted under close proximity to the article that is § 1500.19(e), the requirements of 16 CFR subject to the labeling requirements. 1500.121(b)(3) and 1500.121(c)(2)(iii) shall (9) Descriptive material that accom- apply to statements or indicators on panies a product subject to the labeling the principal display panel directing requirements, including accompanying attention to the complete cautionary material subject to the alternative al- labeling that appears on another dis- lowed by § 1500.19(f), shall comply with play panel. the requirements of 16 CFR (11) Any triangle required by this sec- 1500.121(c)(6) relating to literature con- tion shall be an equilateral triangle. taining instructions for use which ac- The height of such a triangle shall be companies a hazardous substance. If equal to or exceed the height of the let- the descriptive material contains in- ters of the signal word ‘‘WARNING’’. structions for use, the required pre-

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The height of the exclamation point in- subject to the labeling requirements, side the triangle shall be at least half only the signal word and statement of the height of the triangle, and the ex- hazard may be combined. clamation point shall be centered (f) Alternative labeling statements for vertically in the triangle. The triangle small packages. Any cautionary state- shall be separated from the signal word ment required by section 1500.19(b) may by a distance at least equal to the be displayed on a display panel of the space occupied by the first letter of the package of a product subject to the la- signal word. In all other respects, tri- beling requirement other than the angles with exclamation points shall principal display panel only if: conform generally to the provisions of (1) The package has a principal dis- 16 CFR 1500.121 relating to signal play panel of 15 square inches or less, words. (2) The full labeling statement re- (e) Combination of labeling statements. quired by paragraph (b) of this section The labels of products that contain is displayed in three or more languages more than one item subject to the re- on another display panel of the pack- quirements of this section may com- age of the product, and bine information relating to each of (3)(i) In the case of a toy or game the respective hazards, if the resulting subject to § 1500.19(b)(1), a small ball condensed statement contains all of subject to § 1500.19(b)(3), a marble sub- the information necessary to describe ject to § 1500.19(b)(4), or a toy or game the hazard presented by each article. containing such a ball or marble, the However, in the case of a product that principal display panel of the package contains a balloon and another item bears the statement:

and bears an arrow or other indicator (ii) In the case of a balloon subject to pointing toward or directing the pur- § 1500.19(b)(2) or a toy or game con- chaser’s attention to the display panel taining such a balloon, the principal on the package where the full labeling display panel bears the statement: statement appears, or

and bears an arrow or other indicator service in an immediate package that pointing toward or directing the pur- contains descriptive material, the de- chaser’s attention to the display panel scriptive material inside the imme- on the package where the full labeling diate package of the product need not statement appears. bear the required labeling statement (g) Alternative for products manufac- only if the shipping container of the tured outside the United States. In the product contains other accompanying case of a product subject to the label- material that bears the required state- ing requirements of § 1500.19(b) which is ments displayed in a prominent and manufactured outside the United conspicuous manner. Products shipped States and is shipped directly from the from abroad to a U.S. affiliate for ship- manufacturer to the consumer by ment to consumers are included within United States mail or other delivery the scope of this exception.

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(h) Preemption. Section 101(e) of the Internet advertisements must comply Child Safety Protection Act of 1994 pro- with Section 24 of the FHSA as amend- hibits any state or political subdivision ed by the CPSIA no later than Decem- of a state from enacting or enforcing ber 12, 2008. any requirement relating to cautionary (c) Definitions. For the purposes of labeling addressing small parts hazards this section, the following definitions or choking hazards associated with any shall apply. toy, game, marble, small ball, or bal- (1) Ball means a spherical, ovoid, or loon intended or suitable for use by ellipsoidal object that is designed or children unless the state or local re- intended to be thrown, hit, kicked, quirement is identical to a require- rolled, dropped, or bounced. The term ment established by section 24 of the ‘‘ball’’ includes any spherical, ovoid, or FHSA or by 16 CFR 1500.19. Section ellipsoidal object that is attached to a 101(e) allows a state or political sub- toy or article by means of a string, division of a state to enforce a non- elastic cord, or similar tether. The identical requirement relating to cau- term ‘‘ball’’ also includes a multi-sided tionary labeling warning of small parts object formed by connecting planes hazards or choking hazards associated into a generally spherical, ovoid, or el- with any toy subject to the provisions of section 24 of FHSA until January 1, lipsoidal shape that is designated or in- 1995, if the non-identical requirement tended to be used as a ball, and any was in effect on October 2, 1993. novelty item of a generally spherical, ovoid, or ellipsoidal shape that is des- [60 FR 10752, Feb. 27, 1995, as amended at 60 ignated or intended to be used as a FR 41802, Aug. 14, 1995] ball. The term ‘‘ball’’ does not include dice, or balls permanently enclosed in- § 1500.20 Labeling requirement for advertising toys and games. side pinball machines, mazes, or similar other containers. A ball is perma- (a) Scope. This section applies to nently enclosed if, when tested in ac- catalogue and other printed material cordance with 16 CFR 1500.53, it is not advertisements which provide a direct removed from the outer container. means of purchase or order of products (2) Small ball means a ball that, under requiring cautionary labeling under sections 24(a) and (b) of the FHSA. the influence of its own weight, passes (b) Effective Date. Under the Con- in any orientation, entirely through a sumer Product Safety Improvement circular hole with a diameter of 1.75 1 Act of 2008, Public Law 110–314, 122 inches (44.4 mm) in a rigid template ⁄4 Stat. 3016 (August 14, 2008), (‘‘CPSIA’’), inches (6 mm) thick. In testing to the effective date of the CPSIA’s evaluate compliance with this regula- amendment to Section 24 of the FHSA tion, the diameter of opening in the to require cautionary statements in Commission’s test template shall be no catalogues and other printed materials greater than 1.75 inches (44.4 mm). is February 10, 2009. By this rule, the (3) Latex balloon means a toy or deco- Commission is providing a grace period rative item consisting of a latex bag of 180 days, or until August 9, 2009, dur- that is designed to be inflated by air or ing which catalogues and other printed gas. The term does not include inflat- materials printed prior to February 10, able children’s toys that are used in 2009, may be distributed without such aquatic activities such as rafts, water cautionary statements. Catalogues and wings, swim rings, or other similar other printed materials that are print- items. ed on or after February 10, 2009, must (4) Marble means a ball made of hard have the required cautionary state- material, such as glass, agate, marble, ments. All catalogues and other print- or plastic, that is used in various chil- ed materials distributed on or after Au- dren’s games, generally as a playing gust 9, 2009, must comply with this piece or marker. The term ‘‘marble’’ rule. This rule addresses only cata- does not include a marble permanently logues and other printed materials; enclosed in a toy or game. A marble is however, the CPSIA extends the re- permanently enclosed if, when tested quirements for cautionary statements in accordance with 16 CFR 1500.53, it is to Internet advertisements as well. not removed from the toy or game.

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(5) Small part means any object enable consumers to purchase a prod- which, when tested in accordance with uct online or through the use of a tele- the procedures contained in 16 CFR phone number or fax number provided 1501.4(a) and 1501.4(b)(1), fits entirely on the Internet Web site. within the cylinder shown in Figure 1 (d) Advertising requirements. Any toy appended to 16 CFR part 1501. The use or game that requires a cautionary and abuse testing provisions of 16 CFR statement about the choking hazard 1500.51 through 1500.53 and 1501.4(b)(2) associated with small parts, balloons, do not apply to this definition. small balls, or marbles must bear that (6) Direct means of purchase or order cautionary statement in the product’s means any method of purchase that al- advertising if the advertising provides lows the purchaser to order the product a direct means to purchase or order the without being in the physical presence product. of the product. Advertising that pro- (1) The advertising for any article vides a direct means of purchase or that is a toy or game intended for use order of a product would include cata- by children who are at least three logues or other printed advertising ma- years old but less than six years of age terial that contain order blanks, tele- shall bear or contain the following cau- phone numbers or fax numbers for plac- tionary statement if the toy or game ing orders, and Internet Web sites that includes a small part:

(2) The advertising for any latex bal- latex balloon, shall bear the following loon, or toy or game that contains a cautionary statement:

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(3)(i) The advertising for any small of age or older shall bear the following ball intended for children three years cautionary statement:

(ii) The advertising for any toy or eight years of age that contains a game intended for children who are at small ball shall bear the following cau- least three years old but less than tionary statement:

(4)(i) The advertising for any marble or older shall bear the following cau- intended for children three years of age tionary statement:

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(ii) The advertising for any toy or eight years of age that contains a mar- game intended for children who are at ble shall bear the following cautionary least three years old but less than statement:

(e) Abbreviated warnings for catalogues (2) The full cautionary statements and other printed materials. Abbreviated shall be in conspicuous and legible type versions of the required cautionary in contrast by typography, layout or statements are permitted in each indi- color. vidual product advertisement, provided (3) The full cautionary statements that the corresponding full cautionary shall be clearly numbered according to statements appear in the catalogue and the following scheme: a statement referring to the precise location of the full cautionary state- Required cautionary statement Number ments—such as the page number on 16 CFR 1500.19(b)(1) 1 ...... 1 which the cautionary statements can 16 CFR 1500.19(b)(2) 2 ...... 2 be found—is located at the bottom of 16 CFR 1500.19(b)(3)(i) 3 ...... 3 each catalogue page that contains one 16 CFR 1500.19(b)(3)(ii) 4 ...... 4 or more abbreviated cautionary state- 16 CFR 1500.19(b)(4)(i) 5 ...... 5 6 ments. If abbreviated cautionary state- 16 CFR 1500.19(b)(4)(ii) ...... 6 ments are used: 1 See figure 1. 2 See Figure 2. (1) The full cautionary statements 3 See Figure 3. associated with the abbreviated cau- 4 See Figure 4. tionary statements shall appear: 5 See Figure 5. 6 See Figure 6. (i) Near the beginning of the catalogue, before any catalogue pages that (4) The abbreviated cautionary state- contain advertisements of products ments shall consist of items available for purchase, or 1500.20(e)(3)(i) through 1500.20(e)(3)(iv): (ii) Adjacent to the ordering informa- (i) A safety alert symbol substan- tion or order form in the catalogue. tially similar to that shown in figure 7.

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(ii) The phrase, ‘‘CHOKING HAZ- most restrictive age range for all re- ARD,’’ written in capital letters. quired cautionary statements for that (iii) Numbers, separated by commas product. Thus, if an advertised product and enclosed within a single set of pa- requires the cautionary statement rentheses, that identify the applicable specified in 16 CFR 1500.19(b)(2), the cautionary statements for the product prohibited age range in the abbreviated being advertised, followed by a period. cautionary statement shall be ‘‘Not for These numbers shall match the num- under 8 yrs.’’ bers used to identify each full cau- (v) For example, see Figure 8 for the tionary statement, as specified in abbreviated cautionary statement for 1500.20(e)(2). an advertisement of a product that re- (iv) A single prohibited age range quires the cautionary statements spec- written as either ‘‘Not for under 3 yrs’’ ified in 16 CFR 1500.19(b)(1) and 16 CFR or ‘‘Not for under 8 yrs,’’ based on the 1500.19(b)(2).

(f) Alternatives to cautionary state- require the same cautionary statements for individual product advertisement, that cautionary statement, in ments in catalogues and other printed ma- full, may appear at the top of the page terials. Multiple identical full or abbre- or pages in lieu of repeating the cau- viated cautionary statements may be tionary statement in each product ad- replaced with a single full cautionary vertisement, provided that it is com- statement under the following cir- municated to consumers that the cau- cumstances: tionary statement applies to all prod- (1) If all products available for pur- ucts on the catalogue page or pages. chase within a catalogue require the (g) Prominence and conspicuousness of same cautionary statement, that cau- labeling statements. The type size of ab- tionary statement, in full, may appear breviated cautionary statements shall on the front cover, or equally con- be reasonably related to the type size spicuous location, of the catalogue in of any other printed matter in the lieu of repeating the cautionary state- product advertisement, and must be in ment within the catalogue, provided conspicuous and legible type by typog- that it is communicated to consumers raphy, layout, or color with other that the cautionary statement applies printed matter in the advertisement to all products in the catalogue. and separated from other graphic mat- (2) If all products on one catalogue ter. page or on two facing catalogue pages

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(h) Business to Business Catalogue Ex- testing the toxic substances referred to ception. The requirements of section in § 1500.3(c)(1) and (2) is as follows: 24(c)of the Federal Hazardous Sub- (a) Acute dermal toxicity (single expo- stances Act, as amended by section 105 sure). In the acute exposures, the agent of the CPSIA, do not apply to cata- is held in contact with the skin by logues and other printed materials dis- means of a sleeve for periods varying tributed solely between businesses un- up to 24 hours. The sleeve, made of rub- less the recipient business is one that ber dam or other impervious material, could be expected to be purchasing the is so constructed that the ends are re- product for the use of children (instead inforced with additional strips and of for resale, e.g.). Examples of busi- should fit snugly around the trunk of nesses that can be expected to be pur- the animal. The ends of the sleeve are chasing products for the use of children tucked, permitting the central portion include day care centers, schools, and to ‘‘balloon’’ and furnish a reservoir for churches. the dose. The reservoir must have sufficient capacity to contain the dose [73 FR 67736, Nov. 17, 2008, as amended at 73 without pressure. In the following FR 71545, Nov. 25, 2008] table are given the dimensions of sleeves and the approximate body sur- § 1500.40 Method of testing toxic sub- face exposed to the test substance. The stances. sleeves may vary in size to accommo- Guidelines for testing the toxicity of date smaller or larger subjects. In the substances, including testing that does testing of unctuous materials that ad- not require animals, are presented in here readily to the skin, mesh wire the CPSC’s animal testing policy set screen may be employed instead of the forth in 16 CFR 1500.232. A weight-of- sleeve. The screen is padded and raised evidence analysis, including any of the approximately 2 centimeters from the following: existing human and animal exposed skin. In the case of dry powder data, structure activity relationships, preparations, the skin and substance physicochemical properties; and chem- are moistened with physiological sa- ical reactivity, or validated in vitro or line prior to exposure. The sleeve or in silico testing are recommended to screen is then slipped over the gauze evaluate existing information before in that holds the dose applied to the skin. vivo tests are considered. If in vivo test- In the case of finely divided powders, ing is conducted, a sequential testing the measured dose is evenly distributed strategy is recommended to reduce the on cotton gauze which is then secured number of test animals. The method of to the area of exposure.

DIMENSIONS OF SLEEVES FOR ACUTE DERMAL TOXICITY TEST [Test animal—Rabbits]

Measurements in centimeters Range of weight of ani- Average area of exposure Average percentage Diameter at ends Overall length mals (grams) (square centimeters) of total body surface

7.0 12.5 2,500–3,500 240 10.7

(b) Preparation of test animal. The ani- (c) Procedures for testing. The sleeve is mals are prepared by clipping the skin slipped onto the animal which is then of the trunk free of hair. Approxi- placed in a comfortable but immo- mately one-half of the animals are fur- bilized position in a multiple animal ther prepared by making epidermal holder. Selected doses of liquids and so- abrasions every 2 or 3 centimeters lon- lutions are introduced under the gitudinally over the area of exposure. sleeve. If there is slight leakage from The abrasions are sufficiently deep to the sleeve, which may occur during the penetrate the stratum corneum (horny first few hours of exposure, it is col- layer of the epidermis) but not to lected and reapplied. Dosage levels are distrub the derma; that is, not to ob- adjusted in subsequent exposures (if tain bleeding. necessary) to enable a calculation of a

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dose that would be fatal to 50 percent 24-hour period of exposure. This mate- of the animals. This can be determined rial aids in maintaining the test patch- from mortality ratios obtained at var- es in position and retards the evapo- ious doses employed. At the end of 24 ration of volatile substances. After 24 hours the sleeves or screens are re- hours of exposure, the patches are removed, the volume of unabsorbed ma- moved and the resulting reactions are terial (if any) is measured, and the skin evaluated on the basis of the des- reactions are noted. The subjects are ignated values in the following table: cleaned by thorough wiping, observed for gross symptoms of poisoning, and Skin reaction Value 1 then observed for 2 weeks. Erythema and eschar formation: No erythema ...... 0 [38 FR 27012, Sept. 27, 1973, as amended at 77 Very slight erythema (barely perceptible) ...... 1 FR 73294, Dec. 10, 2012; 83 FR 8342, Feb. 27, Well-defined erythema ...... 2 2018] Moderate to severe erythema ...... 3 Severe erythema (beet redness) to slight § 1500.41 Method of testing primary ir- eschar formations (injuries in depth) ...... 4 Edema formation: ritant substances. No edema ...... 0 Guidelines for testing the dermal ir- Very slight edema (barely perceptible) ...... 1 ritation and corrosivity properties of Slight edema (edges of area well defined by definite raising) ...... 2 substances, including testing that does Moderate edema (raised approximately 1 not require animals, are presented in millimeter) ...... 3 the CPSC’s animal testing policy set Severe edema (raised more than 1 millimeter and extending beyond the area of expo- forth in 16 CFR 1500.232. A weight-of- sure) ...... 4 evidence analysis or a validated in vitro 1 The ‘‘value’’ recorded for each reading is the average test method is recommended to evalu- value of the six or more animals subject to the test. ate existing information before in vivo tests are considered. This analysis Readings are again made at the end of should include all of the following that a total of 72 hours (48 hours after the are available: human and animal data, first reading). An equal number of ex- structure activity relationships, phys- posures are made on areas of skin that icochemical properties, and dermal have been previously abraded. The toxicity. If in vivo testing is conducted, abrasions are minor incisions through a sequential testing strategy is rec- the stratum corneum, but not suffi- ommended to reduce the number of ciently deep to disturb the derma or to test animals. The method of testing produce bleeding. Evaluate the reac- the dermal corrosivity and primary ir- tions of the abraded skin at 24 hours ritation of substances referred to in and 72 hours, as described in this para- § 1500.3(c)(3) and (4), respectively, is a graph. Add the values for erythema and patch-test technique on the abraded eschar formation at 24 hours and at 72 and intact skin of the albino rabbit, hours for intact skin to the values on clipped free of hair. Primary irritation abraded skin at 24 hours and at 72 to the skin is measured by a patch-test hours (four values). Similarly, add the technique on the abraded and intact values for edema formation at 24 hours skin of the albino rabbit, clipped free and at 72 hours for intact and abraded of hair. A minimum of six subjects are skin (four values). The total of the used in abraded and intact skin tests. eight values is divided by four to give Introduce under a square patch, such the primary irritation score; for exam- as surgical gauze measuring 1 inch by 1 ple: inch and two single layers thick, 0.5 Exposure Evalua- milliliter (in the case of liquids) or 0.5 Skin reaction time tion value gram (in the case of solids and (hours) semisolids) of the test substance. Dis- Erythema and eschar formation: solve solids in an appropriate solvent Intact skin ...... 24 2 and apply the solution as for liquids. Do ...... 72 1 Abraded skin ...... 24 3 The animals are immobilized with Do ...... 72 2 patches secured in place by adhesive tape. The entire trunk of the animal is Subtotal ...... 8 then wrapped with an impervious ma- Edema formation: terial, such as rubberized cloth, for the Intact skin ...... 24 0

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Exposure other eye, remaining untreated, serves Skin reaction time Evalua- (hours) tion value as a control. For testing liquids, 0.1 milliliter is used. For solids or pastes, Do ...... 72 1 100 milligrams of the test substance is Abraded skin ...... 24 1 Do ...... 72 2 used, except that for substances in flake, granule, powder, or other partic- Subtotal ...... 4 ulate form the amount that has a vol- Total ...... 12 ume of 0.1 milliliter (after compacting as much as possible without crushing Thus, the primary irritation score is 12 or altering the individual particles, ÷ 4 = 3. such as by tapping the measuring container) shall be used whenever this vol- [38 FR 27012, Sept. 27, 1973, as amended at 77 ume weighs less than 100 milligrams. In FR 73294, Dec. 10, 2012] such a case, the weight of the 0.1 milli- § 1500.42 Test for eye irritants. liter test dose should be recorded. The eyes are not washed following instilla- Guidelines for in vivo and in vitro tion of test material except as noted testing of ocular irritation of sub- below. stances, including testing that does not require animals, are presented in the (2) The eyes are examined and the CPSC’s animal testing policy set forth grade of ocular reaction is recorded at in 16 CFR 1500.232. A weight-of-evidence 24, 48, and 72 hours. Reading of reac- analysis or a validated in vitro test tions is facilitated by use of a bin- method is recommended to evaluate ocular loupe, hand slit-lamp, or other existing information before in vivo expert means. After the recording of tests are considered. This analysis observations at 24 hours, any or all should include any of the following: eyes may be further examined after ap- Existing human and animal data on oc- plying fluorescein. For this optional ular or dermal irritation, structure ac- test, one drop of fluorescein sodium tivity relationships, physicochemical ophthalmic solution U.S.P. or equiva- properties, and chemical reactivity. If lent is dropped directly on the cornea. in vivo testing is conducted, a sequen- After flushing out the excess fluores- tial testing strategy is recommended cein with sodium chloride solution to reduce the number of test animals. U.S.P. or equivalent, injured areas of Additionally, the routine use of topical the cornea appear yellow; this is best anesthetics, systemic analgesics, and visualized in a darkened room under ul- humane endpoints to avoid or minimize traviolet illumination. Any or all eyes pain and distress in ocular safety test- may be washed with sodium chloride ing is recommended. solution U.S.P. or equivalent after the (a)(1) In the method of testing the oc- 24-hour reading. ular irritation of a substance referred (b)(1) An animal shall be considered to in § 1500.3(c)(4), six albino rabbits are as exhibiting a positive reaction if the used for each test substance. Animal test substance produces at any of the facilities for such procedures shall be readings ulceration of the cornea so designed and maintained as to ex- (other than a fine stippling), or opacity clude sawdust, wood chips, or other ex- of the cornea (other than a slight traneous materials that might produce eye irritation. Both eyes of each ani- dulling of the normal luster), or in- mal in the test group shall be examined flammation of the iris (other than a before testing, and only those animals slight deepening of the folds (or rugae) without eye defects or irritation shall or a slight circumcorneal injection of be used. The animal is held firmly but the blood vessels), or if such substance gently until quiet. The test material is produces in the conjunctivae (exclud- placed in one eye of each animal by ing the cornea and iris) an obvious gently pulling the lower lid away from swelling with partial eversion of the the eyeball to form a cup into which lids or a diffuse crimson-red with indi- the test substance is dropped. The lids vidual vessels not easily discernible. are then gently held together for one (2) The test shall be considered posi- second and the animal is released. The tive if four or more of the animals in

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the test group exhibit a positive reac- uniform rate across the cup at specified in- tion. If only one animal exhibits a posi- tervals. The flashpoint is taken as the lowest tive reaction, the test shall be regarded temperature at which application of the test as negative. If two or three animals a flame causes the vapor at the surface of the positive reaction, the test is repeated liquid to flash, that is, ignite but not con- using a different group of six animals. tinue to burn. The second test shall be considered APPARATUS positive if three or more of the animals exhibit a positive reaction. If only one 3. The Tag open-cup tester is illustrated in or two animals in the second test ex- Fig. 1. It consists of the following parts, hibit a positive reaction, the test shall which must conform to the dimensions be repeated with a different group of shown, and have the additional characteristics as noted: six animals. Should a third test be needed, the substance will be regarded as an irritant if any animal exhibits a positive response. (c) To assist testing laboratories and others interested in interpreting ocular irritation test results, the CPSC animal testing policy Web page at http:// www.cpsc.gov/library/animaltesting.html will contain the scoring system defined in the U.S. EPA’s Test Guideline, OPPTS 870.2400: Acute Eye Irritation 1 or the OECD Test Guideline 405: Acute Eye Irritation/Corrosion.2 [38 FR 27012, Sept. 27, 1973; 38 FR 30105, Nov. 1, 1973; 62 FR 46667, Sept. 4, 1997; 77 FR 73294, Dec. 10, 2012]

§ 1500.43 Method of test for flashpoint of volatile flammable materials by Tagliabue open-cup apparatus.

SCOPE 1. (a) This method describes a test procedure for the determination of open-cup flashpoints of volatile flammable materials having flashpoints below 175 °F. (b) This method, when applied to paints and resin solutions which tend to skin over (a) Copper bath, preferably equipped with a or which are very viscous, gives less repro- constant level overflow so placed as to main- ducible results than when applied to sol- tain the bath liquid level 1⁄8-inch below the vents. rim of the glass cup. (b) Thermometer holder. Support firmly with OUTLINE OF METHOD ringstand and clamp. 2. The sample is placed in the cup of a Tag (c) Thermometer. For flashpoints above 40 Open Tester, and heated at a slow but con- °F., use the ASTM Tag Closed Tester Ther- stant rate. A small test flame is passed at a mometer, range of + 20 to + 230 °F., in 1 °F. divisions, and conforming to thermometer 1 EPA. 1998. Health Effects Test Guidelines, 9F. of ASTM Standard E 1. For flashpoints OPPTS 870.2400 Acute Eye Irritation. EPA from 20 °F. to 40 °F., use ASTM Tag Closed 712–C–98–195. Washington, DC: U.S. Environ- Tester, Low Range, Thermometer 57F. For mental Protection Agency. (Available: http:// flashpoints below 20 °F., use ASTM Ther- iccvam.niehs.nih.gov/SuppDocs/FedDocs/EPA/ mometer 33F. The original Tag Open-Cup EPAl870l2400.pdf) (Paper Scale) Thermometer will be a permis- 2 OECD. 2002. OECD Guideline for the Test- sible alternate until January 1, 1962. It is ing of Chemicals 405: Acute Eye Irritation/ calibrated to ¥20 °F. Corrosion. Paris: Organisation for Economic (d) Glass test cup. Glass test cup (Fig. 2), of Co-operation and Development. (Available: molded clear glass, annealed, heat-resistant, http://iccvam.niehs.nih.gov/SuppDocs/FedDocs/ and free from surface defects. OECD/OECDtg405.pdf)

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the holder on a suitable ringstand support adjacent to the flash cup. (i) Draft shield, consisting of two rectangular sheets of noncombustible material, 24 inches × 28 inches, are fastened together along the 28-inch side, preferably by hinges. A triangular sheet, 24 inches × 24 inches × 34 inches is fastened by hinges to one of the lat- eral sheets (to form a top when shield is open). The interior of the draft shield shall be painted a flat black.

PROCEDURE 4. (a) Place the tester on a solid table free of vibration, in a location free of perceptible draft, and in a dim light. (b) Run water, brine, or water-glycol solution into the bath to a predetermined level, which will fill the bath to 1⁄8-inch below the top when the cup is in place. An overflow is permissible for water-level control. (c) Firmly support the thermometer vertically halfway between the center and edge of the cup on a diameter at right angles to the guide wire, or on a diameter passing through the center of the cup and the pivot of the taper. Place so that the bottom of the bulb is 1⁄4-inch from the inner bottom surface (e) Leveling device. Leveling device or of the cup. If the old Tagliabue thermometer guide, for proper adjustment of the liquid is used, immerse to well cover the mercury level in the cup (Fig. 3). This shall be made bulb, but not the wide body of the thermom- of No. 18-gage polished aluminum, with a eter. projection for adjusting the liquid level when (d) Fill the glass cup with the sample liquid to a depth just 1⁄8-inch below the edge, as the sample is added to exactly 1⁄8-inch below determined by the leveling device. the level of the edge or rim of the cup. (e) Place the guide wire or swivel device in position, and set the draft shield around the tester so that the sides from right angles with each other and the tester is well toward the back of the shield. (f) If a guide wire is used, the taper, when passed, should rest lightly on the wire, with the end of the jet burner just clear of the edge of the guide wire. If the swivel-type (f) ‘‘Micro,’’ or small gas burner of suitable holder is used, the horizontal and vertical dimensions for heating the bath. A screw positions to the jet are so adjusted that the clamp may be used to help regulate the gas. jet passes on the circumference of a circle, A small electric heater may be used. having a radius of at least 6 inches, across (g) Ignition taper, which is a small the center of the cup at right angles to the straight, blow-pipe type gas burner. The test diameter passing through the thermometer, flame torch prescribed in the method of test and in a plane 1⁄8-inch above the upper edge for flash and fire points by Cleveland Open of the cup. The taper should be kept in the Cup (ASTM designation: D 92) is satisfac- ‘‘off’’ position, at one end or the other of the tory. swing, except when the flame is applied. (h) Alternative methods for maintaining (g) Light the ignition flame and adjust it the ignition taper in a fixed horizontal plane to form a flame of spherical form matching above the liquid may be used, as follows: in size the 5⁄52-inch sphere on the apparatus. (1) Guide wire, 3⁄32-inch in diameter and 31⁄2 (h) Adjust heater source under bath so that inches in length, with a right-angle bend 1⁄2- the temperature of the sample increases at a inch from each end. This wire is placed snug- rate of 2±0.5 °F. per minute. With viscous ma- ly in holes drilled in the rim of the bath, so terials this rate of heating cannot always be that the guide wire is 5⁄8-inch from the center obtained. of the cup and resting on the rim of the cup. INITIAL TEST (2) Swivel-type taper holder, such as is used in ASTM METHOD D 92. The height and 5. Determine an approximate flashpoint by position of the taper are fixed by adjusting passing the taper flame across the sample at

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intervals of 2 °F. Each pass must be in one Specific gravity: 0.8175 to 0.8185 at 20 °C./20 direction only. The time required to pass the °C. as determined by means of a cali- ignition flame across the surface of the sam- brated pycnometer. ple should be 1 second. Remove bubbles from Distillation range: Shall entirely distill the surface of the sample liquid before start- within a 1.0 °C. range which shall include ing a determination. Meticulous attention to the temperature 80.4 °C. as determined by all details relating to the taper, size of taper ASTM method D 1078. flame, and rate of passing the taper is nec- Average these values for each compound. If essary for good results. When determining the difference between the values for these the flashpoint of viscous liquids and those two compounds is less than 15 °F. (8.5 °C.) or liquids that tend to form a film of polymer, more than 27 °F. (16 °C.), repeat the deter- etc., on the surface, the surface film should minations or obtain fresh standards. be disturbed mechanically each time before (b) Calculate a correction factor as follows: the taper flame is passed. X = 92 ¥ A RECORDED TESTS Y = 71 ¥ B 6. Repeat the procedure by cooling a fresh Correction = (X + Y) / 2. portion of the sample, the glass cup, the bath Where: solution, and the thermometer at least 20 °F. below the approximate flashpoint. Resume A = Observed flash of p- xylene, and heating, and pass the taper flame across the B = Observed flash of isopropyl alcohol. sample at two intervals of 2 °F. until the Apply this correction of all determinations. flashpoint occurs. Half units in correction shall be discarded.

