333-016-0005
Definitions

(1) “Act” as used in these rules means ORS 453.005 to 453.135 relating to hazardous substances.

(2) “Administrator” means the Administrator of the Public Health Division of Oregon Health Authority.

(3) “Hazardous Substances Intended or Packaged in a Form Suitable for Use in the Household” or “Hazardous Household Substances” means any hazardous substances as defined in the Act, whether or not packaged, that under any customary or reasonably forseeable condition of purchase, storage, or use may be brought into or around a house, apartment, or other place where people dwell, or in or around any related building or shed, including, but not limited to, a garage, carport, barn, or storage shed. The term includes such articles as polishes or cleaners designed primarily for professional use but that are available in retail stores such as hobby shops for nonprofessional use. Also included are such items as antifreeze and radiator cleaners that although principally for car use may be stored in or around dwelling places. The term does not include industrial supplies that might be taken into a home by a serviceman. An article labeled and marketed solely for industrial use does not become subject to this Act because of the possibility that an industrial worker may misappropriate a supply for his own use. Size of unit or container is not the only index of whether the article is suitable for use in or around the household. The test shall be whether under any reasonably foreseeable condition of purchase, storage, or use, the article may be likely to be found in or around a dwelling.

(4) “Prominently” and “Conspicuously” means that under customary conditions of purchase, storage, and use, the required information shall be visible, noticeable, and in clear and legible English. Some factors affecting a warning’s prominence or conspicuousness are: location, size of type, and contrast of printing against background. Also bearing on the effectiveness of a warning might be the effect of the package contents if spilled on the label. Unless impracticable because of the nature of the substance, the label shall be of such construction and finish as to withstand reasonably foreseeable spillage through foreseeable use.

(5) “Highly Toxic Substance” is any substance falling within any of the following categories:

(a) Any substance that produces death within 14 days in half or more than half of a group of ten or more laboratory white rats each weighing between 200 grams and 300 grams, at a single dose of 50 milligrams or less per kilogram of body weight, when orally administered;

(b) Any substance that produces death within 14 days in half or more than half of a group of ten or more laboratory white rats each weighing between 200 grams and 300 grams when inhaled continuously for a period of one hour or less in an atmospheric concentration of 200 parts per million by volume or less of gas or vapor or two milligrams per liter by volume or less of mist or dust, provided that such concentration is likely to be encountered by humans when the substance is used in any reasonably foreseeable manner;

(c) Any substance that produces death within 14 days in half or more than half of a group of ten or more rabbits weighing between 2.3 kilograms and 3.0 kilograms each, tested in a dosage of 200 milligrams or less per kilogram of body weight when administered by continuous contact with the bare skin for 24 hours or less by the method described in OAR 333-016-0020. The number of animals tested shall be sufficient to give a statistically significant result and be in conformity with good pharmacological practices;

(d) Any substance determined by the Administrator to be “highly toxic” on the basis of human experience.

(6) “Toxic Substance” means any substance other than radioactive substance falling within any of the following categories:

(a) Any substance that produces death within 14 days in one-half or a group of ten or more white rats each weighing between 200 grams and 300 grams, at a single dose of more than 50 milligrams per kilogram but not more that five grams per kilogram of body weight, when orally administered. Substances falling in the toxicity range between 500 milligrams and five grams per kilogram of body weight will be considered for exemption from some or all of the labeling requirements of ORS 453.035 upon showing that, because of the physical form of the substances (solid, a thick plastic, emulsion, etc.) the size or closure of the container, human experience with the article, or any other relevant factors, such labeling is not needed;

(b) Any substance that produces death within 14 days in one-half of a group of ten or more white rats each weighing between 200 grams and 300 grams, when inhaled continuously for a period of one hour or less at an atmospheric concentration of more than 200 parts per million, but not more than 20,000 parts per million by volume of gas or vapor or more than two milligrams but not more than 200 milligrams per liter by volume of mist or dust, provided such concentration is likely to be encountered by man when the substance is used in any reasonably foreseeable manner;

(c) Any substance that produces death within 14 days in one-half of a group of ten or more rabbits weighing between 2.3 kilograms and 3.0 kilograms each tested at a dosage of more than 200 milligrams per kilogram of body weight but not more than 2 grams per kilogram of body weight when administered by continuous contact with the bare skin for 24 hours in the method described in rule 333-016-0020. The number of animals tested shall be sufficient to give statistically significant results and be in conformity with good pharmacological practice;

(d) Any substance that is “toxic” (but not “highly toxic”) on the basis of human experience.

(7) “Irritant” includes primary irritant to the skin as well as substances irritant to the eye or mucous membranes:

(a) The term “primary irritant” means a substance that is not corrosive and that the available data of human experience indicate is a primary irritant; or which results in an empirical score of five or more when tested by the method described in OAR 333-016-0025;

(b) “Eye irritants” means a substance is an irritant to the eye if the available data or human experience indicate it is an irritant to the eye, or if a positive test result is obtained when the substance is tested by the method described in OAR 333-016-0030.

(8) “Corrosive substance” is one that causes visible destruction or irreversible alterations in the tissue at the site of contact. A test for a corrosive substance is whether, by human experience, such tissue destruction occurs at the site of application. A substance would be considered corrosive to the skin if, when tested on the intact skin of the albino rabbit by the technique described in OAR 333-016-0025, the structure of the tissue at the site of contact is destroyed or changed irreversibly in 24 hours or less. Other appropriate tests should be applied when contact of the substance with other than skin tissue is being considered.

(9) A “Strong Allergic Sensitizer” is a substance that produces an allergenic sensitization in a substantial number of persons who come into contact with it. An allergic sensitization develops by means of an “antibody mechanism” in contradistinction to a primary irritant reaction which does not arise because of the participation of an “antibody mechanism.” An allergic reaction ordinarily does not develop on first contact because of necessity of prior exposure to the substance in question. The sensitized tissue exhibits a greatly increased capacity to react to subsequent exposures of the offending agent. Thus, subsequent exposures may produce severe reactions with little correlation to the amounts of excitant involved. A “photodynamic sensitizer” is a substance that causes an alteration in the skin or mucous membranes, in general, or to the skin or mucous membrane at the site to which it has been applied, so that when these areas are subsequently exposed to ordinary sunlight or equivalent radiant energy an inflammatory reaction will develop.

(10) “Extremely Flammable” or “Flammable” substances:

(a) “Extremely flammable” means any substance that has a flashpoint at or below 20°F, as determined by the method described in OAR 333-016-0035;

(b) “Flammable” means any substance that has a flashpoint of above 20°F, to and including 80°F, as determined by the method described in OAR 333-016-0035.

(11) “Extremely Flammable” and “Flammable” solids:

(a) A solid substance is “extremely flammable” if it ignites and burns at an ambient temperature of 80°F or less when subjected to friction, or to percussion or to an electrical spark;

(b) A solid substance is “flammable” if, when tested by the method described in OAR 333-016-0040, it ignites and burns with a self-sustained flame at a rate greater than one-tenth of an inch per second along its major axis.

(12) “Extremely Flammable” and “Flammable” contents of self-pressurized containers:

(a) Contents of self-pressurized containers are “extremely flammable” if, when tested by the method described in OAR 333-016-0045, flashback (a flame extending back to the dispenser) is obtained at any degree of valve opening and the flashpoint, when tested by the method described in OAR 333-016-0050, is less than 20°F;

(b) Contents of self-pressurized containers are “flammable” if, when tested by the method described in rule 333-016-0045, a flame projection exceeding 18 inches is obtained a full valve opening or a flashback (a flame extending back to the dispenser) is obtained at any degree of valve opening.

(13) “Substances that generate pressure.” A substance is hazardous because it generates pressure through decomposition, heat, or other means:

(a) If it explodes when subjected to an electrical spark, or to percussion, or to the flame of a burning paraffin candle for five seconds or less;

(b) If it expels the closure of its container or bursts its container when held at or below 130°F for two days or less;

(c) If it erupts from its opened container at a temperature of 130°F or less after having been held in the closed container at 130°F for two days;

(d) If it comprises the contents of a self-pressurized container.

(14) “Radioactive Substance” means a substance which, because of nuclear instability, emits electromagnetic and/or particulate radiation that is capable of producing ions in its passage through matter. Source materials, special nuclear material, and by-product materials described in ORS 453.605 et seq. are exempt.

(15) As used in ORS 453.005(11) “accompanying literature” means any placard, pamphlet, booklet, book, sign, or other written, printed, or graphic matter or visual device that provides directions for use, written or otherwise, and is used in connection with the display, sale, demonstration, or merchandising of a hazardous substance intended for or packaged in a form suitable for use in the household or by children.

(16) A “Substantial Personal Injury” or “Substantial Illness” means any illness or injury sufficiently significant to cause one or more days of restricted activity. A day of restricted activity is one on which a person cuts down on his usual activities for the whole of that day because of an illness or an injury. The term “usual activities” for any day means the things that the person would ordinarily do on that day. For children under school age, usual activities depend on whatever the usual pattern is for the child’s day, which will in turn be affected by the age of the child, weather conditions, and so forth. For retired or elderly persons, usual activities might consist of almost no activity, but cutting down on even a small amount for as much as a day would constitute restricted activity. On Sundays or holidays “usual activities” are taken to be the things the person usually does on such days — going to church, playing golf, visiting friends or relatives, or staying at home and listening to the radio, reading, looking at television, and so forth. Restricted activity does not imply complete inactivity, but it does imply only the minimum of usual activities. A special nap for an hour after lunch does not constitute cutting down on usual activities, nor does the elimination of a heavy chore as cleaning ashes out of the furnace or hanging out the wash. If a farmer or housewife carries on only the minimum of the day’s chores, however, this is a day of restricted activity. A day spent in bed or a day home from work or school because of illness or injury is, of course, a restricted activity day.

(17) A “Proximate Result” is one that follows in the course of events without an unforeseeable, intervening, independent cause.

(18) “Reasonably Foreseeable Handling or Use” includes the reasonably foreseeable accidental handling or use, not only by the purchaser or intended user of the product, but by all others in a household, especially children.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.035
History:
HD 89, f. 7-31-75, ef. 8-25-75
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0010
Human Experience with Hazardous Substances

Reliable data on human experience with any substance shall be taken into account in determining whether an article is a “hazardous substance” within the meaning of the Act, and when such data give reliable results different from results with animal data, the human experience takes precedence. Experience may show that an article is more or less toxic, irritant, or corrosive to man than to test animals. Experience may also show other factors that are important in determining the degree of hazard to humans represented by the substance; for example, that radiator antifreeze is likely to be stored in the household or garage and likely to be ingested in significant quantities by some persons. Experience also indicates that a particular substance in liquid form is more likely to be ingested than is the same substance in a paste or solid, and that an aerosol is more likely to get into the eyes and the nasal passages than is a liquid.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0015
Hazardous Mixtures

For a mixture of substances, the determination of whether such mixture is “hazardous” as defined in ORS 453.005(7) should be based on the physical, chemical, and pharmacological characteristics of the mixture. A mixture of substances may therefore be less hazardous or more hazardous than its components because of synergistic or antagonistic reactions. It may not be possible to reach a fully satisfactory decision concerning the toxic, irritant, corrosive, flammable, sensitizing, or pressure-generating properties of a substance from what is known about its components or ingredients. It is prudent to test the mixture itself.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0020
Testing Procedures for Hazardous Substances

Method of testing toxic substances. The method of testing the toxic substances defined in OAR 333-016-0005(5)(c) and (6)(c) is as follows:

(1) Acute dermal toxicity (single exposure). In the acute exposures the agent is held in contact with the skin by means of a sleeve for periods varying up to 24 hours. The sleeve, made of rubber dam or other impervious material, is so constructed that the ends are reinforced with additional strips and should fit snugly around the trunk of the animal. The ends of the sleeve are tucked, permitting the central portion to “balloon” and furnish a reservoir for the dose. The reservoir must have sufficient capacity to contain the dose without pressure. In the following table are given the dimensions of sleeves and the approximate body surface exposed to the test substance. The sleeves may vary in size to accommodate smaller or larger subjects. In the testing of unctuous materials that adhere readily to the skin, mesh wire screen may be employed instead of the sleeve. The screen is padded and raised approximately two centimeters from the exposed skin. In the case of dry powder preparations, the skin and substance are moistened with physiological saline prior to exposure. The sleeve is then slipped over the gauze which holds the dose applied to the skin. In the case of finely divided powders, the measured dose is evenly distributed on cotton gauze, which is then secured to the area of exposure. (See Table 1.)

(2) Preparation of test animals. The animals are prepared by clipping the skin of the trunk free of hair. Approximately one-half of the animals are further prepared by making epidermal abrasions every 2 centimeters or 3 centimeters longitudinally over the area of exposure. The abrasions are sufficiently deep to penetrate the stratum corneum (horny layer of the epidermis), but not to disturb the derma — that is, not to obtain bleeding.

(3) Procedures for testing. The sleeve is slipped onto the animal which is then placed in a comfortable but immobilized position in a multiple animal holder. Selected doses of liquids and solutions are introduced under the sleeve. If there is slight leakage from the sleeve which may occur during the first few hours of exposure, it is collected and reapplied. Dosage levels are adjusted in subsequent exposures (if necessary) to enable a calculation of a dose that would be fatal to 50 percent of the animals. This can be determined from mortality ratios obtained at various doses employed. At the end of 24 hours the sleeves or screens are removed, the volume of unabsorbed material, if any, is measured, and the skin reactions are noted. The subjects are cleaned by thorough wiping, observed for gross symptoms of poisoning, and then observed for two weeks.

[ED. NOTE: Tables referenced are available from the agency.]

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0025
Method of Testing Primary Irritant Substances

(1) Primary irritation to the skin is measured by a patch test technique on the abraded and intact skin of the albino rabbit, clipped free of hair. A minimum of six subjects are used in abraded and intact skin tests. Introduce under a square patch such as surgical gauze measuring 1" X 1" two single layers thick, 0.5 milliliter (in the case of liquids) or 0.5 gram (in the case of solids and semi-solids) of the test substance. Dissolve solids in an appropriate solvent and apply the solution as for liquids. The animals are immobilized with patches secured in place by adhesive tape. The entire trunk of the animal is then wrapped with an impervious material such as rubberized cloth, for the 24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances. After 24 hours of exposure, the patches are removed and the resulting reactions are evaluated on the basis of the designated values in the following evaluation of skin reactions:

(a) Erythema and eschar formation:

(A) No erythema — Value of 0;

(B) Very slight erythema (barely perceptible) — Value of 1;

(C) Well-defined erythema — Value of 2;

(D) Moderate to severe erythema — Value of 3;

(E) Severe erythema (beet redness) to slight eschar (injuries in depth) — Value of 4.

(b) Edema formation:

(A) No edema — Value of 0;

(B) Very slight edema (barely perceptible) — Value of 1;

(C) Slight edema (edges of area well defined by definite raising) — Value of 2;

(D) Moderate edema (raised approximately 1 millimeter) — Value of 3;

(E) Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) — Value of 4.

NOTE: The “value” recorded for each reading is the average value of the six or more animals subject to the test.

(2) Readings are again made at the end of a total of 72 hours (48 hours after the first reading). An equal number of exposures are made on areas of skin that have been previously abraded. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. Evaluate the reactions of the abraded skin at 24 hours and 72 hours, as described in this paragraph. Add the values for erythema and eschar formation at 24 hours and at 72 hours for intact skin to the values on abraded skin at 24 hours and at 72 hours (four values). Similarly, add the values for edema formation at 24 hours and at 72 hours for intact and abraded skin (four values). The total of the eight values is divided by four to give the primary irritation score. Exposure times and units:

(a) Erythema and eschar formation:

(A) Intact skin:

(i) 24 hours — Value of 2;

(ii) 72 hours — Value of 1.

(B) Abraded skin:

(i) 24 hours — Value of 3;

(ii) 72 hours — Value of 2.

(C) Subtotal of exposure unit values = 8.

(b) Edema formation:

(A) Intact skin:

(i) 24 hours — Value of 0;

(ii) 12 hours — Value of 1.

(B) Abraded skin:

(i) 24 hours — Value of 1;

(ii) 72 hours — Value of 2.

(C) Subtotal of exposure unit values = 8.

(c) Total exposure unit values = 12.

NOTE: Primary irritation score is 12 divided by 4 = 3.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0030
Test for Eye Irritants

(1)(a) Six albino rabbits are used for each test substance. Animal facilities for such procedures shall be so designed and maintained as to exclude sawdust, wood chips, or other extraneous material that might produce eye irritation. Both eyes of each animal in the test group shall be examined before testing, and only those animals without eye defect or irritation shall be used. The animal is held firmly but gently until quiet. The test material is placed on one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. The lids are then gently held together for one second and the animal is released. The other eye, remaining untreated, serves as a control. For testing liquids, 0.1 milliliter is used. For solids or pastes, 100 milligrams of the test substance is used, except that for substances in flake, granule, powder, or other particulate form the amount that has a volume of 0.1 milliliter (after compacting as much as possible without crushing or altering the individual particles, such as by tapping the measuring container) shall be used whenever this volume weighs less than 100 milligrams. In such a case, the weight of the 0.1 milliliter test dose should be recorded. The eyes are not washed following instillation of test material except as noted below;

(b) The eyes are examined and the grade of ocular reaction is recorded at 24, 48, and 72 hours. Reading of reactions is facilitated by use of a binocular loupe, hand slit-lamp, or other expert means. After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein. For this optional test, one drop of fluorescein sodium ophthalmic solution, U.S.P., or equivalent is dropped directly on the cornea. After flushing out the excess fluorescein with sodium chloride solution, U.S.P., or equivalent, injured areas of the cornea appear yellow; this best visualized in a darkened room under ultraviolet illumination. Any or all eyes may be washed with sodium chloride solution, U.S.P., or equivalent after the 24-hour reading.

(2)(a) An animal shall be considered as exhibiting a positive reaction if the test substance produces at any of the readings ulceration of the cornea (other than a fine stipplin), or opacity of the cornea (other than a slight dulling of the normal luster), or inflammation of the iris (other than a slight deepening of the folds (or rugae) or a slight circumcorneal injection of the blood vessels), or if such substance produces in the conjunctive (excluding the cornea and iris) an obvious swelling with partial eversion of the lids or a diffuse crimson-red with individual vessels not easily discernible;

(b) The test shall be considered positive if four or more of the animals in the test group exhibit a positive reaction. If only one animal exhibits a positive reaction, the test shall be regarded as negative. If two or three animals exhibit a positive reaction, the test is repeated using a different group of six animals. The second test shall be considered positive if three or more of the animals exhibit a positive reaction. If only one or two animals in the second test exhibit a positive reaction, the test shall be repeated with a different group of six animals. Should a third test be needed, the substance will be regarded as an irritant if any animal exhibits a positive response.

(3) To assist testing laboratories and other interested persons in interpreting the results obtained when a substance is tested in accordance with the method described in section (1) of this rule, an “Illustrated Guide for Grading Eye Irritation by Hazardous Substances” will be sold by the Superintendent of Documents, Government Printing Office, Washington, D.C. The guide will contain color plates depicting responses of varying intensity to specific test solutions. The grade of response and the substance used to produce the response will be indicated.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0035
Tentative Method of Test for Flashpoint of Volatile Flammable Materials by Tagliabue Open-Cup Apparatus

(1) Scope:

(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 or which are very viscous, gives less reproducible results than when applied to solvents.

*NOTE: The Public Health Division has obtained permission from the American Society for Testing Materials, Philadelphia, Pennsylvania, to reprint this method in their regulations. The test has been slightly modified for practical reasons.

**NOTE: ASTM Designation: D 1310-59T, issued 1954, revised 1955, 1956, and 1959. This tentative method has been approved by the sponsoring committee and accepted by the American Society for Testing Materials in accordance with established procedures for use pending adoption as standard. Suggestions for revisions should be addressed to the Society at 1916 Race Street, Philadelphia, Pennsylvania.

(2) Outline of Method. The sample is placed in the cup of a Tag Open Tester, and heated at a slow but constant rate. A small test flame is passed at a uniform rate across the cup at specified intervals. The flashpoint is taken as the lowest temperature at which application of the test flame causes the vapor at the surface of the liquid to flash; that is, ignite but not continue to burn.

(3) Apparatus. The Tag Open-Cup Tester is illustrated in Figure 1. It consists of the following parts which must conform to the dimensions shown and have the additional characteristics as noted:

(a) Copper bath, preferably equipped with a constant level overflow so placed as to maintain the bath liquid level one-eighth inch below the rim of the glass cup;

(b) Thermometer holder. Support firmly with ringstand and clamp;

(c) Thermometer. For flashpoints above 40 °F, use the ASTM Tag Closed Tester Thermometer, range of plus 20 to plus 230 °F, in one degree Fahrenheit divisions and conforming to thermometer 9F of ASTM Standard E1. For flashpoints from 20°F to 40°F, use ASTM Tag Closed Tester, Low Range Thermometer 57F. For flashpoints below 20°F, use ASTM Thermometer 33F.;

(d) Glass test cup. Glass test cup (Figure 2) of molded clear glass, annealed, heat-resistant, and free from surface defects;

(e) Leveling device. Leveling device or guide, for proper adjustment of the liquid level in the cup (Figure 3). This shall be made of No. 18-gauge polished aluminum with a projection for adjusting the liquid level when the sample is added to exactly one-eighth inch below the level of the edge or rim of the cup;

(f) “Micro” or small gas burner of suitable dimensions for heating the bath. A screw clamp may be used to help regulate the gas. A small electric heater may be used;

(g) Ignition taper, which is a small, straight, blow-pipe type gas burner. The test flame torch prescribed in the method of test for flash and fire points by Cleveland Open Cup (ASTM designation: D 92) is satisfactory;

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

(A) Guide wire, 3/32 inch in diameter and 3-1/2 inches in length, with a right-angle bend one-half inch from each end. This wire is placed snugly in holes drilled in the rim of the bath, so that the guide wire is 5/8 inch from the center of the cup and resting on the rim of the cup;

(B)(i) Swivel-type taper holder, such as is used in ASTM Method D 92. The height and position of the taper are fixed by adjusting the holder on a suitable ringstand support adjacent to the flash cup.

(ii) Draft shield, consisting of two rectangular sheets of noncombustible material, 24 inches x 28 inches, are fastened together along the 28 inch side, preferably by hinges. A triangular sheet, 24 inches x 24 inches x 34 inches is fastened by hinges to one of the lateral sheets (to form a top when shield is open). The interior of the draft shield shall be painted a flat black.

(4) Procedure:

(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 one-eighth 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 the 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 one-fourth inch from the inner bottom surface of the cup. If the old Tagliabue thermometer is used, immerse to well cover the mercury bulb, but not the wide body of the thermometer;

(d) Fill the glass cup with the sample liquid to a depth just one-eighth inch below the edge, as determined by the leveling device;

(e) Place the guide wire or swivel device in position, and set the draft shield around the tester so that the sides form 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 holder is used, the horizontal and vertical positions of the jet are so adjusted that the jet passes on the circumference of a circle, having a radius of at least six inches across the center of the cup at right angles to the diameter passing through the thermometer, and in a plane one-eighth inch above the upper edge of the cup. The taper should be kept in the “off” position, at one end or the other of the swing, except when the flame is applied;

(g) Light the ignition flame and adjust it to form a flame of spherical form matching in size the 5/32-inch sphere on the apparatus;

(h) Adjust heater source under bath so that the temperature of the sample increases at a rate of two plus or minus 0.5°F per minute. With viscous materials, this rate of heating cannot always be obtained.

(5) Initial Test. Determine an approximate flashpoint by passing the taper flame across the sample at intervals of 2°F. Each pass must be in one direction only. The time required to pass the ignition flame across the surface of the sample should be one second. Remove bubbles from the surface of the sample liquid before starting a determination. Meticulous attention to all details relating to the taper, size of taper flame, and rate of passing the taper is necessary for good results. When determining the flashpoint of viscous liquids and those liquids that tend to form a film of polymer, etc., on the surface, the surface film should be disturbed mechanically each time before the taper flame is passed.

(6) Recorded Tests. Repeat the procedure by cooling a fresh portion of the sample, the glass cup, the bath solution, and the thermometer at least 20°F below the approximate flashpoint. Resume heating and pass the taper flame across the sample at two intervals of 5°F, and then at intervals of 2°F until the flashpoint occurs.

(7) Reporting Data. The average of not less than three recorded tests, other than the initial test, shall be used in determining the flashpoint and flammability of the substance.

(8) Standardization:

(a) Make determinations in triplicate on the flashpoint of standard paraxylene and of standard isopropyl alcohol which meet the following specifications:

(A) Specifications of p-xylene, flashpoint check grade. P-xylene shall conform to the following requirements:

(i) Specific Gravity: 15.56°C/15.56°C, 0.860 minimum, 0.866 maximum;

(ii) Boiling Range: 2°C maximum from start to dry point when tested in accordance with the method of test for distillation of industrial aromatic hydrocarbons (ASTM designation: D 850), or the method of test for distillation range of lacquer solvents and effluents (ASTM designation: D 1078). The range shall include the boiling point of pur-xylene, which is 138.35°C (281.03°F);

(iii) Purity: 95 percent minimum, calculated in accordance with the method of test for determination of purity from freezing points of high-purity compounds (ASTM designation: D 1016), from the experimentally determined freezing point, measured by the method of test for measurement of freezing points of high purity compounds for evaluation of purity (ASTM designation: D 1015).

(B) Specifications for isopropanol, flashpoint check grade. Isopropanol shall conform to the following requirements:

(i) Specific Gravity: 0.8175 to 0.8185 at 20°C/20°C, as determined by means of a calibrated pycnometer;

(ii) Distillation Range: Shall entirely distill within a 1.0 degree Centigrade range which shall include the temperature 80.4°C as determined by ASTM method D 1078. Average these values for each compound. If the difference between the values for these two compounds is less than 15°F (8.5°C) or more than 27°F (16°C), repeat the determinations or obtain fresh standards.

(b) Calculate a correction factor as follows:

X = 92 - A

Y = 71 - B

Correction:

X + Y

Z

Where:

A = Observed flash of p-xylene

B = Observed flash of isopropyl alcohol

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

(9) Precision:

(a) For hydrocarbon solvents having flashpoints between 60°F and 110°F, repeatability is plus or minus 2°F and the reproducibility is plus or minus 5°F;

(b) If results from two tests differ by more than 10°F, they shall be considered uncertain and should be checked. The calibration procedure provided in this method will cancel out the effect of barometric pressure if calibration and tests are run at the same pressure. (Data supporting the precision are given in Appendix III of the 1956 Report of Committee D-1 on Paint, Varnish, Lacquers, and Related Products, Proceedings, American Soc. Testing Mats., Volume 56 (1956).)

[ED. NOTE: Figures referenced are available from the agency.]

[Publications: Publications referenced are available from the agency.]

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0040
Method for Determining Extremely Flammable and Flammable Solids

(1) Preparation of sample:

(a) Granules, powders, and pastes. Pack the sample into a flat, rectangular metal boat with inner dimensions of 6 inches long x 1 inch wide x 1/4 inch deep;

(b) Rigid and pliable solids. Measure the dimensions of the sample and support it by means of metal ringstands, clamps, rings, or other suitable devices as needed, so that the major axis is oriented horizontally and the maximum surface is freely exposed to the atmosphere.

(2) Procedure. Place the prepared sample in a draft-free area that can be ventilated and cleaned after each test. The temperature of the sample at the time of testing shall be between 68°F and 86°F. Hold a burning paraffin candle whose diameter is at least one inch so that the flame is in contact with the surface of the sample at the end of the major axis for five seconds or until the sample ignites, whichever is less. Remove the candle. By means of a stopwatch, determine the time of combustion with self-sustained flame. Do not exceed 60 seconds. Extinguish flame with a CO2 or similar nondestructive type extinguisher. Measure the dimensions of the burnt area and calculate the rate of burning along the major axis of the sample.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0045
Method for Determining Extremely Flammable and Flammable Contents of Self-Pressurized Containers

(1) Equipment required. The test equipment consists of a base eight inches wide, two feet long, marked in six-inch intervals. A rule two feet long and marked in inches is supported horizontally on the side of the base and about six inches above it. A paraffin candle one inch or more in diameter and of such height that the top third of the flame is at the height of the horizontal rule, is placed at the zero point in the base.

(2) Procedure. The test is conducted in a draft-free area that can be ventilated and cleared after each test. Place the self-pressurized container at a distance of six inches from the flame source. Spray for periods of 15 seconds to 20 seconds (one observer noting the extension of the flame and the other operating the container) through the top third of the flame and at a right angle to the flame. The height of the flame should be approximately two inches. Take three readings for each test, and average. As a precaution, do not spray large quantities in a small, confined space. Free space of previously discharged material.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0050
Method for Determining Flashpoint of Extremely Flammable Contents of Self-Pressurized Containers

The apparatus used in the Tagliabue Open-Cup Flashpoint Apparatus as described in OAR 333-016-0035. Some means such as dry ice in an open container is used to chill the pressurized container. The container, the flash cup, and the bath solution of the apparatus (brine or glycol may be used) are chilled to a temperature of about 25°F below zero. The chilled container is punctured to exhaust the propellant. The chilled formulation is transferred to the test apparatus and tested in accordance with the method described in OAR 333-016-0035.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0055
Method for Determining the Sound Pressure Level Produced by Toy Caps

(1) Equipment required. The equipment for the test includes a microphone, a preamplifier (if required), and an oscilloscope:

(a) The microphone-preamplifier system shall have a free-field response uniform to within plus or minus two decibels from 50 hertz to 70 kilohertz or beyond, and a dynamic range covering the interval 70 to 160 decibels relative to 20 micronewtons per square meter. Depending on the model, the microphone shall be used at normal or grazing incidence, whichever gives the most uniform free-field response. The microphone shall be calibrated both before and after the test of a model of cap. The calibration shall be accurate to within plus or minus one decibel. If the calibration is of the pressure type or of the piston-phone plus electro-static actuator type, it shall be corrected to free-field conditions in accordance with the manufacturer’s instructions;

(b) The oscilloscope shall be the storage type or one equipped with a camera. It shall have a response uniform to within plus or minus one decibel from 50 hertz to 250 kilohertz or higher. It shall be calibrated to within plus or minus one decibel against an external voltage source periodically during the tests.

(2) Procedure:

(a) Place the sound source and testing equipment so that neither the sound source nor the microphone is closer than one meter from any wall, floor, ceiling, or other large obstruction. Locate the sound source and the microphone in the same horizontal plane with a distance of 25 centimeters between the diaphragm of the microphone and the position of the sound producing component of the sound source, e.g., explosive or diaphragm. Measure the peak sound pressure level at each of the six designated orientations of the sound source with respect to the measuring microphone. When caps are tested use the type of pistol that would ordinarily be used with the caps being tested. The zero degree orientation corresponds to an unobstructed and direct line from the sound source to the microphone, e.g., the muzzle of a pistol pointing at the microphone. The 90, 180 , and 270 degree orientations are measured in a clockwise direction when looking down on the sound source and correspond to looking down on a pistol with its barrel horizontal as illustrated by the following figure:

0°

270° 90°

180°

(b) Testing Caps With a Pistol and Testing Gun. The hammer and trigger orientations are obtained by rotating the pistol about the axis of the barrel, when the pistol is in the 90-degree of 270-degree orientation, so that the hammer and the trigger are each respectively closest to and in the same horizontal plane with the microphone. Fire ten shots at each of the six orientations, obtaining readings on the oscilloscope of the maximum peak voltage for each shot. Average the results of the ten firings for each of the six orientations;

(c) Sound Sources Other Than Caps and Guns. Rotate the sound source about its axis to the four degrees of orientation. Produce ten sound emissions at each of the orientations obtaining readings on the oscilloscope of the maximum peak voltage for each emission. Average the results of the ten firings for each of the four orientations;

(d) Computation. Using the orientation that yields the highest average value, convert the value to sound pressure levels in decibels relative to 20 micronewtons per square meter using the response to the calibrated measuring microphone.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 89, f. 7-31-75, ef. 8-25-75
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0056
Test Methods for Simulating Use and Abuse, Toys, Games, and Other Articles Intended for Use by Children

(1) Objective. This rule and OAR 333-016-0057, 333-016-0058, and 333-016-0059 describe specific test methods for simulating normal use of toys and other articles intended for children as well as the reasonably foreseeable damage or abuse to which the articles may be subjected. The test methods are for use in exposing potential hazards that would result from the normal use or the reasonably foreseeable damage or abuse of such articles intended for children.

(2) Application:

(a) Toys intended for children 96 months of age or less must satisfy all tests in this section and shall also satisfy tests which have been established for articles intended for the specified age groups of children: 18 months of age and less, over 18 months but not over 36 months of age, and over 36 months but not over 96 months of age, which are set forth in OAR 333-016-0057, 333-016-0058, and 333-016-0059. If an article is marked, labeled, advertised, or otherwise intended for children of an age spanning more than one of such age groups, the article will be subjected to those tests providing the most stringent requirements. If an article is not age-labeled or is unreasonably age-labeled and is intended for children 96 months of age or less, it will also be subjected to the most stringent test requirements;

(b) Each of the test methods described in this rule and in OAR 333-016-0057, 333-016-0058, and 333-016-0059 shall be applied to a previously untested sample, except the tension test which shall be conducted with the test sample used in the torque test if no failure occurred during that test;

(c) Normal use testing:

(A) (Known herein as Requirement No. 1) These tests are intended to simulate normal use conditions so as to assure that hazards are not generated through normal wear and deterioration. The object of these tests shall be to simulate the normal play mode of the toy, and the tests in Requirement No. 2, are therefore unrelated. The tests are intended to uncover hazards, rather than to demonstrate the reliability of the toy. The fact that a mechanism or material of a toy fails during testing is only relevant if the failure creates a potential hazard. Toys shall be subjected to appropriate tests to repeatedly simulate the normal use of the particular toy. For example, levers, wheels, catches, triggers, strings, wires, chains, and so on, that are intended to be actuated by a child shall be repeatedly operated. Spring or power-operated devices shall be similarly tested. The tests shall be carried out in a normal use environment. For example, toys intended for use in the bathtub shall be tested in soapy water, and toys intended for use in the sandbox shall be exposed to sand during testing. The toy should be inspected after such tests, and hazards such as points, sharp edges, and release of small parts shall be evaluated according to the relevant requirements under OAR 333-016-0080;

(B) Abuse testing and impact testing. Tests in (A,i) through (A,iii); (B,i) through (B,v); (E,i) through (E,v); (F,i) through (F,v); and (G,i) through (G,v); (known herein as Requirement No. 2) are to simulate the exposure of a toy to mechanical damage through dropping, throwing, and other actions likely to be performed by a child, and to simulate situations in which possible damage can occur to a toy by reason of it falling from a crib, a table or counter top, or other impact situation which may occur as a result of reasonably foreseeable abuse. After testing, the toy shall be examined for mechanical hazards, such as hazardous sharp edges and points, and ingesting hazards, such as small liberate components, chips, or fragments according to the particular age grading requirement for each hazard, as described in OAR 333-016-0080.

(d) Special impact tests for certain classes of toys exempted from drop tests:

(A) Tip over test for large floor-standing toys. Toys intended for use on the floor, such as refrigerators and ovens, that have a volume of greater than 3 cubic feet, calculated without regard to minor appendages, or a projected base area of 400 square inches or more, shall be tipped over onto an impact area of the construction described in Test (E,i). The impact area shall be sufficiently large to accommodate the toy in whatever attitude it falls. The toy shall be placed on the floor in intended use position and tipped over 3 times by pushing on the floor in intended use position and tipped over 3 times by pushing it slowly past its center of balance, and allowed to fall without restraint. For toys with legs, projected base area is determined by calculation area enclosed by straight lines connecting outermost edge of each leg of the perimeter (Known herein as Test (A,i));

(B) Impact test for projectiles. Projectiles shall be propelled by their discharge mechanism three times into a concrete block wall (or equivalent surface) located at a distance twice the length of the projectile from the front end of the launcher. The discharge mechanism shall be aimed perpendicular to the wall. (Known herein as Test (A,ii)) The discharge mechanisms shall be drop tested according to another test, (F,i);

(C) Tumble test for wheeled toys. Wheeled toys weighing more than 3.0 pounds shall be tumbled down a flight of six steps with risers not less than seven inches high (see Figure 4). The treads may be wood, cement, or metal. The toy shall be caused to fall down the steps two times in each of four attitudes: Tumbling forwardly, tumbling rearwardly end-over-end, and tumbling from each side. The toy shall be pushed slowly over the edge of the top step in the appropriate attitude, and released as soon as it begins to fall of its own weight. The test shall be considered complete for an attitude even if the toy does not reach the bottom of the flight of steps (Known herein as Test (A,iii));

(D) Exemptions from impact tests. The following categories are exempted from test (A,i) through test (A,iii):

(i) Toys or assembled toys having nonwheeled bases, such as gas stations and farm sets in which the base has an area greater than 175 square inches and which do not tip over when placed on a 45 degree incline in any direction. If the toy tips, then it shall be tested according to test (A,i). However, accessories, or components of these toys that are not affixed to the base structure shall conform to test (E,i) or test (F,i) or test (G,i);

(ii) Toys weighing more than ten pounds; and

(iii) Paints, chalks, and crayons. However, the containers provided for these articles shall conform to test (E,i), test (F,i), or test (G,i).

(E) Impact test for toys that cover the face. The toy shall be held firmly in a suitable clamp with that portion covering the eyes in a horizontal plane. Drop a 5/8-inch diameter steel ball weighing 0.56 ounce (tolerance plus 0.03 ounce, minus zero ounce) from a height of 50 inches upon the horizontal upper surface of the toy in the area that would cover the eyes in normal use. The ball may be guided, but not restricted, in its fall by being dropped through a perforated tube extending to within approximately 4-inches of the toy. The toy will be considered to have failed if the material cracks through its entire thickness or if any material visible to the naked eye becomes detached. (Known herein as Test (A,iv).)

(e) Special tests for certain classes of toys exempted from drop and impact tests. These tests relate to the requirements of OAR 333-016-0080:

(A) Tires, wheels, axles:

(i) The toy shall be clamped so that the wheel axle is vertical. A wire hook shaped as shown in Figure 5 shall be positioned on the lower tire and attached to a dead weight of ten pounds if the tire is on a toy intended for children aged up to 18 months, or to a dead weight of 15 pounds if the tire is on a toy intended for children aged from 18 months to 36 months and if the tire falls within the limits of ingestion hazards as defined in OAR 333-016-0080. The load shall be applied gradually and maintained for ten seconds. Test (E,iii) and (E,iv) shall also be applied (Known as Test (B,i).);

(ii) Pull test for wheels on hubs free to rotate. The toy shall be supported or clamped with the axle in a vertical position. If the lower wheel is accessible so that all of the claws of a three-pronged claw hook can be engaged around the wheel hub or tire, then a load of 10, 15, or 20 pounds shall be applied. The load shall be 10 pounds in the case of wheels 3/4-inch or less in diameter on toys intended for children aged less than 18 months, 15 pounds in the case of wheels 3/4-inch or less in diameter on toys intended for children from 18 months but not over 96 months, and 20 pounds in the case of wheels greater than 3/4-inch in diameter. The three-pronged claw hook shall be equivalent in type to that shown in Figure 6 and described in British Standard No. 3443, Code of Safety Requirements for Children’s Toys and Playthings, 1968, p. 12. The load shall be applied gradually over a five-second period and shall be maintained for ten seconds. If the wheel hub or tire is inaccessible to the three-pronged claw, then a suitable test hook shall be substituted for the three-pronged device. The hook shall be applied to the periphery, and the test shall be carried out as described above. Tests (E,iii) and E,iv) shall also be applied (Known herein as Test (B,ii));

(iii) Pull test for wheels fixed onto axles. A schematic diagram of a device for applying torque is shown in Figure 7. A load of 20 pounds is applied. The procedure is that used in Test (B,ii) (Known herein as Test (B,iii));

(iv) Toys assembled with “snap-in” axles. A 15 pound dead weight shall be applied to the axle, adjacent to a bearing, for ten seconds, using a hook and string for attachment to the toy. The toy shall be held horizontally in a test-convenient fixture, and the load shall be applied gradually over a five second period and then shall be maintained for ten seconds. If the axle cannot be hooked as described above, the toys shall be held horizontally, and a ten pound dead weight shall be attached to one wheel by means of a hook or clamp. The load shall be applied gradually over a five-second period and then shall be maintained for ten seconds (Known herein as Test (B,iv));

(v) Compression test for “snap-on” wheel and axle assemblies. This test is for compliance with OAR 333-016-0080(3)(b)(A)(iii) if the axle and wheel are removed by the procedure described in test (B,iv). The wheel and axle assembly shall be positioned with the axle vertical over a hole in a rigid plate as shown in Figure 8. The hole shall be large enough in diameter to permit the axle to pass through. A load of 20 pounds is applied to the upper wheel, using a suitable adaptor to prevent interference with the axle. The load shall be applied gradually over a five-second period and then shall be maintained for ten seconds. When applying the load, the upper wheel shall be guided, if necessary, in order to maintain the axle vertical, but shall not be restrained from moving downward. In those cases where the axle is forced through either wheel, the axle shall not form a hazardous point or projection. (Known herein as Test (B,v))

(B) Bending test for wires and rods. Any toy that is intended to be bent or formed and that is equipped with metal wire(s) or other metal material(s) for retention of form shall be subject to this test. The toy shall be suitably secured in a vise equipped with vise shields of 3/8-inch inside diameter as shown in Figure 9. The component containing the wire or rod shall be held not less than three inches from the clamping point. The component shall then be bent through a 60 degree arc. The component shall then be bent in the reverse direction through a 120 degree arc. A back and forth bending through the 120 degree arc shall be repeated for 30 cycles. One back and forth bending (two 120 degree arc bends) shall constitute one cycle. The test shall be conducted at the rate of one-half cycle or 120 degrees per second with a 60 second rest period occurring after each ten cycles. Apply a maximum force of 10 pounds plus or minus 0.5 pound when testing toys covered by OAR 333-016-0057 and 15 pounds plus or minus 0.5 pound when testing toys covered by OAR 333-016-0058 or 333-016-0059. Apply the force perpendicularly to the major axis of the component at a point two inches (5 centimeters) from the intersection of the component with the main body of the toy or at the end of the component if the component is less than 2 inches plus or minus 0.05 inch (5 centimeters) long (Known herein as Test C,i));

(C) Test for removal of components from toys. The toy shall be restrained in a test-convenient clamp, and the component connected to an extensometer by a 3-pronged claw hook or other suitable means of attachment. Care shall be taken to ensure that the hook or attachment device does not compress the protective components of OAR 333-016-0080(3)(a)(C)(i) and (3)(b)(A)(iii) so that it hinders possible removal. The extensometer shall be pulled perpendicular to the joint between the component and the body of the toy. The load shall be applied gradually over a five second period and then shall be maintained for ten seconds. With regard to the push force requirement in OAR 333-016-0080, the projection, or the toy, shall be held in a test-convenient clamp. A push force of ten pounds shall be applied using an extensometer or dead weight gradually over a period of five seconds and then shall be maintained for ten seconds (Known herein as Test (D,i));

(D) Test for mouth-actuated toys. A piston pump, such as bicycle pump, capable of discharging and taking in more than 18 cubic inches of air in less than three seconds shall be connected to the mouthpiece of the toy, and to the air outlet if applicable. The toy shall be subjected to ten alternation blowing and sucking cycles of 18 cubic inches of air. Any objects released as a result of this test shall be inspected for conformance with OAR 333-016-0080(4)(a) (Known herein as Test D,ii));

(E) Tests for thermal and fire features:

(i) Electrical toy. When tested under the conditions described in test (T,i) an electrical toy shall not attain a temperature at any point sufficiently high to constitute a fire hazard or to adversely affect any materials employed and shall not show a maximum temperature higher than those established by subparagraphs (2)(e)(E)(v) and (vi) of this rule. These maximum surface temperature requirements are not applicable to educational or hobby-type products such as lead-casting sets and wood-burning tools which are appropriately labeled on the shelf pack or package as being intended only for children over twelve years provided that the maximum surface temperature of any such toy does not exceed that reasonably required to accomplish the intended technical effect. Such toys shall be provided with specific instructions and the warning statements required by and in accordance with 333-016-0080, and shall be appropriately labeled as educational or hobby-type products;

(ii) Test conditions (Known herein as Test (T,i)):

(I) General. Tests shall be conducted while the toy is connected to a circuit of 60-cycle-per-second (60 Hertz) current using the materials supplied with the toy or using materials otherwise intended to be used with the toy. Following such tests, the toy shall be energized for a 6-hour period to determine that no hazardous conditions would result from unattended use of the toy;

(II) Voltage. The toy shall be tested at the voltage indicated in the manufacturer’s rating or at 120 volts, whichever is greater.

(iii) Temperature measurements:

(I) General. (Known herein as Test (T,ii)) Temperatures shall be measured by means of instruments utilizing thermocouples of No. 30 AWG (American Wire Gage) wire (either copper and constantan or iron and constantan) and potentiometer-type instruments that are accurate and are calibrated in accordance with current good laboratory practices. The thermocouple wire shall conform with the requirements for “special” thermocouples as listed in the table of limits of error of thermocouples (Table VIII) in “American Standard for Temperature Measurement Thermocouples, C96.1-1964,” approved June 9, 1964, by American National Standards Institute, Inc. The Standard was sponsored and published by the Instrument Society of America;

(II) Test procedures. The thermocouple junction and adjacent thermocouple lead wire shall be securely held in good thermal contact with the surface of the material whose temperature thermal contact will result from securely taping or cementing the thermocouple in place. If a metal surface is involved, brazing or soldering the thermocouple to the metal may be necessary. The surface temperatures of a toy shall be measured with the toy operating in any unattended condition (e.g., with and without opening and closing doors or covers) for a sufficient period of time to allow temperatures to become constant, or, in the case of a toy with a thermostatically controlled heating element, for a sufficient period of time to determine the maximum surface temperature attained. A temperature shall be considered to be constant when three successive readings taken at 15 minute intervals indicate no change.

(iv) Heating devices. Toy ovens, casting toys, popcorn, and candy makers, and other toys requiring the insertion of any materials or substances shall be additionally tested by feeding crumpled strips of newspaper and tissue paper into or onto the toy in place of the intended materials or substances. The test strips shall be conditioned for at least 48 hours in air at a temperature of 25 °C plus or minus 4°C. (77°F plus or minus 7°F) and a relative humidity of 50 percent plus or minus five percent. The test strips shall be two inches wide by eight inches long before crumpling. The crumpled paper shall occupy not more than 25 percent of the accessible volume. The performance of the toy shall be considered unacceptable if flaming occurs within a 60 minute period following the attainment of normal operating temperatures. If a light bulb is used for heating purposes, the test shall be conducted using the largest wattage bulb that can be easily inserted into the socket;

(v) Maximum acceptable surface temperatures. The maximum acceptable surface temperatures for electrically operated toys is set out in Table 1;

(vi) Maximum acceptable material temperatures. The maximum acceptable material temperatures for electrically operated toys is set out in Table 2. (Classes 105, 130, A and B are from “Motors and Generators,” Standard MG-1-1967 published by the National Electrical Manufacturer’s Association.)

(3) Definitions. As used in this rule and in OAR 333-016-0057, 333-016-0058, and 333-016-0059:

(a) “Accessible” — Accessible refers to any portion of a toy that can be contacted by a probe of the approximate shape and size of a child’s finger. The insertion length and diameter of the probe shall be as specified below: Dimensions of probes for defining accessibility:

(A) Age 0–24 months (inclusive): Insertion length of probe — 2 inches; Diameter of probe — 1/4 inch;

(B) Age 25–60 months (inclusive): Insertion length of probe — 2-1/2 inches; Diameter of probe — 1/4 inch;

(C) Age 61–168 months (inclusive): Insertion length of probe — 3 inches; Diameter of probe — 1/4 inch.

NOTE: Age — Refers to the whole time of a beings existence since birth and may be expressed in either months or in years. When years are indicated, it means that the attained age in months is at least 12 times the numerical value indicated.

(b) “Curled Edge” — A curled edge is one in which the portion of the sheet adjacent to the edge is bent into an arc and forms an angle of less than 90 degrees with the base sheet as shown in Figure 10;

(c) “Discharge Mechanism” — A discharge mechanism is a system for releasing and propelling a projectile in a direction determined by the operator of the toy;

(d) “Edge, Hazardous” — A hazardous edge is defined as an edge that can cut a child’s skin during normal use or reasonably foreseeable abuse of a toy. Such an edge is subjectively judged as hazardous if it appears sharp to the casual observer;

(e) “Elastic” — An elastic material is defined as one which will not break and will, essentially, instantaneously recover its former size and shape after being elongated at least ten percent at a testing speed of not less than 20 inches per minute;

(f) “Fabric” — Any material, woven, knitted, fitted, or otherwise produced from or in combination with any natural or synthetic fiber;

(g) “Feathering” — Feathering is a beveling of an edge (or decrease in thickness moving toward the edge) caused during shearing or cutting of sheet metal;

(h) “Flash” — Flash is excess material which escapes between the mating parts of a mold assembly;

(i) “Folding Mechanisms” — Folding mechanisms are those have an assembly of hinged, pivoted, or sliding members that can produce a scissor or shear action during the operation of the mechanisms;

(j) “Hazard” — A hazard is defined as any characteristic of a toy that presents an unreasonable risk of injury or illness during normal use or as a result of reasonably foreseeable abuse;

(k) “Hemmed Edge” — A hemmed edge is one in which the portion of the sheet adjacent to the edge is folded back on the sheet itself through an angle of approximately parallel to the main sheet, as shown in Figure 11;

(l) “Hinge Line Clearance” — The hinge line clearance is the clearance between the stationary portion of the toy and the movable portion along, or adjacent to, a line projected through the axis of rotation. Figure 12 illustrates the hinge line clearance, using a box with a lid as an example;

(m) “Impulsive Noise” — An impulsive noise is one in which the variations in noise level involve maxima at intervals of greater than one second;

(n) “Lap Joint” — A lap joint is one in which an edge overlaps a parallel surface but is not necessarily mechanically attached to it at all points along the length. Typical lap joints are shown in Figure 13;

(o) “Normal Use” — Normal use of a toy is defined as those play modes which conform to the instructions that accompany the toy, or which have been established by tradition or custom;

(p) “Point, Hazardous” — A hazardous point is one that can puncture or lacerate a child’s skin during normal use or reasonably foreseeable abuse. Such a point is subjectively judged as hazardous if it appears sharp to the casual observer;

(q) “Projectile” — A projectile is an unrestrained object propelled by means of a discharge mechanism that is capable of storing and releasing energy under the control of the operator;

(r) “Projection, Hazardous” — A hazardous projection is one that, because of its material and configuration, appears to the casual observer to present a puncture hazard if a child should fall onto it;

(s) “Protective Cap or Cover” — A protective cap or cover is a component that is attached to a potentially hazardous edge or projection to reduce the possibility of injury;

(t) “Protective Tip” — A protective tip is a component that is attached to the impacting end of a projectile to minimize injury if it should impact on the body. A protective tip may perform other functions such as the prevention of damage to the projectile on striking a target, providing a means of attaching the projectile to the target as in the case of suction cups, or the prevention of damage to inanimate objects;

(u) “Reasonably Foreseeable Abuse” — Reasonably foreseeable abuse is defined as conditions to which a child may subject a toy that is not normal use conditions. Examples of abuse would result from:

(A) Curiosity, such as deliberate disassembly;

(B) Lack of physical coordination or manual dexterity, such as dropping; and

(C) Use for a purpose for which the toy is not intended, such as use of a toy football helmet as if it were a real protective device.