REPORTING DATA PRECISION 7. The average of not less than three re- 9. (a) For hydrocarbon solvents having corded tests, other than the initial test, flashpoints between 60 °F. and 110 °F., repeat- shall be used in determining the flashpoint ability is ±2 °F. and the reproducibility is ±5 and flammability of the substance. °F. (b) If results from two tests differ by more STANDARDIZATION than 10 °F., they shall be considered uncertain and should be checked. This calibration 8. (a) Make determinations in triplicate on procedure provided in this method will can- the flashpoint of standard paraxylene and of cel out the effect of barometric pressure if standard isopropyl alcohol which meet the calibration and tests are run at the same following specifications: pressure. Data supporting the precision are (i) Specifications for p-xylene, flashpoint given appendix III of the 1956 Report of Com- check grade. p-xylene shall conform to the fol- mittee D–1 on Paint, Varnish, Lacquers and lowing requirements; Related Products, Proceedings, Am. Soc. Specific gravity: 15.56 °C./15.56 °C., 0.860 min- Testing Mats., Vol. 56 (1956). imum, 0.866 maximum NOTE: The test apparatus and procedure described in § 1500.43 may be used by manufac- Boiling range: 2 °C. maximum from start to turers and labelers of products subject to the dry point when tested in accordance with Federal Hazardous Substances Act to deter- the method of test for distillation of in- mine flashpoint temperatures of those prod- dustrial aromatic hydrocarbons (ASTM ucts under the conditions set forth in designation: D 850), or the method of test § 1500.3(c)(6)(iv), as amended. for distillation range of lacquer solvents and diluents (ASTM) designation D 1078). [51 FR 28537, Aug. 8, 1986] The range shall include the boiling point of pure P-xylene, which is 138.35 °C. § 1500.43a Method of test for flashpoint (281.03 °F.). of volatile flammable materials. Purity: 95 percent minimum, calculated in (a) Scope. (1) This method describes accordance with the method of test for the test procedure which the Commis- determination of purity from freezing sion will use for the determination of points of high-purity compounds (ASTM designation: D 1016), from the experi- the flashpoint of volatile flammable 1 mentally determined freezing point, materials, using a Setaflash low-range measured by the method of test for meas- closed tester, or an apparatus pro- urement of freezing points of high-purity ducing equivalent results. The method compounds for evaluation of purity described in this section is essentially (ASTM designation: D 1015). a Setaflash equilibrium procedure (ii) Specifications for ispropanol, flash point check grade. Isopropanol shall conform to the 1 Setaflash is a registered trademark of following requirements: Stanhope-Seta Limited, Surrey, England.

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which closely parallels the test method the apparatus that is maintained at designated ASTM D 3828-81, ‘‘Standard the expected flashpoint. After a speci- Test Methods for Flash Point by fied time a test flame is applied and Setaflash Closed Tester,’’ published by the observation made whether or not a the American Society for Testing and flash occurred. Materials (ASTM), 1916 Race Street, (ii) The specimen is removed from Philadelphia, Pennsylvania 19103. Man- the cup, the cup cleaned, and the cup ufacturers and labelers of products sub- temperature adjusted 5 °C (9 °F), lower ject to labeling and other requirements or higher depending on whether or not under the Federal Hazardous Sub- a flash occurred previously. A fresh stances Act may use other apparatus specimen is introduced and tested. This and/or test methods which produce procedure is repeated until the equivalent results. flashpoint is established within 5 °C (9 (2) At the option of the user, the pro- °F). cedures described in this section may (iii) The procedure is then repeated be used to determine the actual at 1 °C (2 °F) intervals until the flashpoint temperature of a sample or flashpoint is determined to the nearest to determine whether a product will or 1 °C (2 °F). will not flash at a specified tempera- (iv) If improved accuracy is desired ture (flash/no flash). the procedure is repeated at 0.5 °C (1 (3) If the substance to be tested has a °F). Test procedures are set forth in de- viscosity greater than 150 Stokes at 77 tail at § 1500.43a(j). °F (25 °C), see paragraph (n) of this sec- (3) The test procedures will be modi- tion for modifications to the testing fied, where necessary, to ensure that procedure. the results obtained reflect the hazard (4) If the Commission has reason to of the substance under reasonably fore- believe on the basis of reliable experi- seeable conditions of use. Thus, for ex- ence or other relevant information or ample, the material, if a mixture, will data that the flammability hazard of a normally be tested as it comes from substance is greater or less than its the container, and/or after a period of flammability classification based on evaporation. The period of evaporation flashpoint temperature determined in for a material which is a mixture will accordance with this § 1500.43a and that normally be the time required for the the substance should be reclassified, mixture to evaporate in an open beaker the Commission will initiate a rule- under ambient conditions to 90 percent making proceeding for reclassification of its original volume, or a period of of the substance. Product manufactur- four hours, whichever occurs first. ers and labelers may use reliable expe- However, this period of evaporation rience or other relevant information or will be changed if the results obtained data in addition to the flashpoint tem- do not represent the hazard of the sub- perature of a substance as a basis for stance under reasonably foreseeable compliance with any applicable re- conditions of use. quirements of the Federal Hazardous (c) Definition of flashpoint. The lowest Substances Act in the absence of a rule temperature of the sample, corrected issued by the Commission to reclassify to a barometric pressure of 101.3 kPa the substance. (760 mm Hg), at which application of a (b) Summary of test methods. (1) Meth- test flame causes the vapor of the sam- od A—Flash/No Flash Test. A specified ple to ignite under specified conditions volume of sample is introduced by a sy- of test. The sample is deemed to have ringe into the cup of the apparatus flashed when a large flame appears and that is set and maintained at the speci- instantaneously propagates itself over fied temperature. After a specific time the surface of the sample. Occasion- a test flame is applied and an observa- ally, particularly near actual tion made as to whether or not a flash flashpoint, the application of the test occurred. Test procedures are set forth flame will cause a halo or an enlarged in detail in § 1500.43a(i). flame; this is not a flash and should be (2) Method B—Finite (or Actual) ignored. Flashpoint. (i) A specified voume of (d) Test apparatus. The test apparatus sample is introduced into the cup of is an equilibrium closed-cup tester

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with a range up to 100 °C (212 °F). The Advance the temperature control knob essential dimensions and requirements clockwise until the indicator light is are shown in figure 1 and table 3, and illuminated. 3 Advance the knob clock- are described in § 1500.43a(m). Closed- wise to the next numbered line. After cup flashpoint testers and accessories the thermometer mercury column meeting these requirements are avail- ceases to advance, record the dial read- able from commercial suppliers and ing and the temperature. Advance the distributors of laboratory equipment. knob clockwise to the next numbered (e) Safety precautions. The operator line. After the thermometer mercury must exercise and take appropriate column ceases to advance, read the dial safety precautions during the initial reading and the temperature. Repeat application of the test flame to the this procedure through the full range sample. Samples containing low-flash of the instrument. Plot the dial read- material may give an abnormally strong flash when the test flame is first ings versus the respective tempera- applied. tures. (f) Preparation of samples. (1) Erro- (2) Standardize the instrument using neously high flashpoints may be ob- a sample of material meeting the speci- tained if precautions are not taken to fications in table 1. If the average of avoid the loss of volatile material. In two determinations falls within the ac- preliminary tests of materials taken ceptable limits the instrument is as- directly from the container, do not sumed to be operating properly. If the open containers unnecessarily and average of the two determinations does make a transfer unless the sample tem- not fall within this range, check the perature is at least 10 °C (18 °F) below manufacturer’s operating and mainte- the expected flashpoint. Do not use nance instructions and determine that samples in leaky containers for this they are being followed. In particular, test. be sure that the cup lid assembly (2) Do not store samples in plastic makes a vapor-tight seal with the cup, (polyethylene, polypropylene, etc.) bot- the shutter provides a light-tight seal, tles since volatile material may diffuse and that adequate heat transfer paste through the walls of the bottle. surrounds the thermometer bulb and (3) A 2-ml specimen is required for the immersed portion of the barrel. each test. If possible, obtain at least a (i) Test Method A—for determining 50-ml sample from the bulk test site (1) Determine the tar- and store in a clean, tightly closed con- Flash/No Flash. tainer. get flashpoint as follows: ° (g) Preparation of apparatus. (1) Place (i) Target flashpoint, C = Sc—0.25 the tester on a level, stable surface. (101.3—A) Unless tests are made in a draft-free (ii) Target flashpoint, °C = Sc—0.03 area, surround the tester on three sides (760–B) with a shield for protection. Do not (iii) Target flashpoint, °F = Sf—0.06 rely on tests made in a laboratory (760–B) draft hood or near ventilators. (2) Read the manufacturer’s instruc- where: tions on the care and servicing of the Sc = specification, or uncorrected target, instrument and for correct operation of flashpoint, °C, its controls. Sf = specification, or uncorrected target, ° (h) Calibration and standardization. (1) flashpoint, F, Before initial use determine and plot the relationship between the temperature control dial and the thermometer small knob) at its mid-position and allow it readings at each major (numbered) dial to remain there throughout the calibration. division as follows: The calibration is determined by adjusting the coarse control (large, outer knob) only. Turn the temperature control knob 2 3 When using the tester, it will be found fully counterclockwise (‘‘O’’ reading). that the indicator light may not illuminate and the temperature may not rise until a 2 If the instrument has two temperature temperature control dial setting between one control knobs, set the fine control (center, and two is reached.

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B = ambient barometric pressure, mm Hg, 4 and keep dry ice in a canvas bag, espe- and cially when cracking. A = ambient barometer pressure, kPa. 4 (ii) For target temperature above (2) Inspect the inside of the sample ambient. Switch the instrument on and cup, lid, and shutter mechanism for turn the coarse temperature control cleaniness and freedom from contami- knob fully clockwise (full on) causing nation. Use an absorbent paper tissue the indicator light to illuminate. 6 to wipe clean, if necessary. Put cover When the thermometer indicates a in place and lock securely. The filing temperature about 3 °C (5 °F) below the orifice may be convenienty cleaned target (or specification) temperature, with a pipe cleaner. reduce the heat input to the sample (3) Set the instrument at the target cup by turning the coarse temperature temperature. control knob counter-clockwise to the (i) For target temperature below am- desired control point (see bient. The instrument power switch is § 1500.43a(i)(1)). When the indicator to be in the off position. Fill the light slowly cycles on and off read the refigerant-charged cooling block with a temperature on the thermometer. If suitable material. 5 Raise the lid and necessary, adjust the fine (center) tem- shutter assembly, and position the base perature control knob to obtain the de- of the block in the sample cup, being sired test (target) temperature. When careful not to injure or mar the cup. the test temperature is reached and the When the thermometer reads approxi- indicator lamp slowly cycles on and mately 6 to 10 °C (10 to 20 °F) below the off, prepare to introduce the sample. target temperature, remove the cooling (4) Charge the syringe with a 2-ml block and quickly dry the cup with a specimen of the sample 7 to be tested; paper tissue to remove any moisture. transfer the syringe to the filling ori- Immediately close the lid and shutter fice, taking care not to lose any sam- assembly and secure. Prepare to intro- ple; discharge the test specimen into duce the sample using the syringe, the cup by fully depressing the syringe both of which have been precooled to a plunger, remove the syringe. temperature 5 to 10 °C (10 to 20 °F) (5)(i) Set the timer 8 by rotating its below the target temperature. knob clockwise to its stop. Open the (A) Caution: Do not cool the sample gas control valve and light the pilot block below ¥38 °C, the freezing point and test flames. Adjust the test flame of mercury. with the pinch valve to conform to the (B) Caution: Acetone is extremely size of the 4-mm (5/32-in.) gage. flammable. Keep away from heat, (ii) After the time signal indicates 8 sparks, and flames and keep container the specimen is at test temperature , closed when not actually pouring ace- apply the test flame by slowly and uni- tone. Use only in a well-ventilated formly opening the shutter and closing area. Avoid inhalation and contact with the eyes or skin. Use cloth or 6 The target temperature may be attained leather gloves, goggles or safety shield, by originally turning the coarse temperature control knob to the proper setting (see § 1500.43a(h)(1) for the temperature desired 4 The barometric pressure used in this cal- rather than the maximum setting (full on). culation must be the ambient pressure for The elapsed time to reach the temperature the laboratory at the time of test. Many an- will be greater, except for maximum tem- eroid barometers, such as those used at perature. However, less attention will be re- weather stations and airports, are quired during the intervening period. precorrected to give sea-level readings; these 7 For target or expected temperatures must not be used. below ambient, both syringe and sample 5 If the target or specification temperature must be precooled to cup temperature (see is not less than 5 °C (40 °F) crushed ice and § 1500.43a(i)(3)(i)) before the specimen is water may be used as charging (cooling) taken. fluid. If below 5 °C (40 °F), a suitable charg- 8 For target temperatures below ambient, ing (cooling) fluid is solid carbon dioxide do not set the timer. Adjust the test flame (dry ice) and acetone. If the refrigerant and allow the temperature to rise under am- charged cooling module is unavailable, refer bient conditions until the target tempera- to the manufacturer’s instruction manual ture is reached. Immediately apply the test for alternative methods of cooling. flame as detailed.

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it completely over a period of approxi- °C (5 °F) below the estimated mately 21⁄2 s. 9 Watch closely for a flash flashpoint, turn the coarse tempera- at the cup openings. ture knob counter-clockwise to the dial (iii) The sample is deemed to have reading representing the estimated flashed when a large flame appears and flashpoint temperature as shown on instantaneously propagates itself over the calibration curve (See the surface of the sample (see § 1500.43a(h)(1)). When the indicator § 1500.43a(c)). light slowly cycles on and off, read the (6) Record the test results as ‘‘flash’’ temperature on the thermometer. If or ‘‘no flash’’ and the test temperature. necessary, adjust the fine temperature (7) Turn off the pilot and test flames control knob to obtain the exact de- using the gas control valve. Remove sired temperature. the sample and clean the instrument. (4)(i) Charge the syringe 7 with a 2 ml It may be necessary to allow the cup specimen of the sample 7 to be tested; temperature to decline to a safe level transfer the syringe to the filling ori- before cleaning. fice, taking care not to lose any sam- (j) Test Method B—for determining Fi- ple; discharge the test specimen into nite or Actual Flashpoint. (1) Inspect the the cup by fully depressing the syringe inside of the sample cup, lid, and shut- plunger; remove the syringe. ter mechanism for cleanliness and free- (ii) Set the timer 10 by rotating its dom from contamination. Use an ab- knob clockwise to its stop. Open the sorbent paper tissue to wipe clean, if gas control valve and ignite the pilot necessary. Put cover in place and lock and test flames. Adjust the test flame securely. The filling orifice may be with the pinch valve to conform to the conveniently cleaned with a pipe clean- size of the 4-mm (5⁄32-in.) gage. er. (iii) After the audible time signal in- (2) For expected flashpoints below dicates the specimen is at test tem- 10 ambient. (i) The instrument power perature, apply the test flame by switch is to be in off position. Fill the slowly and uniformly opening the shut- refrigerant-charged cooling block with ter and then closing it completely over 1 a suitable material. 5 Raise the lid and a period of approximately 2 ⁄2 s. Watch shutter assembly, and position the base closely for a flash at the cup opening. of the block in the sample cup, being (iv) The sample is deemed to have careful not to injure or mar the cup. flashed only if a large flame appears When the thermometer reaches a tem- and instantaneously propagates itself perature 5 to 10 °C (10 to 20 °F) below over the surface of the sample. (See the expected flashpoint, remove the § 1500.43a(c).) (v) Turn off the pilot and test flames cooling block and quickly dry the cup using the gas control valve. When the with a paper tissue to remove any cup temperature declines to a safe moisture. Immediately close the lid level, remove the sample and clean the and shutter assembly and secure. Pre- instrument. pare to introduce the sample using the (5)(i) If a flash was observed in syringe, both of which have been § 1500.43a(j)(4)(iii) repeat the procedure precooled to a temperature 5 to 10 °C given in § 1500.43a(j)(2) or (3), and in (10 to 20 °F) below the expected tem- § 1500.43a(j)(4), testing a new specimen perature (See § 1500.43a(j)(5)). at a temperature 5 °C (9 °F) below that (ii) Caution: Do not cool the sample at which the flash was observed. block below ¥38 °C, the freezing point (ii) If necessary, repeat the procedure of mercury. in § 1500.43a(j)(5)(i), lowering the tem- (3) For tests where the expected perature 5 °C (9 °F) each time, until no flashpoint is above ambient. Turn the flash is observed. 9 coarse temperature control knob fully clockwise (full on) causing the indicator light to illuminate. When the 10 For expected flashpoint below ambient, thermometer reaches a temperature 3 do not set the timing device. Adjust the test flame. Allow the temperature to rise under ambient conditions until the temperature 9 Never apply the test flame to the speci- reaches 5 °C (9 °F) below the expected men more than once. Fresh portions of the flashpoint. Immediately apply the test sample must be used for each test. flame.

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(iii) Proceed to § 1500.43a(j)(7). (l) Precision. The precision of the (6)(i) If no flash was observed in method as determined by statistical § 1500.43a(j)(4)(iii) repeat the procedure examination of interlaboratory results given in § 1500.43a(j)(2) or (3), and in is as follows: § 1500.43a(j)(4), testing a fresh specimen (1) Repeatability. The difference be- at a temperature 5 °C (9 °F) above that tween two test results obtained by the at which the specimen was tested in same operator with the same apparatus § 1500.43a(j)(4)(iii). under constant operating conditions on (ii) If necessary repeat the procedure identical test material, would, in the in § 1500.43a(j)(6)(i), above, raising the long run, in the normal and correct op- temperature 5 °C (9 °F) each time until eration of the test method, exceed the a flash is observed. 9 values shown in table 2 only in 1 case (7) Having established a flash within in 20. two temperatures 5 °C (9 °F) apart, re- (2) Reproducibility. The difference peat the procedure at 1 °C (2 °F) inter- between two single and independent re- vals from the lower of the two tem- sults obtained by different operators peratures until a flash is observed. 9 working in different laboratories on Record the temperature of the test identical test material, would, in the when this flash occurs as the long run, in the normal and correct op- flashpoint, allowing for any known eration of the test method, exceed the thermometer correction. Record the values shown in table 2 only in 1 case barometric pressure. 4 in 20. (8) The flashpoint determined in (m) Flash Test Apparatus. (1)(i) Unit § 1500.43a(j)(7) will be to the nearest 1 °C consisting of an aluminum alloy or (2 °F). If improved accuracy is desired nonrusting metal block of suitable con- (that is, to the nearest 0.5 °C (1 °F)), ductivity with a cylindrical depression, test a fresh specimen at a temperature or sample cup, over which is fitted a 0.5 °C (1 °F) below that at which the cover. A thermometer is embedded in flash was observed in § 1500.43a(j)(7). If the block. no flash is observed, the temperature (ii) The cover is fitted with an open- recorded in § 1500.43a(j)(7), is the ing slide and a device capable of insert- flashpoint to the nearest 0.5 °C (1 °F). If ing an ignition flame (diameter 4±0.5 a flash is observed at the lower tem- mm) into the well when the slide de- perature, record this latter tempera- vice shall intersect the plane of the un- ture as the flashpoint. derside of the cover. The cover is also (9) Turn off the pilot and test flames provided with an orifice extending into using the gas control valve. When the the sample well for insertion of the cup temperature declines to a safe test sample and also a suitable clamp- level, remove the sample and clean the ing device for securing the cover tight- instrument. ly to the metal block. The three open- (k) Calculations. If it is desired to cor- ings in the cover shall be within the direct the observed finite flashpoint for ameter of the sample well. When the the effect of barometric pressure, pro- slide is in the open position, the two ceed as follows: Observe and record the openings in the slide shall coincide ex- ambient barometric pressure 4 at the actly with the two corresponding open- time of the test. If the pressure differs ings in the cover. from 101.3 kPa (760 mm Hg), correct the (iii) Electrical heaters are attached flashpoint as follows: to the bottom of the cup in a manner (1) Corrected flashpoint (°C) = C + 0.25 that provides efficient transfer of heat. (101.3–A) An electronic heat control is required (2) Corrected flashpoint (°F) = F + to hold the equilibrium temperature, in 0.06 (760–B) a draft-free area, within 0.1 °C (0.2 °F) (3) Corrected flashpoint (°C) = C + 0.03 for the low-temperature tester. A vis- (760–B) ual indicator lamp shows when energy is or is not being applied. Energy may Where: F = Observed flashpoint, °F, C = observed flashpoint, °C, be supplied from 120 or 240 V, 50 or 60 B = ambient barometric pressure, mm Hg; Hz main service. and (2)(i) Test flame and pilot flame- A = ambient barometric pressure, kPa. regulatable test flame, for dipping into

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the sample cup to try for flash, and a TABLE 1—CALIBRATION OF TESTER—Continued pilot flame, to maintain the test flame, Boiling range ...... 2 °C maximum including are required. These flames may be 138.35 °C (281.03 °F). Freezing point ...... 11.23 °C (52.2 °F) minimum. fueled by piped gas service. A gage ring Flashpoint °C (acceptable 25.6 ±0.5 (78 ±1 F). 4mm (5/32 in.) in diameter, engraved on range). the lid near the test flame, is required A Available as Flash Point Check Fluid (p-xylene) from Spe- cial Products Div., Phillips Petroleum Co., Drawer ‘O,’ Borger, to ensure uniformity in the size of the Texas 79007. test flame. B Caution: Handle xylene with care. Avoid inhalation; use only in a well-ventilated area. Avoid prolonged or repeated (ii) Caution: Never recharge the self- contact with skin. Keep away from flames and heat, except as contained gas tank at elevated tem- necessary for the actual flash point determination. perature, or with the pilot or test flames lighted, nor in the vicinity of TABLE 2—REPEATABILITY AND REPRODUCIBILITY other flames. ° ° Repeatability, Reproducibility, (iii) Audible Signal is required. The Temperature, C ( F) °C (°F) °C (°F) audiable signal is given after 1 min in the case of the low-temperature tester. 20(68) ...... 0.5(0.9) 1.4(2.6) 70(158) ...... 0.5(0.9) 2.9(5.3) (iv) Syringe. 2ml capacity, equipped 93(200) ...... 1.3(2.3) 4.9(8.8) with a needle suitable for use with the 150(300) ...... 2.0(3.6) 7.5(13.5) apparatus, adjusted to deliver 2.00±0.05 200(400) ...... 2.6(4.7) 9.9(17.9) ml. 260(500) ...... 3.3(5.9) 12.4(22.3) (3) Essential dimensions of the test apparatus are set forth in table 3. TABLE 3—ESSENTIAL DIMENSIONS OF FLASH (n) Testing high-viscosity liquids. (1) TEST APPARATUS AB High-viscosity materials may be added Sample Block to the cup by the following procedure: Block diameter ...... 61.5–62.5 (i) Back load a 5 or 10-ml syringe Sample well diameter ...... 49.40–49.70 with the sample to be tested and ex- Sample well depth ...... 9.70–10.00 Top of block to center of thermometer hole .... 16.00–17.00 trude 2 ml into the cup. Spread the Diameter of thermometer hole (approx.) ...... 7.0004 specimen as evenly as possible over the Cover bottom of the cup. Large opening length ...... 12.42–12.47 (ii) If the sample cannot be loaded Large opening width ...... 10.13–10.18 Small opening length ...... 5.05–5.10 into a syringe and extruded, other Small opening width ...... 7.60–7.65 means of adding the sample to the cup Distance between extreme edges of small may be used such as a spoon. Add ap- openings ...... 48.37–48.32 proximately 2 ml of material to the Filling orifice diameter ...... 4.00–4.50 spoon and then push the material from Bore or filler tube ...... 1.80–1.85 Maximum distance of filler tube from base of the spoon into the cup. well with cover closed (max.) ...... 0.75 (iii) If the test specimen does not Slide close the sampling port in the cup, seal Large opening length ...... 12.42–12.47 the cup externally by suitable means. Large opening width ...... 10.13–10.18 Small opening length ...... 5.05–5.10 (2) Using the appropriate procedure, Small opening width ...... 7.60–7.65 either Method A in § 1500.43a(i) or Near edge of large opening to end of slide .... 12.80–12.85 Method B in § 1500.43a(j), determine the Extremes of large and small openings ...... 30.40–30.45 flashpoint of the specimen which has Jet Length of jet ...... 18.30–18.40 been added to the tester in accordance External diameter at end of jet ...... 2.20–2.60 with § 1500.43a(n)(i), except that the Bore of jet ...... 1.60–1.65 time specified is increased from 1 to 5 Height of jet center above top surface of minutes for samples at or above ambi- cover ...... 11.00–11.20 ent temperature. Jet pivot to center of block with cover closed 12.68–12.72 A The O-seal or gasket which provides a seal when the cover is shut, should be made of a heat-resistant material ca- TABLE 1—CALIBRATION OF TESTER pable of withstanding temperatures up to 150 °C for the low- A B range apparatus. Material ...... p-xylene (Caution). B ° When in position, the thermometer bulb should be sur- Specific gravity. 15.6/15.6 C 0.850 to 0.866. rounded with heat-conducting thermoplastic compound, such (60/60 °F). as a paste comprised of zinc oxide and mineral oil.

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[51 FR 28539, Aug. 8, 1986]

§ 1500.44 Method for determining ex- port it by means of metal ringstands, tremely flammable and flammable clamps, rings, or other suitable devices solids. as needed, so that the major axis is ori- (a) Preparation of samples—(1) Gran- ented horizontally and the maximum ules, powders, and pastes. Pack the sam- surface is freely exposed to the atmos- ple into a flat, rectangular metal boat phere. with inner dimensions 6 inches long × 1 (b) Procedure. Place the prepared inch wide × one-fourth inch deep. sample in a draft-free area that can be (2) Rigid and pliable solids. Measure ventilated and cleared after each test. the dimensions of the sample and sup- The temperature of the sample at the

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time of testing shall be between 68 °F. may be used) to a temperature of about and 86 °F. Hold a burning paraffin can- 25 °F below zero. Puncture the chilled dle whose diameter is at least 1 inch, so container to exhaust the propellant. that the flame is in contact with the Transfer the chilled formulation to the surface of the sample at the end of the test apparatus and test in accordance major axis for 5 seconds or until the with the method described in § 1500.43a. sample ignites, whichever is less. Re- move the candle. By means of a stop- [51 FR 28544, Aug. 8, 1986] watch, determine the time of combustion with self-sustained flame. Do not § 1500.48 Technical requirements for determining a sharp point in toys exceed 60 seconds. Extinguish flame and other articles intended for use with a CO2 or similar nondestructive by children under 8 years of age. type extinguisher. Measure the dimensions of the burnt area and calculate (a) Objective. The sharp point test the rate of burning along the major prescribed by paragraph (d) of this sec- axis of the sample. tion will be used by the Commission in making a preliminary determination § 1500.45 Method for determining ex- that points on toys and other articles tremely flammable and flammable intended for use by children under 8 contents of self-pressurized con- years of age, and such points exposed tainers. in normal use or as a result of reason- (a) Equipment required. The test ably foreseeable damage or abuse of equipment consists of a base 8 inches such toys and articles, present a poten- wide, 2 feet long, marked in 6-inch in- tial risk of injury by puncture or lac- tervals. A rule 2 feet long and marked eration under section 2(s) of the Fed- in inches is supported horizontally on eral Hazardous Substances Act (15 the side of the base and about 6 inches U.S.C. 1261(s)). The Commission will above it. A paraffin candle 1 inch or further evaluate points that are identi- more in diameter, and of such height fied as presenting a potential risk of that the top third of the flame is at the puncture or laceration injury to deter- height of the horizontal rule, is placed mine the need for individual product at the zero point in the base. regulatory action. (b) Procedure. The test is conducted (b) Scope—(1) General. The sharp in a draft-free area that can be venti- point test of paragraph (d) of this sec- lated and cleared after each test. Place tion is applicable to toys or other arti- the self-pressurized container at a dis- cles that are introduced into interstate tance of 6 inches from the flame commerce on or after December 22, source. Spray for periods of 15 seconds 1978. The sharp point test shall be ap- to 20 seconds (one observer noting the plied to any accessible portion of the extension of the flame and the other test sample before and after subjecting operating the container) through the the test sample to the use and abuse top third of the flame and at a right tests of §§ 1500.51, 1500.52, and 1500.53 angle to the flame. The height of the (excluding the bite test-paragraph (c) flame should be approximately 2 inches. Take three readings for each of each section). test, and average. As a precaution do (2) Exemptions. (i) Toys and other not spray large quantities in a small, children’s articles that are the subject confined space. Free space of pre- of any of the following regulations are viously discharged material. exempt from this § 1500.48: The regulations for bicycles, non-full-size baby § 1500.46 Method for determining cribs, and full-size baby cribs (parts flashpoint of extremely flammable 1508, 1509, and 1512, of this chapter). contents of self-pressurized con- (ii) Toys that by reason of their func- tainers. tional purpose necessarily present the Use the apparatus described in hazard of sharp points and that do not § 1500.43a. Use some means such as dry have any nonfunctional sharp points ice in an open container to chill the are exempt from this § 1500.48: Provided, pressurized container. Chill the con- Each toy is identified by a conspicuous, tainer, the flash cup, and the bath solu- legible, and visible label at the time of tion of the apparatus (brine or glycol any sale, as having functional sharp

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points. An example of such toys is a cessibility shall be determined by in- toy sewing machine with a needle. serting the appropriate probe with the (iii) Articles, besides toys, intended extension shown in figure 2 in any di- for use by children that by reason of rection up to two and one-quarter their functional purpose necessarily times the minor dimension of the present the hazard of sharp points and probe, recess, or opening, measured that do not have any nonfunctional from any point in the plane of the sharp points are exempt from this opening. Each probe joint may be ro- § 1500.48. An example of such articles is tated up to 90 degrees to simulate a ball-point pen. knuckle movement. (c) Accessibility—(1) General. Any (iii) For any hole, recess, or opening point that is accessible either before or having a minor dimension of 7.36 inches after these tests of §§ 1500.51, 1500.52, (186.9 millimeters) or larger when probe and 1500.53 (excluding the bite test— A is used, or a minor di-mension of 9.00 paragraph (c) of each section) are per- inches (228.6 millimeters), or larger formed shall be subject to the sharp when probe B is used, the total inser- point test of paragraph (d) of this section depth for accessibility is unre- tion. stricted unless other holes, recesses, or (2) Accessible points. (i) An accessible openings within the original hole, re- point for a toy or article intended for cess, or opening are encountered with children 3 years of age or less is one dimensions specified in paragraph (c)(3) that can be contacted by any portion (i) or (ii) of this section. In such in- forward of the collar of the accessi- stances, the appropriate paragraphs bility probe designated as probe A in (c)(3) (i) or (ii) of this section shall be figure 2 of this section. followed. If both probes are to be used, (ii) An accessible point for a toy or a minor dimen-sion that is 7.36 inches article intended for children over 3 (186.9 millimeters or larger shall deter- years up to 8 years of age is one that mine unrestricted access. can be contacted by any portion for- (4) Inaccessible points. Points shall be ward of the collar of the accessibility considered inaccessible without testing probe designated as probe B in figure 2 with a probe if they lie adjacent to a of this section. surface of the test sample and any gap (iii) An accessible point for a toy or between the point and the adjacent article intended for children of ages surface does not exceed 0.020 inch (0.50 spanning both age groups is one that millimeter) either before or after the can be contacted by any portion for- tests of §§ 1500.51, 1500.52, and 1500.53 ward of the collar of either probe A or (excluding the bite test—paragraph (c) B, as shown in figure 2 of this section. of each section) are performed. (3) Insertion depth for accessibility. (i) (d) Sharp point test method—(1) Prin- For any hole, recess, or opening having ciple of operation. The principle of oper- a minor dimension (The minor dimen- ation of the sharp point tester shown in sion of an opening is the diameter of figure 1 of this section is as follows the largest sphere that will pass (Detailed engineering drawings for a through the opening.) smaller than the suggested sharp point tester are avail- collar diameter of the appropriate able from the Commission’s Office of probe, the total insertion depth for ac- the Secretary.): A rectangular opening cessibility shall be up to the collar on measuring 0.040 inch (1.02 millimeters) the appropriate probe. Each probe joint wide by 0.045 inch (1.15 millimeters) may be rotated up to 90 degrees to sim- long in the end of the slotted cap estab- ulate knuckle movement. lishes two reference dimensions. Depth (ii) For any hole, recess, or opening of penetration of the point being tested having a minor dimension larger than determines sharpness. If the point the collar diameter of probe A but less being tested can contact a sensing head than 7.36 inches (186.9 millimeters), that is recessed a distance of 0.015 inch when probe A is used, or a minor di- (0.38 millimeter) below the end cap and mension larger than the collar diame- can move the sensing head a further ter of probe B but less than 9.00 inches 0.005 inch (0.12 millimeter) against a (228.6 millimeters), when probe B is 0.5-pound (2.2-newton) force of a return used, the total insertion depth for ac- spring, the point shall be identified as

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sharp. A sharp point tester of the gen- bration reference marks on the barrel. eral configuration shown in figure 1 of Rotate the gaging can clockwise until this section or one yielding equivalent the indicator lamp lights. Rotate the results shall identify a sharp point. In cap counterclockwise until an equiva- conducting tests to determine the pres- lent of five divisions (the distance be- ence of sharp points, the Commission tween the short lines on the cap) have will use the sharp point tester shown in passed the calibration reference mark. figure 1 of this section and the accessi- Lock the gaging cap in this position by bility probes designated as A or B in rotating the lock ring until it fits firm- figure 2 of this section. ly against the cap. Insert the point (2) Procedure. (i) The sample to be into the gaging slot in all directions in tested shall be held in such a manner which it was accessible by the criteria that it does not move during the test. of paragraph (c) of this section, and (ii) Part of the test sample may need apply a force of 1.00 pound (4.45 new- to be removed to allow the sharp point tons). A glowing light identifies the testing device to test a point that is point as sharp. accessible by the criteria of paragraph (c) of this section. Such dismantling of (iv) The test instruments used by the the test sample could affect the rigid- Commission in its tests for compliance ity of the point in question. The sharp with this regulation shall have gaging point test shall be performed with the slot opening dimensions no greater point supported so that its stiffness ap- than 0.040 inch by 0.045 inch and shall proximates but is not greater than the have the sensing head recessed a depth point stiffness in the assembled sam- of no less than 0.015 inch. The force ap- ple. plied by the Commission when insert- (iii) Using the general configuration ing a point into the gaging slot shall be shown in figure 1 of this section, the no more than 1.00 pound. adjustment and operation of the sharp (e) For the purpose of conformance point tester is as follows: Hold the with the technical requirements pre- sharp point tester and loosen the lock scribed by this § 1500.48, the English fig- ring by rotating it so that it moves to- ures shall be used. The metric approxi- wards the indicator lamp assembly a mations are provided in parentheses for sufficient distance to expose the cali- convenience and information only.