(v) “Rigid” — Rigid refers to any material that has a Young’s modulus in tension of greater than 100,000 psi;

(w) “Rolled Edge” — Rolled edge is one in which the portion of the sheet adjacent to the edge is bent into an arc and forms an angle between 90 degrees and 120 degrees with the main sheet, as shown in Figure 14;

(x) “Toy”:

(A) “Toy” means any toy, game, pacifier, or other article designed, labeled, advertised, or otherwise intended for use by children;

(B) “Mouth toy” means any toy reasonably intended to be placed into or in contact with a child’s mouth.

(4) Prior to testing, each sample shall be subjected to a temperature of 73°F plus or minus 3°F (23°C plus or minus 2°C.) at a relative humidity of 20–70 percent for a period of at least four hours. The toy testing shall commence within five minutes after the toy has been removed from the preconditioning atmosphere.

(5) Toys reasonably intended to be assembled by an adult and not intended to be taken apart by a child shall be tested only in the assembled state if the shelf package and the assembly instruction prominently indicate that the article is to be assembled only by an adult.

(6) Toys intended to be repeatedly assembled and taken apart shall have the individual pieces as well as the completed article subjected to these test procedures.

(7) In situations where a test procedure may be applied in more than one way to a toy test component, the point (or direction) of force (or torque) application which results in the most severe conditions shall be used.

[ED. NOTE: Tables and Figures referenced are available from the agency.]

[Publications: Publications referenced are available from the agency.]

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 89, f. 7-31-75, ef. 8-25-75
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0057
Test Methods for Simulating Use and Abuse of Toys and Other Articles Intended for Children 18 Months of Age or Less

(1) Application. The test methods described in this section shall be used in determining compliance, in addition to other requirements of toys intended for use by children 18 months of age or less.

(2) Impact test. (Drop Test) Known as Test (E,i). Toys subject to special impact test in OAR 333-016-0056(2)(d) excepted.

(a) Application. Toys having a weight of less than three pounds shall be subjected to this test;

(b) Impact medium. The impact medium shall consist of a 0.125-inch nominal thickness of Type IV vinyl-asbestos tile, as specified in Federal specification SS-T-31-2A, over at least 2.5-inch thickness of concrete. The impact area shall be at least three square feet;

(c) Testing procedure. The toy shall be dropped ten times from a height of 4.5 feet plus or minus 0.5-inch. The toy shall be dropped in random orientation. After each drop the test sample shall be allowed to come to rest and examined and evaluated before continuing.

(3) Bite test. Known as Test (E,ii).

(a) Application. A toy (or component or any accessible portion thereof) that has an external dimension of 1-1/4 inches plus or minus .05-inch or less and a design configuration that would permit a child to insert a portion into the mouth in any orientation up to a biting thickness of 1-1/4 inches plus or minus .05-inch, for a penetration of at least one-fourth inch, shall be subject to this test;

(b) Test equipment:

(A) Contact mechanism. The contact mechanism shall be two metal strips, each one thirty-second inch thick. The strips shall be circular or semicircular in shape with a 1-1/2 inch diameter and a one-half inch height. The edges thereof shall be rounded to a radius of one sixty-fourth inch measuring 0.25-inch plus or minus 0.002-inch (0.635 centimeter), high and each having a contact edge radius of 0.020-inch plus or minus 0.002-inch (0.05 centimeter), for at least a 150-degree cross-sectional arc. A suggested contact mechanism appears in Figure 15;

(B) Loading device. The loading device shall be a scale or force gauge having an accuracy of plus or minus .05 pound;

(C) Testing procedure. The toy shall be placed in the loading device in any reasonable position for a restriction of 0.25-inch to 0.5-inch utilizing not more than 180 degrees of the arc and a test load increasing to 25 pounds plus or minus .05 pound over five seconds shall be evenly applied. This load shall be maintained for an additional ten seconds.

(4) Torque test. Known herein as Test (E,iii):

(a) Application:

(A) General. A toy with a projection, part, or assembly that the child can grasp by at least the thumb and forefinger or the teeth shall be subject to this test;

(B) Toys with rotating components. Projections, parts, or assemblies that are rigidly mounted on a rod or shaft designed to rotate shall be tested with the rod or shaft clamped to prevent rotation.

(b) Test equipment:

(A) Loading device. The loading device shall be a torque gauge, torque wrench, or other appropriate device having an accuracy of -2 inch-pound (-0.23 kilogram-centimeter);

(B) Clamp. The clamp shall be capable of holding the test component firmly and transmitting a torsional force (see Figure 16);

(C) Test procedure. With the sample rigidly fastened in any reasonable test position, the clamp is fastened to the test object or component. A torque of two inch-pounds plus or minus 0.2 pound shall be applied clockwise over a period of five seconds or until a rotation of 180 degrees from the original position has been attained, or two inch-pounds exceeded. The torque or maximum rotation shall be maintained for an additional ten seconds. The torque shall then be removed and the test component permitted to return to relaxed condition. This procedure shall then be repeated in a counter-clockwise direction.

(5) Tension test. Known herein as Test (E,iv):

(a) Application:

(A) General. With the exception of tires, wheels, and axles, which are tested by 333-016-0065(2)(e)(A) and test (E,iii) and test (E,iv). Any projection of a toy that the child can grasp by at least the thumb and forefinger or the teeth shall be subject to this test. This test is to be conducted on the toy after it has been subjected to test (E,iii);

(B) Mouth toy. A mouth toy shall be tested immediately after being subjected to the procedure described in paragraph (4)(b)(C) of this rule;

(C) Stuffed toys and beanbags. A stuffed toy or beanbag constructed of pliable materials having seams (such as fabrics) shall have the seams subjected to 10 pounds plus or minus 0.5 pound (4.55 kilograms) of force applied in any direction.

(b) Test equipment:

(A) Clamps. One clamp capable of applying a tension load to the test component is required. A second clamp suitable for applying a tension load perpendicularly to the major axis of the test component is also required;

(B) Loading device. The loading device is a self-indicating gauge or other appropriate means having an accuracy of -0.5 pound (-225 grams);

(c) Test procedure. With the test sample fastened in a convenient position, an appropriate clamp shall be attached to the test object or component. A 10 pound plus or minus 0.5 pound direct force shall be evenly applied parallel to the major axis of the test component over a period of five seconds and then maintained for an additional ten seconds. The tension clamp shall then be removed and a second clamp appropriate for pulling at 90 degrees shall be attached to the test object or component. A ten pound plus or minus 0.5 pound tensile force shall be evenly applied perpendicular to the major axis of the test component over a period of five seconds and then maintained for an additional ten seconds.

(6) Compression test. Known herein as Test (E,v):

(a) Application. This test is required in addition to any other test which may be required in these rules. Any area on the surface of a toy that is accessible to a child and inaccessible to flat-surface contact during the impact test shall be subject to this test;

(b) Test apparatus. The loading device shall be a rigid metal disk of 1-1/2 inches plus or minus 0.15-inch in diameter and three-eighths inch in thickness. The perimeter of the disk shall be rounded to a radius of one thirty-second inch to eliminate irregular edges. The disk shall be attached to a self-indicating gauge scale having an accuracy of plus or minus 0.5 pound;

(c) Test procedure. The shaft shall be positioned so that it is generally perpendicular to the surface under test. A direct force increasing to 20 pounds plus or minus 0.5 pound over a period of five seconds shall be applied through the disk. This load shall be maintained for an additional ten seconds. During the test the toy is to rest on a flat, hard surface in any convenient position.

[ED. NOTE: Figures referenced are available from the agency.]

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 89, f. 7-31-75, ef. 8-25-75
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0058
Test Methods for Simulating Use and Abuse of Toys and Other Articles Intended for Children Over 18 But not Over 36 Months of Age

(1) Application. The test methods described in this section shall be used in addition to other requirements in determining compliance of toys intended for use by children over 18 but not over 36 months of age.

(2) Impact test. (Drop test.) Known herein as Test (F,i):

(a) Application. Toys subject to special impact tests in OAR 333-016-0056(2)(d) excepted. Toys having a weight of less than four pounds plus or minus .01 pound shall be subject to this test;

(b) Impact medium. The impact medium shall consist of a 0.125-inch nominal thickness of Type IV vinyl-asbestos tile, as specified in federal specification SS-T-312A, over at least a 2.5-inch thickness of concrete. The impact area shall be at least three square feet;

(c) Testing procedure. The toy shall be dropped four times from a height of three feet plus or minus 0.5-inch. The toy shall be dropped in random orientation. After each drop the test sample shall be allowed to come to rest and examined and evaluated before continuing.

(3) Bite test. Known herein as Test (F,ii):

(a) Application. A toy (or component or any accessible portion thereof) that has an external dimension of 1-1/4 inches plus or minus 0.05-inch or less and a design configuration that would permit a child to insert a portion into the mouth in any orientation up to a biting thickness of 1-1/4 inches plus or minus 0.05 inch for a penetration of at least one-fourth inch, shall be subject to this test;

(b) Test equipment:

(A) Contact mechanism. The contact mechanism shall be two metal strips each measuring 0.25 inch plus or minus 0.002 inch (0.635 centimeter) high and each having a contact edge radius of 0.020 inch plus or minus 0.002 inch (0.05 centimeter) for at least a 150 degree cross-sectional arc. A suggested contact mechanism appears in Figure 15.

(B) Loading device. The loading device shall be a seal or force gauge having an accuracy of -0.5 pound.

(C) Testing procedure. The toy shall be placed in a loading device in any reasonable position for a penetration of 0.25 inch to 0.5 inch utilizing not more than 180 degrees of the arc and a test load increasing to 50 pound plus or minus 0.5 pound over five seconds shall be evenly applied. This load shall be maintained for an additional ten seconds.

(4) Torque test. Known herein as Test (F,iii):

(a) Application:

(A) General. A toy with a projection, part, or assembly that the child can grasp by at least the thumb and forefinger or the teeth shall be subject to this test;

(B) Toys with rotating components. Projections, parts, or assemblies that are rigidly mounted on a rod or shaft designed to rotate shall be tested with the rod or shaft clamped to prevent rotation.

(b) Test equipment:

(A) Loading device. The loading device shall be a torque gauge, torque wrench, or other appropriate device having an accuracy of -0.2 inch-pound (-0.23 kilogram-centimeter);

(B) Clamp. The clamp shall be capable of holding the test component firmly and transmitting a torsional force (see Figure 16);

(C) Test procedure. With the sample rigidly fastened in any reasonable test position, the clamp is fastened to the test object or component. A torque of three inch-pounds plus or minus 0.2 inch-pounds shall be evenly applied clockwise over a period of five seconds or until a rotation of 180 degrees from the original position has been attained, or 3 inch-pounds plus or minus 0.2 inch-pounds exceeded. The torque or maximum rotation shall be maintained for an additional ten seconds. The torque shall then be removed and the test component permitted to return to relaxed condition. This procedure shall then be repeated in a counterclockwise direction.

(5) Tension test. Known herein as Test (F,iv):

(a) Application:

(A) General. With the exception of tires, wheels, and axles which are tested by 333-016-0056(2)(e)(A) and test (E,iii) and test (E,iv). Any projection of a toy that the child can grasp by at least the thumb and forefinger, or the teeth, shall be subject to this test. This test is to be conducted on the toy after it has been subjected to test (E,iii);

(B) Stuffed toys and beanbags. A stuffed toy or beanbag constructed of pliable materials having seams (such as fabrics) shall have the seams subjected to 15 pounds plus or minus 0.5 pound (6.80 kilograms) of force applied in any direction.

(b) Test equipment:

(A) Clamps. One clamp capable of applying a tension load to the test component is required. A second clamp suitable for applying a tension load perpendicularly to the major axis of the test component is also required.

(B) Loading device. The loading device is to be a self-indicating gauge or other appropriate means having an accuracy of plus or minus 0.5 pound (255 grams).

(c) Test procedure. With the test sample fastened in a convenient position, an appropriate clamp shall be attached to the test object or component. A 15 pound plus or minus 0.5 pound direct force shall be evenly applied parallel to the major axis of the test component over a period of five seconds and then maintained for an additional ten seconds. The tension clamp shall then be removed and a second clamp appropriate for pulling at 90 degrees shall be attached to the test object or component. A 15 pound plus or minus 0.5 pound tensile force shall be evenly applied perpendicular to the major axis of the test component over a period of five seconds and then maintained for an additional ten seconds.

(6) Compression test:

(a) Application. This test is required in addition to any other test which may be required in these rules. Any area on the surface of a toy that is accessible to a child and inaccessible to flat-surface contact during the impact test shall be subject to this test;

(b) Test apparatus. The loading device shall be a rigid metal disk 1-1/8 inches plus or minus 0.015-inch in diameter and three-eighths inch in thickness. The perimeter of the disk shall be rounded to a radius of one 30-second inch to eliminate irregular edges. The disk shall be attached to a self-indicating gauge scale having an accuracy of plus or minus .05 pound;

(c) Test procedure. The shaft shall be positioned so that it is generally perpendicular to the surface under test. A direct force increasing to 25 pounds plus or minus .05 pound over a period of five seconds shall be evenly applied through the disk. This load shall be maintained for an additional ten seconds. During the test the toy is to rest on a flat, hard surface in any convenient position.

[ED. NOTE: Figures referenced are available from the agency.]

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 89, f. 7-31-75, ef. 8-25-75
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0059
Test Methods for Simulating Use and Abuse of Toys and Other Articles Intended for Children Over 36 But Not Over 96 Months of Age

(1) Application. The test methods described in this section shall be used in addition to other requirements in determining compliance of toys intended for use by children over 36 but not over 96 months of age.

(2) Impact test. Known herein as Test (G,i):

(a) Application. Toys subject to special impact tests in 333-016-0056(2)(d) are exempted. Toys having a weight of less than ten pounds plus or minus 0.1 pound shall be subject to this test;

(b) Impact medium. The impact medium shall consist of a 0.125-inch nominal thickness of Type IV vinyl-asbestos tile, as specified in federal specification SS-T-312A, over at least a 2.5-inch thickness of concrete. The impact area shall be at least three square feet;

(c) Testing procedure. The toy shall be dropped four times from a height of three feet plus or minus 0.5-inch. The toy shall be dropped in random orientation. After each drop the test sample shall be allowed to come to rest and examined and evaluated before continuing.

(3) Bite test. Known herein as Test (G,ii):

(a) Application. A toy (or component) that is a mouth toy shall be subject to this test;

(b) Test equipment:

(A) Contact mechanism. The contact mechanism shall be two metal strips each measuring 0.25-inch plus or minus 0.002-inch (0.635 centimeter) high and each having a contact edge radius of 0.020-inch plus or minus 0.002-inch (0.5 centimeter) for at least a 150 degree cross-sectional arc. A suggested contact mechanism appears in Figure 15;

(B) Loading device; The loading device shall be a scale or force gauge having an accuracy of plus or minus 0.5 pound.

(c) Testing procedure. The toy shall be placed in the loading device in any reasonable position for a penetration of 0.25 to 0.5-inch utilizing not more than 180 degrees of the arc and a test load increasing to 100 pounds plus or minus 0.5 pound over five seconds shall be evenly applied. This load shall be maintained for an additional ten seconds.

(4) Torque test. Known herein as Test (G,iii):

(a) Application:

(A) General. A toy with a projection, part, or assembly that the child can grasp by at least the thumb and forefinger or the teeth shall be subject to this test;

(B) Toys with rotating components. Projections, parts, or assemblies that are rigidly mounted on a rod or shaft designed to rotate shall be tested with the rod or shaft clamped to prevent rotation.

(b) Test equipment:

(A) Loading device. The loading device shall be a torque gauge, torque wrench, or other appropriate device having an accuracy of plus or minus 0.2 inch-pound;

(B) Clamp. The clamp shall be capable of holding the test component firmly and transmitting a torsional force (see Figure 16);

(C) Test procedure. With the sample rigidly fastened in any reasonable test position, the clamp is fastened to the test object or component. A torque of four inch-pounds plus or minus 0.2 inch-pound shall be evenly applied clockwise over a period of five seconds or until a rotation of 180 degrees from the original position has been attained, or four inch-pounds plus or minus 0.2 inch-pound exceeded. The torque or maximum rotation shall be maintained for an additional ten seconds. The torque shall then be removed and the test component permitted to return to a relaxed condition. This procedure shall then be repeated in a counterclockwise direction.

(5) Tension test. Known herein as Test (G,iv):

(a) Application:

(A) General. Any projection of a toy that the child can grasp by at least the thumb and forefinger or the teeth shall be subject to this test. The test is to be conducted on the toy after it has been subjected to test (E, iii);

(B) Stuffed toys and beanbags. A stuffed toy or beanbag constructed of pliable materials having seams (such as fabrics) shall have the seams subjected to 15 pound plus or minus 0.5 pound (6.80 kilograms) of force applied in any direction.

(b) Test equipment:

(A) Clamps. One clamp capable of applying a tension load to the test component is required. A second clamp suitable for applying a tension load perpendicularly to the major axis of the test component is also required;

(B) Loading device. The loading device is to be a self-indicating gauge or other appropriate means having an accuracy of plus or minus 0.5 pound (plus or minus 225 grams).

(c) Test procedure. With the test sample fastened in a convenient position, an appropriate clamp shall be attached to the test object or component. A 15 pound plus or minus 0.5 pound direct force shall be evenly applied parallel to the major axis of the test component over a period of five seconds and then maintained for an additional ten seconds. The tension clamp shall then be removed and a second clamp appropriate for pulling at 90 degrees shall be attached to the test object or component. A 15 pound plus or minus 0.5 pound tensile force shall be evenly applied perpendicular to the major axis of the test component over a period of five seconds and then maintained for an additional ten seconds.

(6) Compression test. Known herein as Test (G,v):

(a) Application. This test is required in addition to any other test which may be required in these rules. Any area on the surface of a toy that is accessible to a child and inaccessible to flat-surface contact during the impact test shall be subject to this test;

(b) Test apparatus. The loading device shall be a rigid metal disk 1-1/8 inches plus or minus 0.15-inch in diameter and three-eighths of an inch in thickness. The perimeter of the disk shall be rounded to a radius of one thirty-second of an inch to eliminate irregular edges. This disk shall be attached to the self-indicating gauge scale having an accuracy of plus or minus 0.5 pound;

(c) Test procedure. The shaft shall be positioned so that it is generally perpendicular to the surface under test. A direct force increasing to 30 pounds plus or minus 0.5 pound over a period of five seconds shall be evenly applied through the disk. This load shall be maintained for an additional ten seconds. During the test the toy is to rest on a flat, hard surface in any convenient position.

[ED. NOTE: Figures referenced are available from the agency.]

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 89, f. 7-31-75, ef. 8-25-75
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0060
Products Declared to be Hazardous Substances Under ORS 453.055(1)

The Administrator finds that the following articles are hazardous substances within the meaning of ORS 453.055(1) and 453.005 because they are capable of causing substantial person injury or illness during or as approximate result of any customary or reasonably foreseeable handling or use:

(1) Charcoal Briquettes and other forms of charcoal in containers for retail sale that may be used for cooking or heating indoors with inadequate ventilation.

(2) Paraphenylenediamine and products containing it.

(3) Powdered orris root and products containing it.

(4) Epoxy resins systems containing in any concentration ethylenediamine, diethylenetriamine, and diglycidyl ethers of molecular weight of less than 200.

(5) Formaldehyde and products containing one percent or more of formaldehyde.

(6) Oil of bergamot products containing two percent or more of oil of bergamot.

(7) Fluorocarbons when used as propellants for self-pressurized products.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0065
Products Requiring Special Labeling Under ORS 453.055(2)

(1) Based on human experience as reported in the scientific literature or to the Poison Control Centers or the National Clearing House for Poison Control Centers, together with opinions of informed medical experts, the Administrator finds that the following substances are hazardous:

(a) Diethylene glycol including mixtures containing ten percent or more by weight of diethylene glycol;

(b) Ethylene glycol, including mixtures containing ten percent or more by weight of ethylene glycol;

(c) Products containing five percent or more, by weight, of benzene (also known as benzol) and products containing ten percent or more, by weight, of toluene (also known as toluol), exylene (also known as xylol), or petroleum distillates such as kerosene, mineral seal oil, naptha, gasoline, mineral spirits, stoddard solvent, and related petroleum distillates;

(d) Methyl alcohol including mixtures containing four percent or more by weight of methyl alcohol;

(e) Turpentine, including gum turpentine, gum spirits of turpentine, steam-distilled wood turpentine, sulfate wood turpentine, and destructively distilled wood turpentine and mixtures containing ten percent or more by weight of such turpentine.

(2) The Administrator also finds that these substances present special hazards and that the labeling required by ORS 453.035 is not adequate for the protection of the public health. The following specific label statements are deemed necessary to supplement the labeling required by ORS 453.035:

(a) Methyl alcohol. Because death and blindness might result from the ingestion of methyl alcohol, the label for this substance (including mixtures) within the percentages specified in subsection (1)(d) of this rule shall include the word “danger,” and the additional word “poison,” and the skull and crossbones symbol. The statement of hazard shall include “vapor harmful” and “May be fatal or cause blindness if swallowed.” The label shall also bear the statement “Cannot be made nonpoisonous”;

(b) Benzene, toluene, xylene, petroleum distillates:

(A) Because inhalation of the vapors of products containing five percent or more by weight, of benzene may cause blood dyscrasias, such products shall be labeled with the signal word “danger,” the statement of hazard “vapor harmful,” and the word “poison,” and the skull and crossbones symbol. If the product contains ten percent or more, by weight, of benzene, it shall bear the additional statement of hazard “Harmful or fatal if swallowed” and the additional statements, “If swallowed, do not induce vomiting. Call physician immediately”;

(B) Because products containing ten percent or more, by weight, of toluene, xylene, or any of the other substances listed in subsection (1)(c) of this rule may be aspirated into the lungs, with resulting chemical pneumonitis, pneumonia, and pulmonary edema, such products shall be labeled with the signal word “danger,” the statement of hazard “Harmful or fatal if swallowed,” and the statements, “If swallowed, do not induce vomiting. Call physician immediately”;

(C) Because inhalation of the vapor of products containing ten percent or more, by weight, of toluene or xylene may cause systemic injury, such products shall bear the statement of hazard “vapor harmful” in addition to the statements prescribed in paragraph (B) of this subsection.

(c) Ethylene glycol and diethylene glycol. Because these substances (including mixtures) within the percentages specified above are commonly marketed, stored, and used in a manner increasing the possibility of accidental ingestion, the signal word “warning” is specified. In addition, for ethylene glycol the statement “Harmful or fatal if swallowed” and for diethylene glycol the statement “Harmful if swallowed” are required;

(d) Turpentine. Because products containing ten percent or more, by weight, of turpentine, in addition to oral toxicity resulting in systemic poisoning, may be aspirated into the lungs, with resulting chemical pneumonitis, pneumonia, and pulmonary edema, such products shall be labeled with the signal word “danger” and the statement of hazard “Harmful or fatal if swallowed”;

(e) Charcoal briquettes and other forms of charcoal in containers for retail sale and intended for cooking or heating:

(A) Because inhalation of the carbon monoxide produced by burning charcoal indoors or in confined areas may cause serious injury or death, containers of such products shall bear the following borderlined statement: WARNING: Do Not Use for Indoor Heating or Cooking Unless Ventilation is Provided for Exhausting Fumes to Outside. Toxic Fumes May Accumulate and Cause Death;

(B) For bags of charcoal the statement specified in paragraph (A) of this subsection shall appear within a heavy borderline in a color sharply contrasting to that of the background, on both front and back panels in the upper 25 percent of the panels of the bag at least two inches below the seam, and at least one inch above any reading material or design elements in type size as follows: The signal word “WARNING” shall appear in capital letters at least three-eights inch in height; the remaining text of the aforementioned warning statement shall be printed in letters at least 3/16-inch in height.

(f) Fluorocarbon propellants. Because sudden death may follow deliberate misuse by inhalation of self-pressurized products containing fluorocarbon propellants, containers of such products shall bear the statement: “WARNING — USE ONLY AS DIRECTED; intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.” This statement shall be in addition to any other required under the Act or these rules.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0070
Labeling of Fire Extinguishers

(1) When a substance or mixture of substances labeled for use in or as a fire extinguisher produces substances that are toxic within the meaning of OAR 333-016-0005(5) and (6) when used according to label directions to extinguish a fire, the containers for such substances shall bear the following labeling:

(a) When substances are produced which meet the definition of highly toxic within the meaning of OAR 333-016-0005(5), the signal word “danger” and the statement of hazard “Poisonous gases formed when used to extinguish flame or on contact with heat” are specified;

(b) When substances are produced which meet the definition of toxic within the meaning of OAR 333-016-0005(6), the signal word “caution” or “warning,” and the statement of hazard “Dangerous gas formed when used to extinguish flame or on contact with heat” are specified;

(c) Regardless of whether subsection (a) or (b) of this section apply, any substance or mixture of substances labeled for use as a fire extinguisher that if applied to an electrical fire would subject the user to the likelihood of electrical shock shall be conspicuously labeled, “Caution: Do not use on electrical fires.”

(2) These statements shall be in addition to any other that may be required under the Act or this section. All such substances or mixture of substances shall also bear the additional statements: “Use in an enclosed place may be fatal,” and “Do not enter area until well ventilated and all odor of chemical has disappeared.”

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0075
Banned Hazardous Substances

Under the authority of ORS 453.055(4), the Administrator declares as banned hazardous substances the following articles because they possess such a degree of hazard that adequate cautionary labeling cannot be written and the public health and safety can be served only by keeping such articles out of commerce:

(1) Mixtures that are intended primarily for application to interior masonry walls, floors, etc., as a water repellent treatment and that are “extremely flammable” within the meaning of ORS 453.005(5).

(2) Carbon tetrachloride and mixtures containing it (including carbon tetrachloride and mixtures containing it used in fire extinguishers), excluding unavoidable manufacturing residues carbon tetrachloride in other chemicals that under reasonably foreseeable conditions of use do not result in an atmospheric concentration of carbon tetrachloride greater than ten parts per million.

(3) Liquid drain cleaners containing ten percent or more by weight of sodium and/or potassium hydroxide; except that this subparagraph shall not apply to such liquid drain cleaners if packed in accordance with a standard for special packaging of such articles promulgated under the Federal Poison Prevention Packaging Act of 1970 (Public Law 91-601).

(4) Any full-size baby crib that is not designed and constructed in accordance with paragraphs (4)(a)(A) through (E) of this rule:

(a) The rules in this section set forth the conditions, requirements, and specifications whereby full-size baby cribs are not banned articles intended for use by children under OAR 333-016-0080:

(A) Dimensions. Full-size cribs shall have dimensions as follows:

(i) Interior. The interior dimensions shall be 28-3/8 inches wide as measured between the innermost surfaces of the crib sides and 52-3/8 inches long as measured between the innermost surfaces of the crib end panels, slats, rods, or spindles. Both measurements are to be made at the level of the mattress support spring in each of its adjustable positions and no more than two inches from the crib corner posts;

(ii) Rail height. The rail height dimensions shall be as follows:

(I) The height of the rail or end panel as measured from the top of the dropside rail or panel in its lowest position to the top of the mattress support in its highest position shall be at least nine inches;

(II) The height of the dropside rail or end panel as measured from the top of the dropside rail or end panel in its highest position to the top of the mattress support in its lowest position shall be at least 26 inches.

(B) Spacing of full-size crib components:

(i) The distance between components (such as slats, spindles, crib rods, and corner posts), except those which are more than 20 inches above the mattress support in its lowest position shall not be greater than 2-3/8 inches at any point. Measurement of distance between contoured or irregular slats or spindles shall be done by a 2-3/8 inch wide x 4 inch high x 4 inch long rectangular block which shall not pass through the space;

(ii) The distance between such components shall not exceed 2-1/2 inches when a 20 pound direct force is applied in accordance with the test method in paragraph (C) below. For contoured or irregular slats or spindles the spacing shall not permit passage of a 2-1/2 inch wide x 2-3/4 inch high x 2-3/4 inch long rectangular block above and below the loading wedge when a 20 pound direct force is applied in accordance with said test method.

(C) Component spacing test method:

(i) Construct a right triangular prism (2-1/2 inches high x 5 inches wide x 1-1/2 inches deep) from a rigid material (steel, wood, aluminum, or equivalent). Drill a one-fourth inch diameter hole from the center of the apex to the center of the base and secure a 4 inch eyebolt in the hole;

(ii) Place the wedge midway between two vertical components. Attach a dial push-pull gauge (Chatillon Model DPP-50 or equivalent spring scale) to the eyebolt and exert a 20 pound direct pull on the wedge. The test may be performed by suspending a 20 pound weight from the eyebolt with the crib component placed in a horizontal position.

(D) Hardware:

(i) The full-size crib shall be designed and constructed in a manner that eliminates from any hardware accessible to a child the possibility of the hardware’s presenting a mechanical hazard through pinching, bruising, lacerating, crushing, breaking, amputating, or otherwise injuring portions of the human body when the crib is in normal use or when subjected to reasonably foreseeable damage or abuse;

(ii) Locking or latching devices used to secure dropside rails shall not be accessible to a child from inside the crib. Such devices shall require a minimum force of ten pounds to activate the release mechanism or shall consist of a double-action device requiring two distinct actions to release;

(iii) Wood screws shall not be used in the assembly of stationary sides, dropside rails, or stabilizing bars to crib ends or other components that must be removed in the normal assembly or disassembly of a crib.

(E) Construction and finishing:

(i) All wood surfaces shall be smooth and free from splinters;

(ii) All wood parts shall be free from splits or cracks;

(iii) Crib ends and sides shall have no horizontal bar or other surface accessible to the child inside the crib capable of being used as a toehold located less than 20 inches above the mattress support in its lowest position when the side rail is in its highest position, except the lower horizontal bar of the crib rail may have a vertical dimension that extends no higher than three inches above the mattress support in its lowest position. (A toehold is defined as any ledge projection accessible to the child inside the crib with a dimension greater than three-eighths of an inch.) Spacing between components above the 20 inch level in the crib end panels and crib sides shall not allow the passage of a 4 inch square block;

(iv) Attachments accessible to the child while in the crib, including but not limited to, “built-in” toys, decorations, teething rails, or design components, must be tested in accordance with the test methods of OAR 333-016-0057 and 333-016-0058 of this chapter specifying test methods for simulating use and abuse for toys, games, and other articles intended for use by children. The test methods shall include those for pull, torque, impact, and bite, which would result in a potential for causing laceration, puncture wound, aspiration, ingestion, or other injury. For determining if any small parts present choking, aspiration, and/or ingestion hazards, see OAR 333-016-0057;

(v) The crib’s design shall not incorporate any features accessible to the child inside the crib, such as cutout shapes, scroll designs, wedge configurations, etc., which could trap fingers, hands, or clothing, or that present a potential for laceration or puncture or other injury.

(F) Assembly instructions:

(i) Full-size cribs, when shipped other than completely assembled, shall be accompanied by detailed instructions that include an assembly drawing, a list, and description of all parts and tools required for assembly, and a full-size diagram of the required bolts and other fasteners;

(ii) The instructions:

(I) Shall be so written that an unskilled layman can correctly assemble the crib without making errors that would result in improper and unsafe assembly;

(II) Shall include cautionary statements concerning the secure tightening of bolts and other fasteners;

(III) Shall contain a cautionary statement that when child’s height reaches 35 inches, the child should be placed in a youth or regular bed.

(iii) The warning relative to mattress size for full-size cribs in subparagraph (4)(a)(G)(ii) of this rule may be included in the instructions as an optional measure.

(G) Identifying marks and warning statement. All cribs and retail cartons thereof shall be suitably marked or labeled in accordance with this section:

(i) The crib shall be clearly marked to indicate:

(I) The name and place of business (city and state) of the manufacturer, importer, distributor, and/or seller; and

(II) A model number, stock number, catalogue number, item number, or other symbol expressed numerically, in code, or otherwise, such that only cribs of identical construction, composition, and dimensions shall bear identical markings.

(ii) In the case of full-size cribs, the following warning shall appear on the inside of the head end in a type size of at least one-fourth inch: “Any mattress used in this crib must be at least 27-1/4 inches x 51-5/8 inches with a thickness not exceeding 6 inches.” The marking shall appear in block letters, shall contrast sharply with the background (by color, projection, and/or indentation), and shall be clearly visible and legible;

(iii) Markings on the crib shall be of a permanent nature whether paint-stenciled, die-stamped, molded, or indelibly stamped directly thereon or permanently affixed, fastened, or attached thereto by means of a tag, token, or other suitable medium. The markings shall not be readily removable or subject to obliteration during normal use of the article or when the article is subjected to reasonably foreseeable damage or abuse;

(iv) The retail carton of a crib, under customary conditions of display, shall clearly indicate: The name and place of business (mailing address, including ZIP code) of the manufacturer, importer, distributor, and/or seller; and the model number, stock number, catalogue number, item number, or other symbol described in paragraph (4)(a)(G)(i)(II) of this rule. The information required by this paragraph need not be placed on the retail carton if it appears on the crib in such a manner as to be visible under customary conditions of retail display.

(H) Recordkeeping. The manufacturer or importer shall keep and maintain for three years after production or importation of each lot of full-size cribs records of sale, distribution, and results of all inspections and tests conducted in accordance with this section. These records shall be made available upon request at reasonable times to any officer or employee acting on behalf of the Public Health Division. The manufacturer or importer shall permit such officer or employee to inspect and copy such records, to make such inventories of stock as he deems necessary, and to otherwise verify the accuracy of such records;

(I) Compliance with the foregoing paragraphs (4)(a)(A) through (H) of this rule is required by December 31, 1974.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0077
Pointed Objects in Food Items of Particular Appeal to Children

(1) Under the authority of ORS 453.005(7)(c) and pursuant to provisions of ORS 453.055(3), the Administrator has determined that the following types of articles intended for use by children present a mechanical hazard within the meaning of ORS 453.005(12) because in normal use or when subjected to reasonably foreseeable abuse, they present an unreasonable risk of personal injury by their design and such articles are therefore banned and shall be removed from commerce:

(a) Pointed objects used or intended to be used as handles when contained in food items having particular appeal to children;

(b) A pointed object shall mean an object made of wood, plastic, metal, or other rigid material, any end of which has been sharpened, molded, or otherwise shaped in such a way that:

(A) If the longitudinal axis of the object is round and the tip is flat, the cross section of the tip or the end surface is less than 0.0123 square inches in area (approximately 1/8 of an inch in diameter), or if the tip is rounded, the radius of the arc of the rounded sphere at the tip is less than 1/16 of an inch; or

(B) If the longitude axis is flat, or shaped other than round, the thickness of the cross section at the end is less than 1/16 of an inch and if the dimensions of the end are such that the surface area of the tip is less than 0.0123 square inches, or if such tip is rounded, the arc of this roundness is less than 1/16 inch in radius.

(2) The pointed objects defined in paragraphs (1)(b)(A) and (B) of this rule are illustrated in Figure 17.

[ED. NOTE: Figures referenced are available from the agency.]

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.055
History:
HD 89, f. 7-31-75, ef. 8-25-75
HD 60, f. 5-16-74, ef. 6-11-74

333-016-0080
Toys and Other Articles Intended for Use by Children

Under the authority of ORS 453.005 and pursuant to provisions of ORS 453.055 the Administrator has determined that the following types of toys, including their packaging, and pacifiers and other articles intended for use by children, are banned hazardous substances:

(1) Any toy or material intended for use by children which the customer must assemble, and which after assembly presents a hazardous edge. Hazardous edges shall not be produced when the toy is tested in accordance with Requirements No. 1 and No. 2 (see Appendix 2).

(2) Any toy or article intended for use by children not constructed of new material or reprocessed material that has been so refined that the level of contamination from foreign matter does not exceed that found in new material:

(a) Reprocessed plastic, foam scrap, textile producers fibrous scrap, and fabric trimmings from garment manufacture are acceptable, provided that they are clean and have been sanitized;

(b) Loose fillers for toys shall be free of objectionable matter originating from insect, bird, rodent, man, or other animal infestation and of contaminants such as splinters and metal chips to the extend possible in good manufacturing practice.

(3) Any toy or article intended for use by children which does not comply with the following provisions and the labeling provisions of OAR 333-016-0110:

(a) General:

(A) Sharp edges. Known herein as Requirement No. 4:

(i) Toys in which a potentially hazardous sharp edge is a necessary part of the function of the toy shall carry cautionary labeling as specified in OAR 333-016-0110, if the toy is intended for use by children from 48 months to 120 months. Toys intended for children aged less than 48 months shall not have accessible hazardous functional sharp edges;

(ii) Protection of sheet metal edges. Accessible edges of sheet metal less than 0.020 inch thick except those covered by subparagraph (3)(a)(A)(iii) of this rule, shall be protected by hemming, rolling, curling, or shall be covered with a protective cap or sleeve. If caps or sleeves are used, they shall withstand a pull force of ten pounds, applied in accordance with Test (D,i). Hemmed edges shall be closed to a gap of 0.030 inch or less and the cut edge shall not present hazards from feathering. Gaps of rolled or curled edges shall not exceed 0.060 inch between the bare edge and the base sheet. The gap restriction shall not apply to curled edges if the curled portion of the sheet describes an arc of greater than 360 degrees, as shown in Figure 18. However, the gap at the point at which the curled edge has established a 360 degree arc shall not admit a 1/4 inch diameter probe. If accessible holes or slots in sheet metal of less than 0.020 inch thickness admit a rod of 1/2 inch diameter, to a depth of greater than 0.030 inch, then the edges shall be protected in accordance with this requirement (Additional size requirements for holes are given in Requirement No. 11.);

(iii) Exemptions for sharp metal edges. The edges at the ends of tubes, or the edges at the ends of formed sheet metal profiles, such as those at the ends of a curled edge as shown in Figure 19(a), shall be exempt if the aperture will not admit a 1/4 inch diameter rod and is free of burrs and feathering. Also exempted are unprotected edges less than 3/8 inch in length at the end of a formed profile similar to that shown in Figure 19(b), provided that the unprotected edge is free of burrs and feathering.

(B) Lap joints. Known herein as Requirement No. 5. If the gap between the sheet metal edge and the underlying surface in a lap joint exceeds 0.030 inch, the exposed sheet metal edge shall be protected as described in subparagraph (3)(a)(A)(i) of this rule. The accessible surfaces shall be free of burrs and feathering;

(C) Sharp points. Known herein as Requirement No. 6:

(i) If the ends of bolts or threaded rods are accessible, then the thread shall be finished or covered at the end by cap nuts so as to avoid hazardous sharp edges and burrs. The cap nut shall resist a pull of ten pounds for toys intended for children aged up to 18 months, or 15 pounds for toys intended for children aged from 18 months to and including 168 months of age, applied parallel to the axis of the bolt or threaded rod when tested according to Test (D,i);

(ii) Hazardous points. These requirements are intended to eliminate unexpected hazards from sharp points that may occur because of assembly devices and fasteners such as wires, pins, nails, and staples that are improperly fastened; poorly sheared sheet metal; burrs on screws; splintery wood, etc. Hazardous sharp points may be produced or revealed in use or reasonably foreseeable abuse by the exposure of parts which were designed to be structurally protected. Examples would include the exposure of wire ends and pins or of fasteners through fracture of plastics or deterioration of wood;

(iii) Nails and fasteners. Nails and fasteners that could present a point, edge, ingestion, or projection hazard, except for those used as axles (in which case, see Requirement No. 9) shall not pull out under a force of 20 pounds, applied perpendicular to the joint between the two components, when tested in accordance with Test (D,i). The points of nails or fasteners shall not protrude so as to be accessible. Hazardous points shall not be developed or become accessible after the toy has been tested in accordance with Requirements No. 1 and 2;

(iv) Toys in which an accessible potentially hazardous point is a necessary part of the function of the toy, such as a needle in a sewing kit, or phonograph needle, or darts, shall carry cautionary labeling as specified in OAR 333-016-0110 if the toy is intended for children from 48 to 120 months old. Toys intended for children less than 48 months old shall not have accessible hazardous functional points;

(v) Darts and similar sharp-pointed articles marketed solely for adults shall not be sold by toy stores or in store departments dealing predominately in toys or childrens’ articles. Labels shall bear the following statement on the front of the panel of the carton and on any accompanying literature: WARNING: Not a toy for use by children. May cause serious or fatal injury. Read instructions carefully. Keep out of the reach of children. Such statement shall be printed in sharply contrasting color within a borderline and in letters at least one-quarter inch high on the main panel of the container and at least one-eighth inch high on all accompany literature. Labels shall include in the instructions and rules clear and adequate directions and warning for safe use, including a warning against use when any person or animal is in the vicinity of the intended play or target area;

(vi) Toy bow and arrow sets providing arrow tips shall be protected with rubber or similarly soft, blunt coverings that are firmly glued or affixed in such a manner that they cannot be removed by Test (D,i).

(D) Wires or rods. Known herein as Requirement No. 7. Wires or rods used in the interior of dolls or stuffed toys shall have their ends turned back or covered with protective caps or covers as described in subparagraph (3)(a)(E)(ii) of this rule, if they can become accessible after use or reasonably foreseeable abuse. Wires or rods used as stiffeners or skeletons in toys intended to be bent or formed shall not fracture to produce an accessible point, edge, or projection hazard when tested according to Test (C,i);

(E) Projections. Known herein as Requirement No. 8. This requirement is intended to minimize possible puncture hazards that might be caused by rigid projections such as unprotected ends of axles, actuating levers, and decorative features. This requirement relates to potentially hazardous projections in toys intended for use by children aged 60 months or less. Hazardous projections shall not be exposed after the toy has been tested according to Requirements No. 1 and 2:

(i) Protection of rigid projections. The toy shall be examined in all natural (unsupported) angles of repose. If the toy has a flat, unwheeled base greater than 175 square inches in area, it shall be examined in the normal play position; if however, the toy tips when placed on an incline of 45 degrees in any direction, it shall also be examined in the position that it assumes when it comes to rest. If a projection appears to constitute a potential puncture hazard, then the projection shall be protected by suitable means, such as by turning back the end of a wire, or by affixing a protective cap or cover as described in Protective caps and covers, subparagraph (3)(a)(E)(ii) of this rule, which effectively increases the surface area for potential contact with the body;

(ii) Protective caps or covers. Protective caps or covers shall be smoothly finished, and shall support the weight of the toy when the toy is suspended from the cap or cover, or shall resist a pull of ten pounds parallel to the axis of the projection when tested according to Test (D,i), whichever is greater. Caps or covers shall also resist a push load of ten pounds when tested according to Test (D,i), so as to prevent the cap or cover from being punctured or split during use or abuse.

(b) Wheels, tires, and axles. Known herein as Requirement No. 9. These requirements are intended to eliminate the possibility of ingestion hazards that might be caused by small wheels or tires that separate during normal use or reasonably foreseeable abuse, and puncture hazards from projecting axles, either on the toy or on wheel assemblies that may be removed from the toy during abuse. The requirements in subparagraphs (3)(b)(A)(i), (ii), and (iii) of this rule, apply to transportation wheels on both preassembled and knocked-down toys intended for children aged 96 months or less. In the case of knocked-down toys, the toy shall be tested in the form that it would be assembled by the purchaser, using simple household tools and/or special tools provided by the manufacturer, if any. The requirements do not apply to toys that are designed to be repeatedly assembled and taken apart and are so described on the package, so that the purchaser expects to find removable wheel systems as part of the function of the toy (however, in no case shall the size requirements of Requirements No. 21 and 22 be disregarded). The tests shall be carried out in accordance with methods described in Test (B,i) and the performance levels shall be maintained after testing as described in Requirements No. 1 and 2:

(A) Tire Removal. Tires which are not an ingestion hazard as defined in Requirement 21, shall be tested in accordance with Test (B,i), tires affixed to toys shall withstand a pull force of not less than 10 pounds, if intended for children aged up to 18 months, or 15 pounds, if intended for children aged from 18 months to 36 months. If tires which are not an ingestion hazard pull off under the above conditions, then the remaining hub shall be tested according to subparagraphs (3)(b)(A)(i) and (ii) of this rule:

(i) Wheels 3/4 inch or less in diameter. Wheels 3/4 inch or less in diameter shall withstand a pull force of ten pounds in the case of toys intended for children aged less than 18 months, and 15 pounds for toys intended for children from 18 months but not over 96 months, applied in line with, or parallel to, the axle for 19 seconds if the wheel or axle constitutes an ingestion hazard, as described in Requirements No. 21 and 22, or if the axle presents a laceration or puncture hazard, as described in OAR 333-016-0056(3). The pull test described in Test (B,ii) shall be applied to the wheels while they are on the toy;

(ii) Wheels greater than 3/4 inch diameter. Wheels with a diameter greater than 3/4 inch that are free to rotate on their axles shall withstand a pull force of 20 pounds applied in line with or parallel to the axle, for a period of ten seconds, if when the wheel is removed or displaced, the wheel or axle presents a laceration, puncture, or ingestion hazard, as defined in OAR 333-016-0056(3), Requirements No. 21 and 22, respectively. The parallel pulling force shall be applied to the wheels while they are on the toy, in accordance with Test (B,ii). Wheels with a diameter greater than 3/4 inch that are not free to rotate on their axles shall, in addition, be subjected to a torsional force of four inch-pounds at the same time that the parallel pulling force is applied, in accordance with Test (B,iii);

(iii) “Snap-in” assemblies. If the axle and wheel assembly of a toy is of the “snap-in” type and if there is a clearance between the axle and the body of the toy of 1/2 inch or greater so that fingers can be hooked behind the axle, then a 15 pound pull shall be applied perpendicular to the axle, as described in Test (B,iv). If the wheel assembly is removed by either of these tests, then the wheel assembly shall be examined for possible puncture hazards, as described in Requirement No. 8 that might be caused by the axle if a wheel slides along the axle. A compressive load of 20 pounds shall be applied according to the test specified in Test (B,v).

(c) Folding mechanisms and hinges. Known herein as Requirement No. 10. These requirements are intended to eliminate possible crushing or laceration hazards that might occur in folding mechanisms and hinges. Examples are the sudden collapse or unexpected motion of a folding mechanism or hinge that produces a scissor action; and the changing clearances at the hinge line between two hinged portions, such that the gap will admit fingers at one position of the hinge but not at all positions. These requirements do not relate to the recognized and familiar hazards associated with the changing clearances around the edges of doors or pivoted or hinged sections in toy truck bodies, toy earth moving machinery, and similar toys. The requirements specified in paragraphs (3)(c)(A) and (B) of this rule shall be maintained after testing according to Requirements No. 1 and 2:

(A) Folding mechanisms. Toy furniture and other toys in which a folding mechanism, arm, or bracing is intended to support a weight of greater than five; pounds in normal use or reasonably foreseeable abuse shall have a safety stop, locking device, or adequate clearance to give protection for the fingers, hands, and toes against crushing or laceration by preventing unexpected or sudden movement or collapse of the article;

(B) Hinge line clearances. Toys having a gap or clearance along the hinge line between a stationary portion and a moveable portion that weighs more than 1/2 pound, shall be so constructed that, if the accessible gap at the hinge line will admit a 3/16 inch diameter rod, it will also admit a 1/2 inch diameter rod at all positions of the hinge.

(d) Slots, holes, clearances, and protection of mechanisms. Known herein as Requirement No. 11. These requirements are intended to eliminate possible hazards that may be caused by changing clearances. These requirements shall be maintained after testing according to Requirements No. 1 and 2. The different pinch clearance requirements in paragraphs (3)(d)(A) through (H) of this rule reflect the different modes of entrapment or pinching that may be encountered:

(A) Wheel clearances. This requirement concerns clearance between wheels and rigid wheel wells or fenders of ride-on toys, or the driven wheel(s) of toys powered by electrical, spring, or inertial energy. If such clearances admit a 3/16 inch diameter rod, they shall also admit a 1/2 inch diameter rod in order to prevent the trapping of fingers;

(B) Holes and slots in rigid materials. This requirement is intended to avoid finger entrapment (which may cut off blood circulation). Inaccessible holes and slots in sheet metal and other rigid materials in toys intended for children aged 60 months or less. If an accessible circular hole in any rigid material less than 0.062 inch in thickness can admit a 1/4 inch diameter rod to a depth of 3/8 inch or greater, it shall also admit a 1/2 inch diameter rod;

(C) Chains and belts. These requirements are to prevent finger crushing through entrapment between links of supporting chains or between chains and sprockets, or pulleys and belts;

(D) Supporting chains. Chains that support the weight of a child in toys, such as hanging seats or similar devices, intended for children up to 36 months old shall be shielded if the chain is accessible and if a 3/16 inch diameter rod can be inserted between two links, as in Figure 20, with the chain in slack configuration;

(E) Chains or belts for ride-on toys. Power transmission chains and belts in ride-on toys intended for children through the age of 120 months shall be shielded;

(F) Shielding of mechanisms. Clockwork, battery operated, inertial, or other power driven mechanisms in toys intended for children through the age of 60 months shall be enclosed or shielded so that a 1/4 inch diameter rod three inches long cannot contact parts that could present pinch or laceration hazards;

(G) Winding keys. This requirement is to avoid pinching or laceration of fingers by entrapment between the key and the body of the toy. It applies to toys intended for children aged 24 months or less that use winding keys which rotate as the mechanism unwinds. This requirement applies to keys with flat plates attached to the stem, as distinct from those that have circular knobs to which to apply the torque, and which protrude from a rigid surface. If the clearance between the flukes of the key and the body of the toy will admit a 1/4 inch diameter rod, it shall also admit a 1/2 inch diameter rod at all positions of the key. For keys covered by this requirement, there shall be no opening in the key which can admit a 3/16 inch diameter rod;

(H) Coil springs. This requirement applies to toys containing springs so as to avoid pinching of fingers or toes:

(i) Coil extension springs. Coil extension springs that form part of a component that carries the weight of a child shall be shielded so as to prevent access during use or reasonably foreseeable abuse if a 1/8 inch diameter rod cannot be freely inserted between coils when the spring is at rest, and if a weight of between 3 and 50 pounds can separate adjacent coils so as to admit a 1/8 inch diameter rod;

(ii) Coil compression springs. Accessible coil compression springs that are subjected to a compressive load of 3 to 50 pounds during normal use or reasonably foreseeable abuse of the toy shall be shielded if a 1/4 inch diameter rod can be inserted between the adjacent coils at any point in the action cycle, or when the spring is at rest.

(e) Strings and elastics. Known herein as Requirement No. 12. These requirements are intended to minimize hazards that might be caused by flexible strings and elastics. The term “string” shall include monofilaments, plastic and textile tapes, and chains, as well as those fibrous materials commonly called string:

(A) Crib and playpen toys. Flexible strings attached at one end to a toy intended for use in cribs or playpens shall be less than 12 inches in length. If a string is attached to form a loop, then the perimeter of the loop shall be less than 14 inches;

(B) Pull toys. Flexible strings greater than 12 inches long for pull toys intended for children less than 36 months old shall not be provided with loops or beads or other attachments that could tangle to form a loop;

(C) Self-retracting pull strings. Strings used in string-actuated mechanisms for toys intended for use by children under age 18 months, except monofilament-type strings 1/16 inch or less in diameter, shall not retract when a weight of two pounds is attached to the fully extended string, with the string vertical and the toy held firmly in the most favorable position for retraction. Monofilament-type strings 1/16 inch or less in diameter shall not retract under a load of one pound, when tested in the manner described above;

(D) Elastics. The unaffixed portion of elastic in toys intended for children less than 36 months old shall not extend to more than 12 inches under a load of 5 pounds;

(E) Strings and lines for flying devices. Kite strings and handheld lines over six feet long attached to flying devices intended for use as playthings shall have an electric resistance of more than 108 ohm/cm when tested at a relative humidity of 50 plus or minus five percent and a temperature of 70 plus or minus 5°F when measured by a high voltage, resistance breakdown meter.