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§ 1500.49 Technical requirements for mission in making a preliminary deter- determining a sharp metal or glass mination that metal or glass edges on edge in toys and other articles in- toys and other articles intended for use tended for use by children under 8 by children under 8 years of age, and years of age. such edges exposed in normal use or as (a) Objective. The sharp edge test a result of reasonably forseeable dam- method prescribed by paragraph (d) of age or abuse of such toys and articles, this section will be used by the Com- present a potential risk of injury by

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laceration or avulsion under section solved silica and silicates that also 2(s) of the Federal Hazardous Sub- contain soda and lime. stances Act (15 U.S.C. 1261(s)). The (ii) Metal. For the purpose of this reg- Commission will further evaluate toys ulation the Commission intends the and other articles with edges that are word metal to include both elemental identified as presenting a potential metals and metal alloys. risk of laceration or avulsion injury to (c) Accessibility—(1) General. Any determine the need for individual prod- metal or glass edge that is accessible uct regulation. either before or after the test of (b) Scope—(1) General. The sharp edge §§ 1500.51, 1500.52, and 1500.53 (excluding test of paragraph (d) of this section is the bite test—paragraph (c) of each sec- applicable to toys or other articles con- tion) are performed shall be subject to taining metal or glass edges that are the sharp edge test of paragraph (d) of introduced into interstate commerce this section. Toys reasonably intended after March 26, 1979. Such articles man- to be assembled by an adult and not in- ufactured outside the United States are tended to be taken apart by a child introduced into interstate commerce shall be tested only in the assembled when first brought within as U.S. port state if the shelf package and the as- of entry. Such articles manufactured in sembly instructions prominently indi- the United States are introduced into cate that the article is to be assembled interstate commerce (a) at the time of only by an adult. first interstate sale, or (b) at the time (2) Accessible edges. (i) An accessible of first intrastate sale if one or more metal or glass edge for a toy or article components and/or raw materials were intended for children 3 years of age or received interstate, whichever occurs less is one that can be contacted by earlier. any portion forward of the collar of the (2) Exemptions. (i) Toys and other accessibility probe designated as probe children’s articles that are the subject A in Figure 2 of this section. of any of the following regulations are exempt from this § 1500.49: The regula- (ii) An accessible edge for a toy or ar- tions for bicycles, non-full-size baby ticle intended for children over 3 years cribs, and full-size baby cribs (parts and up to 8 years of age is one that can 1508, 1509, and 1512 of this chapter). be contacted by any portion forward of (ii) Toys that by reason of their func- the collar of the accessibility probe tional purpose necessarily present the designated as Probe B in Figure 2 of hazard of sharp metal or glass edges this section. and that do not have any nonfunc- (iii) An accessible edge for a toy or tional sharp metal or glass edges are article intended for children of ages exempt from this section: Provided, the spanning both age groups is one that toy is identified by a conspicuous, leg- can be contacted by any portion for- ible, and visible label at the time of ward of the collar of either Probe A or any sale, as having functional sharp Probe B, as shown in Figure 2 of this metal or glass edges. Examples of these section. are a pair of toy scissors and toy tool (3) Insertion depth. (i) For any hole, kits. recess, or opening having a minor di- (iii) Articles, besides toys, intended mension (the minor dimension of an for use by children that by reason of opening is the diameter of the largest their functional purpose necessarily sphere that will pass through the open- present the hazard of sharp metal or ing), smaller than the collar diameter glass edges and that do not have any of the appropriate probe, the total in- non-functional sharp metal or glass sertion depth for accessibility shall be edges are exempt from this section. Ex- up to the collar on the appropriate amples of these are children’s ice probe. Each probe joint may be rotated skates and children’s cutlery. up to 90 degrees to simulate knuckle (3) Definitions—(i) Glass. For the pur- movement. pose of this regulation the Commission (ii) For any hole, recess, or opening defines glass as a hard, brittle, amor- having a minor dimension larger than phous substance produced by fusion, the collar diameter of Probe A, but less usually consisting of mutually dis- than 7.36 inches (186.9 millimeters),

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when Probe A is used, or a minor di- ered inaccessible if the gap between the mension larger than the collar diame- inside edge and the parallel surface ter of Probe B, but less than 9.00 inches does not exceed 0.020 inch (0.50 milli- (228.6 millimeters), when Probe B is meter). used, the total insertion depth for ac- (d) Sharp edge test method—(1) Prin- cessibility shall be determined by in- ciple of operation. The test shall be per- serting the appropriate probe with the formed with a sharp edge tester which extension, shown in Figure 2, in any di- contains a cylindrical mandrel capable 1 rection up to 2 ⁄4 times the minor di- of rotation at a constant velocity. (En- mension of the hole, recess, or opening, gineering drawings for a suitable port- measured from any point in the plane able sharp edge test instrument are of the opening. Each probe joint may available from the Commission’s Office be rotated up to 90 degrees to simulate of the Secretary.) The full circum- knuckle movement. ference of the mandrel shall be (iii) For any hole, recess, or opening wrapped with a single layer of poly- having a minor dimension of 7.36 inches (186.9 millimeters) or larger when tetrafluoroethylene (TFE) tape as spec- Probe A is used, or a minor dimension ified in paragraph (e)(3) of this section. of 9.00 inches (228.6 millimeters) or The mandrel shall be applied to the larger when Probe B is used, the total edge to be tested with a normal force of insertion depth for accessibility is un- 1.35 pounds (6.00 Newtons) such that restricted unless other holes, recesses, the edge contacts the approximate cen- or openings within the original hole, ter of the width of the tape as shown in recess, or opening are encountered with Figure 1 of this section. The mandrel dimensions specified in paragraph (c)(3) shall be rotated through one complete (i) or (ii) of this section. In such in- revolution while maintaining the force stances, the appropriate paragraphs against the edge constant. Linear mo- (c)(3) (i) or (ii) of this section shall be tion of the mandrel along the line of followed. If both probes are to be used, the edge shall be prevented. The edge a minor dimension that is 7.36 inches shall be identified as sharp if it com- (186.9 millimeters or larger shall deter- pletely cuts through the tape for a mine unrestricted access. length of not less than 1⁄2 inch (13 milli- (4) Inaccessible edges. Metal or glass meters) at any force up to 1.35 pounds edges shall be considered inaccessible (6.00 Newtons). without testing with a probe if they lie (2) Procedure. (i) The edge of the sam- adjacent to a surface of the test sample to be tested shall be held in such a ple, and any gap between the edge and manner that it does not move during the adjacent surface does not exceed the test. If the full mandrel force of 0.020 inch (0.50 millimeter) both before 1.35 pounds (6.00 Newtons) causes the and after the tests of §§ 1500.51, 1500.52, edge to bend, a reduced mandrel force and 1500.53 (excluding the bite test— may be used. paragraph (c) of each section) are per- (ii) Part of the test sample may need formed. For example, in a lap joint in to be removed to allow the sharp edge which a metal edge is overlapped by a parallel surface, any burr or feather- testing device to test an edge that is edge on the side closest to the pro- accessible by the criteria of paragraph tecting parallel surface is considered (c) of this section. Such dismantling of inaccessible if the gap between the the test sample could affect the rigid- edge and the parallel surface is no ity of the edge in question. The sharp greater than 0.020 inch (0.50 milli- edge test shall be performed with the meter). As an additional example, when edge supported so that its stiffness ap- sheet metal has a hemmed edge a por- proximates but is not greater than the tion of the sheet adjacent to the edge is edge stiffness in the assembled sample. folded back upon itself, approximately (iii) Conduct of a sharp edge test is as 180 degrees, so that it is roughly par- follows: Wrap one layer of polytetra- allel to the main sheet. Any burrs or fluoroethylene (TFE) tape, described in feathering on the inside edge, the side paragraph (e)(3) of this section, around closest to the protecting parallel sur- the full circumference of the mandrel face of the main sheet, will be consid- in an unstretched state. The ends of

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the tape shall be either butted or over- shall be free of scratches, nicks, or lapped not more than 0.10 inch (2.5 mil- burrs and shall have a surface rough- limeters). Apply the mandrel, at the ness no greater than 16 microinches approximate center of the tape, to the (0.40 micron). The test surface shall edge of the test sample with a force of have a hardness no less than 40 as 1.35 pounds (6.00 Newtons) measured in measured on the Rockwell ‘‘C’’ scale, a direction at right angles to the man- as determined pursuant to ASTM E 18– drel axis. The mandrel shall be placed 74 entitled ‘‘Standard Test Methods for so that its axis is at 90 degrees ±5 de- Rockwell Hardness and Rockwell Su- grees to the line of a straight test edge perficial Hardness of Metallic Mate- or 90 degrees ±5 degrees to a tangent at rials,’’ published July 1974 and which is the point of contact with a curved test incorporated by reference in this regu- edge. The point of contact between the lation. (Copies are available from test edge and the mandrel shall be in American Society for Testing and Ma- the approximate center of the width of terials, 1916 Race Street, Philadelphia, the tape. The axis of the mandrel may Pa. 19103.) The diameter of the mandrel be positioned anywhere in a plane shall be 0.375±0.005 inch (9.35±0.12 milli- which is at right angles to either the meters). The mandrel shall be of suit- line of a straight test edge or to a tan- able length to carry out the test. gent at the point of contact with a (3) The tape shall be pressure-sen- curved test edge. The operator should sitive polytetrafluoroethylene (TFE) seek the orientation most likely to high temperature electrical insulation cause the edge to cut the tape. Main- tape as described in Military Specifica- tain the force against the edge and ro- tion MIL-I-23594B (1971) which is incor- tate the mandrel through one complete porated by reference in this regulation. revolution while preventing any linear (Copies are available from Naval Publi- motion of the mandrel along the edge. cations and Forms Center, 5801 Tabor Release the mandrel from the edge and Ave., Philadelphia, Pa. 19120.) The remove the tape without enlarging any thickness of the polytetrafluoro- cut or causing any score to become a ethylene backing shall be between cut. A cut in the tape with a length of 0.0026 inch (0.066 millimeter) and 0.0035 not less than 1⁄2 inch (13 millimeters) inch (0.089 millimeter). 1 The adhesive identifies an edge as sharp. (The test shall be pressure-sensitive silicone instruments used by the Commission in polymer with a nominal thickness of its test for compliance with the regula- 0.003 inch (.08 millimeter). The width of tion will be calibrated to insure that the tape shall not be less than 1⁄4 inch the force with which the mandrel is ap- (6 millimeters). While conducting sharp plied to a test edge does not exceed 1.35 edge tests the temperature of the tape pounds.) shall be maintained between 70 °F (21.1 (e) Specifications for sharp edge test °C) and 80 °F (26.6 °C). equipment. The following specifications (f) For the purpose of conformance shall apply to the equipment to be used with the technical requirements pre- in the sharp edge test described in scribed by this § 1500.49, the English fig- paragraph (d) of this section: ures shall be used. The metric approxi- (1) The rotation of the mandrel shall mations are provided in parentheses for produce a constant tangential velocity convenience and information only. of 1.00±0.08 inch per second (25.4±2.0 millimeters per second) during the cen- 1 The tape that the Commission will use for ter 75 percent of its rotation and shall the sharp edge test is CHR type ‘‘T’’ manu- have a smooth start and stop. factured by The Connecticut Hard Rubber (2) The mandrel shall be made of Co., New and East Streets, New Haven, Conn. steel. The test surface of the mandrel 06509.

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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 43 FR 21324, May 17, 1978]

§ 1500.50 Test methods for simulating (b) Application—general. (1)(i) The test use and abuse of toys and other ar- methods described in §§ 1500.51, 1500.52 ticles intended for use by children. and 1500.53 are to be used in deter- (a) Objective. The objective of mining what is normal use and reason- §§ 1500.51, 1500.52, and 1500.53 is to de- ably foreseeable damage or abuse when scribe specific test methods for simu- specifically referenced under § 1500.18. lating normal use of toys and other ar- Other banning regulations may also ticles intended for use by children as reference these use and abuse toy test well as the reasonably foreseeable dam- procedures. age or abuse to which the articles may (ii) The test methods described in be subjected. The test methods are for §§ 1500.51, 1500.52, and 1500.53 have been use in exposing potential hazards that established for articles intended for the would result from the normal use or specified age groups of children: 18 the reasonably foreseeable damage or months of age or less, over 18 months abuse of such articles intended for chil- but not over 36 months of age, and over dren. 36 months but not over 96 months of

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age. If an article is marked, labeled, tised, or otherwise intended for use by advertised, or otherwise intended for children. children of ages spanning more than (2) Mouth toy means any toy reason- one of these age groups, the article will ably intended to be placed into or in be subjected to the tests providing the contact with a child’s mouth. most stringent requirements. If an ar- [40 FR 1483, Jan. 7, 1975; 40 FR 16191, Apr. 10, ticle is not age-labeled in a clear and 1975] conspicuous manner or, based on such factors as marketing practices and the § 1500.51 Test methods for simulating customary patterns of usage of a prod- use and abuse of toys and other ar- uct by children, is inappropriately age- ticles intended for use by children labeled, and is intended or appropriate 18 months of age or less. for children 96 months of age or less, it (a) Application. The test methods de- will also be subjected to the most scribed in this section shall be used to stringent test requirements. simulate the normal and reasonably (2) For purposes of compliance with foreseeable use, damage, or abuse of the test methods prescribed in toys and other articles intended for use §§ 1500.51, 1500.52, and 1500.53, the by children 18 months of age or less in English system shall be used. The met- conjunction with § 1500.18. ric approximations are provided in pa- (b) Impact test—(1) Application. Except rentheses for convenience and informa- as provided in paragraph (b)(4) of this tion only. section, toys having a weight of less (3) Each of the test methods de- than 3.0 pounds ±0.01 pound (1.4 kilo- scribed in §§ 1500.51, 1500.52, and 1500.53 grams) shall be subject to this test. shall be applied to a previously untest- (2) Impact medium. The impact me- ed sample except the tension test dium shall consist of a 1⁄8-inch (0.3-cen- which shall be conducted with the test timeter) nominal thickness of type IV sample used in the torque test. vinyl-composition tile, composition 1— (4) Prior to testing, each sample shall asbestos free, as specified by para- be subjected to a temperature of 73°±3 graphs 1.2 and 3.1.4 of Interim Amend- °F. (23°±2 °C.) as a relative humidity of ment-1(YD), dated November 14, 1979, 20¥70 percent for a period of at least 4 to the Federal Specification entitled hours. The toy testing shall commence Tile, Floor: Asphalt, Rubber, Vinyl, within five minutes after the toy has Vinyl-Asbestos, SS-T-312B, dated Octo- been removed from the preconditioning ber 10, 1974, 1 over at least a 2.5-inch atmosphere. (6.4-centimeter) thickness of concrete. (5) Toys reasonably intended to be as- The impact area shall be at least 3 sembled by an adult and not intended square feet (0.3 square meter). The to be taken apart by a child shall be Commission recognizes that this speci- tested only in the assembled state if fied impact medium is the equivalent the shelf package and the assembly in- of, and will yield the same impact test structions prominently indicate that results as, a surface covered with the article is to be assembled only by vinyl-asbestos tile meeting the require- an adult. ments of Federal Specification SS-T- (6) Toys intended to be repeatedly as- 312A. sembled and taken apart shall have the (3) Testing procedure. Except as pro- individual pieces as well as the com- vided in paragraphs (b)(4) (i) and (ii) of pleted article subjected to these test this section, the toy shall be dropped 10 procedures. times from a height of 4.5 feet ±0.5 inch (7) In situations where a test proce- (1.37 meters) onto the impact medium dure may be applied in more than one described in paragraph (b)(2) of this way to a toy test component, the point section. The toy shall be dropped in (or direction) of force (or torque) appli- random orientation. After each drop, cation which results in the most severe conditions shall be used. 1 These documents may be ordered from the (c) Definitions. As used in this section General Services Administration, Specifica- and in §§ 1500.51, 1500.52, and 1500.53: tions Unit, Room 6654, 7th and D Streets, (1) Toy means any toy, game, or S.W., Washington, DC 20407. The price of the other article designed, labeled, adver- specification and amendment is $1.00.

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the test sample shall be allowed to the contact mechanism, and a test load come to rest and shall be examined and increasing to 25 pounds ±0.5 pound evaluated before continuing. (11.35 kilograms) shall be evenly ap- (4) Large and bulky toys. (i) A toy that plied within 5 seconds. This load shall has a projected base area of 400 or more be maintained for an additional 10 sec- square inches (2,560 or more square cen- onds. timeters), shall be tested for impact in (d) Flexure test—(1) Application. This accordance with paragraph (b)(4)(iii) of test shall be applied to each component this section. The base area for toys of a toy containing metal wire(s), or with permanently attached legs shall other metal material(s), for stiffening be measured by calculating the area or for retention of form if the compo- enclosed by straight lines connecting nent can be bent through a 60-degree the outermost edge of each leg of the arc by a maximum force of 10 pounds perimeter. ±0.5 pound (4.55 kilograms), applied per- (ii) A toy that has a volume of more pendicularly to the major axis of the than 3 cubic feet (0.085 cubic meter), component at a point 2 inches (5 centi- calculated by the major dimensions meters) from the intersection of the without regard to minor appendages, component with the main body of the shall be tested for impact in accord- toy or at the end of the component if ance with paragraph (b)(4)(iii) of this the component is less than 2 inches section. ±0.05 inch (5 centimeters) long. (iii) The toys described in paragraph (2) Testing procedure. The toy shall be (b)(4)(i) and (ii) of this section shall be secured in a vise equipped with vise tested for impact by tipping them over shields that are fabricated from 13- three times by pushing the samples gauge cold-rolled steel or other similar slowly past their centers of balance material and that have a 0.375-inch onto the impact medium described in (0.95-centimeter) inside radius. The paragraph (b)(2) of this section. component shall then be bent through (c) Bite test—(1) Application. A toy (or a 60-degree arc by a force applied at a component or any accessible portion point on the component 2 inches ±0.05 thereof) that has an external dimen- inch (5 centimeters) from the intersec- sion of 1.25 inches ±0.05 inch (3.18 centi- tion of the component with the main meters) or less and a design configura- body of the toy or applied at the end of tion that would permit a child to insert the component if the component is less a portion into the mouth in any ori- than 2 inches (5 centimeters) long. The entation up to a biting thickness of 1.25 component shall then be bent in the re- inches ±0.05 inch (3.18 centimeters), for verse direction through a 120-degree a penetration of at least 0.25 inch (0.635 arc. This process shall be repeated for centimeter), shall be subject to this 30 cycles at a rate of one cycle per two test. seconds with a 60-second rest period oc- (2) Test equipment—(i) Contact mecha- curring after each 10 cycles. Two 120- nism. The contact mechanism shall be degree arc bends shall constitute one two metal strips or plates each meas- cycle. uring 0.25 inch ±0.002 inch (0.635 centi- (e) Torque test—(1) Application—(i) meter) high and each having a contact General. A toy with a projection, part, edge radius of 0.020 inch ±0.002 inch (0.05 or assembly that a child can grasp with centimeter), for at least a 150-degree at least the thumb and forefinger or cross-sectional arc. A suggested con- the teeth shall be subject to this test. tact mechanism appears in figure 1 of (ii) Toys with rotating components. this section. Projections, parts, or assemblies that (ii) Loading device. The loading device are rigidly mounted on an accessible shall be a scale or force gauge having rod or shaft designed to rotate along an accuracy of ±0.5 pound (±225 grams). with the projections, parts, or assem- (3) Testing procedure. The test article blies shall be tested with the rod or shall be placed in the contact mecha- shaft clamped to prevent rotation. nism in any reasonable position for a (2) Test equipment—(i) Loading device. penetration of 0.25 to 0.5 inch (0.64 to The loading device shall be a torque 1.27 centimeters), which position uti- gauge, torque wrench, or other appro- lizes less than 180 degrees of the arc of priate device having an accuracy of ±0.2

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inch-pound (±0.23 kilogram-centi- appropriate means having an accuracy meter). of ±0.5 pound (±225 grams). (ii) Clamp. The clamp shall be capable (3) Testing procedure. With the test of holding the test component firmly sample fastened in a convenient posi- and transmitting a torsional force. tion, an appropriate clamp shall be at- (3) Testing procedure. With the toy tached to the test object or component. rigidly fastened in any reasonable test A 10-pound ±0.5 pound (4.55–kilogram) position, the clamp is fastened to the direct force shall be evenly applied, test object or component. A torque of 2 within a period of 5 seconds, parallel to inch-pounds ±0.2 inch-pound (2.30 kilo- the major axis of the test component gram-centimeters) shall be applied and maintained for an additional 10 evenly within a period of 5 seconds in a seconds. The tension clamp shall then clockwise direction until a rotation of be removed and a second clamp appro- 180 degrees from the original position priate for pulling at 90 degrees shall be has been attained or 2 inch-pounds (2.30 attached to the test object or compo- kilogram-centimeters) exceeded. The nent. A 10-pound ±0.5 pound (4.55-kilo- torque or maximum rotation shall be gram) tensile force shall be evenly ap- maintained for an additional 10 sec- plied, within a period of 5 seconds, per- onds. The torque shall then be removed pendicularly to the major axis of the and the test component permitted to test component and maintained for an return to a relaxed condition. This pro- additional 10 seconds. cedure shall then be repeated in a counterclockwise direction. (g) Compression test—(1) Application. (f) Tension test—(1) Application—(i) Any area on the surface of a toy that is General. Any projection of a toy that accessible to a child and inaccessible to the child can grasp with at least the flat-surface contact during the impact thumb and forefinger or the teeth shall test shall be subject to this test. be subject to this test. This test is to (2) Test apparatus. The loading device be conducted on the same toy that has shall be a rigid metal disc 1.125 inches been subjected to the torque test de- ±0.015 inch (2.86 centimeters) in diame- scribed in paragraph (e) of this section. ter and 0.375 inch (0.95 centimeter) in (ii) Stuffed toys and beanbags. A thickness. The perimeter of the disc stuffed toy or beanbag constructed of shall be rounded to a radius of 1⁄32 inch pliable materials having seams (such (0.08 centimeter) to eliminate irregular as fabrics) shall have the seams sub- edges. The disc shall be attached to an jected to 10 pounds ±0.5 pound (4.55 appropriate compression scale having kilograms) of force applied in any di- an accuracy of ±0.5 pound (±225 grams). rection. (3) Testing procedure. The disc shall be (2) Test equipment—(i) Clamps. One positioned so that the contact surface clamp capable of applying a tension is parallel to the surface under test. A load to the test component is required. direct force of 20 pounds ±0.5 pound (9.1 A second clamp suitable for applying a kilograms) shall be evenly applied tension load perpendicularly to the within 5 seconds through the disc. This major axis of the test component is load shall be maintained for an addi- also required. tional 10 seconds. During the test the (ii) Loading device. The loading device toy is to rest on a flat, hard surface in is to be a self-indicating gauge or other any convenient position.

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[40 FR 1484, Jan. 7, 1975; 40 FR 6210, Feb. 10, 1975; 40 FR 16192, Apr. 10, 1975; 40 FR 17746, Apr. 22, 1975, as amended at 55 FR 52040, Dec. 19, 1990; 56 FR 9, Jan. 2, 1991; 56 FR 558, Jan. 7, 1991]

§ 1500.52 Test methods for simulating by children over 18 but not over 36 use and abuse of toys and other ar- months of age in conjunction with ticles intended for use by children § 1500.18. over 18 but not over 36 months of (b) Impact test—(1) Application. Except age. as provided in paragraph (b)(4) of this (a) Application. The test methods de- section, toys having a weight of less scribed in this section, shall be used to than 4.0 pounds ±0.01 pound (1.8 kilo- simulate the normal and reasonably grams) shall be subject to this test. foreseeable use, damage, or abuse of toys and other articles intended for use

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(2) Impact medium. The impact me- (c) Bite test—(1) Application. A toy (or dium shall consist of a 1⁄8-inch (0.3-cen- component or any accessible portion timeter) nominal thickness of type IV thereof) that has an external dimen- vinyl-composition tile, composition 1— sion of 1.25 inches ±0.05 inch (3.18 centi- asbestos free, as specified by parameters) or less and a design configura- graphs 1.2 and 3.1.4 of Interim Amend- tion that would permit a child to insert ment-1(YD), dated November 14, 1979, a portion into the mouth in any ori- to the Federal Specification entitled entation up to a biting thickness of 1.25 Tile, Floor: Asphalt, Rubber, Vinyl, inches ±0.05 inches (3.18 centimeters), Vinyl-Asbestos, SS-T-312B, dated Octo- for a penetration of at least 0.25 inch ber 10, 1974, 1 over at least a 2.5-inch (0.635 centimeter), shall be subject to (6.4-centimeter) thickness of concrete. this test. The impact area shall be at least 3 (2) Test equipment—(i) Contact mecha- square feet (0.3 square meter). The nism. The contact mechanism shall be Commission recognizes that this speci- two metal strips or plates each meas- fied impact medium is the equivalent uring 0.25 inch ±0.002 inch (0.635 centi- of, and will yield the same impact test meter) high and each having a contact results as, a surface covered with edge radius of 0.020 inch ±0.002 inch (0.05 vinyl-asbestos tile meeting the require- centimeter) for at least a 150-degree ments of Federal Specification SS-T- cross-sectional arc. A suggested con- 312A. tact mechanism appears in figure 1 of (3) Testing procedure. Except as pro- § 1500.51. vided in paragraph (b)(4) (i) and (ii) of (ii) Loading device. The loading device this section, the toy shall be dropped shall be a scale or force gauge having four times from a height of 3 feet ±0.5 an accuracy of ±0.5 pound (±225 grams). inch (0.92 meter) onto the impact me- (3) Testing procedure. The test article dium described in paragraph (b)(2) of shall be placed in the contact mecha- this section. The toy shall be dropped nism in any reasonable position for a in random orientation. After each drop, penetration of 0.25 to 0.5 inch (0.64 to the test sample shall be allowed to 1.27 centimeters), which position uti- come to rest and shall be examined and lizes less than 180 degrees of the arc of evaluated before continuing. the contact mechanism, and a test load (4) Large and bulky toys. (i) A toy that increasing to 50 pounds ±0.5 pound has a projected base area of 400 or more (22.74 kilograms) shall be evenly ap- square inches (2,560 or more square cen- plied within 5 seconds. This load shall timeters) shall be tested for impact in be maintained for an additional 10 sec- accordance with paragraph (b)(4)(iii) of onds. this section. The base area for toys (d) Flexure test—(1) Application. This with permanently attached legs shall test shall be applied to each component be measured by calculating the area of a toy containing metal wire(s), or enclosed by straight lines connecting other metal material(s), for stiffening the outermost edge of each leg of the or for retention of form if the compo- perimeter. nent can be bent through a 60-degree (ii) A toy that has a volume of more arc by a maximum force of 15 pounds than 3 cubic feet (0.085 cubic meter), ±0.5 pound (6.80 kilograms) applied per- calculated by the major dimensions pendicularly to the major axis of the without regard to minor appendages, component at a point 2 inches ±0.05 shall be tested for impact in accord- inch (5 centimeters) from the intersec- ance with paragraph (b)(4)(iii) of this tion of the component with the main section. body of the toy or at the end of the (iii) The toys described in paragraph component if the component is less (b)(4) (i) and (ii) of this section shall be than 2 inches ±0.05 inch (5 centimeters) tested for impact by tipping them over long. three times by pushing the samples (2) Testing procedure. The toy shall be slowly past their centers of balance secured in a vise equipped with vise onto the impact medium described in shields that are fabricated from 13- paragraph (b)(2) of this section. gauge cold-rolled steel or other similar material and that have a 0.375-inch 1 See footnote 1 to § 1500.51. (0.95-centimeter) inside radius. The