(f) Projectiles. Known herein as Requirement No. 13. These requirements relate to certain, but not all, potential unexpected hazards that might be caused by projectiles and by the firing of improvised projectiles. Certain well-recognized hazards, inherent in such traditional toys as slingshots and darts, are not covered by this requirement. The requirements in paragraphs (3)(f)(A) and (B) of this rule shall apply to toys that discharge projectiles intended for use by children under age of 120 months:

(A) The integrity of protective tips. Protective tips of projectiles shall withstand a pulling force of 15 pounds, when tested according to the procedure of Test (D,i), and shall not produce or reveal hazardous points or edges when fired into a solid object, according to the test procedures described in Test (A,ii);

(B) Discharge mechanisms. Discharge mechanisms shall be unable to discharge hazardous improvised projectiles such as pencils or rocks without modification by the user.

(g) Protection devices. Known herein as Requirement No. 14. Toy protection devices and simulated protective devices such as football helmet and pads which are not the real protective device but which may be worn as a real protective device:

(A) Simulated protective devices, such as helmets, hats, and goggles. This requirement is intended to minimize hazards that might be caused, for example, by goggles or space helmets if the material from which they are constructed readily shatters; or by toys that simulate protective devices, such as football helmets and pads, if the wearer uses the article as a real protective device rather than as a toy. The toy shall conform to the following requirements after testing according to Requirements No. 1 and 2:

(i) Eye protection. Toys that cover the face, such as goggles, space helmets, or face shields, shall be constructed of impact resistant material that will not fail under normal use or reasonably foreseeable abuse so as to generate sharp edges, points, or small pieces that could enter the eye. Toys shall be tested for compliance according to Test (A,iv). Toys that enclose the head are discussed in subsection (3)(m) of this rule;

(ii) Interior finish. The interiors of toys that cover the face shall be smoothly finished so as to be free of hazardous edges, points, and projections.

(B)(i) Simulated protective devices. Toys that simulate safety protective devices, such as football helmets and pads and baseball caps, shall be clearly marked warning the purchaser that they are not safety protective devices. Also, the packages in which these toys come shall be marked in accordance with OAR 333-016-0110;

(ii) The marking on the toy shall withstand normal use, and reasonably foreseeable abuse, and shall be of the same size as required for the package.

(h) Flotation devices. Known herein as Requirement No. 15. This term means toys designed for recreational use but does not include toys used in bathtubs or boats designed for children to ride in. A hazard that needs to be considered is the possible erroneous assumption that flotation toys are life saving devices. This requirement applies to toys designed for water recreational use, as distinct from flotation toys used in the bathtub, but excludes boats designed for children to ride in. Flotation toys designed for recreational use and their packages shall be clearly labeled in accordance with OAR 333-016-0110 so that the purchaser is informed that they are not life saving devices and that they should be used in water only under parental supervision. (The labeling or marking on the toy shall resist normal use and reasonably forseeable abuse, and shall conform to the same size requirements as that for the package.) No advertising copy or graphics shall imply that the child will be safe with such a toy if left unsupervised;

(i) Toxicology. Known herein as Requirement No. 16:

(A) Food and cosmetics. Toys which are intended to be used in conjunction with food or in the preparation of food, or are intended to simulate cosmetics, shall conform to the Federal Food, Drug, and Cosmetic Act;

(B) Handling and packaging of food. All food products supplied with toys shall be handled and packaged incompliance with Title 21, CFR Section 128, which is concerned with sanitation practices in the manufacture, processing, packaging, or holding of human foods;

(C) Crayons, paints, chalks, and other similar material. All crayons, paints, chalks, and other similar material shall conform to the safety requirements of the Act. (These are the same as appear in the Federal Hazardous Substances Act.);

(D) Paint or other similar surface coating material. Surface coatings shall not contain compounds and impurities of antimony, arsenic, cadmium, mercury, lead, or selenium of which the metal content individually or in total (calculated as Sb, As, Cd, Hg, Pb, Se, respectively) is in excess of 0.06 percent by dry weight of the contained solids (including pigments, film solids, and driers). In preparing the coating sample for testing the above metals other than lead, the paint film shall be ground into a fine powder and extracted with five percent hydrochloric acid for one hour at a temperature of 45° to 50°C. also, the surface coatings shall not contain barium compounds or impurities of which the water soluble barium (calculated as Ba) is in excess of 1 percent of the total barium in such coatings. For the purpose of these rules, “paint” includes lacquer, varnish, and similar substances;

(E) Liquids. Liquids contained in toys shall conform to the requirement of the Federal Hazardous Substances Act and Shall conform to State of Oregon requirements for potable water. Liquids shall be tested for coliform bacteria and total plate count according to the rules of the Oregon Public Health Division. (These are “Standard Methods for Examination of Water and Wastewater” published by the American Public Health Association, 13th edition, 1971, Part 405, pages 657, 658, 659, and 660.)

(j) Flammability. Known herein as Requirement No. 17. Fabric used in toys or as components of toys shall comply with the requirements of the Flammable Fabrics Act. Materials other than textile materials shall comply with OAR 333-016-0005(11)(b) and 333-016-0040. These are the same as Title 16, Section 1500.3(c)(6)(iv) and Section 1500.44, CFR;

(k) Plastic, wood, and other components used to make the toy or article. Known herein as Requirement No. 18:

(A) Plastic toys or components made from plastics having a Young’s modulus in tension of greater than 100,000 psi shall be free of accessible hazardous flash, points, and burrs. Accessible portions of plastic toys shall be deburred or deflashed so that their edges are not hazardous. Sections should be designed so as to avoid generation of sharp edges during reasonably foreseeable use or misuse;

(B) Wood. The accessible surfaces and edges of wood used in toys shall be smoothly finished to avoid splinters and sharp edges and free from splinters;

(C)(i) Metal toys. The accessible edges, corner, or mold parting areas of metal parts of 0.020 inch or greater in thickness shall be free of burrs and flash, or covered by durable coatings such as baked enamel. Baked enamel coating or equivalent shall be not less than 0.001 inch thick on the edge, and hazardous edges shall not be exposed after testing according to Requirements No. 1 and 2;

(ii) Sheet metal toys. Sheet metal parts less than 0.020 inch thick shall have the edges protected as described in subparagraph (3)(a)(A)(i) of this rule, if the edges are accessible in use or become accessible as a result of reasonably foreseeable abuse. If a sheet metal edge of less than 0.020 inch in thickness is unprotected on a toy designed for consumer assembly, the outside of the package shall carry a label cautioning the purchaser to exercise care in unpackaging and assembly, according to the requirements of OAR 333-016-0110.

(D) Cellulose Nitrate. A toy shall not, whether wholly or in part, be made of or impregnated with cellulose nitrate. This rule shall not apply to a ball of the kind used for ping-pong or table tennis;

(E) Glass mirrors, vanity sets, or china sets that are either:

(i) Made of shatter resistant, tempered, or laminated glass, plastic, or other material which would not, under normal conditions of use or reasonably foreseeable abuse, break, forming sharp or piercing edges; or

(ii) Labeled as intended for children age six and older.

(l) Stability. Known herein as Requirement No. 19:

(A) Stability of ride-on toys and seats. Any toy intended for use by children age 60 months or less: i.e., ride-on toys with three or more load bearing wheels, such as tricycles and wagon; ride-on action type toys such as hobby horses, stationary toys with seats, such as play furniture and ride-on toys of spherical, cylindrical, or other shapes which do not normally have a stable base shall satisfy subparagraphs (3)(l)(A)(i) through (3)(l)(C) of this rule:

(i) Sideways stability requirement. These requirements recognize two types of possible stability hazards: Those associated with ride-on toys or seats where the feet can provide stabilization, and those situations where the feet are restricted by an enclosing structure. There shall be no sideways stability requirement for ride-on toys if a child at the lowest age of the age range for which the toy is intended can touch the ground flat-footed when sitting on, or straddling, the seat;

(ii) Sideways stability, feet available for stabilization. If a child at the lowest age of the age range for which the ride-on toy or seat is intended cannot place both feet on the ground when seated on or when straddling the seat of a ride-on toy or seat, and his legs are unrestricted in their sideways motion and are thus available for stabilizing, then the toy shall not tip when placed across the slope of a smooth surface inclined ten degrees to the horizontal. A load simulating a child’s weight such as a bag of sand or shot, shall be applied to the seat, and the steering mechanism, if any, shall be in the position where the toy is most likely to tip. The load shall be equal to the upper 97 percentile weight of a child at the highest age of the age range for which the toy is intended, according to the anthropometric charts given in Appendix 1. The load shall be applied so that its center of gravity lies in the true vertical six inches above the center of the seat. In the case of wagons, the load is to be applied on the rearmost one third of the wagon bed. Wheels shall be chocked during the test to restrict rolling, but castors shall be allowed to assume their natural position before chocks are applied;

(iii) Sideways stability, feet unavoidable for stabilization. If the sideways motion of the feet and/or legs is restricted, such as by the enclosed sides of a toy automobile, then the ride-on toy or seat shall not tip when placed across the slope of a smooth surface inclined 15 degrees to the horizontal. Requirements for steering, loading, chocks, and castors, shall be as for sideways stability, feet available subparagraph (3)(l)(A)(ii) of this rule;

(iv) Fore and aft stability. This requirement relates to the stability of the ride-on toy or seat in the front and back direction with respect to the rider, so that the rider cannot easily use the legs for stabilization. All ride-on toys or seats falling within the scope of paragraph (3)(l)(A) of this rule shall not tip forward or backward when the toy, which shall be loaded with a simulated child’s weight, is placed both facing down and up the slope of a smooth surface inclined 15 degrees to the horizontal. Requirements for steering, loading, chocks, and castors shall be as for subparagraph (3)(l)(A)(ii) of this rule. The load shall be applied in the least favorable position on the seat for each direction;

(B) Tipping of stationary floor toys. This requirement is intended to minimize hazards that might be caused by a toy that tips when a door, drawer, or other movable portion is extended to its fullest travel. Stationary floor toys of greater than 30 inches in height and weighing more than ten pounds shall not tip when placed on a ten degree incline in any direction;

(C) Overload requirement for ride-on toys and seats. This requirement is intended to minimize unexpected hazards that could be caused by a toy that is not capable of accepting an overload. All ride-on toys, toys intended for use as seats, or toys designed to support all or part of the weight of a child shall support an overload applied to the seat, or other load-bearing component, without collapsing to produce a hazardous condition. This overload shall be three times the upper 97 percentile weight of a child at the highest age of the age range for which the toy is intended, according to the anthropometric charts given in Appendix 1.

(m) Confined spaces. Known herein as Requirement No. 20. Toys that form enclosures, such as toy storage chests or toy refrigerators, and head-enclosing toys such as space helmets. Paragraphs (3)(m)(A), (B), and (C) of this rule shall be maintained after testing according to Requirements No. 1 and 2:

(A) Ventilation. Any toy having a door or lid, which encloses a continuous volume greater that 1.1 cubic feet, and in which all internal dimensions are greater than six inches, shall provide an unobstructed ventilation area of greater than a total of two square inches when placed on the floor in any configuration and adjacent to two vertical plane surfaces meeting at a 90 degree angle, so as to simulate the corner of a room. If a permanent partition or bars (two or more) which effectively limit the continuous space by making the smallest internal dimension six inches, or less, are used to subdivide a continuous space, the ventilation area shall not be required;

(B) Doors. Doors to enclosures falling within the scope of paragraph (3)(m)(A) of this rule shall be fitted with closures that cannot mechanically latch (examples of acceptable closures are magnetic or friction types);

(C) Toys that enclose the head. Toys that enclose the head, wholly or partially, such as space helmets, which are made of impermeable materials shall provide means for breathing by the incorporation of four ventilation holes, each of which is at least 1/2 square inch, situated at least six inches apart. The requirements of OAR 333-016-0056(2)(d)(E) shall be maintained. Simulated protection toys are in paragraph (3)(g)(B) of this rule.

(4) Any toy or article or packaging intended for use by children which contains the following type of hazard and does not comply with the following provisions, and the provisions of OAR 333-016-0110:

(a) Small toys and small parts of toys. Known herein as Requirement No. 21:

(A)(i) Any toy intended for children under three years of age and such toy or other article or any of its components which are accessible, or parts of the toy or other article which become accessible under conditions of normal use or reasonably foreseeable damage or abuse, will not completely fit, in a noncompressed state, into the truncated right cylinder shown in Figure 21 is banned. Chalk, crayons, and books made entirely of paper are excluded;

(ii) For determining whether or not parts of such toy or other article may become accessible under conditions of normal use or reasonably foreseeable damage or abuse, the applicable tests prescribed in 333-016-0057 shall be utilized in conjunction with Tests (B,i) through (B,v), (C,i), (D,i) and (D,ii). Performance levels after testing in Requirements No. 1 and 2 and of Tests (A,i), (A,ii), and (A,iii) shall be satisfied. Highly porous materials, such as cheesecloth, string, and pom-poms, and any toy or other children’s article that is not generally recognized as being suitable for use only by children three years of age or older will be subject to the provisions of subsection (4)(a) of this rule unless it meets the requirements of subparagraphs (4)(a)(A)(i)and (ii) of this rule:

(I) The shelf package of the article is prominently and clearly marked in the upper right-hand quarter of the principal display panel with the statement: “Contains Small Pieces — Easily Swallowed — Therefore Intended for Children Over 3 Years of Age”;

(II) If the article is unpackaged, the required statement shall appear on the article itself or on a tag securely attached to the article, and the applicable labeling requirement in OAR 333-016-0110 and 333-016-0155.

(B) Known herein as Requirement No. 22. Any mouth-actuated toy or other mouth-actuated article intended for use by children under eight years of age is banned, if such toy or other such article or any of its components which are accessible, or parts of such toy or other such article which becomes accessible under conditions of normal use or reasonably foreseeable damage or abuse, will not completely fit, in a noncompressed state, into the truncated right cylinder shown in Figure 21. For determining whether or not parts of such toy or other such article may become accessible under conditions of normal use or reasonably foreseeable damage or abuse, the applicable tests in OAR 333-016-0058 shall be utilized in conjunction with Test (D,ii) and applicable tests in OAR 333-016-0059. If the air outlet is capable of being inserted into or covered by mouth, then the procedure of Test (D,ii) shall also be applied to the outlet;

(C)(i) Any mouth-actuated toy or other mouth-actuated children’s article that is not generally recognized as being suitable for use only by children eight years of age or older will be subject to the provisions of paragraph (4)(a)(B) of this rule unless it meets the following requirements;

(ii) The shelf package of the article is prominently and clearly marked in the upper right-hand quarter of the principal display panel with the statement: “Contains Small Pieces — Easily Swallowed — Therefore Intended for Children Over 8 Years of Age.” If the article is unpackaged, the required statement shall appear on the article itself or on a tag securely attached to the article and the applicable labeling requirements of OAR 333-016-0110(5) and 333-016-0115.

(b) Toys which induce sound levels:

(A) Impulse sound. Known herein as Requirement No. 23:

(i) Articles which produce impulse sound shall not produce peak sound pressure levels greater than 158 decibels when tested in accordance with OAR 333-016-0055;

(ii) Any article producing peak sound pressure levels greater than 138 decibels but not greater than 158 decibels when tested in accordance with OAR 333-016-0055 shall bear the following statement on the carton and in the accompanying literature in accordance with OAR 333-016-0115: “Warning: Do not fire closer than one foot to the ear. Do not use indoors.” Labeling requirements of OAR 333-016-0110 shall also be satisfied;

(iii) Caps (paper or plastic) intended for use with toy guns and toy guns not intended for use with caps if such caps when so used or such toy guns produce impulse-type sound at a peak pressure level at or above 138 decibels, referred to 0.0002 dyne per square centimeter when measured in an anechoic chamber at a distance of 24 centimeters (or the distance at which the sound source would ordinarily be from the ear of the child using it if such distance is less than 25 centimeters) in any direction from the source of the sound.

(B) Continuous sound levels. Known herein as Requirement No. 24. Continuous sound levels which exceed the following intensity and duration limits when measured on the scale of a standard sound level meter at a slow response. When noise levels are determined by octave band analysis, the equivalent A-weighted sound level may be determined by octave band analysis, the equivalent A-weighted sound level may be determined as follows: Equivalent sound level contours. Octave band sound pressure levels may be converted to the equivalent A-weighted sound level by plotting them on the graph as set out in Exhibit 1 and noting the A-weighted sound level corresponding to the point of highest penetration into the sound level contours. This equivalent A-weighted sound level, which may differ from the actual A-weighted sound level of the noise, is used to determine exposure limits from the table in Exhibit 1.

*If the variations in noise levels involve maxima at intervals of 1 second or less, it is to be considered continuous.

(c) An electrical toy. This term means any electrically operated toy or other electrically operated article intended for use by children which is intended to be operated by electrical current from nominal 120 volt (110–120 v.) branch circuits. If the package (including packaging materials) of the toy is intended to be used with the product, it is considered to be part of the toy:

(A) General labeling requirements. Known herein as Requirement No. 25:

(i) Any electrical toy shall conform to the general labeling requirements of this section, i.e., paragraphs (4)(c)(A) and (B) of this rule and to the specific requirements relating to hot surfaces, i.e., paragraph (4)(c)(B) of this rule;

(ii) The markings required on an electrical toy by this section shall be of a permanent nature, such as paint-stenciled, die-stamped, molded, or indelibly stamped. The markings shall not be permanently obliterable by spillage of any material intended for use with the toy and shall not be readily removable by cleaning substances. All markings on the toy and labeling of the shelf pack or package required by this section shall contrast sharply with the background (whether by color, projection, or indentation) and shall be readily visible and legible. Such markings and labeling shall appear in lettering of a height not less than that specified in OAR 333-016-0110(2), except that those words shown in capital letters in this section shall appear in capital lettering of a height not less than twice that specified in OAR 333-016-0110(2). Electrically operated toys shall bear the statement: “CAUTION — ELECTRIC TOY.” The shelf pack or package and the instructions of such toys shall bear the statement in the upper right-hand quarter of the principal display panel: “CAUTION — ELECTRIC TOY: Not Recommended For Children _____Years of Age. As with all electric products, precautions should be observed during handling and use to prevent electric shock.” The blank in the preceding statement shall be filled in by the manufacturer, but in no instance shall the manufacturer indicate that the article is recommended for children under eight years of age if it contains a heating element. In the case of other electrically operated products which may not be considered to be “toys” but are intended for use by children, the term “ELECTRICALLY OPERATED PRODUCT” may be substituted for the term “ELECTRIC TOY.”

(B) Hot surfaces. Known herein as Requirement No. 26:

(i) Labeling. Electrical toys having Type “C” or “D” surfaces described in this paragraph as Type “C” or “B” which reach temperatures greater than those shown in Table 3 shall be defined as hot and shall be marked where readily noticeable when the hot surface is in view with the statement: “HOT — Do Not Touch.” When the marking is on other than the hot surface, the word “HOT” shall be followed by appropriate descriptive words such as “Molten Material,” “Sole Plate,” or “Heating Element,” and the statement “Do Not Touch.” An alternative statement for a surface intended to be handheld as a functional part of the toy shall be “HOT — Handle Carefully,” the blank being filled in by the manufacturer with a description of the potential hazard such as “Curier” or “Cooking Surface.” Surfaces requiring precautionary statements of thermal hazards are those exceeding the following temperatures when measured by the test described in Test (T,i) and (T,ii);

(ii) Surface types:

(I) Type A. A part or surface of a toy (such as a handle) likely to be grasped by the hand or fingers for the purpose of carrying the toy or lifting a separable lid;

(II) Type B. A part or surface of a toy that part of a handle, knob, or similar component, but which is not normally grasped or contacted by the hand or fingers for carrying (including parts of a handle within seven-sixteenths of an inch of the surface to which the handle is attached and parts of a knob within 1/4 inch of the surface to which the knob is attached, if the remainder of the knob is large enough to be grasped), or a handle, knob, or part that may be touched but which need not be grasped for carrying the toy or lifting a lid, door, or cover (e.g., support part of a handle or knob);

(III) Type C. A part or surface that can be touched by casual contact or that can be touched without employing the aid of a common household tool (screwdriver, pliers, or other similar household tool) and that is either a surface that performs an intended heating function (e.g., the sole plate of a flatiron, a cooking surface, or a heating element surface), or a material heated by the element and intended to be used as the product of the toy, excluding pans, dishes, or other containers used to hold the material to be cooked or baked if a common utensil or other device is supplied with the toy and specific instruction are established for using such a device to remove the container from the heated area;

(IV) Type C Marked. A Type C surface which has been marked with a precautionary statement of thermal hazards in accordance with subparagraph (4)(c)(B)(i) of this rule;

(V) Type D. An accessible part or surface of a toy other than Types A, B, C, or E, of this paragraph;

(VI) Type D Marked. A Type D surface which has been marked with a precautionary statement of thermal hazards in accordance with subparagraph (4)(c)(B)(i) of this rule;

(VII) Type E. A heated surface in an oven or other article that is inaccessible or protected by an electrical-thermal safety interlock.

(d) Any article known as a “baby-bouncer,” “walker-jumper,” or “baby-walker” and any other similar article which is intended to be used by very young children (usually from about four months to 18 months old) while sitting, walking, bouncing, jumping, and/or reclining for napping shall comply with the following provisions:

(A) Frames are designed and constructed in such a manner as to prevent injury from any scissoring or pinching which may occur when the members of the frame or other components rotate about a common axis or fastening point;

(B) Coil springs which expand sufficiently to allow space for insertion of a finger, toe, or another part of a child’s anatomy are covered or otherwise designed to prevent injuries;

(C) Holes, slots, cracks, or hinged components in any portion of the article through which a child could insert a finger, toe, or another part of the anatomy are guarded or otherwise designed to prevent injuries;

(D) The articles are designed and constructed so as to eliminate from any portion of the article the possibility of presenting a mechanical hazard through pinching, bruising, lacerating, crushing, breaking, amputating, or otherwise injuring normal use or when subjected to reasonably foreseeable damage or abuse;

(E) The article is labeled:

(i) With a conspicuous statement of the name and address of the manufacturer, packer, distributor, or seller; and

(ii) To bear on the article itself and/or the package containing the article and/or shipping container in addition to the invoice(s) and shipping document(s), a code or mark in a form or manner that will permit future identification of any given batch, lot, or shipment by the manufacturer; and

(F) A company manufacturing the article shall make, keep, and maintain for three years records of sale, distribution, and the results of the inspections and tests conducted in accordance with these rules and shall make such records available upon request at all reasonable hours of any officer or employee of the Public Health Division, or any other employee acting on behalf of the Administrator, and shall permit such officer or employee to inspect and copy such records and to make such inventories of stock as he deems necessary and otherwise to check the correctness of such records.

(e) “Clacker balls.” Toys usually known as “clacker balls” and consisting of two balls of plastic or other material connected by a length of line or cord or similar connector intended to be operated in a rhythmic manner by a upward and downward motion of the hand so that the balls will meet forcefully at the top and bottom of two semicircles, thus causing a “clacking” sound shall comply with the following conditions: “Clacker balls” shall have been designed, manufactured, assembled, labeled, and tested in accordance with the following requirements, and when tested at the point of production or while in interstate commerce or while held for sale after shipment in interstate commerce do not exceed the failure rate requirements as set out in Table 4:

(A) The toy shall be so designed and fabricated that:

(i) Each ball weighs less than 50 grams; will not shatter, crack, or chip; is free of cracks, flash (ridges due to imperfect moldings), totally enclosed internal voids (holes, cavities, or air bubbles), and crazing (tiny surface cracks); and is free of rough or sharp edges around any hole where the cord enters or over any surface with which the cord may make contact;

(ii) The cord is of high tensile strength, synthetic fibers that are braided or woven, having a breaking strength in excess of 100 pounds; is free of fraying or any other defect that might tend to reduce its strength in use; is not molded in balls made of casting resins which tend to wick or run up into the cord; and is affixed to a ball at the center of the horizontal plane of the ball when it is suspended by the cord;

(iii) When the cord is attached to the ball by means of a knot, the end beneath the knot is chemically fused or otherwise treated to prevent the knot from slipping out or untying in use.

(B) The toy shall be tested at the time of production:

(i) By using a sampling procedure described in Table 4 to determine the number of units to be tested;

(ii) By subjecting each ball tested to ten drops of a five-pound steel impact rod or weight (2-1/2 inches in diameter with a flat head) dropped 48 inches in a vented steel or aluminum tube (2-3/8 inches in diameter) when the ball is placed on a steel or cast iron mount. Any ball showing any chipping, cracking, or shattering shall be counted as a failure within the meaning of the third column in Table 4;

(iii) By inspecting each ball tested for smoothness of finish in any holes, on outer surfaces, and on any other portion with which the cord is intended to come into contact. A cotton swab shall be rubbed vigorously over each such surface or area; if any cotton fibers are removed, the ball shall be counted as a failure within the meaning of the fourth column of Table 4;

(iv) By fully assembling the toy and testing the cord in such a manner as to test both the strength of the cord and the adequacy with which the cord is attached to the ball and any holding device such as a tab or ring included in the assembly. The fully assembled article shall be vertically suspended by one ball and a 100-pound test applied to the bottom ball. Any breaking, fraying, or unraveling of the cord or any sign of slipping, loosening, or unfastening shall be counted as a failure within the meaning of the fourth column in Table 4;

(v) By additionally subjecting any ring or other holding device to a 50-pound test load applied to both cords. The holding device is to be securely fixed horizontally in a suitable clamp in such a manner as to support 50 percent of the area of such holding device and the balls are suspended freely. Any breaking, cracking, or crazing of the ring or other holding device shall be counted as a failure within the meaning of the fourth column in Table 4;

(vi) By cutting each ball tested in half and then cutting each half perpendicularly to the first cut into three or more pieces of approximately equal thickness. Each portion is to be inspected before and after cutting, and any ball showing any flash, crack, crazing, or internal voids on such inspection is to be counted as a failure within the meaning of the fourth column in Table 4. A transparent ball shall be subjected to the same requirements except that it may be visually inspected without cutting.