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component shall then be bent through be subject to this test. This test is to a 60-degree arc by a force applied at a be conducted on the same toy that has point on the component 2 inches ±0.05 been subjected to the torque test de- inch (5 centimeters) from the intersec- scribed in paragraph (e) of this section. tion of the component with the main (ii) Stuffed toys and beanbags. A body of the toy or applied at the end of stuffed toy or beanbag constructed of the component if the component is less pliable materials having seams (such than 2 inches (5 centimeters) long. The as fabrics) shall have the seams sub- component shall then be bent in the re- jected to 15 pounds ±0.5 pound (6.80 verse direction through a 120-degree kilograms) of force applied in any di- arc. This process shall be repeated for rection. 30 cycles at a rate of one cycle per two (2) Test equipment—(i) Clamps. One seconds with a 60-second rest period oc- clamp capable of applying a tension curring after each 10 cycles. Two 120- load to the test component is required. degree arc bends shall constitute one A second clamp suitable for applying a cycle. tension load perpendicularly to the (e) Torque test—(1) Application—(i) major axis of the test component is General. A toy with a projection, part, also required. or assembly that a child can grasp with (ii) Loading device. The loading device at least the thumb and forefinger or is to be a self-indicating gauge or other the teeth shall be subject to this test. appropriate means having an accuracy (ii) Toys with rotating components. of ±0.5 pound (±255 grams). Projections, parts, or assemblies that (3) Testing procedure. With the test are rigidly mounted on an accessible sample fastened in a convenient posi- rod or shaft designed to rotate along tion, an appropriate clamp shall be at- with the projections, parts, or assem- tached to the test object or component. blies shall be tested with the rod or A 15-pound ±0.5 pound (6.80-kilogram) shaft clamped to prevent rotation. direct force shall be evenly applied, (2) Test equipment—(i) Loading device. within a period of 5 seconds, parallel to The loading device shall be a torque the major axis of the test component gauge, torque wrench, or other appro- and maintained for an additional 10 priate device having an accuracy of ±0.2 seconds. The tension clamp shall then inch-pound (±0.23 kilogram-centi- be removed and a second clamp appro- meter). priate for pulling at 90 degrees shall be (ii) Clamp. The clamp shall be capable attached to the test object or compo- of holding the test component firmly nent. A 15-pound ±0.5 pound (6.80-kilo- and transmitting a torsional force. gram) tensile force shall be evenly ap- (3) Testing procedure. With the toy plied, within a period of 5 seconds, per- rigidly fastened in any reasonable test pendicularly to the major axis of the position, the clamp is fastened to the test component and maintained for an test object or component. A torque of 3 additional 10 seconds. inch-pounds ±0.2 inch-pound (3.46 kilo- (g) Compression test—(1) Application. gram-centimeters) shall be applied Any area on the surface of a toy that is evenly within a period of 5 seconds in a accessible to a child and inaccessible to clockwise direction until a rotation of flat-surface contact during the impact 180 degrees from the original position test shall be subject to this test. has been attained or 3 inch-pounds ±0.2 (2) Test apparatus. The loading device inch-pound (3.46 kilogram-centimeters) shall be a rigid metal disc 1.125 inches exceeded. The torque or maximum ro- ±0.015 inch (2.86 centimeters) in diame- tation shall be maintained for an addi- ter and 0.375 inch (0.95 centimeter) in tional 10 seconds. The torque shall then thickness. The perimeter of the disc be removed and the test component shall be rounded to a radius of 1⁄32 inch permitted to return to a relaxed condi- (0.08 centimeter) to eliminate irregular tion. This procedure shall then be re- edges. The disc shall be attached to an peated in a counterclockwise direction. appropriate compression scale having (f) Tension test—(1) Application—(i) an accurancy of ±0.5 pound (±225 General. Any projection of a toy that grams). the child can grasp with at least the (3) Testing procedure. The disc shall be thumb and forefinger or the teeth shall positioned so that the contact surface

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is parallel to the surface under test. A the test sample shall be allowed to direct force of 25 pounds ±0.5 pound come to rest and shall be examined and (11.4 kilograms) shall be evenly applied evaluated before continuing. within 5 seconds through the disc. This (4) Large and bulky toys. (i) A toy that load shall be maintained for an addi- has a projected base area of 400 or more tional 10 seconds. During the test the square inches (2,560 or more square cen- toy is to rest on a flat, hard surface in timeters) shall be tested for impact in any convenient position. accordance with paragraph (b)(4)(iii) of this subsection. The base area for toys [40 FR 1485, Jan. 7, 1975; 40 FR 6210, Feb. 10, 1975; 40 FR 16192, Apr. 10, 1975, as amended at having permanently attached legs shall 56 FR 10, Jan. 2, 1991] be measured by calculating the area enclosed by straight lines connecting § 1500.53 Test methods for simulating the outermost edge of each leg of the use and abuse of toys and other ar- perimeter. ticles intended for use by children (ii) A toy that has a volume of more over 36 but not over 96 months of than 3 cubic feet (0.085 cubic meter), age. calculated by the major dimensions (a) Application. The test methods de- without regard to minor appendages, scribed in this section shall be used to shall be tested for impact in accord- simulate the normal and reasonably ance with paragraph (b)(4)(iii) of this foreseeable use, damage, or abuse of section. toys and other articles intended for use (iii) The toys described in paragraph by children over 36 but not over 96 (b)(4) (i) and (ii) of this section shall be months of age in conjunction with tested for impact by tipping them over § 1500.18. three times by pushing the samples (b) Impact test—(1) Application. Except slowly past their centers of balance as provided in paragraph (b)(4) of this onto the impact medium described in section, toys having a weight of less paragraph (b)(2) of this section. than 10.0 pounds ±0.01 pound (4.6 kilo- (c) Bite test—(1) Application. A toy (or grams) shall be subject to this test. component) that is a mouth toy shall (2) Impact medium. The impact me- be subject to this test. dium shall consist of a 1⁄8-inch (0.3-cen- (2) Test equipment—(i) Contact mecha- timeter) nominal thickness of type IV nism. The contact mechanism shall be vinyl-composition tile, composition 1— two metal strips or plates each meas- asbestos free, as specified by para- uring 0.25 inch ±0.002 inch (0.635 centi- graphs 1.2 and 3.1.4 of Interim Amend- meter) high and each having a contact ment-1(YD), dated November 14, 1979, edge radius of 0.020 inch ±0.002 inch (0.5 to the Federal Specification entitled centimeter) for at least a 150-degree Tile, Floor: Asphalt, Rubber, Vinyl, cross-sectional arc. A suggested con- Vinyl-Asbestos, SS-T-312B, dated Octo- tact mechanism appears in figure 1 of ber 10, 1974, 1 over at least a 2.5-inch § 1500.51. (6.4-centimeter) thickness of concrete. (ii) Loading device. The loading device The impact area shall be at least 3 shall be a scale or force gauge having square feet (0.3 square meter). The an accuracy of ±0.5 pound (±225 grams). Commission recognizes that this speci- (3) Testing procedure. The test article fied impact medium is the equivalent shall be placed in the contact mecha- of, and will yield the same impact test nism in any reasonable position for a results as, a surface covered with penetration of 0.25 to 0.5 inch (0.64 to vinyl-asbestos tile meeting the require- 1.27 centimeters), which position uti- ments of Federal Specification SS-T- lizes less than 180 degrees of the arc of 312A. the contract mechanism, and a test (3) Testing procedure. except as pro- load increasing to 100 pounds ±0.5 vided in paragraph (b)(4) (i) and (ii) of pound (45.50 kilograms) shall be evenly this section, the toy shall be dropped applied within 5 seconds. This load four times from a height of 3 feet ±0.5 shall be maintained for an additional 10 inch (0.92 meter) onto the impact me- seconds. dium described in paragraph (b)(2) of (d) Flexure test—(1) Application. This this section. The toy shall be dropped test shall be applied to each component in random orientation. After each drop, of a toy containing metal wire(s), or

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other metal material(s), for stiffening test object or component. A torque of 4 or for retention of form if the compo- inch-pounds ±0.2 inch-pound (4.60 kilo- nent can be bent through a 60-degree gram-centimeters) shall be applied arc by a maximum force of 15 pounds evenly within a period of 5 seconds in a ±0.5 pound (6.80 kilograms) applied per- clockwise direction until a rotation of pendicularly to the major axis of the 180 degrees from the original position component at a point 2 inches ±0.05 has been attained or 4 inch-pounds ±0.2 inch (5 centimeters) from the intersec- inch-pound (4.60 kilogram-centimeters) tion of the component with the main exceeded. The torque or maximum ro- body of the toy or at the end of the tation shall be maintained for an addi- component if the component is less tional 10 seconds. The torque shall then than 2 inches ±0.05 inch (5 centimeters) be removed and the test component long. permitted to return to a relaxed condi- (2) Testing procedure. The toy shall be tion. This procedure shall then be re- secured in a vise equipped with vise peated in a counterclockwise direction. shields that are fabricated from 13- (f) Tension test—(1) Application—(i) gauge cold-rolled steel or other similar General. Any projection of a toy that material and that have a 0.375-inch the child can grasp with at least the (0.95-centimeter) inside radius. The thumb and forefinger or the teeth shall component shall then be bent through be subject to this test. This test is to a 60-degree arc by a force applied at a be conducted on the same toy that has point on the component 2 inches (5 cen- been subjected to the torque test de- timeters) from the intersection of the scribed in paragraph (e) of this section. component with the main body of the (ii) Stuffed toys and beanbags. A toy or applied at the end of the compo- stuffed toy or beanbag constructed of nent if the component is less than 2 pliable materials having seams (such inches (5 centimeters) long. The com- as fabrics) shall have the seams sub- ponent shall then be bent in the re- jected to 15 pounds ±0.5 pound (6.80 verse direction through a 120-degree kilograms) of force applied in any di- arc. This process shall be repeated for rection. 30 cycles at a rate of one cycle per two seconds with a 60-second rest period oc- (2) Test equipment—(i) Clamps. One curring after each 10 cycles. Two 120- clamp capable of applying a tension degree arc bends shall constitute one load to the test component is required. cycle. A second clamp suitable for applying a (e) Torque test—(1) Application—(i) tension load perpendicularly to the General. A toy with a projection, part, major axis of the test component is or assembly that a child can grasp with also required. at least the thumb and forefinger or (ii) Loading device. The loading device the teeth shall be subject to this test. is to be a self-indicating gauge or other (ii) Toys with rotating components. appropriate means having an accuracy Projections, parts, or assemblies that of ±0.5 pound (±225 grams). are rigidly mounted on an accessible (3) Testing procedure. With the test rod or shaft designed to rotate along sample fastened in a convenient posi- with the projections, parts, or assem- tion, and appropriate clamp shall be at- blies shall be tested with the rod or tached to the test object or component. shaft clamped to prevent rotation. A 15-pound ±0.5 pound (6.80-kilogram) (2) Test equipment—(i) Loading device. direct force shall be evenly applied, The loading device shall be a torque within a period of 5 seconds, parallel to gauge, torque wrench, or other appro- the major axis of the test component priate device having an accuracy of ±0.2 and maintained for an additional 10 inch-pound (±0.23 kilogram-centi- seconds. The tension clamp shall then meter). be removed and a second clamp appro- (ii) Clamp. The clamp shall be capable priate for pulling at 90 degrees shall be of holding the test component firmly attached to the test object or compo- and transmitting a torsional force. nent. A 15-pound ±0.5 pound (6.80-kilo- (3) Testing procedure. With the toy gram) tensile force shall be evenly ap- rigidly fastened in any reasonable test plied, within a period of 5 seconds, per- position, the clamp is fastened to the pendicularly to the major axis of the

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test component and maintained for an of the act, even though it contains a additional 10 seconds. fuel to be used in the heating, cooking, (g) Compression test—(1) Application. or refrigeration system of a house. Any area on the surface of a toy that is accessible to a child and inaccessible to § 1500.82 Exemption from full labeling flat-surface contact during the impact and other requirements. test shall be subject to this test. (a) Any person who believes a par- (2) Test apparatus. The loading device ticular hazardous substance intended shall be a rigid metal disc 1.125 inches or packaged in a form suitable for use ±0.015 inch (2.86 centimeters) in diame- in the household or by children should ter and 0.375 inch (0.95 centimeter) in be exempted from full label compliance thickness. The perimeter of the disc otherwise applicable under the act, be- shall be rounded to a radius of 1⁄32 inch cause of the size of the package or be- (0.08 centimeter) to eliminate irregular cause of the minor hazard presented by edges. The disc shall be attached to an the substance, or for other good and appropriate compression scale having sufficient reason, may submit to the an accuracy of ±0.5 pound (±225 grams). Commission a request for exemption (3) Testing procedure. The disc shall be under section 3(c) of the act, presenting positioned so that the contact surface facts in support of the view that full is parallel to the surface under test. A compliance is impracticable or is not direct force of 30 pounds ±0.5 pound necessary for the protection of the pub- (13.6 kilograms) shall be evenly applied lic health. The Commission shall deter- within 5 seconds through the disc. This mine on the basis of the facts sub- load shall be maintained for an addi- mitted and all other available informa- tional 10 seconds. During the test the tion whether the requested exemption toy is to rest on a flat, hard surface in is consistent with adequate protection any convenient position. of the public health and safety. If the [40 FR 1486, Jan. 7, 1975; 40 FR 16192, Apr. 10, Commission so finds, it shall detail the 1975, as amended at 56 FR 10, Jan. 2, 1991] exemption granted and the reasons therefor by an appropriate order pub- § 1500.81 Exemptions for food, drugs, lished in the FEDERAL REGISTER. cosmetics, and fuels. (b) The Commission may on its own (a) Food, drugs, and cosmetics. Sub- initiative determine on the basis of stances subject to the Federal Food, facts available to it that a particular Drug, and Cosmetic Act are exempted hazardous substance intended or pack- by section 2(f)(2) of the act; but where aged in a form suitable for use in the a food, drug, or cosmetic offers a sub- household or by children should be ex- stantial risk of injury or illness from empted from full labeling compliance any handling or use that is customary otherwise applicable under the act be- or usual it may be regarded as mis- cause of the size of the package or be- branded under the Federal Food, Drug, cause of the minor hazard presented by and Cosmetic Act because its label the substance or for other good and fails to reveal material facts with re- sufficient reason. If the Commission so spect to consequences that may result finds, it shall detail the exemption from use of the article (21 U.S.C. 321(n)) granted and the reasons therefor by an when its label fails to bear information appropriate order in the FEDERAL REG- to alert the householder to this hazard. ISTER. (b) Fuels. A substance intended to be (c) Any person who believes a par- used as a fuel is exempt from the re- ticular article should be exempted quirements of the act when in con- from being classified as a ‘‘banned haz- tainers that are intended to be or are ardous substance’’ as defined by sec- installed as part of the heating, cool- tion 2(q)(1)(A) of the act (repeated in ing, or refrigeration system of a house. § 1500.3(b)(15)(i)(A)), because its func- A portable container used for delivery tional purpose requires inclusion of a or temporary or additional storage, hazardous substance, it bears labeling and containing a substance that is a giving adequate directions and warn- hazardous substance as defined in sec- ings for safe use, and it is intended for tion 2(f) of the act, is not exempt from use by children who have attained suf- the labeling prescribed in section 2(p) ficient maturity, and may reasonably

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be expected, to read and heed such di- (3) Paper items such as newspapers, rections and warnings, may submit to wrapping papers, toilet and cleansing the Commission a request for exemp- tissues, and paper writing supplies are tion under section 2(q)(1)(B)(i) of the exempt from the labeling requirements act (repeated in proviso (1) under of section 2(p)(1) of the act (repeated in § 1500.3(b)(15(i)), presenting facts in sup- § 1500.3(b)(14)(i)) insofar as they apply port of his contention. The commission to the products being considered haz- shall determine on the basis of the ardous because of being an ‘‘extremely facts submitted, and all other available flammable solid’’ or ‘‘flammable solid’’ information, whether the requested ex- as defined in § 1500.3(c)(6)(v) and (vi). emption is consistent with the pur- (4) Thread, string, twine, rope, cord, poses of the act. If the Commission so and similar materials are exempt from finds, it shall detail the exemption the labeling requirements of section granted and the reasons therefor by an 2(p)(1) of the act (repeated in appropriate order in the FEDERAL REG- § 1500.3(b)(14)(i)) insofar as they apply ISTER. to the products being considered haz- (d) On its own initiative, the Com- ardous because of being an ‘‘extremely mission may determine on the basis of flammable solid’’ or ‘‘flammable solid’’ available facts that a particular as defined in Sec. 1500.3(c)(6)(v) and banned hazardous substance should be (vi). exempted from section 2(q)(1)(A) of the (5) Laboratory chemicals intended act (repeated in § 1500.3(b)(15)(i)(A)), be- only for research or investigational cause its functional purpose requires and other laboratory uses (except those inclusion of a hazardous substance, it in home chemistry sets) are exempt bears labeling giving adequate direc- from the requirements of placement tions and warnings for safe use, and it provided in § 1500.121 if all information is intended for use by children who required by that section and the act have obtained sufficient maturity, and appears with the required prominence may reasonably be expected, to read on the label panel adjacent to the main and heed such directions and warnings. panel. If the Commission so finds, it shall de- (6) [Reserved] tail the exemption granted and the rea- (7) Rigid or semirigid ballpoint ink sons therefor by an appropriate order cartridges are exempt from the label- in the FEDERAL REGISTER. ing requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)), § 1500.83 Exemptions for small pack- insofar as such requirements would be ages, minor hazards, and special necessary because the ink contained circumstances. therein is a ‘‘toxic’’ substance as de- (a) The following exemptions are fined in § 1500.3(c)(2)(i), if: granted for the labeling of hazardous (i) The ballpoint ink cartridge is of substances under the provisions of such construction that the ink will, § 1500.82: under any reasonably foreseeable con- (1) When the sole hazard from a sub- ditions of manipulation or use, emerge stance in a self-pressurized container is only from the ballpoint end; that it generates pressure or when the (ii) When tested by the method de- sole hazard from a substance is that it scribed in § 1500.3(c)(2)(i), the ink does is flammable or extremely flammable, not have an LD–50 single oral dose of the name of the component which con- less than 500 milligrams per kilogram tributes the hazards need not be stated. of body weight of the test animal; and (2) Common matches, including book (iii) The cartridge does not have a ca- matches, wooden matches, and so- pacity of more than 2 grams of ink. called ‘‘safety’’ matches are exempt (8) Containers of paste shoe waxes, from the labeling requirements of sec- paste auto waxes, and paste furniture tion 2(p)(1) of the act (repeated in and floor waxes containing toluene § 1500.3(b)(14)(i)) insofar as they apply (also known as toluol), xylene (also to the product being considered haz- known as xylol), petroleum distillates, ardous because of being an ‘‘extremely and/or turpentine in the concentrations flammable solid’’ or ‘‘flammable solid’’ described in § 1500.14(a)(3) and (5) are as defined in § 1500.3(c)(6)(v) and (vi). exempt from the labeling requirements

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of § 1500.14(b)(3)(ii) and (5) if the (i) The total amount of methyl alco- visicosity of such products is suffi- hol by weight in the product does not ciently high so that they will not flow exceed 15 percent; and from their opened containers when in- (ii) The contents of any container verted for 5 minutes at a temperature does not exceed 2 fluid ounces. of 80 °F., and are exempt from bearing (11) Packages containing polishing or a flammability warning statement if cleaning products which consist of a the flammability of such waxes is due carrier of solid particulate or fibrous solely to the presence of solvents that composition and which contain toluene have flashpoints above 80 °F. when (also known as toluol), xylene (also tested by the method described in known as xylol), or petroleum dis- § 1500.43. tillates in the concentrations described (9) Porous-tip ink-marking devices in § 1500.14(a) (1) and (2) are exempt are exempt from the labeling require- from the labeling requirements of ments of section 2(p)(1) of the act (re- § 1500.14(b)(3)(ii) if such toluene, xylene, peated in § 1500.3(b)(14)(i)) and from the or petroleum distillate is fully ab- labeling requirements of § 1500.14(b)(1), sorbed by the solid, semisolid, or fi- (2), and (3)(ii) and (iii) insofar as such brous carrier and cannot be expressed requirements would be necessary be- therefrom with any reasonably foresee- cause the ink contained therein is a able conditions of manipulation. toxic substance as defined in (12) Containers of dry ink intended to § 1500.3(c)(2)(i), and/or because the ink be used as a liquid ink after the addi- contains 10 percent or more by weight tion of water are exempt from the la- of toluene (also known as toluol), xy- beling requirements of section 2(p)(1) of lene (also known as xylol), or petro- the act (repeated in § 1500.3(b)(14)(i)) leum distillates as defined in and from the labeling requirements of § 1500.14(a)(3), and/or because the ink § 1500.14(b) (1) and (2) insofar as such re- contains 10 percent or more by weight quirements would be necessary because of ethylene glycol; provided that: the dried ink contained therein is a (i) The porous-tip ink-marking devices are of such construction that: toxic substance as defined in (A) The ink is held within the device § 1500.3(c)(2)(i) and/or because the ink by an absorbent material so that no contains 10 percent or more of ethylene free liquid is within the device; and glycol as defined in § 1500.14(a)(2); pro- (B) Under any reasonably foreseeable vided that: conditions of manipulation and use, in- (i) When tested by the method de- cluding reasonably foreseeable abuse scribed in § 1500.3(c)(2)(i), the dry ink by children, the ink will emerge only concentrate does not have an LD–50 (le- through the porous writing nib of the thal dose, median; lethal for 50 percent device; and or more of test group) single oral dose (ii)(A) The device has a capacity of of less than 1 gram per kilogram of not more than 10 grams of ink and the body weight of the test animal. ink, when tested by methods described (ii) The dry ink concentrate enclosed in § 1500.3(c)(2)(i), has an LD–50 single in a single container does not weigh oral dose of not less than 2.5 grams per more than 75 milligrams. kilogram of body weight of the test (iii) The dry ink concentrate does not animal; or contain over 15 percent by weight of (B) The device has a capacity of not ethylene glycol. more than 12 grams of ink and the ink, (13) Containers of liquid and semi- when tested by methods described in solid substances such as viscous-type § 1500.3(c)(2)(i), has an LD–50 single oral paints, varnishes, lacquers, roof coat- dose of not less than 3.0 grams per kilo- ings, rubber vulcanizing preparations, gram of body weight of the test animal. floor covering adhesives, glazing com- (10) Viscous nitrocellulose-base adhe- pounds, and other viscous products sives containing more than 4 percent containing toluene (also known as tol- methyl alcohol by weight are exempt uol), xylene (also known as xylol), or from the label statement ‘‘Cannot be petroleum distillates in concentrations be made nonpoisonous’’ required by described in § 1500.14(a)(3) are exempt § 1500.14(b)(4) if: from the labeling requirements of

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§ 1500.14(b)(3)(ii) insofar as that subdivi- mixture of drycleaning solvents, are sion applies to such toluene, xylene, or exempt from the labeling requirements petroleum distillates, provided that the of section 2(p)(1) of the act (repeated in viscosity of the substance or of any liq- § 1500.3(b)(14)(i)) insofar as they apply uid that may separate or be present in to the ‘‘flammable solid’’ hazard as de- the container is not less than 100 fined in § 1500.3(c)(6)(vi), provided that: Saybolt universal seconds at 100 °F. (i) The article is packaged in a sealed (14) Customer-owned portable con- foil envelope; tainers that are filled by retail vendors (ii) The total amount of solvent in with gasoline, kerosene (kerosine), or each package does not exceed 4.5 milli- other petroleum distillates are exempt liters; and from the provision of section 2(p)(1)(A) (iii) The article will ignite only when of the act (which requires that the in contact with an open flame, and name and place of business of the man- when so ignited, the article burns with ufacturer, distributor, packer, or seller a sooty flame. appear on the label of such containers) (19) Packages containing articles in- provided that all the other label state- tended as single-use spot removers, and ments required by section 2(p)(1) of the which consist of a cotton pad or other act and § 1500.14(b)(3) appear on the la- absorbent material containing methyl bels of containers of the substances alcohol, are exempt from the labeling named in this subparagraph. requirements of § 1500.14(b)(4), if: (15) Cellulose sponges are exempt (i) The total amount of cleaning sol- from the labeling requirements of sec- vent in each package does not exceed tion 2(p)(1) of the act and § 1500.14(b)(1) 4.5 milliliters of which not more than insofar as such requirements would be 25 percent is methyl alcohol; and necessary because they contain 10 per- (ii) The liquid is completely held by cent or more of diethylene glycol as de- the absorbent materials so that no free fined in § 1500.14(a)(1), provided that: liquid is within the packages mar- (i) The cellulose sponge does not con- keted. tain over 15 percent by weight of (20) Cigarette lighters containing pe- diethylene glycol; and troleum distillate fuel are exempt from (ii) The diethylene glycol content is the labeling requirements of section completely held by the absorbent cel- 2(p)(1) of the act (repeated in lulose material so that no free liquid is § 1500.3(b)(14)(i)) and § 1500.14(b)(3) inso- within the sponge as marketed. far as such requirements would be nec- (16) Containers of substances which essary because the petroleum distillate include salt (sodium chloride) as a contained therein is flammable and be- component are exempt from the label- cause the substance is named in ing requirements of section 2(p)(1) of § 1500.14(a)(3) as requiring special label- the act (repeated in § 1500.3(b)(14)(i)) in- ing, provided that: sofar as such requirements would be (i) Such lighters contain not more necessary because the salt contained than 10 cubic centimeters of fuel at the therein is present in a quantity suffi- time of sale; and cient to render the article ‘‘toxic’’ as (ii) Such fuel is contained in a sealed defined in § 1500.3(3)(2)(i), provided that compartment that cannot be opened the labels of such containers bear a without the deliberate removal of the conspicuous statement that the prod- flush-set, screw-type refill plug of the uct contains salt. lighter. (17) The labeling of substances con- (21) Containers of dry granular fer- taining 10 percent or more of ferrous tilizers and dry granular plant foods oxalate is exempt from the require- are exempt from the labeling requirement of § 1500.129(f) that it bear the ments of section 2(p)(1) of the act (re- word ‘‘poison’’ which would be required peated in § 1500.3(b)(14)(i)) insofar as for such concentration of a salt of ox- such requirements would be necessary alic acid. because the fertilizer or plant food con- (18) Packages containing articles in- tained therein is a toxic substance as tended as single-use spot removers, and defined in § 1500.3(c)(2)(i), provided that: which consist of a cotton pad or other (i) When tested by the method de- absorbent material saturated with a scribed in § 1500.3(c)(2)(i), the product

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has a single dose LD–50 of not less than Read cautions on individual containers 3.0 grams per kilogram of body weight carefully. Not to be used by children of the test animal; except under adult supervision (ii) The label of any such exempt dry ; and granular fertilizers discloses the iden- (iii) The outer carton of such set tity of each of the hazardous ingredi- bears on the main display panel within ents; the borders of a rectangle, and in the (iii) The label bears the name and ad- type size specified in § 1500.121, the cau- dress of the manufacturer, packer, dis- tion statement specified in paragraph tributor, or seller; and (a)(23)(ii) of this section. (iv) The label bears the statement ‘‘Keep out of the reach of children’’ or (24) Fire extinguishers containing its practical equivalent. fire extinguishing agents which are (22) Small plastic capsules containing stored under pressure or which develop a paste composed of powdered metal pressure under normal conditions of solder mixed with a liquid flux are ex- use are exempt from the labeling re- empt from the requirements of section quirements of section 2(p)(1) of the act 2(p)(1) of the act (repeated in (repeated in § 1500.3(b)(14)(i)) insofar as § 1500.3(b)(14)(i)), if: such requirements apply to the pres- (i) The capsule holds not more than sure hazard as defined in § 1500.3(c)(7)(i), one-half milliliter of the solder mix- provided that: ture; (i) If the container is under pressure (ii) The capsule is sold only as a com- both during storage and under condi- ponent of a kit; and tions of use, it shall be designed to (iii) Adequate caution statements ap- withstand a pressure of at least 6 times ° pear on the carton of the kit and on the charging pressure at 70 F., except any accompanying labeling which that carbon dioxide extinguishers shall bears directions for use. be constructed and tested in accord- (23) Chemistry sets and other science ance with applicable Interstate Com- education sets intended primarily for merce Commission specifications; or use by juveniles, and replacement con- (ii) If the container is under pressure tainers of chemicals for such sets, are only during conditions of use, it shall exempt from the requirements of sec- be designed to withstand a pressure of tion 2(p)(1) of the act (repeated in not less than 5 times the maximum § 1500.3(b)(14)(i)), if: pressure developed under closed nozzle (i) The immediate container of each conditions at 70 °F. or 11⁄2 times the chemical that is hazardous as defined maximum pressure developed under in the act and regulations thereunder closed nozzle conditions at 120 °F., bears on its main panel the name of whichever is greater. such chemical, the appropriate signal (25) Cleaning and spot removing kits word for that chemical, and the addi- intended for use in cleaning carpets, tional statement ‘‘Read back panel be- furniture, and other household objects; fore using’’ (or ‘‘Read side panel before kits intended for use in coating, paint- using,’’ if appropriate) and bears on the ing, antiquing, and similarly proc- back (or side) panel of the immediate essing furniture, furnishings, equip- container the remainder of the appro- ment, sidings, and various other sur- priate cautionary statement for the faces; and kits intended for use in pho- specific chemical in the container; tographic color processing are exempt (ii) The experiment manual or other from the requirements of section 2(p)(1) instruction book or booklet accom- of the act (repeated in § 1500.3(b)(14)(i)) panying such set bears on the front and from the requirements of § 1500.14, page thereof, as a preface to any writ- provided that: ten matter in it (or on the cover, if any (i) The immediate container of each there be), the following caution state- hazardous substance in the kit is fully ment within the borders of a rectangle labeled and in conformance with the and in the type size specified in requirements of the act and regula- § 1500.121: tions thereunder; and WARNING—This set contains chemi- (ii) The carton of the kit bears on the cals that may be harmful if misused. main display panel (or panels) within a

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borderline, and in the type size speci- (ii) Each individual article in the as- fied in § 1500.121, the caution statement sortment is fully labeled and in con- ‘‘(Insert proper signal word as specified formance with the requirements of the in paragraph (a)(25)(iii) of this section). act and regulations thereunder; and This kit contains the following chemi- (iii) The outer package bears on the cals that may be harmful if misused: main display panel (or panels), within (List hazardous chemical components the borders of a rectangle and in the by name.) Read cautions on individual type size specified in § 1500.121, the cau- containers carefully. Keep out of the tion statement ‘‘WARNING—This as- reach of children.’’ sortment contains items that may be (iii) If either the word ‘‘POISON’’ or hazardous if misused and should be ‘‘DANGER’’ is required on the con- used only under adult supervision. IM- tainer of any component of the kit, the PORTANT—Read cautions on indi- same word shall be required to appear vidual items carefully.’’ (See also as part of the caution statement on the § 1500.14(b)(7); § 1500.17(a) (3), (8) and (9); kit carton. If both ‘‘POISON’’ and § 1500.85(a)(2); and part 1507). ‘‘DANGER’’ are required in the label- (28) Packages containing felt pads ing of any component or components in impregnated with ethylene glycol are the kit, the word ‘‘POISON’’ shall be exempt from the labeling requirements used. In all other cases the word of § 1500.14(b)(1), if: ‘‘WARNING’’ or ‘‘CAUTION’’ shall be (i) The total amount of ethylene gly- used. col in each pad does not exceed 1 gram; (26) Packages containing articles in- and tended as single-use spot removers and (ii) The liquid is held by the felt pad containing methyl alcohol are exempt so that no free ethylene glycol is with- from the labeling specified in in the package. § 1500.14(b)(4), if: (29) Cigarette lighters containing bu- (i) The total amount of cleaning sol- tane and/or isobutane fuel are exempt vent in each unit does not exceed 1 mil- from the labeling requirements of sec- liliter, of which not more than 40 per- tion 2(p)(1) of the act (repeated in cent is methyl alcohol; § 1500.3(b)(14)(i)) insofar as such require- (ii) The liquid is contained in a ments would otherwise be necessary sealed glass ampoule enclosed in a because the fuel therein is extremely plastic container with a firmly at- flammable and under pressure, pro- tached absorbent wick at one end vided that: through which the liquid from the (i) The lighters contain not more crushed ampoule must pass, under the than 12 grams of fuel at the time of contemplated conditions of use; and sale; and (iii) The labeling of each package of (ii) The fuel reservoir is designed to the cleaner bears the statement withstand a pressure of at least 11⁄2 ‘‘WARNING—Keep out of the reach of times the maximum pressure which children,’’ or its practical equivalent, will be developed in the container at and the name and place of business of 120 °F. the manufacturer, packer, distributor, (30) The outer retail containers of or seller. solder kits each consisting of a small (27) Packaged fireworks assortments tube of flux partially surrounded by a intended for retail distribution are ex- winding of wire-type cadmium-free sil- empt from section 2(p)(1) of the act (re- ver solder are exempt from the labeling peated in § 1500.3(b)(14)(i)), if: requirements of section 2(p)(1) of the (i) The package contains only fire- act (repeated in § 1500.3(b)(14)(i)), if: works devices suitable for use by the (i) The metal solder contains no cad- public and designed primarily to mium and is not otherwise hazardous produce visible effects by combustion, under the provisions of the act; except that small devices designed to (ii) The tube of flux in the kit is fully produce audible effects may also be in- labeled and in conformance with the cluded if the audible effect is produced act and regulations thereunder, and by a charge of not more than 2 grains any accompanying literature that of pyrotechnic composition; bears directions for use also bears all

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the information required by section (33) Containers of mineral oil having 2(p) of the act; and a capacity of not more than 1 fluid (iii) The main panel of the outer con- ounce and intended for use in pro- tainer bears in type size specified in ducing a smoke effect for toy trains are § 1500.121 the following: (A) The signal exempt from the labeling specified in word; (B) a statement of principal haz- § 1500.14(b)(3), if: ard or hazards; (C) the statement (i) The mineral oil meets the speci- ‘‘Keep out of the reach of children,’’ or fications in the N.F. for light liquid its practical equivalent; and (D) in- petrolatum; structions to read other cautionary in- (ii) The mineral oil has a viscosity of structions on the tube of flux within. at least 130 Saybolt universal seconds (31) Visual novelty devices consisting at 100 °F.; of sealed units, each of which unit is a (iii) The article contains no other in- steel and glass cell containing gredient that contributes to the haz- perchloroethylene (among other ard; and things), are exempt from the require- (iv) The label declares the presence ments of § 1500.121(a) that would other- light liquid petrolatum and the name wise require a portion of the warning and place of business of the manufac- statement to appear on the glass face turer, packer, distributor, or seller. of the device, provided that: (34) Viscous products containing (i) The device contains not more than more than 4 percent by weight of meth- 105 milliliters of perchloroethylene and yl alcohol, such as adhesives, asphalt- contains no other component that con- base roof and tank coatings, and simi- tributes substantially to the hazard; lar products, are exempt from bearing and the special labeling required by (ii) The following cautionary state- § 1500.14(b)(4), if: ment appears on the device (other than (i) The product contains not more on the bottom) in the type size speci- than 15 percent by weight of methyl al- fied in § 1500.121 (c) and (d): cohol; CAUTION—IF BROKEN, RESULTANT VAPORS (ii) The methyl alcohol does not sepa- MAY BE HARMFUL rate from the other ingredients upon standing or through any foreseeable Contains perchloroethylene. Do not expose to extreme heat. If broken indoors, open win- use or manipulation; dows and doors until all odor of chemical is (iii) The viscosity of the product is gone. not less than 7,000 centipoises at 77 °F., Keep out of the reach of children. unless the product is packaged in a A practical equivalent may be sub- pressurized container and is dispensed stituted for the statement ‘‘Keep out of as a liquid unsuitable for drinking; and the reach of children.’’ (iv) The labeling bears the statement (32) Hollow plastic toys containing ‘‘Contains methyl alcohol. Use only in mineral oil are exempt from the label- well-ventilated area. Keep out of the ing specified in § 1500.14(b)(3)(ii), if: reach of children.’’ (i) The article contains no other in- (35) Individual detonators or blasting gredient that would cause it to possess caps are exempt from bearing the the aspiration hazard specified in statement, ‘‘Keep out of the reach of § 1500.14(b)(3)(ii); children,’’ or its practical equivalent, (ii) The article contains not more if: than 6 fluid ounces of mineral oil; (i) Each detonator or cap bears con- (iii) The mineral oil has a viscosity spicuously in the largest type size of at least 70 Saybolt universal seconds practicable the statement, ‘‘DAN- at 100 °F.; GEROUS—BLASTING CAPS—EXPLO- (iv) The mineral oil meets the speci- SIVE’’ or ‘‘DANGEROUS—DETO- fications in the N.F. for light liquid NATOR—EXPLOSIVE’’; and petrolatum; and (ii) The outer carton and any accom- (v) The container bears the state- panying printed matter bear appro- ment ‘‘CAUTION—Contains light liquid priate, complete cautionary labeling. petrolatum N.F. Discard if broken or (36) Individual toy rocket propellant leak develops.’’ devices and separate delay train and/or

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recovery system activation devices in- and must appear on any outer package, tended for use with premanufactured accompanying leaflet, and display model rocket engines are exempt from card. If there is no outer package, ac- bearing the full labeling required by companying leaflet, or display card, section 2(p)(1) of the act (repeated in then the remainder of the required cau- § 1500.3(b)(14)(i)) insofar as such require- tionary labeling must be displayed on a ments would be necessary because the tag or other suitable material that is articles are flammable or generate securely affixed to the article so that pressure, provided that: the labeling will remain attached (i) The devices are designed and con- throughout the conditions of merchan- structed in accordance with the speci- dising and distribution to the ultimate fications in § 1500.85(a)(8), (9) or (14); consumer. That labeling which must (ii) Each individual device or retail appear on any outer package, accom- package of devices bears the following: (A) The statement ‘‘WARNING— panying leaflet, tag, or other suitable FLAMMABLE: Read instructions be- material must comply with the size, fore use’’; placement, contrast, and conspicuous- (B) The common or usual name of the ness requirements of § 1500.121(d). article; (38) Rigid or semi-rigid writing in- (C) A statement of the type of engine struments and ink cartridges having a and use classification; writing point and an ink reservoir are (D) Instructions for safe disposal; and exempt from the labeling requirements (E) Name and place of business of of section 2(p)(1) of the act (repeated in manufacturer or distributor; and § 1500.3(b)(14)(i) of the regulations) and (iii) Each individual rocket engine or of regulations issued under section 3(b) retail package of rocket engines dis- of the act (§ 1500.14(b)(1, 2)) insofar as tributed to users is accompanied by an such requirements would be necessary instruction sheet bearing complete because the ink contained therein is a cautionary labeling and instructions ‘‘toxic’’ substance as defined in for safe use and handling of the indi- § 1500.3(c)(2)(i) and/or because the ink vidual rocket engines. contains 10 percent or more by weight (37) Glues with a cyanoacrylate base ethylene glycol or diethylene glycol, if in packages containing 3 grams or less all the following conditions are met: are exempt from the requirement of (i) The writing instrument or car- § 1500.121(d) that labeling which is per- tridge is of such construction that the mitted to appear elsewhere than on the main label panel must be in type size ink will, under any reasonably foresee- no smaller than 6 point type, provided able condition of manipulation and use, that: emerge only from the writing tip. (i) The main panel of the immediate (ii) When tested by the method de- container bears both the proper signal scribed in § 1500.3(c)(2)(i), the ink does word and a statement of the principal not have an LD–50 single oral dose of hazard or hazards associated with this less than 2.5 grams per kilogram of product, as provided by § 1500.121 (a) body weight of the test animal. and (c); (iii) If the ink contains ethylene gly- (ii) The main panel of the immediate col or diethylene glycol, the amount of container also bears an instruction to such substance, either singly or in read carefully additional warnings combination, does not exceed 1 gram elsewhere on the label and on any per writing instrument or cartridge. outer package, accompanying leaflet, (iv) The amount of ink in the writing and display card. The instruction to instrument or cartridge does not ex- read additional warnings must comply ceed 3 grams. with the size, placement, conspicuousness, and contrast requirements of [38 FR 27012, Sept. 27, 1973; 42 FR 33026, June § 1500.121; and 29, 1977, as amended at 43 FR 32745, July 28, (iii) The remainder of the cautionary 1978; 43 FR 47176, Oct. 13, 1978; 44 FR 42678, labeling required by the act that is not July 20, 1979; 46 FR 11513, Feb. 9, 1981; 48 FR on the main label panel must appear 16, Jan. 3, 1983; 68 FR 4699, Jan. 30, 2003; 74 FR elsewhere on the label in legible type 27249, June 9, 2009; 75 FR 49380, Aug. 13, 2010]

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§ 1500.85 Exemptions from classifica- constructed nonmetallic tube that will tion as banned hazardous sub- not fragment into sharp, hard pieces. stances. (iv) Are designed so that they will (a) The term banned hazardous sub- not burst under normal conditions of stances as used in section 2(q)(1)(A) of use, are incapable of spontaneous igni- the act shall not apply to the following tion, and do not contain any type of ex- articles provided that these articles plosive or pyrotechnic warhead other bear labeling giving adequate direc- than a small parachute or recovery- tions and warnings for safe use: system activation charge. (1) Chemistry sets and other science (9) Separate delay train and/or recov- education sets intended primarily for ery system activation devices intended juveniles, and replacement components for use with premanufactured model for such sets, when labeled in accord- rocket engines wherein all of the chem- ance with § 1500.83(a)(23). ical ingredients are preloaded so the (2) Firecrackers designed to produce user does not handle any chemical in- audible effects, if the audible effect is gredient and are so designed that the produced by a charge of not more than main casing or container does not rup- 50 milligrams (.772 grains) of pyro- ture during operation. technic composition. (See also (10) Solid fuel pellets intended for use § 1500.14(b)(7); § 1500.17(a) (3), (8) and (9); in miniature jet engines for propelling and part 1507). model jet airplanes, speed boats, racing (3) [Reserved] cars, and similar models, provided such (4) Educational materials such as art materials, preserved biological speci- solid fuel pellets: mens, laboratory chemicals, and other (i) Weigh not more than 11.5 grams articles intended and used for edu- each. cational purposes. (ii) Are coated with a protective res- (5) Liquid fuels containing more than inous film. 4 percent by weight of methyl alcohol (iii) Contain not more than 35 per- that are intended and used for oper- cent potassium dichromate. ation of miniature engines for model (iv) Produce a maximum thrust of airplanes, boats, cars, etc. not more than 71⁄2 ounces when used as (6) Novelties consisting of a mixture directed. of polyvinyl acetate, U.S. Certified Col- (v) Burn not longer than 12 seconds ors, and not more than 25 percent by each when used as directed. weight of acetone, and intended for (11) Fuses intended for igniting fuel blowing plastic balloons. pellets exempt under subparagraph (10) (7) Games containing, as the sole haz- of this paragraph. ardous component, a self-pressurized (12) Kits intended for construction of container of soap solution or similar model rockets and jet propelled model foam-generating mixture provided that airplanes requiring the use of the foam-generating component has no difluorodichloromethane as a propel- hazards other than being in a self-pres- lant, provided the outer carton bears surized container. (8) Model rocket propellant devices on the main panel in conspicuous type designed for use in light-weight, recov- size the statement ‘‘WARNING—Care- erable, and reflyable model rockets, fully read instructions and cautions be- provided such devices: fore use.’’ (i) Are designed to be ignited by elec- (13) Flammable wire materials in- trical means. tended for electro-mechanical actu- (ii) Contain no more than 62.5 grams ation and release devices for model (2.2 ounces) of propellant material and kits described in paragraph (12) of this produce less than 80 newton-seconds section, provided each wire does not ex- (17.92 pound seconds) of total impulse ceed 15 milligrams in weight. with thrust duration not less than 0.050 (14) Model rocket propellant devices second. (model rocket motors) designed to pro- (iii) Are constructed such that all the pel rocket-powered model cars, pro- chemical ingredients are preloaded vided— into a cylindrical paper or similarly (i) Such devices:

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(A) Are designed to be ignited elec- the track or line, are unstable and fail trically and are intended to be oper- to operate in a guided fashion so that ated from a minimum distance of 15 they will not strike the operator or by- feet (4.6 m) away; standers. (B) Contain no more than 4 g. of pro- (b) [Reserved] pellant material and produce no more [38 FR 27012, Sept. 27, 1973, as amended at 41 than 2.5 Newton-seconds of total im- FR 22935, June 8, 1976; 42 FR 43391, Aug. 29, pulse with a thrust duration not less 1977; 48 FR 16, Jan. 3, 1983; 68 FR 4699, Jan. 30, than 0.050 seconds; 2003] (C) Are constructed such that all the chemical ingredients are pre-loaded § 1500.86 Exemptions from classifica- into a cylindrical paper or similarly tion as a banned toy or other constructed non-metallic tube that will banned article for use by children. not fragment into sharp, hard pieces; (a) The term banned hazardous sub- (D) Are designed so that they will not stance as used in section 2(q)(1)(A) of burst under normal conditions of use, the act (repeated in § 1500.3(b)(15)(i)(A)) are incapable of spontaneous ignition, of the act shall not apply to the fol- and do not contain any type of explo- lowing articles: sive or pyrotechnic warhead other than (1) Toy rattles described in a small recovery system activation § 1500.18(a)(1) in which the rigid wires, charge; sharp protrusions, or loose small ob- (E) Bear labeling, including labeling jects are internal and provided that that the devices are intended for use by such rattles are constructed so that persons age 12 and older, and include they will not break or deform to expose instructions providing adequate warn- or release the contents either in nor- ings and instructions for safe use; and mal use or when subjected to reason- (F) Comply with the requirements of ably foreseeable damage or abuse. 16 CFR 1500.83(a)(36)(ii and iii); and (2) Dolls and stuffed animals and (ii) The surface vehicles intended for other similar toys described in use with such devices: § 1500.18(a)(3) in which the components (A) Are lightweight, weighing no that have the potential for causing lac- more than 3.0 oz. (85 grams), and con- eration, puncture wound injury, or structed mainly of materials such as other similar injury are internal, pro- balsa wood or plastics that will not vided such dolls, stuffed animals, and fragment into sharp, hard pieces; other similar toys are constructed so (B) Are designed to utilize a braking that they will not break or deform to system such as a parachute or shock expose such components either in nor- absorbing stopping mechanism; mal use or when subjected to reason- (C) Are designed so that they cannot ably foreseeable damage or abuse. accept propellant devices measuring (3) [Reserved] larger than 0.5″ (13 mm) in diameter (4) Any article known as a ‘‘baby- and 1.75″ (44 mm) in length; bouncer’’ or ‘‘walker-jumper’’ and any (D) Are designed so that the engine other similar article (referred to in mount is permanently attached by the this paragraph as ‘‘article(s)’’), except manufacturer to a track or track line an infant walker subject to part 1216 of that controls the vehicle’s direction for this chapter, described in § 1500.18(a)(6) the duration of its movement; provided: (E) Are not designed to carry any (i) The frames are designed and con- type of explosive or pyrotechnic mate- structed in a manner to prevent injury rial other than the model rocket motor from any scissoring, shearing, or pinch- used for primary propulsion; ing when the members of the frame or (F) Bear labeling and include instruc- other components rotate about a com- tions providing adequate warnings and mon axis or fastening point or other- instructions for safe use; and wise move relative to one another; and (G) Are designed to operate on a (ii) Any coil springs which expand track or line that controls the vehicles’ when the article is subjected to a force direction for the duration of their that will extend the spring to its max- movement and either cannot operate imum distance so that a space between off the track or line or, if operated off successive coils is greater than one-

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eighth inch (0.125 inch) are covered or (5) Clacker balls described in otherwise designed to prevent injuries; § 1500.18(a)(7) that have been designed, and manufactured, assembled, labeled, and (iii) All holes larger than one-eighth tested in accordance with the following inch (0.125 inch) in diameter and slots, requirements, and when tested at the cracks, or hinged components in any point of production or while in inter- portion of the article through which a state commerce or while held for sale child could insert, in whole or in part a after shipment in interstate commerce finger, toe, or any other part of the do not exceed the failure rate require- anatomy are guarded or otherwise de- ments of the table in paragraph signed to prevent injuries; and (a)(5)(vi) of this section: (iv) The articles are designed and (i) The toy shall be so designed and constructed to prevent accidental col- fabricated that: lapse while in use; and (A) Each ball: Weighs less than 50 (v) The articles are designed and con- grams; will not shatter, crack, or chip; structed in a manner that eliminates is free of cracks, flash (ridges due to from any portion of the article the pos- imperfect molding), and crazing (tiny sibility of presenting a mechanical haz- surface cracks); and is free of rough or ard through pinching, bruising, lacer- sharp edges around any hole where the ating, crushing, breaking, amputating, cord enters or over any surface with or otherwise injuring portions of the which the cord may make contact. human body when in normal use or Each ball is free of internal voids when subjected to reasonably foresee- (holes, cavities, or air bubbles) if the able damage or abuse; and balls are made of materials other than (vi) Any article which is introduced those materials (such as ABS (acrylo- into interstate commerce after the ef- nitrile butadiene styrene), nylon, and fective date of this subparagraph is la- high-impact polystyrene) that are injection-molded and possess high-im- beled: pact characteristics. (A) With a conspicuous statement of (B) The cord: Is of high tensile the name and address of the manufac- strength, synthetic fibers that are turer, packer, distributor, or seller; braided or woven, having a breaking and strength in excess of 445 Newtons (100 (B) With a code mark on the article pounds); is free of fraying or any other itself and on the package containing defect that might tend to reduce its the article or on the shipping con- strength in use; is not molded in balls tainer, in addition to the invoice(s) or made of casting resins which tend to shipping document(s), which code mark wick up or run up on the outside of the will permit future identification by the cord; and is affixed to a ball at the cen- manufacturer of any given model (the ter of the horizontal plane of the ball manufacturer shall change the model when it is suspended by the cord. number whenever the article undergoes Clacker balls where the mass of each a significant structural or design modi- ball is less than 12 grams (0.42 oz.) and fication); and the distance between the center of the (vii) The manufacturer or importer of pivot and the center of the ball cannot the article shall make, keep, and main- exceed 180 mm (7.1 inches) may have a tain for 3 years records of sale, dis- minimum cord breaking strength of tribution, and results of inspections less than 445 Newtons (100 pounds), as and tests conducted in accordance with computed by the following formula: this subparagraph and shall make such records available at all reasonable Adjusted Cord Breaking Strength in New- hours upon request by any officer or tons = 0.1382(mb) (Rp), where mb = mass of a employee of the Consumer Product single ball in grams and R = pivot length in mm. Safety Commission and shall permit p such officer or employee to inspect and (C) When the cord is attached to the copy such records, to make such stock ball by means of a knot, the end be- inventories as he deems necessary, and neath the knot is chemically fused or to otherwise check the correctness of otherwise treated to prevent the knot such records. from slipping out or untying in use.

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(ii) The toy shall be tested at the than 12 grams (0.42 oz.) and the dis- time of production: tance between the center of the pivot (A) By using the sampling procedure and the center of the ball cannot ex- described in the table in subdivision ceed 180 mm (7.1 inches) may be tested (vi) of this subparagraph to determine with a force of under 445 Newtons (100 the number of units to be tested. pounds). The test force for these clack- (B) By subjecting each ball tested to er balls shall be the same as the cord 10 drops of a 2.25 kg (5-pound) steel im- breaking strength calculated in pact rod or weight (57-mm (21⁄4-inch) di- § 1500.86(a)(5)(i)(B). Any breaking, fray- ameter with a flat head) dropped 1220 ing, or unraveling of the cord or any mm (48 inches) in a vented steel or alu- sign of slipping, loosening, or unfas- minum tube (60-mm (23⁄8-inch) inside tening shall be counted as a failure diameter) when the ball is placed on a within the meaning of the fourth col- steel or cast iron mount. Clacker balls umn of the table in paragraph (a)(5)(vi) where the mass of each ball is less than of this section. 12 grams (0.42 oz.) and the distance be- (E) By additionally subjecting any tween the center of the pivot and the ring or other holding device to a 222- center of the ball cannot exceed 180 Newton (50-pound) test load applied to mm (7.1 inches) may be tested by drop- both cords; the holding device is to be ping the impact weight from a height securely fixed horizontally in a suit- of less than 1220 mm (48 in.), where the able clamp in such a manner as to sup- height is computed as follows: port 50 percent of the area of such holding device and the balls are suspended Adjusted drop height in mm = 179 × ¥5 freely. Clacker balls where the mass of 10 (mb) (Rp2), where mb = mass of a single ball in grams and each ball is less than 12 grams (0.42 oz.) and the distance between the center of Rp = pivot length in mm. the pivot and the center of the ball Any ball showing any chipping, crack- cannot exceed 180 mm (7.1 inches) may ing, or shattering shall be counted as a have their holding device tested with a failure within the meaning of the third force of less than 222 Newtons (50 column of the table in paragraph pounds). The holding device test force (a)(5)(vi) of this section. for these clacker balls shall be half of (C) By inspecting each ball tested for the cord breaking strength calculated smoothness of finish on any surface of in § 1500.86(a)(5)(i)(B). Any breaking, the ball which may come in contact cracking, or crazing of the ring or with the cord during use. A cotton other holding device shall be counted swab shall be rubbed vigorously over as a failure within the meaning of the each such surface or area of the ball; if fourth column of the table in para- any cotton fibers are removed, the ball graph (a)(5)(vi) of this section. shall be counted as a failure within the (F) By cutting each ball tested in meaning of the fourth column of the half and then cutting each half per- table in subdivision (vi) of this para- pendicularly to the first cut into three graph. The toy shall also be checked to or more pieces of approximately equal ascertain that there is no visibly per- thickness. Each portion is to be in- ceptible ‘‘wicking up’’ or ‘‘running up’’ spected before and after cutting, and of the casting resins on the outside of any ball showing any flash, crack, craz- the cord in the vicinity where the ball ing, or internal voids on such inspec- is attached. tion is to be counted as a failure within (D) By fully assembling the toy and the meaning of the fourth column of testing the cord in such a manner as to the table in paragraph (a)(5)(vi) of this test both the strength of the cord and section. Balls that are injection-mold- the adequacy with which the cord is ated and possess high-impact characteris- tached to the ball and any holding de- tics (such as injection-molded balls vice such as a tab or ring included in made of ABS, nylon, or high-impact the assembly. The fully assembled arti- polystyrene) though exempt from the cle shall be vertically suspended by one requirements that there be no internal ball and a 445-Newton (100-pound) test voids, must be tested to determine the applied to the bottom ball. Clacker presence of any flash, crack or grazing. balls where the mass of each ball is less A transparent ball shall be subjected to

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the same requirements except that it and held securely between the thumb may be visually inspected without cut- and forefinger,’’ or words to that effect ting. which will provide adequate instruc- (iii) The toy shall be fully assembled tions and warnings to prevent the hold- for use at time of sale, including the ing device from accidentally slipping proper attachments of balls, cords, out of the hand. Such statements shall knots, loops, or other holding devices. be printed in sharply contrasting color (iv) The toy shall be labeled: within a borderline and in letters at (A) With a conspicuous statement of 1 least 6 mm ( ⁄4 inch) high on the main the name and address of the manufac- panel of the container and at least 3 turer, packer, distributor, or seller. mm (1⁄8) high on all accompanying lit- (B) To bear on the toy itself and/or erature. the package containing the toy and/or (v) The manufacturer of the toy shall the shipping container, in addition to make, keep, and maintain for 3 years the invoice(s) and shipping document(s), a code or mark in a form and records of sale, distribution, and re- manner that will permit future identi- sults of inspections and tests con- fication of any given batch, lot, or ducted in accordance with this sub- shipment by the manufacturer. paragraph and shall make such records (C) To bear a conspicuous warning available upon request at all reason- statement on the main panel of the re- able hours by any officer or employee tail container and display carton and of the Consumer Product Safety Com- on any accompanying literature: That mission, and shall permit such officer if cracks develop in a ball or if the cord or employee to inspect and copy such becomes frayed or loose or unfastened, records and to make such inventories use of the toy should be discontinued; of stock as he deems necessary and and if a ring or loop or other holding otherwise to check the correctness of device is present, the statement ‘‘In such records. use, the ring or loop must be placed (vi) The lot size, sample size, and around the middle finger and the two failure rate for testing clacker balls cords positioned over the forefinger are as follows:

Failure rate constituting Number of units in batch, shipment, deliv- Number of units in ran- Failure rate constituting rejection when testing per ery, lot, or retail stock dom sample rejection when testing per § 1500.86(a)(5)(ii) (C), § 1500.86(a)(5)(ii)(B) (D), (E), and (F)

50 or less ...... 8 1 1 51 to 90 ...... 13 1 1 91 to 150 ...... 20 1 1 151 to 280 ...... 32 1 2 281 to 500 ...... 50 1 2 501 to 1,200 ...... 80 2 4 1,201 to 3,200 ...... 125 2 6 3,201 to 10,000 ...... 200 3 10 10,001 to 35,000 ...... 315 4 16 35,001 to 150,000 ...... 500 6 25 150,001 to 500,000 ...... 800 8 40 500,001 and over ...... 1,250 11 62

(vii) Applicability of the exemption that the entire batch, shipment, deliv- provided by this paragraph shall be de- ery, lot, or retail stock has failed and termined through use of the table in thus is not exempted under this para- paragraph (a)(5)(vi) of this section. A graph from classification as a banned random sample of the number of arti- hazardous substance. cles as specified in the second column (6) [Reserved] of the table shall be selected according (7) Dive sticks and similar articles to the number of articles in a par- described in § 1500.18(a)(19) that come to ticular batch, shipment, delivery, lot, rest at the bottom of a container of or retail stock per the first column. A water in a position in which the long failure rate as shown in either the axis of the article is greater than 45 de- third or fourth column shall indicate grees from vertical when measured in

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accordance with the following test cation in the vertical direction and method: shall have a means to adjust the rate of (i) Test equipment. load application. (A) A container that is filled with tap (B) Compression disk—the loading water to a depth at least 3 inches [76 device that is attached to the force mm] greater than the longest dimen- gauge shall be a rigid metal disk with sion of the dive stick. The container a minimum diameter of 1.125 inches [29 shall: mm]. (1) Be sufficiently wide to allow the (C) Vise or other clamping device. dive stick to lie along the bottom with (ii) Testing procedure its long axis in a horizontal position, (A) Position the bottom of the dive (2) Have clear side walls to permit ob- stick in the clamping device so that servation of the dive stick under water, the longest axis of the dive stick is and vertical. The bottom end of the dive (3) Be placed on a level surface and stick is the end that sinks to the bot- have a flat bottom. tom of a pool of water. Secure the bot- (B) A protractor or other suitable tom of the dive stick in the clamp such angle measurement device that has an that the clamping mechanism covers indicator for 45 degrees from vertical. no more than the bottom 1⁄2 inch [13 (ii) Testing procedure mm] of the dive stick. (A) If the dive stick is sold such that (B) Apply a downward force at a rate the consumer is required to attach an of 0.05 in/sec (±0.01 in/sec) [1.3 mm.sec additional component(s) to the dive ±0.3 mm/sec] at the top of the dive stick, then the product shall be tested stick with the compression disk posi- both with and without the attach- tioned so that the plane of the disk ment(s). contact surface is perpendicular to the (B) From just above the water sur- long axis of the dive stick. face, drop the dive stick into the con- (C) Apply the load for a period of 40 tainer. seconds or until the maximum recorded (C) Let the dive stick sink and come force exceeds 5-lbf [22 N]. to rest at the bottom of the container. (D) Record the maximum force that If the dive stick is designed so that the was measured during the test. weight can be adjusted by adding water (b) [Reserved] or other substance, adjust the weight (9) Boston Billow Nursing Pillow and so that the dive stick sinks and comes substantially similar nursing pillows to rest with its long axis positioned as that are designed to be used only as a close to vertical as possible. nursing aide for breastfeeding mothers. (D) Align the angle measurement de- For example, are tubular in form, C- or vice alongside the dive stick under- crescent-shaped to fit around a nursing water and wait for the dive stick to mother’s waist, round in circumference come to rest if there is any water dis- and filled with granular material. turbance. Determine whether the long axis of the dive stick is greater than or [38 FR 27012, Sept. 27, 1973, as amended at 53 FR 46839, Nov. 18, 1988; 59 FR 9076, 9077, Feb. less than 45 degrees from vertical. 25, 1994; 66 FR 13651, Mar. 7, 2001; 68 FR 70140, (8) Dive sticks and similar articles Dec. 17, 2003; 73 FR 77495, Dec. 19, 2008; 75 FR described in § 1500.18(a)(19) in which the 35282, June 21, 2010; 78 FR 66841, Nov. 7, 2013] maximum force measured in the following test method is less than 5–lbf § 1500.87 Children’s products con- [22N]. The test shall be conducted in taining lead: inaccessible compo- the ambient environment of the labora- nent parts. tory and not under water. (a) The Consumer Product Safety Im- (i) Test equipment. provement Act (CPSIA) provides for (A) A compression rig that has a specific lead limits in children’s prod- force gauge or equivalent device that is ucts. Section 101(a) of the CPSIA pro- calibrated for force measurements vides that by February 10, 2009, prod- within a minimum range of 0 to 5 lbf ucts designed or intended primarily for [0–22 N] and with an accuracy of ±0.1 lbf children 12 and younger may not con- [±0.44 N] or better. The test rig shall tain more than 600 ppm of lead. After have a system to guide this force appli- August 14, 2009, products designed or

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intended primarily for children 12 and (f) For products intended for children younger cannot contain more than 300 that are over 18 months but not over 36 ppm of lead. On August 14, 2011, the months of age, the use and abuse tests limit may be further reduced to 100 set forth under the Commission’s regu- ppm after three years, unless the Com- lations at 16 CFR 1500.50 and 16 CFR mission determines that it is not tech- 1500.52 (excluding the bite test of nologically feasible to have this lower § 1500.52(c)), will be used to evaluate ac- limit. cessibility of lead-containing compo- (b) Section 101 (b)(2) of the CPSIA nent parts of a children’s product as a provides that the lead limits do not result of normal and reasonably fore- apply to component parts of a product seeable use and abuse of the product. that are not accessible to a child. This (g) For products intended for children section specifies that a component part that are over 36 months but not over 96 is not accessible if it is not physically months of age, the use and abuse tests exposed by reason of a sealed covering set forth under the Commission’s regu- or casing and does not become phys- lations at 16 CFR 1500.50 and 16 CFR ically exposed through reasonably fore- 1500.53 (excluding the bite test of seeable use and abuse of the product in- § 1500.53(c)), will be used to evaluate ac- cluding swallowing, mouthing, break- cessibility of lead-containing compo- ing, or other children’s activities, and nent parts of a children’s product as a the aging of the product, as determined result of normal and reasonably fore- by the Commission. Paint, coatings, or seeable use and abuse of the product. electroplating may not be considered (h) For products intended for chil- to be a barrier that would render lead dren over 96 months through 12 years of in the substrate to be inaccessible to a age, the use and abuse tests set forth child. under the Commission’s regulations at (c) Section 101(b)(2)(B) of the CPSIA 16 CFR 1500.50 and 16 CFR 1500.53 (ex- directs the Commission to promulgate cluding the bite test of § 1500.53(c)) in- by August 14, 2009, this interpretative tended for children aged 37–96 months rule to provide guidance with respect will be used to evaluate accessibility of to what product components or classes lead-containing component parts of a of components will be considered to be children’s product as a result of normal inaccessible. and reasonably foreseeable use and (d) The accessibility probes specified abuse of the product. for sharp points or edges under the (i) A children’s product that is or Commissions’ regulations at 16 CFR contains a lead-containing part which 1500.48–1500.49 will be used to assess the is enclosed, encased, or covered by fab- accessibility of lead-component parts ric and passes the appropriate use and of a children’s product. A lead-con- abuse tests on such covers, is inacces- taining component part would be con- sible to a child unless the product or sidered accessible if it can be contacted part of the product in one dimension is by any portion of the specified segment smaller than 5 centimeters. of the accessibility probe. A lead-con- (j) The intentional disassembly or de- taining component part would be construction of products by children older sidered inaccessible if it cannot be con- than age 8 years by means or knowl- tacted by any portion of the specified edge not generally available to younger segment of the accessibility probe. children, including use of tools, will (e) For products intended for children not be considered in evaluating prod- that are 18 months of age or less, the ucts for accessibility of lead-con- use and abuse tests set forth under the taining components. Commission’s regulations at 16 CFR [74 FR 39540, Aug. 7, 2009] 1500.50 and 16 CFR 1500.51 (excluding the bite test of § 1500.51(c)), will be used § 1500.88 Exemptions from lead limits to evaluate accessibility of lead-con- under section 101 of the Consumer taining component parts of a children’s Product Safety Improvement Act product as a result of normal and rea- for certain electronic devices. sonably foreseeable use and abuse of (a) The Consumer Product Safety Im- the product. provement Act (CPSIA) provides for