(C) The toy shall be fully assembled for use at the time of sale, including the proper attachments of balls, cords, knots, loops, or other holding devices;

(D) The toy shall be labeled:

(i) With a conspicuous statement of the name and address of the manufacturer, packer, distributor, or seller;

(ii) To bear on the toy itself and/or the package containing the toy and/or the shipping container, in addition to the invoice(s) and shipping document(s), a code or mark in a form and manner that will permit future identification of any given batch, lot, or shipment by the manufacturer;

(iii) To bear a conspicuous warning statement on the front panel of the retail and display carton and on any accompanying literature: That if cracks develop in a ball or if the cord becomes frayed or loose or unfastened, use of the toy should be discontinued; and if a ring or loop or other holding device is present, the statement, “In use, the ring or loop must be placed around the middle finger and the two cords positioned over the forefinger and held securely between the thumb and forefinger” or words to that effect which will provide adequate instructions and warnings to prevent the holding device from accidentally slipping out of the hand. Such statements shall be printed in sharply contrasting color within a borderline and in letters at least one-quarter inch high on the main panel of the container and at least 1-1/8 inch high on all accompanying literature.

(E) The manufacturer of the toy shall make, keep, and maintain for three years records of sale, distribution, and results of inspections and tests conducted in accordance with this subparagraph and shall make such records available upon request at all reasonable hours by any officer or employee of the Public Health Division, or any other employee acting on behalf of the Administrator; and shall permit such officer or employee to inspect and copy such records, and to make such inventories of stock as he deems necessary and otherwise to check the correctness of such records;

(F) The lot size, sample size, and failure rate for testing clacker balls are set out in Table 4;

(G) Applicability of the exemption provided by this subparagraph shall be determined through use of Table 4. A random sample of the number of articles as specified in the second column of the table shall be selected according to the number of articles in a particular batch, shipment, deliver, lot, or retail stock per the first column. A failure rate as shown in either the third or fourth column shall indicate that the entire batch, shipment, delivery, lot, or retail stock has failed and thus is not exempted under this subparagraph from classification as a banned hazardous substance.

(f) Packaging. Known herein as Requirement No. 27. This requirement is intended to minimize the possibility of asphyxiation hazards that might be caused by thin packaging plastic. Flexible plastic sheets used as packaging materials for shelf packages or used with toys shall be at least 0.00150 inch in nominal thickness but the actual thickness shall ever be less than 0.00125 inch, except for flexible film bags having a combined length and fully extended opening perimeter of less than 23 inches, or bags having an opening perimeter of less than 14 inches, measured after the perimeter has been stretched to its fullest extent. Shrink plastic of less than 0.00150 inch nominal thickness shall be exempt from this requirement, if it is in the form of an overwrap that would normally be destroyed when the package is opened by a consumer. Thickness shall be determined in accordance with Method C of American Society for Testing and Materials (ASTM) D 374-68, Standard Methods of Test for Thickness of Solid Electrical Insulation.

(5) Any toy or article intended for use by children which, even though labeled in accordance with these rules, reliable data on human experience shows the toy or article to be hazardous within the meaning of the Act.

(6) Any toy or article intended for use by children which does not satisfy any applicable requirement or test of these rules. All applicable requirements and tests shall be satisfied.

[ED. NOTE: Exhibits, Appendices, Tables referenced are available from the agency.]

[Publications: Publications referenced are available from the agency.]

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005, 453.035 & 453.055
History:
HD 89, f. 7-31-75, ef. 8-25-75
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0082
Repurchase of Banned Hazardous Substances

Banned hazardous toys and other banned hazardous substances shall be repurchased in accordance with ORS 453.075.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.055 & 453.075
History:
HD 40-1973, f. 8-2-73, ef. 8-15-73

333-016-0085
Exemptions for Foods, Drugs, Cosmetics, and Fuels

(1) Foods and drugs otherwise regulated by this state are exempted by ORS 453.015(5); but where a food, drug, or cosmetic offers a substantial risk of injury or illness from any handling or use that is customary or usual, it may be regarded as misbranded under the laws of this state because its label fails to reveal material facts with respect to consequences that may result from use of the article when its label fails to bear information to alert the householder to this hazard.

(2) Fuels. A substance intended to be used as a fuel is exempt from the requirements of the Act when in containers that are intended to be or are installed as part of the heating, cooking, or refrigeration system of a house. A portable container used for delivery or temporary or additional storage, and containing a substance that is a hazardous substance as defined in ORS 453.005(7)(a), is not exempt from the labeling prescribed in ORS 453.015(2) even though it contains a fuel to be used in the heating, cooking, or refrigeration system of a house.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.015
History:
HD 40-1973, f. 8-2-73, ef. 8-15-73

333-016-0090
Exemption from Full Labeling and Other Requirements

(1) Any person who believes a particular hazardous substance intended or packaged in a form suitable for use in the household or by children should be exempted from full label compliance otherwise applicable under the Act, because of the size of the package or because of the minor hazard presented by the substance, or for other good and sufficient reason, may submit to the Administrator a request for exemption under ORS 453.035(4), presenting facts in support of the view that full compliance is impracticable or is not necessary for the protection of the public health. The Administrator shall determine on the basis of the facts submitted and all other available information whether the requested exemption is consistent with the adequate protection of the public health and safety. If he so finds, he shall detail the exemption granted and the reasons therefore by an appropriate means.

(2) The Administrator may on his own initiative determine on the basis of facts available to him that a particular hazardous substance intended or packaged in a form suitable for use in the household or by children should be exempted from full labeling compliance otherwise applicable under the Act because of the size of the package or because of minor hazard presented by the substance or for other good and sufficient reason. If he so finds, he shall detail the exemption granted and the reasons therefore by an appropriate means.

(3) Any person who believes a particular article should be exempted from being classified as a “banned hazardous substance” as provided by ORS 453.055 because it falls within the provisions of ORS 453.035(4) may submit to the Administrator a request for exemption presenting facts in support of his contention. The Administrator shall determine on the basis of the facts submitted, and all other available information, whether the requested exemption is consistent with the purposes of the Act. If he so finds, he shall detail the exemption granted and the reasons therefore by an appropriate means.

(4) On his own initiative the Administrator may determine on the basis of available facts that a particular banned hazardous substance should be exempted from ORS 453.055, because it falls within the provisions of ORS 453.035(4). If he so finds, he shall detail the exemption granted and the reasons therefore by an appropriate means.

(5) Any person who believes that a particular toy should be temporarily exempted from the labeling provisions of these rules promulgated in 1975 because of the minor hazard presented by the toy or for other good and sufficient reason may submit to the Administrator a request for such temporary exemption from the 1975 labeling requirements until March 30, 1976, provided that the labeling requirements of the rules in effect between August 15, 1973, and the 1975 rules will apply during the temporary exemption.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.035 & 453.055
History:
HD 89, f. 7-31-75, ef. 8-25-75
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0095
Exemptions for Small Packages, Minor Hazards, and Special Circumstances

The following exemptions are granted for the labeling of hazardous substances under the provisions of OAR 333-016-0090:

(1) When the sole hazard from a substance in a self-pressurized container is that it generates pressure or when the sole hazard from a substance is that it is flammable or extremely flammable, the name of the component which contributes the hazard need not be stated.

(2) Common matches, including book matches, wooden matches, and so-called “safety” matches are exempted from the labeling requirements of ORS 453.035(2) insofar as they apply to the product being considered hazardous because of being “flammable” or “extremely flammable” as defined in OAR 333-016-0005.

(3) Paper items such as newspapers, wrapping papers, toilet and cleansing tissues, and paper writing supplies are exempted from the labeling requirements of ORS 453.005 to 453.135 insofar as they apply to the products being considered hazardous because of being “flammable” or “extremely flammable” as defined in OAR 333-016-0005.

(4) Thread, string, twine, rope, cord, and similar materials are exempted from the labeling requirements of ORS 453.035(2) insofar as they apply to the products being considered hazardous because of being “flammable” or “extremely flammable” as defined in OAR 333-016-0005.

(5) Laboratory chemicals intended only for research or investigational and other laboratory uses (except those in home chemistry sets) shall be exempt from the requirements of placement provided in OAR 333-016-0115 if all information required by this section and the Act are placed with the required prominence on the label panel adjacent to the main panel.

(6) Small-arms ammunition packaged in retail containers is exempted from the labeling requirements of ORS 453.035(2), provided that such containers bear the following label statements:

(a) The common or usual name of the ammunition in the container;

(b) The statement: “Warning — Keep out of the reach of children” or its practical equivalent;

(c) The name and place of business of the manufacturer, packer, seller, or distributor;

(d) The term “ammunition” as used in this paragraph includes small-arms ammunition and loads for powder-actuated tools in a form ready for use in a pistol, revolver, rifle, shotgun, or powder-actuated tool, including blank cartridges and shells.

(7) Rigid or semi-rigid ball-point ink cartridges are exempt from the labeling requirements of ORS 453.035(2) insofar as such requirements would be necessary because the ink contained therein is a “toxic” substance as defined in OAR 333-016-0005, provided that:

(a) The ball-point ink cartridge is of such construction that the ink will, under any reasonably foreseeable conditions of manipulation or use, emerge only from the ball-point end;

(b) When tested by the method described in OAR 333-016-0005, the ink does not have an LD 50 single oral dose of less than 500 milligrams per kilogram of body weight of the test animal;

(c) The cartridge does not have a capacity of more than two grams of ink.

(8) Containers of paste shoe waxes, paste auto waxes, and paste furniture and floor waxes containing toluene (also known as toluol), xylene (also known as xylol), petroleum distillates, and/or turpentine in the concentrations described in OAR 333-016-0065 are exempt from the labeling requirements of OAR 333-016-0065 if the viscosity of such products is sufficiently high that they will not flow from their opened containers when inverted for five minutes at a temperature of 80°F and are exempt from bearing a flammability warning statement if the flammability of such waxes is due solely to the presence of solvents which have flashpoints above 80°F when tested by the method described in OAR 333-016-0035.

(9) Porous-tip ink marking devices are exempt from the labeling requirements of ORS 453.035(2) and OAR 333-016-0065 insofar as such requirements would be necessary because the ink contained therein is a toxic substance as defined in OAR 333-016-0005 and/or because the ink contains ten percent or more by weight of toluene (also known as toluol), xylene (also known as xylol), or petroleum distillates as defined in 333-016-0065 and/or because the ink contains ten percent or more by weight of ethylene glycol, provided that:

(a) The porous-tip ink marking devices are of such construction that the ink is held within the device by an absorbent material so that there is no free liquid within the device, and under any reasonably foreseeable conditions of manipulation and use including reasonably foreseeable abuse by children, the ink will emerge only through the porous writing nib of the device; and

(b)(A) The device has a capacity of not more than 10 grams of ink, and the ink, when tested by methods described in OAR 333-016-0005 has an LD 50 single oral dose of not less than 2.5 grams per kilogram of body weight of the test animal; or

(B) The device has a capacity of not more than 12 grams of ink, and the ink, when tested by methods described in OAR 333-016-0005 has an LD 50 single oral dose of not less than 3.0 grams per kilogram of body weight of the test animal.

(10) Viscous nitrocellulose-base adhesives containing more than four percent methyl alcohol by weight are exempted from the label statement: “Cannot be made nonpoisonous” required by OAR 333-016-0065, provided that:

(a) The total amount of methyl alcohol by weight in the product does not exceed 15 percent; and

(b) The contents of any container does not exceed two fluid ounces.

(11) Packages containing polishing or cleaning products which consist of a carrier of solid particulate or fibrous composition and which contain toluene (also known as toluol), xylene (also known as xylol), petroleum distillates in the concentrations described in OAR 333-016-0065 are exempt from the labeling requirements of OAR 333-016-0065 provided that such toluene, xylene, or petroleum distillates are fully absorbed by the solid, semi-solid, or fibrous carrier and cannot be expressed therefrom with any reasonably foreseeable conditions of manipulation.

(12) Containers of dry ink intended to be used as a liquid ink after the addition of water are exempt from the labeling requirements of ORS 453.035(2) and OAR 333-016-0065, insofar as such requirements would be necessary because the dried ink contained therein is a toxic substance as defined in OAR 333-016-0005 and/or because the ink contains ten percent or more by weight of ethylene glycol as defined in OAR 333-016-0065, provided that:

(a) When tested by the method described in OAR 333-016-0005, the dry ink concentrate does not have an LD 50 single oral dose of less than one gram per kilogram of body weight of the test animal;

(b) The dry ink concentrate enclosed in a single container does not weigh more than 75 milligrams;

(c) The dry ink concentrate does not contain over 15 percent by weight of ethylene glycol.

(13) Containers of liquid and semi-solid substances such as viscous-type paints, varnishes, lacquers, roof coating, rubber-vulcanizing preparations, floorcovering adhesives, glazing compounds, and other viscous products containing toluene (also known as toluol), xylene (also known as xylol), or petroleum distillates in concentrations described in OAR 333-016-0065 are exempt from the labeling requirements of OAR 333-016-0065 insofar as that paragraph applies to such toluene, xylene, or petroleum distillates, provided that the viscosity of the substances, or any liquid that may separate or be present in the container, is not less than 150 Saybolt Universal seconds at 100°F.

(14) Customer-owned portable containers that are filled by retail vendors with gasoline, kerosene (kerosene), or other petroleum distillates are exempt from the provision of ORS 453.035(2)(i) which requires that the name and place of business of the manufacturer, distributor, packer, or seller appear on the label of such containers, provided that all the other label statements required by ORS 453.035(2) and OAR 333-016-0065 appear on the labels of containers of the substances named in this paragraph.

(15) Cellulose sponges are exempt from the labeling requirements of ORS 453.035(2) and OAR 333-016-0065 insofar as such requirements would be necessary because they contain ten percent or more of diethylene glycol as defined in OAR 333-016-0065, provided that:

(a) The cellulose sponge does not contain over 15 percent by weight of diethylene glycol;

(b) The diethylene glycol content is completely held by the absorbent cellulose material so that there is no free liquid within the sponge as marketed.

(16) Containers of substances which include salt (sodium chloride) as a component are exempt from the labeling requirements of ORS 453.035(2) insofar as such requirements would be necessary because the salt contained therein is present in a quantity sufficient to render the article “toxic” as defined in OAR 333-016-0005, provided that the labels of such containers bear a conspicuous statement that the product contains salt.

(17) The labeling of substances containing ten percent or more of ferrous oxalite is exempt from the requirement of OAR 333-016-0145 provided that it bears the word “poison” which would otherwise be required for such concentration of a salt of oxalic acid.

(18) Packages containing articles intended as single-use spot removers, and which consist of a cotton pad or other absorbent material saturated with a mixture of dry-cleaning solvents, are exempt from the labeling requirements of ORS 453.035(2) insofar as they apply to the “flammable” hazard as defined in OAR 333-016-0005, provided that:

(a) The article is packaged in a sealed foil envelope;

(b) The total amount of solvent in each package does not exceed 4.5 milliliters;

(c) The article will ignite only when in contact with an open flame, and when so ignited, the article burns with a sooty flame.

(19) Packages containing article intended as single-use spot removers and which consist of a cotton pad or other absorbent material containing methyl alcohol, are exempted from the labeling requirements of OAR 333-016-0065, provided that:

(a) The total amount of cleaning solvent in each package does not exceed 4.5 milliliters, of which not more than 25 percent is methyl alcohol;

(b) The liquid is completely held by the absorbent materials so that there is no free liquid within the packages marketed.

(20) Cigarette lighters containing petroleum distillate fuel are exempt from the labeling requirements of ORS 453.035(2) and OAR 333-016-0065, insofar as such requirements would be necessary because the petroleum distillate contained therein is “flammable” and because the substance is named in 333-016-0065 of the rules as requiring special labeling, provided:

(a) That such lighters contain not more than ten cubic centimeters of fuel at the time of sale; and

(b) That such fuel is contained in a sealed compartment that cannot be opened without the deliberate removal of the flush-set, screw-type refill plug of the lighter.

(21) Containers of dry granular fertilizers and dry granular plant foods are exempt from the labeling requirements of ORS 453.035(2) insofar as such requirements would be necessary because the fertilizer or plant food contained therein is a toxic substance as defined in OAR 333-016-0005, provided that:

(a) When tested by the method described in 333-016-0005, the product has an LD 50 single dose of not less than 3.0 grams per kilogram of body weight of the test animal;

(b) The label of any such exempt dry granular fertilizers discloses the identity of each of the hazardous ingredients;

(c) The label bears the name and address of the manufacturer, packer, distributor, or seller; and

(d) The label bears the statement “Keep out of the reach of children” or its practical equivalent.

(22) Small, plastic capsules containing a paste composed of powdered metal solder mixed with a liquid flux are exempt from the requirements of ORS 453.035(2), provided that:

(a) The capsule holds not more than one-half milliliter of the solder mixture;

(b) The capsule is sold only as a component of a kit; and

(c) Adequate caution statements appear on the carton of the kit and on any accompanying labeling which bears directions for use.

(23) Chemistry sets and other science education sets intended primarily for use by juveniles, and replacement containers of chemicals for such sets, are exempt from the requirements of ORS 453.035(2), provided that:

(a) The immediate container of each chemical that is hazardous as defined in the Act and rules bears on its main panel the name of such chemicals, the appropriate signal word for that chemical, and the additional statement, “Read back panel before using” (or “Read side panel before using” if appropriate) and bears on the back (or side) panel of the immediate container the remainder of the appropriate cautionary statement for the specific chemical in the container;

(b) The experiment manual or other instruction booklet accompanying such set bears on the front page of the leaflet as a preface to any written matter in the leaflet (or on the cover, if there is any) the following caution statement within the borders of a rectangle and in the type size specified in OAR 333-016-0115: WARNING: This set contains chemicals that may be harmful if misused. Read cautions on individual containers carefully. Not to be used by children except under adult supervision.

(c) The outer carton of such set bears on the main display panel within the borders of a rectangle and in the type size specified in OAR 333-016-0115 the caution statement specified in subsection (b) of this subparagraph.

(24) Fire extinguishers containing fire extinguishing agents which are stored under pressure or which develop pressure under normal conditions of use are exempt from the labeling requirements of ORS 453.035(2) insofar as such requirements apply to the pressure hazard as defined in OAR 333-016-0005(13), provided that:

(a) If the container is under pressure both during storage and under conditions of use, it shall be designed to withstand a pressure of at least six times the charging pressure at 70°F, except that carbon dioxide extinguishers shall be constructed and tested in accordance with applicable Interstate Commerce Commission specifications; or

(b) If the container is under pressure only during conditions of use, it shall be designed to withstand a pressure of not less than five times the maximum pressure developed under closed-nozzle conditions at 70°F or one and one-half times the maximum pressure developed under closed-nozzle conditions at 120°F, whichever is greater.

(25) Cleaning and spot removing kits intended for use in cleaning carpets, furniture, and other household objects; kits intended for use in coating, painting, antiquing, and similarly processing furniture, furnishings, equipment, sidings, and various other surfaces; and kits intended for use in photographic color processing are exempt from the requirements of ORS 453.035(2) and OAR 333-016-0065, provided that:

(a) The immediate container of each hazardous substance in the kit is fully labeled and in conformance with the requirements of the Act and rules issued thereunder;

(b) The carton of the kit bears on the main display panel (or panels) within a borderline, and in the type size specified in OAR 333-016-0115, the following caution statement: “(Insert proper signal word as specified in subsection (c) of this rule). This kit contains the following chemicals that may be harmful if misused: (List hazardous chemical components by name). Read cautions on individual containers carefully. Keep out of the reach of children”; and

(c) If either the word “POISON” or “DANGER” is required in the labeling of any component or components in the kit, the word “POISON” shall be used. In all other cases, the word “WARNING” or “CAUTION” shall be used.

(26) Packages containing articles intended as single use spot removers and containing methyl alcohol are exempt from the labeling specified in OAR 333-016-0065, provided that:

(a) The total amount of cleaning solvent in each unit does not exceed one milliliter, of which not more than 40 percent is methyl alcohol;

(b) The liquid is contained in a sealed glass ampoule enclosed in a plastic container with a firmly attached absorbent wick at one end through which the liquid from the crushed ampoule must pass, under the contemplated conditions of use;

(c) The labeling of each package of the cleaner bears the statement, “Warning: Keep out of the reach of children.” or its practical equivalent, and the name and place of business of the manufacturer, packer, distributor, or seller.

(27) Packaged fireworks assortments intended for retail distribution are exempt from ORS 453.035(2), provided that:

(a) The package contains only fireworks devices exempted under ORS 480.110 to 480.165;

(b) Each individual article in the assortment is fully labeled and in conformance with the requirements of the Act and rules issued thereunder; and

(c) The outer package bears on the main display panel (or panels) within the borders of a rectangle and in the type size specified in 333-016-0115 the following caution statement: “Warning: This assortment contains items that may be hazardous if misused and should be used only under adult supervision. Important: Read cautions on individual items carefully.”

(28) Packages containing felt pads impregnated with ethylene glycol are exempt from the labeling requirements of 333-016-0065, provided that:

(a) The total amount of ethylene glycol in each pad does not exceed one gram; and

(b) The liquid is held by the felt pad so that there is no free ethylene glycol within the package.

(29) Cigarette lighters containing butane and/or isobutane fuel are exempt from the labeling requirements of ORS 453.035(2) insofar as such requirements would otherwise be necessary because the fuel therein is extremely flammable under pressure, provided that:

(a) The lighters contain not more than 12 grams of fuel at the time of sale;

(b) The fuel reservoir is designed to withstand a pressure of at least one and one-half times the maximum pressure which will be developed in the container at 120°F.

(30) The outer retail containers of solder kits each consisting of a small tube of flux partially surrounded by a winding of wire-type cadmium-free silver solder are exempt from the labeling requirements of ORS 453.035(2), provided that:

(a) The metal solder contains no cadmium and is not otherwise hazardous under the provisions of the Act;

(b) The tube of flux in the kit is fully labeled and in conformance with the Act and rules thereunder, and any accompanying literature which bears directions for use also bears all the information required by ORS 453.035(2);

(c) The main panel of the outer container bears in type size specified in OAR 333-016-0115 the following: The signal word, the statement of principal hazard or hazards, the statement, “Keep out of the reach of children” or its practical equivalent, and instructions to read other cautionary instructions on the tube of flux within.

(31) Visual novelty devices consisting of sealed units, each of which unit is a steel or glass cell containing perchloroethylene, among other things, are exempted from the requirements of OAR 333-016-0115 that would otherwise require a portion of the warning statement to appear on the glass face of the device, provided that:

(a) The device contains not more than 105 milliliters of perchloroethylene and contains no other component that contributes substantially to the hazard;

(b) The following cautionary statement appears on the device (other than on the bottom) in the type size specified in OAR 333-016-0115: “Caution: If broken, resultant vapors may be harmful. Contains perchloroethylene. Do not expose to extreme heat. If broken indoors, open windows and doors until all odor of chemical is gone. Keep out of the reach of children.” A practical equivalent may be substituted for the statement “Keep out of the reach of children.”

(32) Hollow plastic toys containing mineral oil are exempt from the labeling specified in OAR 333-016-0065 under the following conditions:

(a) The article contains no other ingredient that would cause it to possess the aspiration hazard specified in OAR 333-016-0065;

(b) The article contains not more than six fluid ounces of mineral oil;

(c) The mineral oil has a viscosity of at least 70 S.U.S. at 100°F;

(d) The mineral oil meets the specifications in the N.F. for light liquid petrolatum;

(e) The container bears the statement “Caution: Contains light liquid petrolatum N.F. Discard if broken or leak develops.”

(33) Containers of mineral oil having a capacity of not more than one fluid ounce and intended for use in producing a smoke effect for toy trains are exempt from the labeling specified in 333-016-0065 under the following conditions:

(a) The mineral oil meets the specifications in the N.F. for light liquid petrolatum;

(b) The mineral oil has a viscosity of at least 130 S.U.S. at 100°F;

(c) The article contains no other ingredient that contributes to the hazard;

(d) The label declares the presence of light liquid petrolatum and the name and place of business of the manufacturer, packer, distributor, or seller.

(34) Viscous products containing more than four percent by weight of methyl alcohol, such as adhesives, asphalt-base roof and tank coatings, and similar products are exempt from bearing the special labeling that would otherwise be required by OAR 333-016-0065, provided that:

(a) The product contains not more than 15 percent by weight of methyl alcohol;

(b) The methyl alcohol does not separate from the other ingredients upon standing or through any foreseeable use or manipulation;

(c) The viscosity of the product is not less than 7,000 centipoises at 77°F, unless the product is packaged in a pressurized container and is dispensed as a liquid unsuitable for drinking;

(d) Labeling bears the statement, “Contains methyl alcohol — Use only in well-ventilated area — Keep out of the reach of children.”

(35) Individual blasting caps are exempt from bearing the statement, “Keep out of the reach of children” or its practical equivalent, provided that:

(a) Each cap bears conspicuously in the largest type size practicable the statement, “DANGEROUS — BLASTING CAPS — EXPLOSIVE”;

(b) The outer carton and any accompanying printed matter bear appropriate complete cautionary labeling.