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specific lead limits in children’s prod- tent limits set forth in paragraph (a) of ucts. Section 101(a) of the CPSIA pro- this section. vides that by February 10, 2009, prod- (d) Exemptions for lead as used in ucts designed or intended primarily for certain electronic components parts in children 12 and younger may not con- children’s electronic devices include: tain more than 600 ppm of lead. After (1) Lead blended into the glass of August 14, 2009, products designed or cathode ray tubes, electronic compo- intended primarily for children 12 and nents, and fluorescent tubes. younger cannot contain more than 300 (2) Lead used as an alloying element ppm of lead. On August 14, 2011, the in steel. The maximum amount of lead limit will be further reduced to 100 shall be less than 0.35% by weight (3,500 ppm, unless the Commission deter- ppm). mines that it is not technologically (3) Lead used in the manufacture of feasible to meet this lower limit. Sec- aluminum. The maximum amount of tion 101(b)(2) of the CPSIA further pro- lead shall be less than 0.4% by weight vides that the lead limits do not apply (4,000 ppm). to component parts of a product that (4) Lead used in copper-based alloys. are not accessible to a child. This sec- The maximum amount of lead shall be tion specifies that a component part is less than 4% by weight (40,000 ppm). not accessible if it is not physically ex- (5) Lead used in lead-bronze bearing posed by reason of a sealed covering or shells and bushings. casing and does not become physically (6) Lead used in compliant pin con- exposed through reasonably foreseeable nector systems. use and abuse of the product including (7) Lead used in optical and filter swallowing, mouthing, breaking, or glass. other children’s activities, and the (8) Lead oxide in plasma display pan- aging of the product, as determined by els (PDP) and surface conduction elec- the Commission. Paint, coatings, or tron emitter displays (SED) used in electroplating may not be considered structural elements; notably in the to be a barrier that would render lead front and rear glass dielectric layer, in the substrate to be inaccessible to a the bus electrode, the black stripe, the child. address electrode, the barrier ribs, the (b) Section 101(b)(4) of the CPSIA pro- seal frit and frit ring, as well as in vides that if the Commission deter- print pastes. mines that it is not technologically (9) Lead oxide in the glass envelope of feasible for certain electronic devices Black Light Blue (BLB) lamps. to comply with the lead limits, the Commission must issue requirements (e) Components of electronic devices by regulation to eliminate or minimize that are removable or replaceable, such the potential for exposure to and acces- as battery packs and light bulbs that sibility of lead in such electronic de- are inaccessible when the product is as- vices and establish a compliance sched- sembled in functional form or are oth- ule unless the Commission determines erwise granted an exemption, are not that full compliance is not techno- subject to the lead limits in paragraph logically feasible within a schedule set (a) of this section. by the Commission. (f) Commission staff is directed to re- (c) Certain accessible lead-containing evaluate and report to the Commission component parts in children’s elec- on the technological feasibility of com- tronic devices unable to meet the lead pliance with the lead limits in para- limits set forth in paragraph (a) of this graph (a) of this section for children’s electronic devices, including the tech- section due to technological infeasi- nological feasibility of making acces- bility are granted the exemptions that sible component parts inaccessible, and follow in paragraph (d) of this section the status of the exemptions, no less below, provided that use of lead is nec- than every five years after publication essary for the proper electronic func- of a final rule in the FEDERAL REGISTER tioning of the component part and it is on children’s electronic devices. not technologically feasible for the component part to meet the lead con- [75 FR 3158, Jan. 20, 2010]

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§ 1500.89 Procedures and require- (3) Contain the name and address, ments for determinations regarding and e-mail address or telephone num- lead content of materials or prod- ber, of the requestor. ucts under section 101(a) of the (4) Provide documentation including: Consumer Product Safety Improve- ment Act. (i) A detailed description of the product or material and how it is used by a (a) The Consumer Product Safety Im- child; provement Act provides for specific (ii) Representative data on the lead lead limits in children’s products. Sec- content of parts of the product or mation 101(a) of the CPSIA provides that terials used in the production of a by February 10, 2009, products designed product; or intended primarily for children 12 (iii) All relevant data or information years of age or younger may not con- on manufacturing processes through tain more than 600 ppm of lead. After which lead may be introduced into the August 14, 2009, products designed or material or product; intended primarily for children 12 (iv) An assessment of the likelihood years of age or younger cannot contain or lack thereof that the manufacturing more than 300 ppm of lead. On August processes will result in lead contami- 14, 2011, the limit will be further re- nation of a material or product that or- duced to 100 ppm, unless the Commis- dinarily does not contain lead; sion determines that this lower limit is not technologically feasible. Paint, (v) All relevant data or information coatings or electroplating may not be on the facilities used to manufacture considered a barrier that would make the material or product, and any other the lead content of a product inacces- materials used in the product; sible to a child or prevent the absorp- (vi) An assessment of the likelihood tion of any lead in the human body or lack thereof that the use of leaded through normal and reasonably fore- materials in a facility will result in seeable use and abuse of the product. lead contamination of a material or (b) The Commission may, either on product that ordinarily does not con- its own initiative or upon the request tain lead; of any interested person, make a deter- (vii) Any other information relevant mination that a material or product to the potential for lead content of the does not contain leads levels that ex- product or material to exceed the stat- ceed 600 ppm, 300 ppm, or 100 ppm, as utory lead limit specified in the re- applicable. quest, that is 600 ppm, 300 ppm, or 100 (c) A determination by the Commis- ppm, as applicable; sion under paragraph (b) of this section (viii) Detailed information on the re- that a material or product does not lied upon test methods for measuring contain lead levels that exceed 600 lead content of products or materials ppm, 300 ppm, or 100 ppm, as applicable including the type of equipment used does not relieve the material or prod- or any other techniques employed and uct from complying with the applicable a statement as to why the data is rep- lead limit as provided under paragraph resentative of the lead content of such (a) of this section. products or materials generally; and (d) To request a determination under (ix) Any data or information that is paragraph (b) of this section, the re- unfavorable to the request that is rea- quest must: sonably available to the requestor. (1) Be e-mailed to [email protected]. (e) Where a submission fails to meet and titled ‘‘Section 101 Request for all of the requirements of paragraph (d) Lead Content Determination.’’ Re- of this section, the Office of the Sec- quests may also be mailed, preferably retary shall notify the person submit- in five copies, to the Office of the Sec- ting it, describe the deficiency, and ex- retary, Consumer Product Safety Com- plain that the request may be resub- mission, Room 502, 4330 East West mitted when the deficiency is cor- Highway, Bethesda, Maryland 20814, or rected. delivered to the same address. (f) Upon receipt of a complete request (2) Be written in the English lan- for a determination, the Office of Haz- guage. ard Identification and Reduction

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(EXHR) will assess the request to de- If the Commission, after review of the termine whether the product or mate- staff’s final recommendation, deter- rial is one that does not contain lead in mines that a material or product does excess of the limits as provided under not and would not exceed the lead con- paragraph (a) of this section. EXHR tent limits, it will decide by ballot will make an initial recommendation vote, on whether to publish a final rule within thirty (30) calendar days, to the in the FEDERAL REGISTER. extent practicable. EXHR may request (i) The filing of a request for a deter- an extension from the Executive Direc- mination does not have the effect of tor of the CPSC, if necessary, to make staying the effect of any provision or its initial determination. A complete limit under the statutes and regula- request is one that does not require ad- tions enforced by the Commission. ditional information from the re- Even though a request for a determina- questor for EXHR to make an initial tion has been filed, unless a Commis- recommendation to the Commission. sion determination is issued in final (g) Where the Office of Hazard Identi- form after notice and comment, mate- fication and Reduction’s (EXHR) ini- rials or products subject to the lead tial recommendation is to deny the re- limits under section 101 of the CPSIA quest for a lead content determination, must be tested in accordance with sec- it will provide, in a staff memorandum tion 102 of the CPSIA, unless the test- to the Commission, submitted to the ing requirement is otherwise stayed by Commission for ballot vote, the basis the Commission. for the denial with sufficient detail for the Commission to make an informed [74 FR 10480, Mar. 11, 2009] decision that reasonable grounds for a determination are not presented. The § 1500.90 Procedures and require- Commission, by ballot vote, will render ments for exclusions from lead lim- a decision on the staff’s recommenda- its under section 101(b) of the Con- sumer Product Safety Improvement tion. The ballot vote and the staff Act. memorandum will be posted on the CPSC Web site. Any determination by (a) The Consumer Product Safety Im- the Commission to grant a request will provement Act provides for specific be published in the FEDERAL REGISTER lead limits in children’s products. Sec- for comment. If the Commission con- tion 101(a) of the CPSIA provides that cludes that the request shall be denied, by February 10, 2009, products designed the requestor shall be notified in writ- or intended primarily for children 12 ing of the denial from the Office of the years of age or younger may not con- Secretary along with the official ballot tain more than 600 ppm of lead. After results and the EXHR staff’s memo- August 14, 2009, products designed or randum of recommendation. intended primarily for children 12 (h) Where the Office of Hazard Identi- years of age or younger cannot contain fication and Reduction’s (EXHR) ini- more than 300 ppm of lead. On August tial recommendation is to grant the re- 14, 2011, the limit will be further request for a lead content determination, duced to 100 ppm, unless the Commis- it will submit the basis for that rec- sion determines that this lower limit is ommendation to the Commission in a not technologically feasible. Paint, memorandum to be voted on by ballot, coatings or electroplating may not be with sufficient detail for the Commis- considered a barrier that would make sion to make an informed decision that the lead content of a product inacces- reasonable grounds for a determination sible to a child or prevent the absorp- are presented. If the notice of proposed tion of any lead in the human body rulemaking (NPR) is published, it will through normal and reasonably fore- invite public comment in the FEDERAL seeable use and abuse of the product. REGISTER. EXHR will review and evalu- (b) Exclusion of certain materials or ate any comments and supporting doc- products and inaccessible component umentation before making its final parts. The CPSIA provides the fol- recommendation to the Commission lowing functional purpose exception for final agency action, by staff memo- from the lead limits stated in section randum submitted to the Commission. 101(a) of the CPSIA.

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(1) Functional purpose exception—(i) In the exception and any materials re- general. The Commission, on its own ceived through notice and a hearing. initiative or upon petition by an inter- (C) Admissible evidence. In dem- ested party, shall grant an exception to onstrating that it meets the require- the limit under paragraph (a) of this ments of paragraph (b)(1)(i) of this sec- section for a specific product, class of tion, a party seeking an exception product, material, or component part if under such paragraph may rely on any the Commission, after notice and a nonproprietary information submitted hearing, determines that: by any other party seeking such an ex- (A) The product, class of product, ception and such information shall be material, or component part requires considered part of the record presented the inclusion of lead because it is not by the party that relies on that infor- practicable or not technologically fea- mation. sible to manufacture such product, (D) Scope of exception. If an exception class of product, material, or compo- is sought for an entire product, the nent part, as the case may be, in ac- burden is on the petitioning party to cordance with paragraph (a) of this sec- demonstrate that the criteria in para- tion by removing the excessive lead or graph (b)(1)(i) of this section are met by making the lead inaccessible; with respect to every accessible compo- (B) The product, class of product, ma- nent or accessible material of the prod- terial, or component part is not likely uct. to be placed in the mouth or ingested, (iv) Limitation on exception. If the taking into account normal and rea- Commission grants an exception for a sonably foreseeable use and abuse of product, class of product, material, or such product, class of product, mate- component part under paragraph rial, or component part by a child; and (b)(1)(i) of this section, the Commission (C) An exception for the product, may, as necessary to protect public class of product, material, or compo- health or safety: nent part will have no measurable ad- (A) Establish a lead limit that such verse effect on public health or safety, product, class of product, material, or taking into account normal and rea- component part may not exceed; or sonably foreseeable use and abuse. (B) Place a manufacturing expiration (ii) Measurement. For purposes of date on such exception or establish a paragraph (b)(1)(i)(C) of this section, schedule after which the manufacturer there is no measurable adverse effect of such product, class of product, mate- on public health or safety if the excep- rial, or component part shall be in full tion described in paragraph (b)(1)(i) of compliance with the limit established this section will result in no measur- under paragraph (b)(1)(iv)(A) of this able increase in blood lead levels of a section or the limit set forth under child. The Commission may adopt an paragraph (a) of this section. alternative method of measurement (v) Application of exception. An excep- other than blood lead levels if it deter- tion under paragraph (b)(1)(i) of this mines, after notice and a hearing, that section for a product, class of product, such alternative method is a better sci- material, or component part shall entific method for measuring adverse apply regardless of the date of manu- effect on public health and safety. facture unless the Commission ex- (iii) Procedures for granting excep- pressly provides otherwise. tion—(A) Burden of proof. A party seek- (vi) Previously submitted petitions. A ing an exception under paragraph party seeking an exception under this (b)(1)(i) of this section has the burden paragraph may rely on materials pre- of demonstrating that it meets the re- viously submitted in connection with a quirements of such paragraph. petition for exclusion under this sec- (B) Grounds for decision. In the case tion. In such cases, petitioners must where a party has petitioned for an ex- notify the Commission of their intent ception, in determining whether to to rely on materials previously sub- grant the exception, the Commission mitted. Such reliance does not affect may base its decision solely on the ma- petitioners’ obligation to demonstrate terials presented by the party seeking that they meet all requirements of this

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paragraph as required by paragraph terial is changed or altered so that it (b)(1)(iii)(A) of this section. exceeds the lead content limits. (2) [Reserved] (d) The following materials do not exceed the lead content limits under sec- [74 FR 10480, Mar. 11, 2009, as amended at 78 tion 101(a) of the CPSIA provided that FR 41298, July 10, 2013] these materials have neither been treated or adulterated with the addi- § 1500.91 Determinations regarding lead content for certain materials tion of materials that could result in or products under section 101 of the the addition of lead into the product or Consumer Product Safety Improve- material: ment Act. (1) Precious gemstones: diamond, (a) The Consumer Product Safety Im- ruby, sapphire, emerald. provement Act provides for specific (2) Semiprecious gemstones and other lead limits in children’s products. Sec- minerals, provided that the mineral or material is not based on lead or lead tion 101(a) of the CPSIA provides that compounds and is not associated in na- by February 10, 2009, products designed ture with any mineral based on lead or or intended primarily for children 12 lead compounds (excluding any mineral and younger may not contain more that is based on lead or lead com- than 600 ppm of lead. After August 14, pounds including, but not limited to, 2009, products designed or intended pri- the following: aragonite, bayldonite, marily for children 12 and younger can- boleite, cerussite, crocoite, galena, not contain more than 300 ppm of lead. linarite, mimetite, phosgenite, On August 14, 2011, the limit may be vanadinite, and wulfenite). further reduced to 100 ppm, unless the (3) Natural or cultured pearls. Commission determines that it is not (4) Wood. technologically feasible to have this (5) Paper and similar materials made lower limit. Paint, coatings or electro- from wood or other cellulosic fiber, in- plating may not be considered a barrier cluding, but not limited to, paperboard, that would make the lead content of a linerboard and medium, and coatings product inaccessible to a child. Mate- on such paper which become part of the rials used in products intended pri- substrate. marily for children 12 and younger that (6) CMYK process printing inks (ex- are treated or coated with paint or cluding spot colors, other inks that are similar surface-coating materials that not used in CMYK process, inks that do are subject to 16 CFR part 1303, must not become part of the substrate under comply with the requirements for lead 16 CFR part 1303, and inks used in paint under section 14(a) of the Con- after-treatment applications, including sumer Product Safety Act (CPSA), as screen prints, transfers, decals, or amended by section 102(a) of the other prints). CPSIA. (7) Textiles (excluding any textiles (b) Section 3 of the CPSIA grants the that contain treatments or applica- Commission general rulemaking au- tions that do not consist entirely of thority to issue regulations, as nec- dyes) consisting of: essary, either on its own initiative or (i) Natural fibers (dyed or undyed) in- upon the request of any interested per- cluding, but not limited to, cotton, son, to make a determination that a kapok, flax, linen, jute, ramie, hemp, material or product does not exceed kenaf, bamboo, coir, sisal, silk, wool the lead limits as provided under para- (sheep), alpaca, llama, goat (mohair, graph (a) of this section. cashmere), rabbit (angora), camel, (c) A determination by the Commis- horse, yak, vicuna, qiviut, guanaco; sion under paragraph (b) of this section (ii) Manufactured fibers (dyed or that a material or product does not undyed) including, but not limited to, contain lead levels that exceed 600 rayon, azlon, lyocell, acetate, ppm, 300 ppm, or 100 ppm, as applicable, triacetate, rubber, polyester, olefin, does not relieve the material or prod- nylon, acrylic, modacrylic, aramid, uct from complying with the applicable spandex. lead limit as provided under paragraph (8) Other plant-derived and animal- (a) of this section if the product or ma- derived materials including, but not

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limited to, animal glue, bee’s wax, ardous substances and contains other seeds, nut shells, flowers, bone, sea criteria for such cautionary statements shell, coral, amber, feathers, fur, leath- that are acceptable to the Commission er. as satisfying section 2(p)(2) of the Act. (e) The following metals and alloys Labels that do not comply with this do not exceed the lead content limits regulation may be considered mis- under section 101(a) of the CPSIA, pro- branded. vided that no lead or lead-containing (2) Definitions. For the purposes of metal is intentionally added but does this section: not include the non-steel or non-pre- (i) Container means the immediate cious metal components of a product, package from which a hazardous sub- such as solder or base metals in elec- stance may be dispensed and also any troplate, clad, or fill applications: article, package or wrapping, such as a (1) Surgical steel and other stainless tube or cone used for a firework or a steel within the designations of Unified wet cell battery casing containing sul- Numbering System, UNS S13800–S66286, furic acid, which is necessary for the not including the stainless steel des- substance to function during actual ignated as 303Pb (UNS S30360). use. (2) Precious metals: Gold (at least 10 karat); sterling silver (at least 925/ (ii) Cautionary material, cautionary la- 1000); platinum; palladium; rhodium; beling, and cautionary labeling required osmium; iridium; ruthenium, titanium. by the Act mean all items of labeling information required by sections 2(p)(1) [74 FR 43041, Aug. 26, 2009, as amended at 80 of the FHSA (repeated in 16 CFR FR 61732, Oct. 14, 2015] 1500.3(b)(14)(i) or by the regulations which require additional labeling under § 1500.121 Labeling requirements; prominence, placement, and con- section 3(b) of the Act. spicuousness. (iii) Display panel means any surface (a)(1) Background and scope. Section of the immediate container, and of any 2(p)(1) of the Federal Hazardous Sub- outer container or wrapping, which stances Act (FHSA) or ‘‘the Act’’), 15 bears labeling. U.S.C. 1261(p)(1), requires that haz- (iv) Principal display panel means the ardous substances bear certain cau- portion(s) of the surface of the imme- tionary statements on their labels. diate container, and of any outer con- These statements include: signal tainer or wrapping, which bear(s) the words; affirmative statements of the labeling designed to be most promi- principal hazard(s) associated with a nently displayed, shown, presented, or hazardous substance; the common or examined under conditions of retail usual name, or chemical name, of the sale. (See paragraph (c)(1) of this sec- hazardous substance; the name and tion.) place of business of the manufacturer, (v) Type size means the actual height packer, distributor, or seller; state- of the printed image of each upper case ments of precautionary measures to or capital letter as it appears on the follow; instructions, when appropriate, label of a hazardous substance. (See for special handling and storage; the paragraph (c)(2) of this section.) statement ‘‘Keep Out of the Reach of (vi) Signal word means the appro- Children’’ or its practical equivalent; priate word ‘‘DANGER,’’ ‘‘WARNING,’’ and, when appropriate, first-aid in- or ‘‘CAUTION,’’ as required by sections structions. Section 2(p)(2) of the Act 2(p)(1) (C) or (D) of the Act. specifies that all such statements shall (vii) Statement of principal hazard(s) be located prominently on the label of means that wording descriptive of the such a substance and shall appear in principal or primary hazard(s) associ- conspicuous and legible type in con- ated with a hazardous substance re- trast by typography, layout, or color quired by section 2(p)(1)(E) of the Act. with other printed matter on the label. Some examples of such statements are This regulation contains the Commis- ‘‘HARMFUL OR FATAL IF SWAL- sion’s interpretations and policies for LOWED,’’ ‘‘VAPOR HARMFUL,’’ the type size and placement of cau- ‘‘FLAMMABLE,’’ and ‘‘SKIN AND EYE tionary material on the labels of haz- IRRITANT.’’

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(viii) Other cautionary material means (3), by a border line or by a space no all labeling statements, other than smaller than the minimum allowable ‘‘signal words’’ or ‘‘statement(s) of height of the type size for cautionary principal hazard(s),’’ required by the material required by the Act (exclusive Act or by regulations issued under the of signal words and statements of haz- Act. ard) on the principal display panel. (b) Prominent label placement. To sat- (iii) Depending on the design of the isfy the requirement of the Act that package or the configuration of the cautionary labeling statements shall label, or both, a package may have appear ‘‘prominently’’ on the label of a more than one principal display panel. hazardous substance, all such state- If so, each principal display panel must ments shall be placed on the label as bear, at a minimum, the signal word, follows: statement of principal hazard or haz- (1) Horizontal placement of labeling ards, and, if appropriate, instructions statements. Except for the name and to read carefully any cautionary mate- place of business of the manufacturer, rial that may be placed elsewhere on packer, distributor, or seller, all cau- the label. tionary material required by the Act (A) Where the principal display panel shall appear in lines that are generally of the immediate container consists of parallel to any base on which the pack- a lid, cap, or other item which may be age rests as it is designed to be dis- separated from the immediate con- played for sale or, on display panels tainer and discarded, the container other than the principal display panel, shall be deemed to have a second prin- in lines generally parallel to all other cipal display panel elsewhere on the labeling on that panel. This require- immediate container which must bear, ment does not apply to labeling on col- at a minimum, the signal word, state- lapsible tubes, cylindrical containers ment of principal hazard(s), and in- with a narrow diameter, or F-type con- structions, if appropriate, to read any tainers where both the ‘‘front’’ and cautionary material which may be ‘‘back’’ of the container are principal placed elsewhere on the label. display panels. (See paragraph (e) of this section.) (3) Prominent label placement—other (2) Principal display panel labeling. (i) display panel labeling. All items of cau- All items of cautionary labeling re- tionary labeling required by the Act quired by the Act may appear on the which do not appear on the principal principal display panel on the imme- display panel shall be placed together diate container and, if appropriate, on on a display panel elsewhere on the any other container or wrapper. See container. The name and place of busi- paragraph (b)(4) of this section for re- ness of the manufacturer, packer, dis- quirements and exceptions for labeling tributor, or seller may appear sepa- outer containers and wrappings. rately on any display panel. Where cau- (ii) The signal word, the statement of tionary material appears on a display principal hazard(s), and, if appropriate, panel other than the principal display instructions to read carefully any cau- panel, the principal display panel shall tionary material that may be placed bear the statement ‘‘Read carefully elsewhere on the label shall be blocked other cautions on the lll panel,’’ or together within a square or rectan- its practical equivalent. [A description gular area, with or without a border, of the location of the other panel is to on the principal display panel on the be inserted in the blank space.] immediate container and, where re- (4) Outer container or wrappings. All quired by paragraph (b)(4) of this sec- cautionary labeling appearing on the tion, on any outer container or wrap- immediate container of a hazardous ping. All cautionary statements placed substance shall also appear on any on the principal display panel shall be outer container or wrapping used in separated on all sides from other print- the retail display of the substance, in ed or graphic matter, with the excep- the same manner as required for the tion of the declaration of net contents immediate container. Those cau- required under the Fair Packaging and tionary labeling statements appearing Labeling Act, 15 U.S.C. 1453(a) (2) and on the immediate container which are

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clearly legible through any outer con- immediate container, or of the side or tainer or wrapper used in retail display surface of any outer container or wrap- need not appear on the outer container ping, that bears the labeling designed or wrapping itself. (See section 2(n)(1) to be most prominently displayed, of the Act.) shown, presented, or examined under (5) Placement of the word ‘‘Poison’’ and conditions of retail sale. This area is the skull and crossbones symbol. The not limited to the portion of the sur- word ‘‘poison’’ and, when appropriate, face covered with labeling; rather, it the skull and crossbones symbol shall includes the entire surface. Flanges at appear on the label of a hazardous sub- the tops and bottoms of cans, conical stance as follows: shoulders of cans, handles, and shoul- (i) If a hazardous substance is ‘‘high- ders and necks of bottles and jars are ly toxic,’’ as defined in § 1500.3(c)(i) and excluded in measuring the area. For section 2(h)(1) of the FHSA, the label the purposes of determining the proper must bear the word ‘‘poison’’ in accord- type size for cautionary labeling, the ance with section 2(p)(1)(H) of the Act, area of the principal display panel (or in addition to the signal word ‘‘DAN- other panel bearing cautionary label- GER,’’ and must also bear the skull ing, under paragraph (c)(2)(ii) of this and crossbones symbol. Some products, section) is to be computed as follows: under § 1500.14(b) of the regulations, (i) In the case of a rectangular pack- may, in addition to any required signal age, where one entire side is the prin- word, be required to bear the word cipal display panel, the product of the ‘‘poison’’ and the skull and crossbones height times the width of that side symbol because of the special hazard shall be the area of the principal dis- associated with their ingredients. In play panel. both instances, the word ‘‘poison’’ and (ii) In the case of a cylindrical or the skull and crossbones symbol need nearly cylindrical container or tube on not appear on the principal display which the principal display panel ap- panel on the container, unless all other pears on the side, the area of the prin- cautionary labeling required by the cipal display panel shall be 40 percent Act appears on the principal display of the product of the height of the con- panel. The word ‘‘poison’’ and the skull tainer times its circumference. and crossbones symbol, when required, (iii) In the case of any other shape of must appear either together with other container, the area of the principal dis- cautionary labeling on a display panel play panel shall be 40 percent of the other than the principal display panel total surface of the container, exclud- or together with the signal word and ing those areas, such as flanges at tops statement(s) of principal hazard on the and bottoms, specified in paragraph principal display panel. (c)(1) above. However, if such a con- (ii) Where, pursuant to a regulation tainer presents an obvious principal issued under section 3(b) of the Act, the display panel (such as an oval or hour- label of a hazardous substance requires glass shaped area on the side of a con- the word ‘‘poison’’ instead of a signal tainer for dishwashing detergent), the word, the word, ‘‘POISON’’ shall appear area to be measured shall be the entire in capital letters on the principal dis- area of the obvious principal display play panel, together with the state- panel. ment(s) of the principal hazard. Certain (2) Type-size requirements. (i) The term substances for which the word ‘‘poi- type size refers to the height of the ac- son’’ is required instead of any signal tual printed image of each upper case word are listed in § 1500.129. or capital letter as it appears on the (c) Conspicuousness—type size and label. The size of cautionary labeling style. To satisfy the requirement that shall be reasonably related to the type cautionary labeling statements under size of any other printing appearing on the Act be conspicuous and legible, the same panel, but in any case must such statements shall conform to the meet the minimum size requirements following requirements: in table 1. (1) Area of principal display panel. The (ii) When an item of labeling is re- area of the principal display panel is quired to be in a specified type size, all the area of the side or surface of the upper case, or capital, letters must be

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at least equal in height to the required and part 1505), the type size of all cau- type size, and all other letters must be tionary statements appearing on any the same style as the upper case or display panel shall comply with the capital letters. Unless otherwise speci- specifications in table 1 when the area fied in the regulations (examples ap- of the display panel is measured by the pear at §§ 1500.14(b)(6), 1512.19, 1508.9, method in paragraph (c)(1) above:

TABLE I Area of principal display panel in square inches ...... 0–2 >2–5 >5–10 >10–15 >15–30 >30 Type 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 cautionary rection for use and shall be placed to- labeling does not appear on the prin- gether within the same general area. cipal display panel, the statement to (ii) The type size of such cautionary ‘‘Read carefully other cautions on the labeling shall be reasonably related to lll panel,’’ or its practical equiva- the type size of any other printed mat- lent, must appear in, as a minimum, ter in the accompanying literature and the same type size as that required in must be in conspicuous and legible table 1 for the other cautionary mate- type by typography, layout, or color rial which appears elsewhere on the with other printed matter on the label. label of a hazardous substance. The size The signal word and statement of prin- of the cautionary labeling that does cipal hazard or hazards shall appear in not appear on the principal display capital letters. panel is determined by the area of the panel on which it does appear. (d) Conspicuousness—contrast. To sat- (3) Type style—proportion. The ratio of isfy the requirement that cautionary the height of a capital or uppercase let- labeling statements appear in con- ter to its width shall be such that the spicuous and legible type which is in height of the letter is no more than 3 contrast by typography, layout, or times its width. color with the other printed matter on (4) Signal word and statements of haz- the label, such statements shall con- ard—capital letters. The signal word, the form to the following requirements: word ‘‘poison’’ if required instead of a (1) Color. Where color is the primary signal word (see § 1500.129), and the method used to achieve appropriate statement of principal hazard or haz- contrast, the color of any cautionary ards shall be in capital letters. labeling statement shall be in sharp (5) Multiple statement of hazard—type contrast with the color of the back- size and style. All statements of prin- ground upon which such a statement cipal hazard or hazards on a label shall appears. Examples of combinations of appear in the same size and style of colors which may not satisfy the re- type, and shall appear in the same quirement for sharp contrast are: black color or have the same degree of bold- letters on a dark blue or dark green ness. background, dark red letters on a light (6) Accompanying literature containing red background, light red letters on a directions for use. Where literature ac- reflective silver background, and white companying the package of a haz- letters on a light gray or tan back- ardous substance has directions for ground. use, written or otherwise, section 2(n) (2) Interference with conspicuousness— of the Act requires the literature to bear cautionary labeling. labeling design, vignettes, or other printed (i) All such cautionary labeling shall material. For cautionary information be in reasonable proximity to any di- appearing on panels other than the

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principal display panel, the label de- 30, 1985. Labels printed prior to the ef- sign, the use of vignettes, or the prox- fective date of this rule may be applied imity of other labeling or lettering until not later than December 28, 1987. shall not be such that any cautionary This rule applies to all hazardous sub- labeling statement is obscured or ren- stances to which labels are applied dered inconspicuous. after December 28, 1987. (e) Collapsible metal tubes. Collapsible [49 FR 50383, Dec. 28, 1984] metal tubes containing hazardous substances shall be labeled so that all cau- § 1500.122 Deceptive use of dis- tionary labeling required by the Act claimers. appears as close to the dispensing end A hazardous substance shall not be of the container as possible. The place- deemed to have met the requirements ment and conspicuousness of these of section 2(p) (1) and (2) of the act (re- statements shall conform to the provi- peated in § 1500.3(b)(14) (i) and (ii)) if sions of paragraphs (b), (c), and (d) of there appears in or on the label (or in this section. any accompanying literature; words, (f) Unpackaged hazardous substances. statements, designs, or other graphic Where practicable, unpackaged haz- material that in any manner negates ardous substances intended, or distrib- or disclaims any of the label state- uted in a form suitable, for use in or ments required by the act; for example, around a household or by children shall the statement ‘‘Harmless’’ or ‘‘Safe be labeled so that all items of informa- around pets’’ on a toxic or irritant sub- tion required by the Act appear upon stance. the article itself. In instances where this is impracticable (for example, be- § 1500.123 Condensation of label infor- cause of the size or nature of the arti- mation. cle), the required cautionary labeling Whenever the statement of the prin- must be displayed by means of a tag or cipal hazard or hazards itself provides other suitable material that is no less the precautionary measures to be fol- than five square inches in area and is lowed or avoided, a clear statement of securely affixed to the article so that the principal hazard will satisfy the re- the labeling will remain attached quirements of section 2(p)(1) (E) and throughout conditions of merchan- (F) of the act (repeated in dising and distribution to the ultimate § 1500.3(b)(14)(i) (E) and (F)). When the consumer. The placement and con- statement of precautionary measures spicuousness of all cautionary labeling in effect provides instruction for first- appearing on such a tag or material, or aid treatment, the statement of the on an unpackaged article, shall con- precautionary measures will satisfy form to the provisions of paragraphs the requirements of section 2(p)(1) (F) (b), (c), and (d) of this section. For the and (G) of the act (repeated in purposes of determining the proper § 1500.3(b)(14)(i) (F) and (G)). type size to use on a tag or other material, the area of one side of the tag or § 1500.125 Labeling requirements for other material shall be the area of the accompanying literature. principal display panel. When any accompanying literature (g) Exemptions. All requirements of includes or bears any directions for use the Act are satisfied by compliance (by printed word, picture, design, or with this § 1500.121. However, exemp- combination thereof), such placard, tions can be granted under section 3(c) pamphlet, booklet, book, sign, or other of the Act and § 1500.83, or under the graphic or visual device shall bear all provisions of another statute should the information required by section this section be incorporated in regula- 2(p) of the act (repeated in tions under another statute. Section § 1500.3(b)(14)). 1500.82 contains the requirements for exemption requests under the Federal § 1500.126 Substances determined to Hazardous Substances Act. be ‘‘special hazards.’’ (h) Effective date. The provisions of Whenever the Commission deter- this rule apply to hazardous substances mines that for a particular hazardous bearing labels printed after December substance intended or packaged in a

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form suitable for use in the household § 1500.128 Label comment. or by children, the requirements of sec- The Commission will offer informal tion 2(p) of the act (repeated in comment on any proposed label and ac- § 1500.3(b)(14)) are not adequate for the companying literature involving a haz- protection of the public health and ardous substance if furnished with: safety because of some special hazard, (a) Complete labeling or proposed la- the Commission, by an appropriate beling, which may be in draft form. order in the FEDERAL REGISTER, shall (b) Complete quantitative formula. specify such reasonable variations or additional label requirements that it (c) Adequate clinical pharmacological, toxicological, physical, and finds are necessary for the protection chemical data applicable to the pos- of the public health and safety. Such sible hazard of the substance. order shall specify a date that is not less than 90 days after the order is pub- (d) Any other information available lished (unless emergency conditions that would facilitate preparation of a suitable label, such as complaints of stated in the order specify an earlier injuries resulting from the product’s date) after which any such hazardous use or other evidence that would fur- substance intended, or packaged in a nish human-experience data. form suitable, for use in the household or by children that fails to bear a label § 1500.129 Substances named in the in accordance with such order shall be Federal Caustic Poison Act. deemed to be a misbranded hazardous substance. The Commission finds that for those substances covered by the Federal § 1500.127 Substances with multiple Caustic Poison Act (44 Stat. 1406), the hazards. requirements of section 2(p)(1) of the Federal Hazardous Substances Act (re- (a) Any article that presents more peated in § 1500.3(b)(14)(i)) are not ade- than one type of hazard (for example, if quate for the protection of the public the article is both toxic and flam- health. Labeling for those substances, mable) must be labeled with: An af- in the concentrations listed in the Fed- firmative statement of each such haz- eral Caustic Poison Act, were required ard; the precautionary measures de- to bear the signal word ‘‘poison.’’ The scribing the action to be followed or Commission concludes that the lack of avoided for each such hazard; instruc- the designation ‘‘poison’’ would indi- tions, when necessary or appropriate, cate to the consumer a lesser hazard for first-aid treatment of persons suf- and that such would not be in the in- fering from the ill effects that may re- terest of the public health. Under the sult from each such hazard; instruc- authority granted in section 3(b) of the tions for handling and storage of arti- act, the Commission therefore finds cles that require special care in han- that for the following substances, and dling and storage because of more than at the following concentrations, the one type of hazard presented by the ar- word ‘‘poison’’ is necessary instead of ticle; and the common or usual name any signal word: (or the chemical name if there is no (a) Hydrochloric acid and any prepa- common or usual name) for each haz- ration containing free or chemically ardous component present in the arti- unneutralized hydrochloric acid (HCl) cle. in a concentration of 10 percent or (b) Label information referring to the more. possibility of one hazard may be com- (b) Sulfuric acid and any preparation bined with parallel information con- containing free or chemically cerning any additional hazards pre- unneutralized sulfuric acid (H2 SO4) in sented by the article if the resulting a concentration of 10 percent or more. condensed statement contains all of (c) Nitric acid or any preparation the information needed for dealing containing free or chemically with each type of hazard presented by unneutralized nitric acid (HNO3) in a the article. concentration of 5 percent or more. [38 FR 27012, Sept. 27, 1973; 38 FR 30105, Nov. (d) Carbolic acid (C6 H5 OH), also 1, 1973] known as phenol, and any preparation

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containing carbolic acid in a con- tures above 120 °F. Keep out of the reach of centration of 5 percent or more. children. (e) Oxalic acid and any preparation The word ‘‘CAUTION’’ may be sub- containing free or chemically stituted for the word ‘‘WARNING’’. A unneutralized oxalic acid (H2 C2 O4) in practical equivalent may be sub- a concentration of 10 percent or more. stituted for the statement ‘‘Keep out of (f) Any salt of oxalic acid and any the reach of children.’’ preparation containing any such salt in (c) That portion of the warning state- a concentration of 10 percent or more. ment set forth in paragraph (b) of this (g) Acetic acid or any preparation section in capital letters should be containing free or chemically printed on the main (front) panel of the unneutralized acetic acid (HC2 H2 O2) in container in capital letters of the type a concentration of 20 percent or more. size specified in § 1500.121(c). The bal- (h) Hypochlorous acid, either free or ance of the cautionary statements may combined, and any preparation con- appear together on another panel if the taining the same in a concentration front panel also bears a statement such that will yield 10 percent or more by as ‘‘Read carefully other cautions on weight of available chlorine. lllll panel.’’ (i) Potassium hydroxide and any (d) If an article has additional haz- preparation containing free or chemi- ards, such as skin or eye irritancy, tox- cally unneutralized potassium hydrox- icity, or flammability, appropriate ad- ide (KOH), including caustic potash and ditional front and rear panel pre- vienna paste (vienna caustic), in a con- cautionary labeling is required. centration of 10 percent or more. (j) Sodium hydroxide and any prepa- § 1500.133 Extremely flammable con- ration containing free or chemically tact adhesives; labeling. unneutralized sodium hydroxide (a) Extremely flammable contact ad- (NaOH), including caustic soda and lye hesives, also known as contact bonding in a concentration of 10 percent or cements, when distributed in con- more. tainers intended or suitable for house- (k) Silver nitrate, sometimes known hold use may be misbranded under the as lunar caustic, and any preparation act if the containers fail to bear a containing silver nitrate (AgNO3) in a warning statement adequate for the concentration of 5 percent or more. protection of the public health and (l) Ammonia water and any prepara- safety. tion containing free or chemically (b) The following warning statement uncombined ammonia (NH3), including is considered as the minimum cau- ammonium hydroxide and tionary labeling adequate to meet the ‘‘hartshorn,’’ in a concentration of 5 requirements of section 2(p)(1) of the percent or more. act (repeated in § 1500.3(b)(14)(i)) with respect to containers of more than one- § 1500.130 Self-pressurized containers: labeling. half pint of contact adhesive and similar liquid or semiliquid articles having (a) Self-pressurized containers that a flashpoint at or below 20 °F. as deter- fail to bear a warning statement ade- mined by the method in § 1500.43, when quate for the protection of the public the only hazard foreseeable is that health and safety may be misbranded caused by the extreme flammability of under the act, except as otherwise pro- the mixture: vided pursuant to section 3 of the act. (b) The following warning statement DANGER will be considered as meeting the re- EXTREMELY FLAMMABLE quirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) if the only VAPORS MAY CAUSE FLASH FIRE hazard associated with an article is Vapors may ignite explosively. that the contents are under pressure: Prevent buildup of vapors—open all win- dows and doors—use only with cross-ventila- WARNING—CONTENTS UNDER PRESSURE tion. Do not puncture or incinerate container. Keep away from heat, sparks, and open Do not expose to heat or store at tempera- flame.

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Do not smoke, extinguish all flames and form saline emesis is no longer appro- pilot lights, and turn off stoves, heaters, priate. This is because the use of salt electric motors, and other sources of ignition to induce vomiting can cause severe during use and until all vapors are gone. hypernatremia (salt poisoning) with Close container after use. Keep out of the reach of children. potentially toxic effects, particularly in children 5 years old or younger, the (c) The words that are in capital let- age group most often involved in acci- ters in the warning statement set forth dental poisonings. In view of the avail- in paragraph (b) of this section should ability of safer and more effective be printed on the main (front) panel or emetics such as ipecac syrup, the Com- panels of the container in capital let- mission no longer recommends a direc- ters of the type size specified in tion to perform saline emesis as a first § 1500.121(c). The balance of the cau- aid direction for inducing vomiting. tionary information may appear to- (c) The Commission believes that, for gether on another panel provided the products for which directions for saline front panel bears a statement such as emesis have been given in the past, ipe- ‘‘Read carefully other cautions on cac syrup, U.S.P., is the most appro- lll panel,’’ the blank being filled in priate emetic, unless a particular con- with the identification of the specific traindication exists in connection with label panel bearing the balance of the any particular hazardous substance. cautionary labeling. It is recommended (d) The Commission wishes to empha- that a borderline be used in conjunc- size that this policy does not require tion with the cautionary labeling. that any specific first aid instruction (d) If an article has additional haz- or wording be used. Where appropriate, ards, or contains ingredients listed in the label may include directions (1) § 1500.14 as requiring special labeling, that the victim immediately contact a appropriate additional front and rear doctor or poison control center and/or panel precautionary labeling is re- (2) that vomiting be induced using quired. methods other than salt. It is, of (e) Since the Commission has issued course, the manufacturer’s responsi- a regulation banning under the Con- bility to insure that the label provides sumer Product Safety Act extremely enough information in addition to first flammable contact adhesives covered aid instructions to fulfill all other la- by this labeling regulation (sec. 16 CFR beling required by statute or regula- part 1302), paragraphs (a), (b), (c) and tion. (d) of this section are revoked as to the subject products after June 13, 1978. (Sec. 30(a), 86 Stat. 1231 (15 U.S.C. 2079(a))) [38 FR 27012, Sept. 27, 1973, as amended at 42 [43 FR 33704, Aug. 1, 1978] FR 63742, Dec. 19, 1977] § 1500.135 Summary of guidelines for § 1500.134 Policy on first aid labeling determining chronic toxicity. for saline emesis. A substance may be toxic due to a (a) This section states the Consumer risk of a chronic hazard. (A regulatory Product Safety Commission’s policy definition of ‘‘toxic’’ that pertains to concerning first aid instructions for chronic toxicity may be found at 16 the use of a salt solution to induce CFR 1500.3(c)(2).) The following discus- vomiting (saline emesis) in the event of sions are intended to help clarify the ingestion of hazardous substances. complex issues involved in assessing (b) In many cases where hazardous risk from substances that may poten- substances are ingested, the rec- tially cause chronic hazards and, where ommended first aid instructions for in- possible, to describe conditions under ducing vomiting have contained a which substances should be considered statement that this should be accom- toxic due to a risk of the specified plished by drinking a solution of salt chronic hazards. The guidelines are not (sodium chloride) in warm water. At intended to be a static classification one time, this direction was considered system, but should be considered along medically acceptable. However, the with available data and with expert Commission has obtained information judgment. They are not mandatory. showing that the instruction to per- Rather, the guidelines are intended as

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an aid to manufacturers in determining association can be ruled out with rea- whether a product subject to the FHSA sonable confidence. presents a chronic hazard. All default (iii) Based on statistical analysis, the assumptions contained in the guide- association has been shown unlikely to lines on hazard and risk determination be due to chance. are subject to replacement when alter- (2) Probable Human Carcinogenic Sub- natives which are supported by appro- stances. Substances are also toxic by priate data become available. The fol- reason of their probable carcino- lowing are brief summaries of more ex- genicity when they meet the ‘‘limited tensive discussions contained in the evidence’’ criteria of carcinogenicity in guidelines. Thus, the guidelines should humans or the ‘‘sufficient evidence’’ be consulted in conjunction with these criteria of carcinogenicity in animals summaries. Copies of the guidelines described below. This category is simi- may be obtained from the Office of lar to EPA’s Group B, IARC’s Group 2, Compliance and Enforcement, Con- or ANSI’s Categories 2 and 3. Evidence sumer Product Safety Commission, derived from animal studies that has Washington, DC 20207. (In addition to been shown not to be relevant to hu- the chronic hazards discussed below, mans is not included. For example, issues relating to the chronic hazard of such evidence would result when there sensitization are discussed in 16 CFR was an identified mechanism of action 1500.3(c)(5).) for a chemical that causes cancer in (a) Carcinogenicity. Substances are animals that has been shown not to toxic by reason of their potential car- apply to the human situation. It is rea- cinogenicity in humans when they are sonable, for practical purposes, to re- known or probable human carcinogenic gard an agent for which there is ‘‘suffi- substances as defined below. Sub- cient’’ evidence of carcinogenicity in stances that are possible human car- animals as if it presented a carcino- cinogenic substances or for which there genic risk to humans. is no evidence of carcinogenic effect (i) ‘‘Limited evidence’’ of carcino- under the following categories lack genicity in humans. The evidence is con- sufficient evidence to be considered sidered limited for establishing a caus- toxic by virtue of their potential car- al relationship between exposure to the cinogenicity. agent and cancer when a causal inter- (1) Known Human carcinogenic Sub- pretation is credible, but chance, bias, stances (‘‘sufficient evidence’’ in hu- or other confounding factors could not mans). Substances are toxic by reason be ruled out with reasonable con- of their carcinogenicity when they fidence. meet the ‘‘sufficient evidence’’ criteria (ii) ‘‘Sufficient evidence’’ of carcino- of carcinogenicity from studies in hu- genicity in animals. Sufficient evidence mans, which require that a causal rela- of carcinogenicity requires that the tionship between exposure to an agent substance has been tested in well-de- and cancer be established. This cat- signed and -conducted studies (e.g., as egory is similar to the Environmental conducted by National Toxicology Pro- Protection Agency’s (EPA) Group A, gram (NTP), or consistent with the Of- the International Agency for Research fice of Science Technology Assessment on Cancer’s (IARC) Group 1, or the and Policy (OSTP) guidelines) and has American National Standards Insti- been found to elicit a statistically sig- tute’s (ANSI) Category 1. A causal rela- nificant (p <0.05) exposure-related in- tionship is established if one or more crease in the incidence of malignant epidemiological investigations that tumors, combined malignant and be- meet the following criteria show an as- nign tumors, or benign tumors if there sociation between cancer and exposure is an indication of the ability of such to the agent. benign tumors to progress to malig- (i) No identified bias that can ac- nancy: count for the observed association has (A) In one or both sexes of multiple been found on evaluation of the evi- species, strains, or sites of independent dence. origin; or experiments using different (ii) All possible confounding factors routes of administration or dose levels; which could account for the observed or

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(B) To an unusual degree in a single (iv) The association has been shown experiment (one species/strain/sex) unlikely to be due to chance, based on with regard to unusual tumor type, un- statistical analysis. usual tumor site, or early age at onset (2) Probable Neurotoxic Substances. of the tumor. Substances are also toxic by reason of The presence of positive effects in their probable neurotoxicity when they short-term tests, dose-response effects meet the ‘‘limited evidence’’ criteria of data, or structure-activity relationship neurotoxicity in humans, or the ‘‘suf- are considered additional evidence. ficient evidence’’ criteria derived from (3) Possible Human Carcinogenic Sub- animal studies. Evidence derived from stance (‘‘limited evidence’’ animal car- animal studies that has been shown not cinogen). In the absence of ‘‘sufficient’’ to be relevant to humans is not in- or ‘‘limited’’ human data, agents with cluded. Such evidence would result, for ‘‘limited’’ evidence of carcinogenicity example, when there was an identified from animal studies fall into this cat- mechanism of action for a chemical egory. Such substances, and those that that causes neurotoxicity in animals do not fall into any other group, are that has been shown not to apply to not considered ‘‘toxic.’’ This does not the human situation. imply that the substances are or are (i) ‘‘Limited evidence’’ of neurotoxicity not carcinogens, only that the evidence in humans. The evidence derived from is too uncertain to provide for a deter- human studies is considered limited for mination. This category is similar to neurotoxicity when the evidence is less EPA’s Group C, IARC’s Group 3, or than convincing, i.e., one of the cri- ANSI’s category 4. teria of ‘‘sufficient evidence’’ of (b) Neurotoxicity. Substances are toxic neurotoxicity for establishing a causal by reason of their potential association between exposure to the neurotoxicity in humans when they agent and neurotoxicity is not met, meet the ‘‘sufficient evidence’’ or leaving some uncertainties in estab- ‘‘limited evidence’’ criteria of lishing a causal association. neurotoxicity in humans, or when they (ii) ‘‘Sufficient evidence’’ of meet the ‘‘sufficient evidence’’ criteria neurotoxicity in animals. Sufficient evi- of neurotoxicity in animals. dence of neurotoxicity derived from (1) Known Neurotoxic Substances animal studies for a causal association (‘‘sufficient evidence in humans’’). Sub- between exposure to a chemical and stances are toxic by reason of their neurotoxicity requires that: neurotoxicity and are considered (A) The substance has been tested in ‘‘known neurotoxic substances’’ when well-designed and -conducted studies they meet the ‘‘sufficient evidence’’ (e.g., NTP’s neurobehavioral battery, criteria of neurotoxicity derived from or conforming to EPA’s neurotoxicity studies in humans which require that a test guidelines); and causal association between exposure to (B) The substance has been found to an agent and neurotoxicity be estab- elicit a statistically significant (p lished with a reasonable degree of cer- <0.05) increase in any neurotoxic effect tainty. Substances in this category in one or both sexes of multiple spe- meet the definition of ‘‘neurotoxic’’ as cies, strains, or experiments using dif- stated above. ‘‘Sufficient evidence,’’ ferent routes of administration and derived from human studies, for a caus- dose-levels. al association between exposure to a (3) Possible Neurotoxic Substances. chemical and neurotoxicity is consid- ‘‘Possible neurotoxic substances’’ are ered to exist if the studies meet the fol- the substances which meet the ‘‘lim- lowing criteria. ited evidence’’ criteria of neurotoxicity (i) A consistent pattern of neuro- evidence derived from animal studies logical dysfunction is observed. in the absence of human data, or in the (ii) The adverse effects/lesions ac- presence of inadequate human data, or count for the neurobehavioral dysfunc- data which do not fall into any other tion with reasonable certainty. group. Substances in this category are (iii) All identifiable bias and con- not considered ‘‘toxic.’’ founding factors are reasonably dis- (c) Developmental and Reproductive counted after consideration. Toxicity—(1) Definitions of ‘‘Sufficient’’

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and ‘‘Limited’’ Evidence. The following with respect to experimental proce- definitions apply to all categories stat- dures (e.g., doses, exposure, follow-up, ed below. number of animals/group, reporting of (i) ‘‘Sufficient evidence’’ from human the data, etc.) which would prevent studies for a causal association be- classification of the evidence in the tween human exposure and the subse- group of ‘‘sufficient evidence.’’ quent occurrence of developmental or (2) Developmental Toxicants. Sub- reproductive toxicity is considered to stances are toxic by reason of their po- exist if the studies meet the following tential developmental or reproductive criteria: toxicity when they meet the ‘‘suffi- (A) No identified bias that can ac- cient evidence’’ or ‘‘limited evidence’’ count for the observed association has criteria of developmental or reproduc- been found on evaluation of the evi- tive toxicity in humans, or when they dence. meet the ‘‘sufficient evidence’’ criteria (B) All possible confounding factors of developmental or reproductive tox- which could account for the observed icity in animals. The Food and Drug association can be ruled out with rea- Administration (FDA) and the Euro- sonable confidence. pean Economic Community (EEC) have (C) Based on statistical analysis, the developed categories for teratogens but association has been shown unlikely to not other developmental toxicants. The be due to chance. teratogen guidelines limit the informa- (ii) ‘‘Limited evidence’’ from human tion only to structural birth defects studies exists when the human epide- and do not include other hazards of de- miology meets all but one of the cri- velopmental toxicity such as teria for ‘‘sufficient evidence’’; i.e., the embryonal death, fetal death, or func- statistical evidence is borderline as optional deficiencies which are also imposed to clear-cut, there is a source of portant in assessing the overall tox- bias, or there are confounding factors icity of a substance when administered that have not been and cannot be ac- during pregnancy. Recently, EPA has counted for. proposed a system for classifying de- (iii) ‘‘Sufficient evidence’’ from ani- velopmental toxicity. The Occupa- mal studies exists when tional Safety and Health Administra- (A) Obtained from a good quality ani- tion (OSHA) has not yet developed any mal study; and classification for developmental tox- (B) The substance has been found to icity. The commission has established elicit a statistically significant (p<0.05) the following categories for determina- treatment-related increase in multiple tion of developmental toxicity accord- endpoints in a single species/strain, or ing to the available evidence. in the incidence of a single endpoint at (i) Known Human Developmental Toxi- multiple dose levels or with multiple cant (‘‘sufficient evidence in humans’’). A routes of administration in a single substance is considered a ‘‘known species/strain, or increase in the inci- human developmental toxicant’’ if dence of a single endpoint in multiple there is ‘‘sufficient’’ human evidence to species/strains/ experiments. establish a causal association between (iv) ‘‘Limited evidence’’ from animal human exposure and the subsequent oc- studies exists when: currence of developmental toxicity (A) Obtained from a good quality manifested by death of the conceptus study and there is a statistically sig- (embryo or fetus), or structural or nificant (p<0.05) treatment-related in- functional birth defects. This category crease in the incidence of a single end- (Human Developmental Toxicant) is point in a single species/strain/experi- comparable to category 1 of the EEC ment at a single dose level adminis- and categories D and X of FDA, except tered through only one route and such that these guidelines are limited to evidence otherwise does not meet the teratogens. This category is also com- criteria for ‘‘sufficient evidence’’; or parable to the category ‘‘definitive evi- (B) The evidence is derived from dence for human developmental tox- studies which can be interpreted to icity’’ proposed by EPA. show positive effects but have some (ii) Probable Human Developmental qualitative or quantitative limitations Toxicant. A substance is considered a

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‘‘probable human developmental toxi- verse effects on male reproductive cant’’ if there is ‘‘limited’’ human evi- main endpoints. This category is com- dence or ‘‘sufficient’’ animal evidence parable to the one termed ‘‘Probable to establish a causal association be- Positive’’ in the EPA guidelines on tween human exposure and subsequent male reproductive risk assessment. occurrence of developmental toxicity. However, the EPA category is based This group (Probable Human Develop- only on sufficient animal evidence. mental Toxicant) is comparable to the CPSC believes that limited human evi- category ‘‘adequate evidence for dence is also sufficient for a chemical human developmental toxicity’’ pro- to be placed in this category. posed by EPA. This category is also (iii) Possible Human Male Reproductive comparable to category 2 of the EEC Toxicant. A substance is considered a and category A1 of FDA, except that ‘‘possible human male reproductive these guidelines are limited to toxicant’’ if there is limited animal teratogens. evidence, in the absence of human (iii) Possible Human Developmental data, or in the presence of inadequate Toxicant. A substance is considered a ‘‘possible human developmental toxi- human data, or which does not fall into cant’’ if there is ‘‘limited’’ animal evi- any other group, to establish a causal dence, in the absence of human data, or association between human exposure in the presence of inadequate human and adverse effects on male reproduc- data, or which does not fall into any tive main endpoints. This category is other group, to establish a causal asso- comparable to the one termed ‘‘Pos- ciation between human exposure and sible Positive A’’ in the EPA guidelines subsequent occurrence of develop- on male reproductive risk assessment. mental toxicity. EEC, FDA, and EPA EPA proposes to use either limited have not developed a category com- human or limited animal evidence data parable to this group. The Commission to classify a toxicant as a ‘‘Possible believes that data from well planned Positive A’’ toxicant. As described animal studies are important to con- above, CPSC would elevate limited sider even though they may provide human evidence to the category only limited evidence of developmental ‘‘Probable Human Male Reproductive toxicity. Toxicant.’’ (3) Male Reproductive Toxicants. Male (4) Female Reproductive Toxicants. Fe- reproductive toxicants can be grouped male reproductive toxicants can be into the following different categories grouped into the following different based on evidence obtained from categories based on evidence obtained human or animal studies. from human or animal studies. EPA (i) Known Human Male Reproductive has proposed guidelines for assessing Toxicant. A substance is considered a female reproductive risk but has not ‘‘known human male reproductive toxi- yet proposed a specific system for cat- cant’’ if there is ‘‘sufficient’’ human egorization of female reproductive evidence to establish a causal associa- toxicants. tion between human exposure and the adverse effects on male reproductive (i) Known Human Female Reproductive main endpoints which are mating abil- Toxicant. A substance is considered a ity, fertility, and prenatal and post- ‘‘known human female reproductive natal development of the conceptus. toxicant’’ if there is ‘‘sufficient’’ This category is comparable to the one human evidence to establish a causal termed ‘‘Known Positive’’ in the EPA association between human exposure guidelines on male reproductive risk and adverse effects on female reproduc- assessment. tive function such as mating ability, (ii) Probable Human Male Reproductive fertility, and prenatal and postnatal Toxicant. A substance is considered a development of the conceptus. ‘‘probable human male reproductive (ii) Probable Human Female Reproduc- toxicant’’ if there is ‘‘limited’’ human tive Toxicant. A substance is considered evidence or ‘‘sufficient’’ animal evi- a ‘‘probable human female reproduc- dence to establish a causal association tive toxicant’’ if there is ‘‘limited’’ between human exposure and the ad- human evidence or ‘‘sufficient’’ animal

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evidence to establish a causal associa- monitoring technique should be appro- tion between human exposure and ad- priate for the health effect of interest. verse effects on female reproductive (B) Modeling. Predictions of exposure function. to a chemical using mathematical (iii) Possible Human Female Reproduc- models can be based on physical and tive Toxicant. A substance is considered chemical principles, such as mass bal- a ‘‘possible human female reproductive ance principles. Mass balance models toxicant’’ if there is ‘‘limited’’ animal should consider the source strength of evidence, in the absence of human the product of interest, housing char- data, or in the presence of inadequate acteristics, and ambient conditions human data, or which does not fall into likely to be encountered by the studied any other group, to establish a causal population. association between human exposure (C) Surrogate Data. Surrogate data and adverse effects on female reproduc- should only be used when data con- tive function. cerning the chemical of interest are (d) Other Subjects Related to the Deter- sparse or unavailable and when there is mination that a Substance is Toxic. a reasonable assurance that the surro- Under the FHSA, for a toxic substance gate data will accurately represent the to be considered hazardous, it must not chemical of interest. only have the potential to be hazardous (ii) Oral Ingestion. Oral ingestion but there must also be the potential studies may involve direct monitoring that persons are exposed to the sub- of sources of chemicals as well as lab- stance, that the substance can enter oratory simulations. The estimation of the body, and that there is a signifi- exposure from ingestion of chemicals cant risk of an adverse health effect as- present in consumer products is pre- sociated with the customary handling dicted based upon estimates of use of and use of the substance. Under these the product and absorption of the guidelines, existence of an adverse chemical from the gastrointestinal health effect means that such exposure tract. The following criteria should be is above the ‘‘acceptable daily intake’’ (‘‘ADI’’). The ADI is based on the risks established for laboratory simulations posed by the substance, and whether to estimate exposure: they are acceptable under the FHSA. (A) A simulant or range of simulants This section addresses those issues by should be carefully selected to mimic providing guidelines concerning assess- the possible range of conditions which ment of exposure, assessment of bio- occur in humans, such as full and availability, determination of accept- empty stomachs, or various saliva able risks and the ADI to children and compositions at different times of the adults, and assessment of risk. day. (1) Assessment of Exposure. An expo- (B) The mechanical action to which a sure assessment may comprise a single product is submitted must be chosen to exposure scenario or a distribution of represent some range of realistic condi- exposures. Reasonably foreseeable use, tions to which a human may subject as well as accidental exposure, should the product. be taken into consideration when de- (iii) Dermal Exposure. (A) Dermal ex- signing exposure studies. The following posure involves estimating the amount guidelines should be used in the assess- of substance contacting the skin. This ment of exposure. may involve experiments measuring (i) Inhalation. Inhalation studies to the amount of material leached from a assess exposure should be reliable stud- product contacting a liquid layer which ies using direct monitoring of popu- interfaces with the skin, or the amount lations, predictions of exposure of substance which migrates from a through modeling, or surrogate data. product (in solid or liquid form) which (A) Direct Monitoring. Populations to is in contact with the skin. be monitored should be selected ran- (B) Parameters to be considered in- domly to be representative of the gen- clude: Surface area of the skin con- eral population, unless the exposure of tacted, duration of contact, frequency a particular subset population is the of contact, and thickness of a liquid desired goal of the assessment. The interfacial layer.

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(2) Assessment of Bioavailability. (i) ticipated for human use of a substance The need to consider bioavailability in is available, a study by another route estimating the risk from use of a prod- of exposure may be used. Pharmaco- uct containing a toxic substance only kinetic methods may be used if suffi- arises when it is anticipated that the cient data are available. absorption characteristics of a sub- (vi) When exposure scenarios are dif- stance to which there is human expo- ferent from those used in the under- sure will differ from those characteris- lying study upon which estimates of tics for the substance tested in the risk are based, proportionality should studies used to define the dose-response be applied. If pharmacokinetic methods relationship. are used to adjust for risks at high (ii) In determining the need to assess versus low exposure levels, level-time bioavailability, the factors to be exam- measures should not be combined with- ined include: out taking the non-linearity into ac- (A) The physical or chemical form of count. the substance, (4) Acceptable Risks—(i) ADI for Car- (B) The route of exposure (inhalation, cinogens. The maximum acceptable ingestion, or through the skin), daily intake (‘‘ADI’’) is that exposure (C) The presence of other constitu- of a toxic (by virtue of its carcino- ents in the product which interfere genicity) substance that is estimated with or alter absorption of the toxic to lead to a lifetime excess risk of one substance, and in a million. Exposure refers to the an- (D) Dose. ticipated exposure from normal life- (3) Assessment of Risk. This section on time use of the product, including use quantitative risk assessment applies to as a child as well as use as an adult. estimates of risk for substances that (ii) ADI for Neurotoxicological and De- are toxic by reason of their carcino- velopmental/Reproductive Agents. Due to genicity. the difficulties in using a numerical (i) Generally, the study leading to risk assessment method to determine the highest risk should be used in the risk for neurotoxicological or develop- risk assessment; however, other factors mental/reproductive toxicants, the may influence the choice of study. Commission is using a safety factor ap- (ii) Risk should be based on the max- proach, as explained below. imum likelihood estimate from a (A) Human Data. If the hazard is multistage model (such as Global83 or ascertained from human data, a safety later version) unless the maximum factor of ten will be applied to the lowest No Observed Effect Level (‘‘NOEL’’) likelihood estimate is not linear at low seen among the relevant studies. If no dose, in which case the 95% upper con- NOEL can be determined, a safety fac- fidence limit on risk should be used. tor of 100 will be applied to the Lowest (iii) For systemic carcinogens, if esti- Observed Effect Level (‘‘LOEL’’). Both mates of human risk are made based on the NOEL and LOEL are defined in animal data, a factor derived from di- terms of daily dose level. viding the assumed human weight (70 (B) Animal Data. If the hazard is kg) by the average animal weight dur- ascertained from animal data, a safety ing the study and taking that to the 1⁄3 factor of one hundred will be applied to power should be used. There is the pos- the lowest NOEL. If no NOEL can be sibility that this factor may be determined, a safety factor of one changed, using the 1⁄4 power instead of thousand will be applied to the lowest the 1⁄3 power, as part of a unified Fed- LOEL. Both the NOEL and LOEL are eral regulatory approach. If such an ap- defined in terms of daily dose level. proach is adopted, it will apply here. (iv) When dose is expressed as parts [57 FR 46665, Oct. 9, 1992] per million, and the carcinogen acts at the site of contact, humans and ani- § 1500.210 Responsibility. mals exposed to the same amount for The provisions of these regulations the same proportion of lifetime should (16 CFR subchapter C of chapter II) be assumed to be equally sensitive. with respect to the doing of any act (v) If no experimental study having shall be applicable also to the causing the same route of exposure as that an- of such act to be done.