(36) Individual toy rocket propellant devices and separate delay train and/or recovery system activation devices intended for use with premanufactured model rocket engines are exempted from bearing the full labeling required by ORS 453.035(2) insofar as such requirements would otherwise be necessary because the articles are flammable or generate pressure, provided that:

(a) The devices are designed and constructed in accordance with the specifications in OAR 333-016-0105(6);

(b) Each individual device or retail package of devices bears the following:

(A) The statement, “Warning — Flammable. Read instructions before use”;

(B) The common or usual name of the article;

(C) A statement of the type of engine and use classification;

(D) Instructions for safe disposal;

(E) Name and place of business of manufacturer or distributor.

(c) Each individual rocket engine or retail package of rocket engines distributed to users is accompanied by an instruction sheet bearing complete cautionary labeling and instructions for safe use and handling of the individual rocket engines.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.035
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0100
Exemption for Unlabeled Containers

(1) Except as provided by sections (2) and (3) of this rule, a shipment or other delivery of a hazardous substance that, in accordance with the practice of the trade is to be labeled in substantial quantity at an establishment other than that where originally manufactured or packed, shall be exempt during the time of introduction into the movement in commerce within this state during the time of holding in that establishment from compliance with the labeling requirement of ORS 453.035(2) if:

(a) The person who introduced the shipment or delivery into commerce within this state is the operator of the establishment where the hazardous substance is to be received and labeled; or

(b) The person who introduced the shipment or delivery is not the operator, and the shipment or delivery is made to the establishment under a written agreement, signed by and containing the post office address of the person and the operator, and containing whatever specifications for the labeling of the hazardous substance that are necessary to insure, if such specifications are followed, that the hazardous substance will not be misbranded within the meaning of the Act upon completion of the labeling. The person and the operator shall each keep a copy of the agreement until two years after the final shipment or delivery under the agreement has been completed and shall make copies of the agreement available for inspection upon request of any properly authorized officer or employee of the Public Health Division.

(2) An exemption of a shipment or delivery of a hazardous substance under subsection (1)(a) of this rule shall, at the beginning of the act of removing the shipment or delivery or any part thereof from the establishment, become void ab initio if the hazardous substance comprising the shipment, delivery, or part is misbranded within the meaning of the Act when so removed.

(3) An exemption of a shipment or delivery of a hazardous substance under subsection (1)(b) of this rule shall become void ab initio with respect to the person who introduced the shipment or delivery into commerce within this state upon refusal by that person to make available for inspection a copy of the agreement as required by subsection (1)(b) of this rule.

(4) An exemption of a shipment or other delivery of a hazardous substance under subsection (1)(b) of this rule shall expire:

(a) At the beginning of the act of removing the shipment or delivery, or any part thereof, from the establishment if the hazardous substance comprising the shipment, delivery, or part is misbranded within the meaning of the Act when so removed; or

(b) Upon refusal by the operator of the establishment where the hazardous substance is to be labeled, to make available for inspection a copy of the agreement required by subsection (1)(b) of this rule.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.035
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0105
Exemptions from Classification as Banned Hazardous Substances

The term “banned hazardous substances” as used in ORS 453.055 shall not apply to the following articles, provided that these articles bear labeling giving adequate directions and warnings for safe use:

(1) Chemistry sets and other science education sets intended primarily for juveniles, and replacement components for such sets when labeled in accordance with ORS 453.015 and 453.035 and OAR 333-016-0095(23).

(2) Educational materials such as art materials, preserved biological specimens, laboratory chemicals, and other articles intended and used for educational purposes.

(3) Liquid fuels containing more than four percent by weight of methyl alcohol that are intended and used for operation of miniature engines for model airplanes, boats, cars, etc.

(4) Novelties consisting of a mixture of polyvinyl acetate, U.S. certified colors, and not more than 25 percent by weight of acetone, and intended for blowing plastic balloons.

(5) Games containing, as the sole hazardous component, a self-pressurized container of soap solution or similar foam-generating mixture, provided that the foam-generating component has no hazards other than being in a self-pressurized container.

(6) Model rocket propellant devices designed for use in light-weight, recoverable, and reflyable model rockets, provided such devices:

(a) Are designed to be ignited by electrical means;

(b) Contain no more than 62.5 grams (2.2 ounces) of propellant material and produce less than 80 newton-seconds (17.92 pound-seconds) of total impulse with thrust duration not less than 0.050 second;

(c) Are constructed such that all chemical ingredients are preloaded into a cylindrical paper or similarly constructed nonmetallic tube that will not fragment into sharp, hard pieces;

(d) Are designed so that they will not burst under normal conditions of use, are incapable of spontaneous ignition, and do not contain any type of explosive or pyrotechnic warhead other than a small parachute or recovery-system activation charge.

(7) Separate delay train and/or recovery system activation devices intended for use with premanufactured model rocket engines wherein all of the chemical ingredients are preloaded so the user does not handle any chemical ingredient and are so designed that the main casing or container does not rupture during operation.

(8) Self-pressurized products containing fluorocarbon propellants, provided that the product has no hazards other than being self-pressurized and containing a fluorocarbon propellant and is labeled in accordance with OAR 333-016-0150.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.015, 453.035 & 453.055
History:
HD 89, f. 7-31-75, ef. 8-25-75
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0110
Labeling of Toys, Including Games

(1)(a) Labeling, literature, and marking. Known herein as Requirement No. 28. References in these rules to OAR 333-016-0110 shall include all subparagraphs of OAR 333-016-0110. Labeling requirements of OAR 333-016-0115 which are applicable to the product and which are in addition to or more demanding of the manufacturers shall apply in addition to the requirements of this section.

(b) General labeling requirements:

(A) Age grading. Toy packages shall be labeled to indicate the minimum recommended age (by months or by years) of children for whom the toy is intended;

(B) Instructional literature. Information and instructions provided with the toy, whether on the package or in leaflet form, shall be easy to read and understand;

(C) Producers markings. The principal components of toys or containers shall be marked with the name and address of the producer or distributor. This marking shall be legible and so positioned as to be easily seen by the customer and shall resist normal use conditions. Toys shall carry a code which will enable the producer to identify model changes, except for toys comprising many loose components, in which case, the code shall be placed on the permanent storage container.

(2) Protective labeling. Known herein as Requirement No. 29:

(a) Certain toys or packages are required to carry protective labeling in order to comply with OAR 333-016-0080(3)(a)(A)(i) (sharp edges); 333-016-0080(3)(a)(C)(iv); 333-016-0080(3)(g)(A) and (B); 333-016-0080(3)(h); and 333-016-0080(4)(b)(A), (B), and (C). They shall be labeled with the word “CAUTION” and a statement of the hazard on the principal display panel. In addition, the toys falling under the requirements of OAR 333-016-0080(3)(g)(A) and 333-016-0080(3)(h) shall themselves be labeled with the word “CAUTION” and a statement of the hazard. The principal display panel is defined as that part of a package which is most likely to be displayed, presented, shown, or examined under normal and customary conditions of display for retail sale;

(b) Additional and special cautionary labeling requirements are provided in OAR 333-016-0080(3)(a)(C)(v); 333-016-0080(4)(a)(A), (B), and (C); 333-016-0080(4)(b)(A)(i); 333-016-0080(4)(c)(A)(i), (ii), and (iii); 333-016-0080(4)(d)(E); and 333-016-0080(4)(e)(D).

(3) Printing size. Known herein as Requirement No. 30. All markings required by rules OAR 333-016-0080 and 333-016-0110 shall be of a permanent nature, whether paint-stenciled, die-stamped, molded, or indelibly stamped. All required markings shall appear in block lettering. Markings shall contrast sharply with their background (whether by color, projection, or indentation), and shall be readily visible and legible. Minimum lettering heights shall be as follows: Surface Area Displayed Marking (square inches) — Minimum Height of Lettering (inches):

(a) Under 5 — 1/16;

(b) 5 or more and under 25 — 1/8;

(c) 25 or more and under 100 — 3/16;

(d) 100 or more and under 400 — 1/4;

(e) 400 or more — 1/2.

(4) The term “toy” as used in this rule includes games.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.035
History:
HD 89, f. 7-31-75, ef. 8-25-75
HD 40, f. 8-2-73, ef. 8-15-75

333-016-0115
Labeling Requirements, Placement, Conspicuousness, Contrast

(1) The signal word, the statement of the principal hazard or hazards, and instructions to read carefully any cautionary information that may be placed elsewhere on the label shall appear together on the main panel of the label. Such information shall be placed together and distinctively apart from other wording or designs. The necessary prominence shall be achieved by placement within the borders of a square or rectangle with or without a borderline, and by the use of suitable contrasts with the background achieved by distinctive typography or color, and by both color and typography when needed. For hazardous substances that contain toxic or highly toxic chemicals, the label shall include in addition to all other requirements of these rules the generic name of the chemical or chemicals which present the most significant hazards.

(2) If the product is “highly toxic” as defined in OAR 333-016-0005 and ORS 453.005(a), (B), or (C), the labeling shall also include in conjunction with the word “poison,” the skull and crossbones symbol. The word “poison” is not considered a signal word as that term is used in section (1) of this rule.

(3) The signal word and statement of hazard shall be in capital letters. The size of the signal word (and the word “poison” if required) shall be of a size bearing a reasonable relationship to the other type on the main panel, but shall not be less than 18 point type, and the size of the statement of hazard shall not be less than 12 point type, unless the label space on the container is too small to accommodate such type size. When the size of the label space requires a reduction in type size, the reduction shall be made to a size no smaller than is necessary and in no event to a size smaller than six point type.

(4) All the items of label information required by ORS 453.035(2)(a) through (i) may appear on the main panel; but if they do not, all such items not required by section (1) of this rule to appear on the main panel shall be placed together in a distinctive place elsewhere on the label with adequate contrast, achieved by typography, color, or layout except that the name and place of business of the manufacturer, packer, distributor, or seller may appear separately on the same or on a different panel. The type size used shall bear a reasonable relationship to the printing on the panel involved and shall be no smaller than ten point unless the available label space requires reduction, in which event it shall be reduced no smaller than 6 point type unless because of small label space an exception has been granted under ORS 453.035(4) and 333-016-0095.

(5) Collapsible metal tubes containing hazardous substances shall be labeled so that all items of label information required by ORS 453.035(2)(a) through (i) shall appear as close to the dispensing end of the container as possible. The size, placement, and conspicuousness of these statements shall conform with sections (1), (3), and (4) of this rule.

(6) Unpackaged hazardous substances intended or in a form suitable for use in or around a household or by children shall be labeled so that all items of information required by the Act or by rules in this part shall appear upon the article itself. In instances where such labeling is impracticable because of the size or nature of the article, the required cautionary labeling must be displayed by means of a tag or other suitable material that is securely affixed to the article so that the labeling will remain attached throughout conditions of merchandising and distribution to the ultimate consumer. The size, placement, and conspicuousness of these statements shall conform with sections (1), (3), and (4) of this rule.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.035
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0120
Deceptive Use of Disclaimers

A hazardous substance shall not be deemed to have met the requirements of ORS 453.035(2)(a) through (i) if there appears in or on the label or in accompanying literature, words, statements, designs, or other graphic material that in any manner negates or disclaims any of the label statements required by the Act; for example, a statement on a toxic or irritant substance, such as “harmless” or “safe around pets.”

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.035
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0125
Condensation of Label Information

Whenever the statement of the principal hazard or hazards itself provides the precautionary measures to be followed or avoided, a clear statement of the principal hazard will satisfy both the provisions of ORS 453.035(2)(c) and (d). When the statement of precautionary measures in effect provides instruction for first-aid treatment the statement of the precautionary measures will satisfy both ORS 453.035(2)(d) and (e).

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.035
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0130
Labeling Requirements for Accompanying Literature

When any accompanying literature includes or bears any directions for use (by printed word, picture, design, or combination of such methods), such placard, pamphlet, booklet, book, sign, or other graphic or visual device shall bear all the information required by ORS 453.035(2).

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.035
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0135
Substances Determined to be “Special Hazards” (e.g., to children)

Whenever the Administrator determines that for a particular hazardous substance intended or packaged in a form suitable for use in the household or by children, the requirements of ORS 453.035(2) are not adequate for the protection of the public health and safety because of some special hazard, he shall issue an order by an appropriate means, which specifies such reasonable variations or additional label requirements that he finds are necessary for the protection of the public health and safety. Such order shall specify a date that is not less than 90 days after the order is published (unless emergency conditions stated in the order specify an earlier date) after which any such hazardous substance intended, or packaged in a form suitable for use in the household or by children, that fails to bear a label in accordance with such order shall be deemed as a misbranded hazardous substance.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.035
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0140
Substances with Multiple Hazards or Other Special Hazards

(1) Any article that presents more than one type of hazard (for example, if the article is both “toxic” and “flammable”) must be labeled with an affirmative statement of each such hazard; precautionary measures describing the action to be followed or avoided for each such hazard; instructions, when necessary or appropriate, for first-aid treatment of persons suffering from the ill effects that may result from each such hazard; instructions for handling and storage of articles that require special care in handling and storage because of more than one type of hazard presented by the article, or for any other reason, as well as the common or usual name (or the chemical name if there is no common or usual name) for each hazardous component present in the article.

(2) Label information referring to the possibility of one hazard may be combined with parallel information concerning any additional hazards presented by the article, provided that the resulting condensed label statement shall contain all of the information needed for dealing with each type of hazard presented by the article.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.035
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0145
For the Following Substances and at the Following Concentrations, the Word “Poison” Is Necessary Instead of Any Signal Word

(1) Hydrochloric acid and any preparation containing free or chemicallyunneutralized hydrochloric acid (HC1) in a concentration of ten percent or more.

(2) Sulfuric acid and any preparation containing free or chemically unneutralized sulfuric acid (HSO4) in a concentration of ten percent or more.

(3) Nitric acid or any preparation containing free or chemically unneutralized nitric acid (HNO3) in a concentration of five percent or more.

(4) Carbolic acid (C6H5OH), also known as phenol, and any preparation containing carbolic acid in a concentration of five percent or more.

(5) Oxalic acid and any preparation containing free or chemically unneutralized oxalic acid (COOH22H2O) in a concentration of ten percent or more.

(6) Any salt of oxalic acid and any preparation containing any such salt in a concentration of ten percent or more.

(7) Acetic acid or any preparation containing free or chemically unneutralized acetic acid (CH3COOH) in a concentration of 20 percent or more.

(8) Hypochlorous acid, either free or combined and any preparation containing the same in a concentration that will yield ten percent or more by weight of available chlorine.

(9) Potassium hydroxide and any preparation containing free or chemically unneutralized potassium hydroxide (KOH) including caustic potash and vienna paste (vienna caustic) in a concentration of ten percent or more.

(10) Sodium hydroxide and any preparation containing free or chemically unneutralized sodium hydroxide (NaOH) including caustic soda and lye in a concentration of ten percent or more.

(11) Silver nitrate, sometimes known as lunar caustic and any preparation containing silver nitrate (AgNO3) in a concentration of five percent or more.

(12) Ammonia water and any preparation containing free or chemically uncombined ammonia (NH3) including ammonium hydroxide and “hartshorn” in a concentration of five percent or more.

(13) Arsenic and its preparations, in concentrations that fall within the definition of toxic substance described in OAR 333-016-0005(6)(a).

(14) Corrosive sublimate (mercuric-chloride), in concentrations that fall within the definition of toxic substance described in OAR 333-016-0005(6)(a).

(15) Cyanides and preparations of cyanides, including hydrocyanic acid, in concentrations that fall within the definition toxic substance described in OAR 333-016-0005(6)(a).

(16) Strychnine (C2H22N2O2) in concentrations that fall within the definition of toxic substance described in OAR 333-016-0005(6)(a).

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005 & 453.035
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0150
Self-Pressurized Containers; Labeling

(1) Self-pressurized containers that fail to bear a warning statement adequate for the protection of the public health and safety may be misbranded under the Act, except as otherwise provided pursuant to ORS 453.035.

(2) The following warning statement will be considered as meeting the requirements of ORS 453.035 if the only hazard associated with an article is that the contents are under pressure:

“WARNING — CONTENTS UNDER PRESSURE. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 degrees Fahrenheit. Keep out of the reach of children.”

The word “CAUTION” may be substituted for the word “WARNING.” A practical equivalent may be substituted for the statement “Keep out of the reach of children.”

(3) That portion of the warning statement set forth in section (2) of this rule in capital letters should be printed on the main (front) panel of the container in capital letters of the type size specified in OAR 333-016-0115. The balance of the cautionary statements may appear together on another panel, provided that the front panel also bears a statement such as, “Read carefully other cautions on ________ panel.”

(4) If an article has additional hazards, such as skin or eye irritancy, toxicity, or flammability, appropriate additional front and rear panel precautionary labeling is required.

(5) If the article contains a fluorocarbon propellant, it shall bear on its label the additional statement,

“WARNING — Use only as directed; intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal,” and “contains fluorocarbons.”

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.035
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0155
Methyl Alcohol-Base Radiator Antifreeze; Labeling

(1) Methyl alcohol-base (methanol-base) radiator antifreeze distributed in containers intended or suitable for household use may be misbranded under the Act if the containers fail to bear a warning statement adequate to the protection of the public health and safety, except as otherwise provided pursuant to ORS 453.025.

(2) The following warning statement will be considered as meeting the requirements of ORS 453.005 to 453.135 with respect to methyl alcohol-base radiator antifreeze when the only hazard foreseeable is that caused by the methyl alcohol content and when the article has a flashpoint in the “flammable” range as that term is defined in ORS 453.005:

“DANGER — POISON (Skull and Crossbones Symbol) MAY BE FATAL OR CAUSE BLINDNESS IF SWALLOWED

FLAMMABLE — VAPOR HARMFUL

Contains methyl alcohol (methanol). Cannot be made nonpoisonous. Avoid contact with eyes. Use only in a well-ventilated area. Keep away from heat and open flame. Do not store in open or unlabeled containers. First-aid: In case of contact with eyes, flush thoroughly with water. If swallowed, induce vomiting (give a tablespoonful of salt in a glass of warm water). Repeat until vomit fluid is clear. Call a physician immediately. Keep out of reach of children.”

(3) The words that are in capital letters in the warning statement set forth in section (2) of this rule shall be printed on the main (front) panel or panels of the container in capital letters of the type size specified in OAR 333-016-0115, except that the word “POISON” and the skull and crossbones symbol may appear on another panel with the balance of the cautionary information. The balance of the cautionary statements may appear together on another panel, provided the front panel bears a statement such as, “Read carefully other cautions on _____ panel.”

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005, 453.015, 453.025, 453.035, 453.045, 453.055, 453.065, 453.075, 453.085, 453.095, 453.105, 453.115, 453.125 & 453.135
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0160
Ethylene Glycol-Base Radiator Antifreeze; Labeling

(1) Ethylene glycol-base radiator antifreeze distributed in containers intended or suitable for household use may be misbranded under the Act if the containers fail to bear the following warning statements which the Administrator considers necessary for the protection of the public health and safety, and which will be considered as meeting the requirements of ORS 453.005 to 453.135 with respect to ethylene glycol-base radiator antifreeze, with and without added sodium arsenite of over 0.01 percent by weight, when the only hazard foreseeable is by the ethylene glycol and (if present) the added sodium arsenite:

(a) Ethylene glycol antifreeze containing less than 0.01 percent by weight of sodium arsenite:

“WARNING — HARMFUL OR FATAL IF SWALLOWED

Do not drink antifreeze or solution. If swallowed, induce vomiting immediately. Call a physician. Ethylene glycol base. Do not store in open or unlabeled containers. Keep out of reach of children.”

(b) Ethylene glycol antifreeze containing 0.01 percent but no more than one percent by weight of sodium arsenite:

“WARNING — HARMFUL OR FATAL IF SWALLOWED

“Do not drink antifreeze or solution. If swallowed, induce vomiting immediately. Call a physician. Ethylene glycol base containing sodium arsenite (less than one percent).

Antidote for sodium arsenite: Dimercaprol (BAL) to be administered only by a physician.

Do not store in open or unlabeled containers. Keep out of reach of children.”

(2) The words that are in capital letters in the warning statements set forth in subsection (b) of this section shall be printed on the main (front) panel or panels of the container in capital letters of the type size specified in OAR 333-016-0115. The balance of the cautionary statements may appear together on another panel, provided the front panel bears a statement such as, “Read carefully other cautions on __________ panel.”

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005, 453.015, 453.025, 453.035, 453.045, 453.055, 453.065, 453.075, 453.085, 453.095, 453.105, 453.115, 453.125 & 453.135
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0165
Extremely Flammable Contact Adhesives; Labeling

(1) Extremely flammable contact adhesives, also known as contact bonding cements, when distributed in containers intended or suitable for household use may be misbranded under the Act if the containers fail to bear a warning statement adequate for the protection of the public health and safety.

(2) The following warning statement is considered as a minimum cautionary labeling adequate to meet the requirements of ORS 453.005 to 453.135 of the Act with respect to containers of more than one-half pint of contact adhesive and similar liquid or semiliquid articles having a flashpoint at or below 20°F as determined by the method in 333-016-0035 when the only hazard foreseeable is that caused by the extreme flammability of the mixture:

“DANGER EXTREMELY FLAMMABLE VAPORS MAY CAUSE FLASH FIRE

Vapors may ignite explosively. Prevent build-up of vapors — open all windows and doors — use only with cross ventilation. Keep away from heat, sparks, and open flame. Do not smoke, extinguish all flames and pilot lights, and turn off stoves, heaters, electric motors, and other sources of ignition during use and until all vapors are gone.

Close container after use.

Keep out of the reach of children.”

(3) The words that are in capital letters in the warning statement set forth in section (2) of this rule shall be printed on the main (front) panel or panels of the container in capital letters of the type size specified in OAR 333-016-0115. The balance of the cautionary information may appear together on another panel, provided the front panel bears a statement such as, “Read carefully other cautions on ______ panel,” the blank being filled in with the identification of the specific label panel bearing the balance of the cautionary labeling. It is recommended that a borderline be used in conjunction with the cautionary labeling.

(4) If an article has additional hazards, or contains ingredients listed in OAR 333-016-0065 as requiring special labeling, appropriate additional front and rear panel precautionary labeling is required.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.005, 453.015, 453.025, 453.035, 453.045, 453.055, 453.065, 453.075, 453.085, 453.095, 453.105, 453.115, 453.125 & 453.135
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0170
Procedural Rules

Procedure for the issuance, amendment, or repeal of rules declaring particular substances to be hazardous substances or banned hazardous substances shall be as specified in ORS Chapter 183 and the Attorney General’s Model Rules of Procedure thereunder.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.095
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0175
Prohibited Acts and Penalties

The provisions of these rules with respect to the doing of any act shall be applicable also to the causing of such act to be done.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.085 & 453.095
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0180
Guaranty

In case of the giving of a guaranty or undertaking referred to in ORS 453.085(5), each person signing such guaranty or undertaking or causing it to be signed, shall be considered to have given it. Each person causing a guaranty or undertaking to be false is chargeable with violation of ORS 453.085(5).

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.085
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0185
Examinations and Investigations; Samples

When any officer or employee of the Public Health Division collects a sample of a hazardous substance for analysis under the Act, the sample shall be designated as an official sample if records or other evidence is obtained by him or any other officer or employee of the Public Health Division, indicating that the shipment or other lot of the article from which such sample was collected was introduced or delivered for introduction into this state or was in or was received in this state. Only samples so designated by an employee of the Public Health Division shall be considered to be official samples. All employees shall pay or offer to pay the owner, operator, or agent in charge, their cost for any such sample and give a receipt describing the sample obtained. For the purpose of determining whether or not a sample is collected for analysis, the term “analysis” includes examinations and tests. The owner of a hazardous substance of which an official sample is collected is the person who owns the shipment or other lot of the article from which the sample is collected.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 453.105
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-0190
“Administrator” Intended to Include “State Public Health Officer”

Wherever in the foregoing rules OAR 333-016-0005 through 333-016-0185 the term “Administrator” is used, it is intended to also include and shall be deemed to additionally refer to the “State Public Health Officer” as defined in ORS 431.045.

Statutory/Other Authority: ORS 453.095
Statutes/Other Implemented: ORS 431.045
History:
HD 40, f. 8-2-73, ef. 8-15-73

333-016-2001
Toxic Free Kids Program; Effective Date

(1) OAR 333-016-2001 to 333-016-3080 implement the Toxic Free Kids Act established by the Legislature in ORS 431A.253 to 431A.280. The presence of a high priority chemical of concern in a children’s product does not necessarily mean that the product is harmful to human health or that there is any violation of existing safety standards or laws. The information required to be reported in these rules will help fill a data gap that exists for both consumers and agencies.

(2) These rules apply to any children’s product sold or offered for sale in Oregon by a manufacturer on or after January 1, 2017 that contains a high priority chemical listed in OAR 333-016-2020.

Statutory/Other Authority: ORS 431A.253 - 431A.280 & ORS 413.042
Statutes/Other Implemented: ORS 431A.253 - 431A.280
History:
PH 9-2021, adopt filed 02/28/2021, effective 03/01/2021

333-016-2010
Definitions

The following definitions apply to OAR 333-016-2001 to 333-016-3080.

(1) "Alternatives Assessment" or "AA" as described in OAR 333-016-3060 means the evaluation of the possibility of replacing chemicals in products or processes with inherently safer alternatives in order to better protect human health.

(2) "Analytical methods" means defined protocols for the analysis of the presence of a HPCCCH in a sample of a medium, including laboratory testing that can be described and is readily reproducible by another party.

(3) "Bioavailability" means the extent to which a HPCCCH at or above the practical quantification limit for the chemical established in OAR 333-016-2035(2) Exhibit A in leachate or air may be absorbed by a child.