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§ 1500.211 Guaranty. other delivery of an article shall expire In the case of the giving of a guar- when such article, after shipment or anty or undertaking referred to in sec- delivery by the person who gave such tion 5(b)(2) of the act, each person sign- guaranty or undertaking, becomes mis- ing such guaranty or undertaking, or branded within the meaning of the act. causing it to be signed, shall be consid- § 1500.213 Presentation of views under ered to have given it. Each person section 7 of the act. causing a guaranty or undertaking to be false is chargeable with violations of (a) Presentation of views under sec- section 4(d) of the act. tion 7 of the act shall be private and informal. The views presented shall be § 1500.212 Definition of guaranty; sug- confined to matters relevant to the gested forms. contemplated proceeding. Such views (a) A guaranty or undertaking re- may be presented by letter or in person ferred to in section 5(b)(2) of the act by the person to whom the notice was may be: given, or by his representative. In case (1) Limited to a specific shipment or such person holds a guaranty or under- other delivery of an article, in which taking referred to in section 5(b)(2) of case it may be a part of or attached to the act applicable to the article on the invoice or bill of sale covering such which such notice was based, such shipment of delivery; or guaranty or undertaking, or a verified (2) General and continuing, in which copy thereof, shall be made a part of case, in its application to any shipment such presentation of views. or other delivery of an article, it shall (b) Upon request, reasonably made, be considered to have been given at the by the person to whom a notice ap- date such article was shipped or deliv- pointing a time and place for the pres- ered, or caused to be shipped or deliv- entation of views under section 7 of the ered, by the person who gives the guar- act has been given, or by his represent- anty of undertaking. ative, such time or place, or both such (b) The following are suggested forms time and place, may be changed if the of guaranty or undertaking referred to request states reasonable grounds in section 5(b)(2) of the act. therefor. Such request shall be ad- (1) Limited form for use on invoice or dressed to the office of the Consumer bill of sale. Product Safety Commission that issued the notice. (Name of person giving the guaranty or undertaking) § 1500.214 Examinations and investiga- hereby guarantees that no article listed tions; samples. herein is misbranded within the meaning of the Federal Hazardous Substances Act. When any officer or employee of the (Signature and post-office address of person Commission collects a sample of a haz- giving the guaranty or undertaking) ardous substance for analysis under the (2) General and continuing forms. act, the sample shall be designated as an official sample if records or other The article comprising each shipment or evidence is obtained by him or any other delivery hereafter made by lllll other officer or employee of the Com- (Name of person giving the guaranty or un- mission indicating that the shipment dertaking) or other lot of the article from which to, or on the order of llllllllll (Name and post-office address of person to such sample was collected was intro- whom the guaranty or undertaking is duced or delivered for introduction into given) interstate commerce, or was in or was is hereby guaranteed, as of the date of such received in interstate commerce, or shipment or delivery, to be, on such date, was manufactured within a Territory not misbranded within the meaning of the not organized with a legislative body. Federal Hazardous Substances Act. Only samples so designated by an offi- (Signature and post-office address of person cer or employee of the Commission giving the guaranty or undertaking) shall be considered to be official sam- (c) The application of a guaranty or ples: undertaking referred to in section (a) For the purpose of determining 5(b)(2) of the act to any shipment or whether or not a sample is collected for

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analysis, the term ‘‘analysis’’ includes body, even exposures to small amounts examinations and tests. of lead can contribute to the overall (b) The owner of a hazardous sub- level of lead in the blood and to the stance of which an official sample is subsequent risk of adverse health ef- collected is the person who owns the fects. Therefore, any unnecessary expo- shipment or other lot of the article sure of children to lead should be from which the sample is collected. avoided. The scientific community generally recognizes a level of 10 § 1500.230 Guidance for lead (Pb) in micrograms of lead per deciliter of consumer products. blood as a threshold level of concern (a) Summary. (1) The U.S. Consumer with respect to lead poisoning. To Product Safety Commission issues this avoid exceeding that level, young chil- guidance to manufacturers, importers, dren should not chronically ingest distributors, and retailers to protect more than 15 micrograms of lead per children from hazardous exposure to day from consumer products. lead in consumer products. 1 The Com- (c) Guidance. (1) Under the Federal mission identifies the major factors Hazardous Substances Act (FHSA), 15 that it considers when evaluating prod- U.S.C. 1261(f)(1), household products ucts that contain lead, and informs the that expose children to hazardous public of its experience with products quantities of lead under reasonably that have exposed children to poten- foreseeable conditions of handling or tially hazardous amounts of lead. use are ‘‘hazardous substances.’’ A (2) To reduce the risk of hazardous household product that is not intended exposure to lead, the Commission re- for children but which creates such a quests manufacturers to eliminate the risk of injury because it contains lead use of lead that may be accessible to requires precautionary labeling under children from products used in or the Act. 15 U.S.C. 1261(p). A toy or around households, schools, or in recre- other article intended for use by chil- ation. The Commission also rec- dren which contains a hazardous ommends that, before purchasing prod- amount of lead that is accessible for ucts for resale, importers, distributors, children to ingest is a banned haz- and retailers obtain assurances from ardous substance. 15 U.S.C. manufacturers that those products do 1261(q)(1)(B). In evaluating the poten- not contain lead that may be accessible tial hazard associated with products to children. that contain lead, the Commission (b) Hazard. Young children are most staff considers these major factors on a commonly exposed to lead in consumer case-by-case basis: the total amount of products from the direct mouthing of lead contained in a product, the bio- objects, or from handling such objects availability of the lead, the accessi- and subsequent hand-to-mouth activ- bility of the lead to children, the age ity. The specific type and frequency of and foreseeable behavior of the chil- behavior that a child exposed to a prod- dren exposed to the product, the fore- uct will exhibit depends on the age of seeable duration of the exposure, and the child and the characteristics and the marketing, patterns of use, and life pattern of use of the product. The ad- cycle of the product. verse health effects of lead poisoning in (2) Paint and similar surface coatings children are well-documented and may have long-lasting or permanent con- containing lead have historically been sequences. These effects include neuro- the most commonly-recognized sources logical damage, delayed mental and of lead poisoning among the products physical development, attention and within the Commission’s jurisdiction. learning deficiencies, and hearing prob- The Commission has, by regulation, lems. Because lead accumulates in the banned paint and other similar surface coatings that contain more than 0.06% lead (‘‘lead-containing paint’’), toys 1 This guidance is not a rule. It is intended and other articles intended for use by to highlight certain obligations under the Federal Hazardous Substances Act. Compa- children that bear lead-containing nies should read that Act and the accom- paint, and furniture articles for con- panying regulations in this part for more de- sumer use that bear lead-containing tailed information. paint. 16 CFR Part 1303. In recent

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years, however, the Commission staff relevant to this determination from has identified a number of disparate manufacturers, or have such evalua- products—some intended for use by tions conducted themselves. children and others simply used in or [63 FR 70649, Dec. 22, 1998] around the household or in recre- ation—that presented a risk of lead § 1500.231 Guidance for hazardous liq- poisoning from sources other than uid chemicals in children’s prod- paint. These products included vinyl ucts. miniblinds, crayons, figurines used as (a) Summary. The U.S. Consumer game pieces, and children’s jewelry. Product Safety Commission issues this (3) In several of these cases, the guidance to manufacturers, importers, staff’s determination that the products distributors, and retailers to protect presented a risk of lead poisoning re- children from exposure to hazardous sulted in recalls or in the replacement chemicals found in liquid-filled chil- of those products with substitutes, in dren’s products, such as rolling balls, addition to an agreement to dis- bubble watches, necklaces, pens, paper- continue the use of lead in future pro- weights, keychains, liquid timers, and duction. The Commission believes that, mazes. 1 The Commission identifies the had the manufacturers of these lead- major factors that it considers when containing products acted with pru- evaluating liquid-filled children’s prod- dence and foresight before introducing ucts that contain hazardous chemicals, the products into commerce, they and informs the public of its experience would not have used lead at all. This in with exposure to these hazardous turn would have eliminated both the chemicals to children. To reduce the risk to young children and the costs risk of exposure to hazardous chemi- and other consequences associated with cals, such as mercury, ethylene glycol, the corrective actions. diethylene glycol, methanol, meth- (4) The Commission urges manufac- ylene chloride, petroleum distillates, turers to eliminate lead in consumer toluene, xylene, and related chemicals, products to avoid similar occurrences the Commission requests manufactur- in the future. However, to avoid the ers to eliminate the use of such chemi- possibility of a Commission enforce- cals in children’s products. The Com- ment action, a manufacturer who be- mission also recommends that, before lieves it necessary to use lead in a con- purchasing products for resale, import- sumer product should perform the req- ers, distributors, and retailers obtain uisite analysis before distribution to assurances from manufacturers that determine whether the exposure to lead liquid-filled children’s products do not causes the product to be a ‘‘hazardous contain hazardous liquid chemicals. substance.’’ If the product is a haz- (b) Hazard. During reasonably fore- ardous substance and is also a chil- seeable handling or use of liquid-filled dren’s product, it is banned. If it is a children’s products, hazardous chemi- hazardous household substance but is cals may become accessible to young not intended for use by children, it re- children in a manner that places chil- quires precautionary labeling. This dren at risk. Young children are ex- same type of analysis also should be posed to the chemicals from directly performed on materials substituted for mouthing them or from handling such lead. objects and subsequent hand-to-mouth (5) The Commission also notes that, or hand-to-eye activity. The specific under the FHSA, any firm that pur- type and frequency of behavior that a chases a product for resale is respon- child exposed to a product will exhibit sible for determining whether that depends on the age of the child and the product contains lead and, if so, wheth- characteristics and pattern of use of er it is a ‘‘hazardous substance.’’ The Commission, therefore, recommends 1 that, prior to the acquisition or dis- This guidance is not a rule. It is intended to highlight certain obligations under the tribution of such products, importers, Federal Hazardous Substances Act. Compa- distributors, and retailers obtain infor- nies should read that Act and the accom- mation and data, such as analyses of panying regulations in this part for more de- chemical composition or accessibility, tailed information.

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the product. The adverse health effects ardous substances pose a risk to young of these chemicals to children include children and, consequently, manufac- chemical poisoning from ingestion of turers should not have included them the chemicals, pneumonia from aspira- in the product design or manufacturing tion of the chemicals into the lungs, process. and skin and eye irritation from expo- (3) Therefore, the Commission con- sure to the chemicals. The chemicals siders the use of hazardous chemicals may also be combustible. in children’s products such as those de- (c) Guidance. (1) Under the Federal scribed above to be ill-advised and en- Hazardous Substances Act (FHSA), courages manufacturers to avoid using products that are toxic or irritants and them in such products. Further, the that may cause substantial injury or Commission recommends that, before illness under reasonably foreseeable purchasing such products for resale, conditions of handling or use, including importers, distributors, and retailers reasonably foreseeable ingestion by obtain assurances from the manufac- children, are ‘‘hazardous substances.’’ turers that liquid-filled children’s 15 U.S.C. 1261(f)(1). A product that is products do not contain hazardous liq- not intended for children, but that cre- uid chemicals. ates a risk of substantial injury or ill- [63 FR 70648, Dec. 22, 1998] ness because it contains hazardous chemicals, requires precautionary la- § 1500.232 Statement on animal testing beling under the Act. 15 U.S.C. 1261(p). policy. A toy or other article intended for use (a) Summary. (1) The U.S. Consumer by children that contains an accessible Product Safety Commission issues this and harmful amount of a hazardous statement of policy on animal testing chemical is banned. 15 U.S.C. and alternatives to animal testing of 1261(q)(1)(A). In evaluating the poten- hazardous substances regulated under tial hazard associated with children’s the Federal Hazardous Substances Act products that contain hazardous (FHSA). The FHSA requires appro- chemicals, the Commission’s staff con- priate cautionary labeling on certain siders certain factors on a case-by-case hazardous household products to alert basis, including: the total amount of consumers to the potential hazard(s) the hazardous chemical in a product, that the products may present. Among the accessibility of the hazardous the hazards addressed by the FHSA are chemicals to children, the risk pre- toxicity, corrosivity, sensitization, and sented by that accessibility, the age irritation. and foreseeable behavior of the chil- (2) In order to determine the appro- dren exposed to the product, and the priate cautionary labeling, it is nec- marketing, patterns of use, and life essary to have objective criteria by cycle of the product. which the existence of each hazard can (2) The Commission’s staff has identi- be determined. Hazards such as tox- fied a number of liquid-filled children’s icity, tissue corrosiveness, eye products, such as rolling balls, bubble irritancy, and skin irritancy result watches, necklaces, pens, paper- from the biological response of living weights, maze toys, liquid timers, and tissue and organs to the presence of the keychains, that contain hazardous hazardous substance. One means of chemicals. In several of these cases, characterizing these hazards is to use the staff determined that these prod- animal testing as a proxy for the ucts violated the FHSA because they human reaction. In fact, the FHSA de- presented a risk of chemical poisoning fines the hazard category of ‘‘highly and/or chemical pneumonia from aspi- toxic’’ in terms of animal toxicity ration. This determination resulted in when groups of 10 or more rats are ex- recalls or in the replacement of those posed to specified amounts of the sub- products with substitutes, as well as in stance. The Commission’s regulations agreements with the manufacturers to under the FHSA concerning toxicity discontinue the use of hazardous and irritancy allow the use of animal chemicals in liquid-filled children’s tests to determine the presence of the products in future production. The hazard when human data or existing Commission believes that these haz- animal data are not available.

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(3) Neither the FHSA nor the Com- upon review, determine whether to mission’s regulations requires animal post the test method on the animal testing. The FHSA and its imple- testing Web site. menting regulations only require that (b) Statement of policy on animal test- a product be labeled to reflect the haz- ing. (1) Neither the FHSA nor the Com- ards associated with that product. If mission’s regulations requires animal animal testing is conducted, Commis- testing. Reliable human experience al- sion policy supports limiting such tests ways takes precedence over results to a minimum number of animals and from animal data. In the cases where advocates measures that eliminate or animal tests are conducted, the Com- reduce the pain or discomfort to ani- mission prefers test methods that re- mals that can be associated with such duce stress and suffering in test ani- tests. The Commission has prepared mals and that use fewer animals while this statement of policy with respect maintaining scientific integrity. To to animal testing to encourage the this end, the Commission reviews rec- manufacturers subject to the FHSA to ommendations on alternative test follow a similar policy. methods developed by the scientific (4) In making the appropriate hazard and regulatory communities. Current determinations, manufacturers of prod- descriptions of test method rec- ucts subject to the FHSA should use ommendations approved by or known existing alternatives to animal testing to the Commission can be accessed via whenever possible. These include: prior the Internet at: http://www.cpsc.gov/li- human experience (e.g., published case brary/animaltesting.html. The Commis- studies), in vitro or in silico test meth- sion strongly supports the use of sci- ods that have been approved by the entifically sound alternatives to ani- Commission, literature sources con- mal testing. The following parts of this taining the results of prior animal test- section outline some of these altering or limited human tests (e.g., clin- natives. Testing laboratories and other ical trials, dermal patch testing), and interested persons requiring assistance expert opinion (e.g., hazard assessment, interpreting the results obtained when structure-activity analysis). If a manu- a substance is tested in accordance facturer or other entity performs a with the methods described here, or in hazard test for FHSA labeling purposes following the testing strategies out- that has not been previously approved lined in the section, should refer to the by the Commission, CPSC staff will Commission’s animal testing Web page consider the data on a case-by-case at: http://www.cpsc.gov/library/ basis and, upon review, determine animaltesting.html. whether to post the test method on the (i) Acute toxicity. The traditional animal testing Web site. The Commis- FHSA animal test for acute toxicity sion recommends resorting to animal determines the median lethal dose testing only when the other informa- (LD50) or lethal concentration (LC50), tion sources have been exhausted. At the dose or concentration that is ex- this time, the Commission recommends pected to kill half the test animals. use of the most humane procedures Procedures for determining the median with the fewest animals possible to LD50/LC50 are described in section achieve reliable results. Recommended 2(h)(1) of the Act and supplemented in procedures are summarized in the fol- § 1500.3(c)(1) and (2) and the test method lowing statement and can be accessed outlined in § 1500.40. The Commission on the Commission’s Web page at: recommends in vitro alternatives over http://www.cpsc.gov/library/ in vivo LD50/LC50 tests, or using modi- animaltesting.html. If a manufacturer or fications of the traditional LD50/LC50 other entity performs a hazard test for test during toxicity testing that reduce FHSA labeling purposes that has not the number of animals tested whenever been previously approved by the Com- possible. Data from in vitro or in silico mission (e.g., an ICCVAM-rec- test methods that have not been ap- ommended test method or one of the proved by the Commission may be sub- tests described in the current version mitted to the Commission for consider- of the FHSA), CPSC staff will consider ation of their acceptability. Commis- the data on a case-by-case basis and, sion-approved testing alternatives are

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identified on the Web site at: http:// chemical properties that indicate the www.cpsc.gov/library/animaltesting.html substance might be a dermal corrosive and include: or irritant. If there is any indication (A) In vitro and in vivo test methods from this analysis that the substance that have been scientifically validated is either corrosive or irritating to the and approved for use in toxicity testing skin, the substance should be labeled by the Commission; appropriately. If the substance is not (B) Valid in vitro methods to estimate corrosive in vitro, but no data exist re- a starting dose for an acute in vivo test; garding its irritation potential, human (C) A sequential version of the tradi- patch testing should be considered. If tional LD50/LC50 tests described in in vitro data are unavailable, human § 1500.3(c)(1) and (2) and the test method patch testing is not an option, and described in § 1500.40, in which dose there are insufficient data to deter- groups are run successively rather than mine the weight-of-evidence, a tiered simultaneously; in vivo animal test is recommended. (D) A limit-dose test where the LD50/ (A) In a tiered in vivo dermal study, a LC50 is determined as a point estimate, single rabbit is tested initially. If the which can still be used to categorize a outcome is positive for corrosivity, hazard, although it gives no informa- testing is stopped, and the substance is tion on hazard dose-response. In the labeled appropriately. If the substance limit test, animals (10 rats) each re- is not corrosive, two more rabbits ceive a single dose of product at 5g per should be patch-tested to complete the kilogram of body weight. If not more assessment of skin irritation potential. than one animal dies in 14 days, the (B) If a tiered test is not feasible, the product is considered to have an LD50 of greater than 5g/kg, and thus, deemed Commission recommends the test to be nontoxic. Only if two or more method described in § 1500.41. Note that animals die is a second group of 10 rats in any in vivo dermal irritation test tested (at a lower dose). This procedure method, the Commission recommends reduces the number of animals tested using a semiocclusive patch to cover from the 80 to 100 animals involved in the animal’s test site and eliminating a full LD50 test to, typically, 10 to 20 the use of stocks for restraint during rats per product. This reduction in the the exposure period, thereby allowing number of animals tested is justified the animal free mobility and access to because an exact LD50 is not required food and water. by either the FHSA or the regulations. (iii) Ocular irritation. A weight-of-evi- The FHSA requires only a categorical dence analysis is recommended to determination that the toxicity is evaluate existing information before greater than 5g/kg, between 50 mg/kg any in vivo ocular irritation testing is and 5g/kg, or less than 50 mg/kg. considered. This analysis should incor- (ii) Dermal irritation/corrosivity. An ac- porate any existing data on humans ceptable in vitro test method or weight- and animals, validated in vitro or in of-evidence analysis is recommended silico test data (identified on the Com- before in vivo dermal irritation testing mission’s animal testing Web site at: is considered to determine appropriate http://www.cpsc.gov/library/ cautionary labeling. The weight-of-evi- animaltesting.html), the substance’s der- dence analysis should incorporate any mal corrosivity/irritation (primary existing data on humans and animals, skin irritants and corrosives are also validated in vitro or in silico test results usually eye irritants and therefore do (valid tests are identified on the Com- not need to be tested in the eye), evi- mission’s animal testing Web site at: dence of ocular irritation of one or http://www.cpsc.gov/library/ more structurally related substances animaltesting.html), the substance’s der- or mixtures of such substances, data mal toxicity, evidence of corrosivity/ir- demonstrating high acidity or alka- ritation of one or more structurally re- linity of the substance, and any other lated substances or mixtures of such relevant physicochemical properties substances, data demonstrating low or that indicate the substance might be a high pH (≤2 or ≥11.5) of the substance, dermal corrosive or irritant or ocular and any other relevant physico- irritant.

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(A) When the weight-of-evidence is (iv) Dermal sensitization. An accept- insufficient to determine a substance’s able in vitro test method (examples of ocular irritation, a Commission-ap- valid in vitro tests are identified on the proved in vitro or in silico assay for ocu- Commission’s animal testing Web site lar irritancy should be run to assess at: http://www.cpsc.gov/library/ eye irritation potential and determine animaltesting.html), or weight-of-evi- labeling. Examples of Commission-vali- dence analysis is recommended before dated in vitro assays are identified on in vivo animal sensitization testing is the Commission’s animal testing Web considered to determine appropriate site at: http://www.cpsc.gov/library/ cautionary labeling. The weight-of-evi- animaltesting.html). If no valid in vitro dence analysis should incorporate any test exists, the test strategy for deter- existing data on humans and animals, mining dermal corrosion/irritation out- validated in vitro or in silico test re- lined in paragraph (b)(1)(ii)(B) of this section can be followed to determine sults, and any relevant physico- ocular irritation. chemical properties that indicate the (B) If the dermal test strategy out- substance might be a dermal sensitizer. lined in section paragraph (b)(1)(ii)(B) If there is any indication from this of this section leads to a conclusion of analysis that the substance is sensi- not corrosive, a tiered in vivo ocular ir- tizing to the skin, the substance should ritation test should be performed, in be labeled appropriately. which a single rabbit is exposed to the (2) [Reserved] substance initially. If the outcome of [77 FR 73288, Dec. 10, 2012] this initial test is positive, testing is stopped, and the substance is labeled IMPORTS an eye irritant. If the outcome of this initial test is negative, one to two § 1500.265 Imports; definitions. more rabbits are tested for ocular irritation, and the outcome of this test For the purposes of the regulations will determine the label. If a tiered prescribed under section 14 of the act: test is not feasible, the Commission (a) The term owner or consignee recommends the test method described means the person who has the rights of in § 1500.42. a consignee under the provisions of the (C) When any ocular irritancy testing Tariff Act of 1930 (secs. 483, 484, 485, 46 on animals is conducted, including the Stat. 721 as amended; 19 U.S.C. 1483, method described in § 1500.42, the Com- 1484, 1485). mission recommends a threefold plan (b) The term area office director means to reduce animal suffering: The use of the director of the area office of the preemptive pain management, includ- Consumer Product Safety Commission ing topical anesthetics and systemic having jurisdiction over the port of analgesics that eliminate or reduce entry through which a hazardous sub- suffering that may occur as a result of stance is imported or offered for im- the application process or from the test port, or such officer of the area office substance itself (an example of a typ- as he may designate to act in his behalf ical preemptive pain treatment is two in administering and enforcing the pro- applications of tetracaine ophthalmic visions of section 14 of the act. anesthetic, 10–15 minutes apart, prior to instilling the test material to the § 1500.266 Notice of sampling. eye); post-treatment with systemic analgesics for pain relief; and implemen- When a sample of a hazardous sub- tation of humane endpoints, including stance offered for import has been re- scheduled observations, monitoring, quested by the director of the area of- and recording of clinical signs of dis- fice, the collector of customs having tress and pain, and recording the na- jurisdiction over the hazardous sub- ture, severity, and progression of eye stance shall give to the owner or con- injuries. The specific techniques that signee prompt notice of delivery of, or have been approved by the Commission intention to deliver, such sample. Upon can be found at: http://www.cpsc.gov/library/animaltesting.html.

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receipt of the notice, the owner or con- bring the hazardous substance into signee shall hold such hazardous sub- compliance with the act may be filed stance and not distribute it until fur- only by the owner or consignee and ther notice from the area office direc- shall: tor or the collector of customs of the (a) Contain detailed proposals for results of examination of the sample. bringing the article into compliance with the act. § 1500.267 Payment for samples. (b) Specify the time and place where The Consumer Product Safety Com- such operations will be carried out and mission will pay for all import samples the approximate time for their comple- that are found to be in compliance with tion. the requirements of the act. Billing for reimbursement should be made by the § 1500.270 Granting of authorization. owner or consignee to the Commission (a) When authorization contemplated area office headquarters in the terri- by § 1500.269 is granted, the area office tory of which the shipment was offered director shall notify the applicant in for import. Payment for samples will writing, specifying: not be made if the hazardous substance (1) The procedure to be followed: is found to be in violation of the act, (2) That the operations are to be car- even though subsequently brought into ried out under the supervision of an of- compliance under the terms of an au- ficer of the Consumer Product Safety thorization to bring the article into Commission or the Bureau of Customs, compliance. as the case may be; (3) A time limit, reasonable in the § 1500.268 Hearing. light of the circumstances, for comple- (a) If it appears that the hazardous tion of the operations; and substance may be subject to refusal of (4) Such other conditions as are nec- admission, the area office director essary to maintain adequate super- shall give the owner or consignee a vision and control over the article. written notice to that effect, stating (b) Upon receipt of a written request the reasons therefor. The notice shall for extension of time to complete such specify a place and a period of time operations, containing reasonable during which the owner or consignee grounds therefor, the area office direc- shall have an opportunity to introduce tor may grant such additional time as testimony. Upon timely request, giving he deems necessary. reasonable grounds therefor, such time (c) An authorization may be amended and place may be changed. Such testi- upon a showing of reasonable grounds mony shall be confined to matters rel- therefor and the filing of an amended evant to the admissibility of the haz- application for authorization with the ardous substance, and may be intro- area office director. duced orally or in writing. (d) If ownership of a hazardous sub- (b) If such owner or consignee substance covered by an authorization mits or indicates his intention to sub- changes before the operations specified mit an application for authorization to in the authorization have been com- relabel or perform other action to pleted, the original owner will be held bring the hazardous substance into responsible, unless the new owner has compliance with the act, such testi- executed a bond and obtained a new au- mony shall include evidence in support thorization. Any authorization granted of such application. If such application under this section shall supersede and is not submitted at or prior to the nullify any previously granted author- hearing, the area office director shall ization with respect to the article. specify a time limit, reasonable in the light of the circumstances, for filing § 1500.271 Bonds. such application. (a) The bonds required under section 14(b) of the act may be executed by the § 1500.269 Application for authoriza- owner or consignee on the appropriate tion. form of a customs single-entry or term Application for authorization to bond, containing a condition for the re- relabel or perform other action to delivery of the merchandise or any part

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thereof upon demand of the collector of (e) The minimum charge for services customs and containing a provision for of supervising officers and of analysts the performance of conditions as may shall be not less than the charge for 1 legally be imposed for the relabeling or hour, and time after the first hour other action necessary to bring the shall be computed in multiples of 1 hazardous substance into compliance hour, disregarding fractional parts less with the act in such manner as is pre- than one-half hour. scribed for such bond in the customs [38 FR 27012, Sept. 27, 1973, as amended at 57 regulations in force on the date of re- FR 28605, June 26, 1992] quest for authorization. The bond shall be filed with the collector of customs. (b) The collector of customs may can- PART 1501—METHOD FOR IDENTI- cel the liability for liquidated damages FYING TOYS AND OTHER ARTI- incurred under the above-mentioned CLES INTENDED FOR USE BY provisions of such a bond, if he receives CHILDREN UNDER 3 YEARS OF an application for relief therefrom, AGE WHICH PRESENT CHOKING, upon the payment of a lesser amount ASPIRATION, OR INGESTION or upon such other terms and condi- HAZARDS BECAUSE OF SMALL tions as shall be deemed appropriate PARTS under the law and in view of the circumstances, but the collector shall not Sec. act under this regulation in any case 1501.1 Purpose. unless the area office director is in full 1501.2 Scope. agreement with the action. 1501.3 Exemptions. 1501.4 Size requirements and test procedure. § 1500.272 Costs chargeable in connec- 1501.5 Enforcement procedure. tion with relabeling and reconditioning inadmissible imports. AUTHORITY: Secs. 2(f)(1)(D), (q)(1)(A), (s), The cost of supervising the relabeling 3(e)(1), and 10; 74 Stat. 372, 374, 375 as amended; 80 Stat. 1304–05, 83 Stat. 187–89 (15 U.S.C. or other action necessary in connection 1261, 1262, 1269). with an import of a hazardous substance that fails to comply with the SOURCE: 44 FR 34903, June 15, 1979, unless act shall be paid by the owner or con- otherwise noted. signee who files an application request- § 1501.1 Purpose. ing such action and executes a bond, pursuant to section 14(b) of the act. Section 1500.18(a)(9) of this chapter The cost of such supervision shall in- classifies as a banned hazardous sub- clude, but not be restricted to, the fol- stance any toy or other article in- lowing: tended for use by children under 3 (a) Travel expenses of the supervising years of age that presents a choking, officer. aspiration, or ingestion hazard because (b) Per diem in lieu of subsistence of of small parts. This part 1501 describes the supervising officer when away from certain articles that are subject to his home station as provided by law. § 1500.18(a)(9); lists certain articles that (c) Services of the supervising officer, are specifically exempted; and provides to be calculated at the rate of a GS 11, a test method for determining whether step 1 employee, except that such serv- an article is hazardous to children ices performed by a customs officer and under 3 because it, or one of its compo- subject to the provisions of the Act of nents that can be detached or broken February 13, 1911, as amended (sec. 5, 36 off during normal or reasonable fore- Stat. 901 as amended; 19 U.S.C. 267), seeable use, is too small. shall be calculated as provided in that Act. § 1501.2 Scope. (d) Services of the analyst, to be cal- (a) This regulation (§ 1500.18(a)(9) and culated at the rate of a GS 12, step 1 the criteria described in § 1501.4 below) employee (which shall include the use applies to all toys and other articles of the chemical laboratories and equip- intended for use by children under 3 ment of the Consumer Product Safety years (36 months) of age that are intro- Commission). duced into interstate commerce after

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