(4) "Chemical" means:

(a) A substance with a distinct molecular composition and the breakdown products of the substance that form through decomposition, degradation or metabolism.

(b) A group of structurally related substances and the breakdown products of the substances that form through decomposition, degradation or metabolism.

(5) "Chemical Abstracts Service Registry Number" means the number assigned for identification of a particular chemical by the Chemical Abstracts Service, a service of the American Chemical Society that indexes and compiles abstracts of worldwide chemical literature called Chemical Abstracts.

(6) "Child" means an individual under 12 years of age.

(7)(a) "Children’s cosmetics" means products that are intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, moisturizing, beautifying, promoting attractiveness or altering the appearance.

(b) "Children’s cosmetics" does not mean soap, dietary supplements or food and drugs approved by the United States Food and Drug Administration.

(8)(a) "Children’s product" means:

(A) Any of the following products that are made for, marketed for use by or marketed to children under 12 years of age:

(i) A product designed or intended by the manufacturer to facilitate sucking, teething, sleep, relaxation, feeding or drinking.

(ii) Children’s clothing and footwear.

(iii) Car seats.

(iv) Children’s cosmetics.

(v) Children’s jewelry.

(vi) Toys.

(B) Any component part of a product specified in paragraph (A) of this subsection.

(b) "Children’s product" does not mean:

(A) Athletic shoes with cleats or spikes.

(B) Batteries.

(C) BB guns, pellet guns and air rifles.

(D) Bicycles and tricycles.

(E) Chemistry sets.

(F) Consumer electronic products, including personal computers, audio and video equipment, calculators, wireless telephones and game consoles, handheld devices that incorporate a video screen and are used to access interactive software, and the associated peripherals.

(G) Interactive software intended for leisure and entertainment, such as computer games, and their storage media, such as compact discs.

(H) Model rockets.

(I) Pocketknives and multitools.

(J) Roller skates.

(K) Scooters.

(L) Sets of darts with metallic points.

(M) Slings and catapults.

(N) Snow sporting equipment, including skis, poles, boots, snowboards, sleds and bindings.

(O) Sporting equipment and accessories, including but not limited to bats, balls, gloves, sticks, pucks, pads, helmets and other protective equipment, weight training and exercise aids, protective eyewear, backpacks and tents, raingear, sport bags and luggage, and golf equipment.

(P) Video toys that can be connected to a video screen and are operated at a nominal voltage exceeding 24 volts.

(Q) Food and beverages and food and beverage packaging regulated by the United States Food and Drug Administration or the United States Department of Agriculture.

(9) “Class of chemicals” has the meaning given that term in ORS 431A.253.

(10) "Component part" means a uniquely identifiable material or coating (including ink or dye) that is intended to be included as a part of a finished children's product, including, but not limited to:

(a) Bio-based materials (animal or plant based);

(b) Synthetic polymers (such as but not limited to synthetic rubber, plastics, and foams);

(c) Metals (including alloys);

(d) Glass, ceramic and siliceous material;

(e) Surface coatings (such as but not limited to paints, plating, and waterproofing);

(f) Homogenous mixtures (gels, creams, powders, liquids, adhesives, synthetic fragrances);

(g) Inks/dyes/pigments; and

(h) Textiles (synthetic fibers and blends).

(11) "Contaminant" has the meaning given that term in ORS 431A.253.

(12) "De minimis level" has the meaning given that term in ORS 431A.253.

(13) "Essential use" means a function of a HPCCCH in a children’s product considered critical for performance of a product.

(14) "Exposure scenarios" means the mechanisms by which children may be exposed to HPCCCHs found in a children’s product.

(15) "Hazard Assessment" or "HA" as described in OAR 333-016-3030 means an evaluation of whether a chemical or chemicals substituted for a HPCCCH in a children’s product make that product less hazardous than it was when it contained the HPCCCH.

(16) "HPCCCH" means high priority chemicals of concern to children’s health.

(17) "High priority chemicals of concern list" means the high priority chemicals of concern for children’s health identified by the Oregon Health Authority in OAR 333-016-2020.

(18) "Intentionally added chemical" has the meaning given that term in ORS 431A.253.

(19) "Leachability" means the extent to which a HPCCCH is reasonably anticipated to migrate from a children’s product through normal and reasonably foreseeable use and abuse of such product determined by measuring a HPCCCH at or above the practical quantification limit for the chemical established in OAR 333-016-2035(2) Exhibit A in media during simulated exposure scenarios.

(20) "Manufacturer" has the meaning given that term in ORS 431A.253.

(21) "Manufacturing control program" or "MCP" means a program implemented by the manufacturer or its suppliers to control the amount of a HPCCCH present as a contaminant at or above de minimis levels through the implementation of tools, processes and oversight that support effective chemicals management at all levels to include supply chain management, quality assurance and educational programs. Control includes the minimization, reduction or elimination of contaminants when possible.

(22) "Mouthable" has the meaning given that term in ORS 431A.253.

(23) "Non-essential use" means a function of a HPCCCH in a children’s product that is not critical for the performance of a product but is included for other reasons such as market demand.

(24) "Owner" for purposes of clarifying the definition of "manufacturer" means the person or entity, whether an importer or a distributor, that offers the children’s product for sale in Oregon.

(25) "Practical quantification limit" has the meaning given that term in ORS 431A.253.

(26) "Product category" means the "brick" level of the GS1 Global Product Classification (GPC) standard, which identifies products that serve a common purpose, are of a similar form and material, and share the same set of category attributes.

(27) "Quantitative Exposure Assessment" or "QEA" means an assessment as described in OAR 333-016-3050 of whether a HPCCCH used in children’s products is or is not reasonably anticipated to result in exposure based upon an analysis of leachability and bioavailability of the HPCCCH used in children’s products.

(28) "Reasonably foreseeable use and abuse" includes: non-incidental skin contact; swallowing; mouthing; inhalation of gaseous products emitted by a children’s product; the aging of a children’s product; and may include breaking during typical and reasonable use by children or other situations of a similar nature.

(29) “Subclass of chemicals” has the meaning given that term in ORS 431A.253.

(30) "Substitutable role" means a role for or presence of a HPCCCH that might be regarded as essential but where alternatives to the HPCCCH have been identified that have comparable functionality and performance making the use of the HPCCCH no longer essential.

(31) "These rules" means OAR 333-016-2001 to 333-016-3080.

(32) "Trade association" has the meaning given that term in ORS 431A.253.

Statutory/Other Authority: ORS 413.042 & ORS 431A.253 - 431A.280
Statutes/Other Implemented: ORS 431A.253 - 431A.280
History:
PH 56-2023, amend filed 12/15/2023, effective 01/01/2024
PH 9-2021, amend filed 02/28/2021, effective 03/01/2021
PH 29-2015, f. 12-29-15, cert. ef. 1-1-16

333-016-2020
Chemicals of High Concern to Children

The following chemicals are designated as high priority chemicals of concern for children’s health when used in children’s products:

(1) Formaldehyde (50-00-0).

(2) Aniline (62-53-3).

(3) N-Nitrosodimethylamine (62-75-9).

(4) Benzene (71-43-2).

(5) Vinyl chloride (75-01-4).

(6) Acetaldehyde (75-07-0).

(7) Methylene chloride (75-09-2).

(8) Carbon disulfide (75-15-0).

(9) Methyl ethyl ketone (78-93-3).

(10) 1,1,2,2-Tetrachloroethane (79-34-5).

(11) Tetrabromobisphenol A (TBBPA) (79-94-7).

(12) Bisphenol A (BPA) (80-05-7).

(13) Bisphenol S (BPS) (80-09-1).

(14) Dicyclohexyl phthalate (DCHP) (84-61-7).

(15) Diethyl phthalate (DEP) (84-66-2).

(16) Diisobutyl phthalate (DIBP) (84-69-5).

(17) Di-n-butyl phthalate (DBP) (84-74-2).

(18) Di-n-hexyl phthalate (DnHP) (84-75-3).

(19) Butyl benzyl phthalate (BBP) (85-68-7).

(20) N-Nitrosodiphenylamine (86-30-6).

(21) Hexachlorobutadiene (HCDB) (87-68-3).

(22) Propyl paraben (94-13-3).

(23) Butyl paraben (94-26-8).

(24) 2-Aminotoluene (95-53-4).

(25) 2,4-Diaminotoluene (95-80-7).

(26) Methyl paraben (99-76-3).

(27) 4-Hydroxybenzoic acid (99-96-7).

(28) Ethylbenzene (100-41-4).

(29) Styrene (100-42-5).

(30) 4-Nonylphenol (104-40-5); 4-NP and its isomer mixtures including CAS 84852-15-3 and CAS 25154-52-3.

(31) 4-Chloroaniline (106-47-8).

(32) Acrylonitrile (107-13-1).

(33) Ethylene glycol (107-21-1).

(34) Toluene (108-88-3).

(35) Phenol (108-95-2).

(36) 2-Methoxyethanol (109-86-4).

(37) Ethylene glycol monoethyl ether (110-80-5).

(38) Triphenyl phosphate (TPP) (115-86-6).

(39) Tris(2-chloroethyl) phosphate (TCEP) (115-96-8).

(40) Di-2-ethylhexyl phthalate (DEHP) (117-81-7).

(41) Di-n-octyl phthalate (DnOP) (117-84-0).

(42) Hexachlorobenzene (118-74-1).

(43) 3,3’-Dimethylbenzidine and Dyes Metabolized to 3,3’-Dimethylbenzidine (119-93-7).

(44) Ethyl paraben (120-47-8).

(45) 1,4-Dioxane (123-91-1).

(46) Tetrachloroethene (127-18-4).

(47) Benzophenone-2 (Bp-2) (131-55-5).

(48) 4-tert-Octylphenol (140-66-9).

(49) Estragole (140-67-0).

(50) 2-Ethylhexanoic acid (149-57-5).

(51) Pentachlorobenzene (608-93-5).

(52) Bisphenol F (BPF) (620-92-8).

(53) C.I. Solvent yellow 14 (842-07-9).

(54) N-Methylpyrrolidone (872-50-4).

(55) Decabromodiphenyl ether (BDE-209) (1163-19-5).

(56) Ethylhexyl diphenyl phosphate (EHDPP) (1241-94-7).

(57) Perfluorooctane sulfonic acid and its salts; PFOS (1763-23-1).

(58) 4-Octylphenol (1806-26-4).

(59) 2-Ethyl-hexyl-4-methoxycinnamate (5466-77-3).

(60) Mercury & mercury compounds (7439-97-6).

(61) Antimony and Antimony compounds (7440-36-0).

(62) Arsenic and Arsenic compounds (7440-38-2), including arsenic trioxide (1327-53-3) and dimethyl arsenic (75-60-5).

(63) Cadmium and cadmium compounds (7440-43-9).

(64) Cobalt and cobalt compounds (7440-48-4).

(65) Tris(1-chloro-2-propyl) phosphate (TCPP) (13674-84-5).

(66) Tris(1,3-dichloro-2-propyl) phosphate (TDCPP) (13674-87-8).

(67) Butylated hydroxyanisole (BHA) (25013-16-5).

(68) Hexabromocyclododecane (25637-99-4).

(69) Diisodecyl phthalate (DIDP) (26761-40-0).

(70) Diisononyl phthalate (unbranched) (DINP) (28553-12-0).

(71) Short-chain chlorinated paraffins (SCCP) (85535-84-8).

(72) Chlorinated paraffins (108171-26-2).

(73) 2-ethylhexyl-2,3,4,5-tetrabromobenzoate (TBB) (183658-27-7).

Statutory/Other Authority: ORS 413.042 & ORS 431A.255
Statutes/Other Implemented: ORS 431A.255
History:
PH 91-2021, amend filed 12/29/2021, effective 01/01/2022
PH 9-2021, amend filed 02/28/2021, effective 03/01/2021
PH 252-2018, amend filed 09/11/2018, effective 01/01/2019
PH 29-2015, f. 12-29-15, cert. ef. 1-1-16

333-016-2030
Modifications to the List of High Priority Chemicals of Concern for Children’s Health

(1) The Oregon Health Authority (Authority) shall consider adding a chemical to the list of high priority chemicals of concern for children’s health in OAR 333-016-2020 if the chemical:

(a) Has been added to any of the following:

(A) Washington’s list of Chemicals of High Concern to Children (WAC 173-334-130);

(B) Maine’s list of Chemicals of High Concern (Maine law 38 § 1693-A(2));

(C) Minnesota’s list of Chemicals of High Concern (Minn. Stat. 2010 116.9401 – 116.9407);

(D) Vermont’s list of Chemicals of high concern to children (18 V.S.A. chapter 38A § 1773);

(b) Is currently or subsequently identified by the United States Environmental Protection Agency (USEPA) as being "carcinogenic to humans", or "likely to be carcinogenic to humans" through USEPA’s Integrated Risk Information System;

(c) Has been or is subsequently found to have a reference dose or reference concentration based on neurotoxicity through USEPA’s Integrated Risk Information System;

(d) Is currently or subsequently identified in monographs on the Potential Human Reproductive and Developmental Effects, United States Office of Health and Human Services National Toxicology Program, Office of Health Assessment and Translation as a reproductive or developmental toxicant; or

(e) Is currently or subsequently identified by the Centers for Disease Control and Prevention in its National Report on Human Exposure to Environmental Chemicals.

(2) The Authority may, in its discretion, include a class of chemicals or subclass of chemicals on the list of high priority chemicals of concern for children’s health, in accordance with ORS 431A.255(1)(b). In making a decision whether to include a class or subclass of chemicals in the list, the Authority will consider the provisions in section (1) of this rule.

(3) The Authority shall also consider adding a chemical to the list of HPCCCHs in OAR 333-016-2020 if that the chemical, on or after the effective date of these rules:

(a) Is found to have the potential, as demonstrated by credible, peer-reviewed scientific evidence to:

(A) Harm the normal development of a fetus or child or cause other developmental toxicity;

(B) Act as a carcinogen;

(C) Cause genetic damage or reproductive harm;

(D) Disrupt the endocrine system;

(E) Damage the nervous system, immune system or organs;

(F) Cause other systemic toxicity;

(G) Be a very persistent toxic substance by having a half-life greater than or equal to one of the following:

(i) A half-life in soil or sediment of greater than one hundred eighty days.

(ii) A half-life greater than or equal to sixty days in water or evidence of long-range transport; or

(H) Be a very bioaccumulative toxic substance by having a bioconcentration factor or bioaccumulation factor greater than or equal to five thousand, or if neither are available, having a log Kow greater than 5.0; and

(b) Has been found through:

(A) Biomonitoring to be present in human blood, umbilical cord blood, breast milk, urine or other bodily tissues or fluids;

(B) Sampling and analysis to be present in household dust, indoor air, drinking water or elsewhere in the home environment; or

(C) Monitoring to be present in fish, wildlife or the natural environment.

(4) The Authority may remove a chemical, class or subclass of chemicals from the list if the Authority determines that:

(a) The chemical, class or subclass of chemicals is no longer being used in children’s products; or

(b) The chemical, class or subclass of chemicals has been removed from any of the lists identified in subsection (1)(a) through (e) of this rule.

(5) The list of HPCCCHs in OAR 333-016-2020 may only be modified by following the Administrative Procedures Act rulemaking process.

Statutory/Other Authority: ORS 413.042 & ORS 431A.255
Statutes/Other Implemented: ORS 431A.255
History:
PH 56-2023, amend filed 12/15/2023, effective 01/01/2024
PH 9-2021, amend filed 02/28/2021, effective 03/01/2021
PH 29-2015, f. 12-29-15, cert. ef. 1-1-16

333-016-2035
Manufacturer Disclosure of High Priority Chemicals of Concern for Children’s Health Used in Children’s Products: Practical Quantification Limits

(1) The practical quantification limit for a chemical that is a contaminant is 100 parts per million.

(2) The practical quantification limits for intentionally added chemicals are the limits established in Exhibit A, incorporated by reference.

[ED. NOTE: To view attachments referenced in rule text, click here to view rule.]

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 431A.253 – 431A.280
History:
PH 91-2021, amend filed 12/29/2021, effective 01/01/2022
PH 9-2021, amend filed 02/28/2021, effective 03/01/2021
PH 280-2018, amend filed 12/10/2018, effective 01/01/2019
PH 10-2017, minor correction filed 10/12/2017, effective 10/12/2017
PH 34-2016, f. & cert. ef. 12-1-16

333-016-2060
Notification Requirements

(1) For purposes of this rule, "unit" has the same meaning as "component part" as that is defined in OAR 333-016-2010.

(2) A manufacturer of a children’s product sold or offered for sale in this state that contains a HPCCCH listed in OAR 333-016-2020 as an individual chemical or a member of a class or subclass of chemicals, in an amount at or above a de minimis level must submit:

(a) A notice to the Oregon Health Authority (Authority) that contains all the information required in these rules, unless the manufacturer or product is exempt; and

(b) A nonrefundable fee of $250 for the notification of each HPCCCH as specified in OAR 333-016-2080.

(3) The first manufacturer’s notice due on January 1, 2018, applies to children’s products sold or offered for sale in this state between January 1, 2017 and December 31, 2017. For the reporting years 2018, 2020, and 2022, reports are due on January 1st.

(4) On and after January 1, 2024, manufacturer reports are due on January 31st of even numbered years for the previous two-year biennial notice period. For example, for the reporting year 2024, a manufacturer must include children’s products sold or offered for sale between January 1, 2022, and December 31, 2023, that contain a HPCCCH listed in OAR 333-016-2020.

(5) The notice required in section (2) of this rule must include the following:

(a) The name and Chemical Abstracts Service Registry Number of the chemical contained in the children’s product;

(b) The product category of the children’s product that contains the chemical;

(c) A description of the function of the chemical in the children’s product;

(d) The amount of the chemical used in each unit within each product category. The amount of the chemical used in each unit of the children’s product is to be reported as a range rather than an exact amount. If there are multiple concentrations for a given unit in a particular product category, the manufacturer must use the highest concentration for reporting.

(e) The target age category for whom the children’s product is intended, either ages 0-3, 3-12 or 0-12 years-old;

(f) The number of the children’s product that contain the high priority chemical either sold or offered for sale in Oregon during the biennial notice period;

(g) The name and address of the manufacturer, and the name, address and telephone number of the contact person for the manufacturer;

(h) The name, address and contact information for the trade association submitting the notification on behalf of the affected industry; and

(i) Any other information that the manufacturer deems relevant to the appropriate use of the children’s product.

(6) No later than January 1, 2020, and every other year thereafter, notices to the Authority shall be submitted utilizing the Interstate Chemicals Clearinghouse’s High Priority Chemicals Data System (HPCDS) or alternate data system designated by the Authority. A link to the data system will be made available on the Toxic Free Kids Program website: www.healthoregon.org/toxicfreekids.

(7) If a manufacturer, required to report under ORS 431A.258, is acquired by another business entity, merges into another business entity or separates into distinct business entities, the new controlling entity must submit the required biennial notices to the Authority.

(8) If a manufacturer has included a children’s product in a notice required under these rules, and determines that there is no change to the information for the product except the number of products sold or offered for sale submitted to the Authority in the previous notice, the manufacturer may, in lieu of including the children’s product again in a subsequent notice, submit a written statement, or if available, an electronic notification indicating that the previous reported data is still valid for that children’s product. The notification shall include the number of products sold or offered for sale during the biennial notice period.

(9) A trade association may provide the notice required in these rules on behalf of a member manufacturer. If a trade association reports on a member manufacturer’s behalf, the trade association must specify which member or members the association is reporting on behalf of, including the name and contact information of a representative for each of those members, and must submit the fees for each member as required in OAR 333-016-2080.

(10) A trade association who fulfills the notice or exemption from notice requirements as well as waiver or hazard assessment requests in these rules on behalf of a member manufacturer will not be held liable for a violation or penalty as a result of the member manufacturer’s noncompliance with the requirements of these rules.

(11) A manufacturer may, during the notification process, submit to the Authority recommendations regarding technical, financial or logistical support considered necessary for the implementation of innovation and green chemistry solutions related to HPCCCH used in children’s products.

(12) Only one person or entity that falls within the definition of manufacturer is required to report with respect to a particular children’s product. The Authority will hold the following primarily responsible for ensuring that it receives a complete, accurate, and timely notice for the children's product, in the following order:

(a) Any person or entity that manufactured the children's product, unless it has no presence in the United States.

(b) Any person or entity that distributed or made available for distribution the children's product, unless it has no presence in the United States.

(c) The importer or owner of the children's product in the United States.

(13) The Authority will enforce the reporting requirements in this rule against a manufacturer in the same order as the priority order for reporting in section (12) of this rule.

(14) If a manufacturer has included a children’s product in a notice required under these rules, and removes the HPCCCH from that children’s product it shall, within 180 days of removal, submit a written statement, or if available, an electronic notification indicating the HPCCCH that was removed, whether another HPCCCH was substituted and the date the removal was effective, unless the Authority has already been notified under OAR 333-016-3010(1). Such notification will help the Authority avoid any unnecessary enforcement actions because of a failure to report or failure to comply with the other requirements of these rules.

Statutory/Other Authority: ORS 413.042 & 431A.258
Statutes/Other Implemented: ORS 431A.258
History:
PH 56-2023, amend filed 12/15/2023, effective 01/01/2024
PH 91-2021, amend filed 12/29/2021, effective 01/01/2022
PH 40-2021, temporary amend filed 08/26/2021, effective 08/26/2021 through 02/21/2022
PH 9-2021, amend filed 02/28/2021, effective 03/01/2021
PH 253-2018, amend filed 09/11/2018, effective 10/01/2018
PH 5-2017, f. 1-31-17, cert. ef. 2-1-17
PH 34-2016, f. & cert. ef. 12-1-16

333-016-2065
Formal Communications Regarding Toxic Free Kids

Formal communication between manufacturers or trade associations and the Authority relating to waiver, chemical substitution, chemical removal, or exemption requests, and their fees, shall be to and from ToxicFreeKids.Program@dhsoha.state.or.us.

Statutory/Other Authority: ORS 413.042 & ORS 431A.258
Statutes/Other Implemented: ORS 431A.258
History:
PH 9-2021, adopt filed 02/28/2021, effective 03/01/2021

333-016-2070
Exemptions from Notice Requirement

(1) A manufacturer of children’s products with annual worldwide gross sales of less than $5 million, as reported on the most recent tax return filed by the manufacturer before the notification required under OAR 333-016-2060, is exempt from all the requirements of these rules.

(2) If, following the filing of the most recent tax return, a manufacturer’s annual worldwide gross sales are $5 million or more, the manufacturer must submit a notice as required under OAR 333-016-2060. The notice must be submitted during the next applicable reporting period or within 180 days of the filing, whichever is later.

(3) A manufacturer or trade association may submit to the Authority a request for an exemption from these rules if the HPCCCH in a children’s product is present only as a contaminant at or above the de minimis level, and a manufacturing control program (MCP) is in place. A request for an exemption must be accompanied by any applicable fees in OAR 333-016-2080.

(a) An exemption request submitted by a trade association on behalf of its members must identify each member for which the exemption is being requested, including the name and contact information of a representative for each of those members.

(b) A request for an exemption from these rules by any entity must be received by the Authority before the last day (December 31st) of the two-year biennial notice period.

(4) In order to meet the standards for an exemption an MCP must be structured using at least one of the following categories:

(a) Manufacturing processes, for example polymerization of plastic resin, injection-molding of plastic, pad-transfer printing, silk screening;

(b) Materials or group of materials, for example multiple styrenic plastics;

(c) Component parts;

(d) A HPCCCH present as a contaminant at or above the de minimis level; or

(e) Finished products.

(5) In addition to the information provided in section (4) of this rule a manufacturer or a trade association must document in its exemption request the specific HPCCCH present as a contaminant at or above the de minimis level that the MCP is intended to address and the product categories where the HPCCCH are found. MCPs submitted in support of an exemption request by a trade association on behalf of a member or members must include the product categories for which each member is seeking an exemption.

(6) In order for the manufacturer to demonstrate that an MCP meets the minimum standards for an exemption, the MCP must meet generally-recognized industry best manufacturing practices and processes for the control of a HPCCCH, such as but not limited to:

(a) The most current and appropriate International Standards Organization (ISO) requirements for a specific manufacturing process or facility. The manufacturer must demonstrate how the ISO certification held by the manufacturer or supplier is controlling the contaminant in a component part or in the finished children’s product.

(b) Another established certification or standards manufacturing control program such as, but not limited to, Sony Corporations Green Partners Standards, the European ROHS (Restriction of Hazardous Substances in Electronic Parts), and EN-71.

(c) The most current American Society for Testing and Materials (ASTM) International standards that provide the recommended industry standards for materials used or produced in the manufacturing process;

(d) Any proven alternative methodology that will enable the manufacturer to demonstrate:

(A) That the methodology controls the contaminant to the lowest practicable levels in the finished children’s product; and

(B) That the alternative methodology is as or more effective at controlling the contaminant than the standards in subsections (a) through (c) of this section.

(7) For any category described in section (4) of this rule a manufacturer must provide adequate evidence that the contaminant is being controlled, including but not limited to:

(a) Periodic laboratory test reports from a third-party laboratory accredited to the current ISO/IEC 17025 standards by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) mutual recognition arrangement. The laboratory must be accredited for the method used to conduct the testing. The testing must show the presence, if quantifiable, and the amount of a HPCCCH, including documentation that characterizes the test methodology.

(b) A supplier’s certificate of analysis documenting the maximum levels of contaminant in any category described in section (4) of this rule for which the exemption is being requested. A certificate of analysis must include:

(A) The name and address of the laboratory that performed the tests;

(B) The name and description of the product or material being tested, including, if known, the batch number used by the original manufacturer;

(C) The date of the batch’s manufacture;

(D) A description of methodology employed to take samples from the batch to ensure that samples are representative of the product or material being tested;

(E) A reference to the analytical laboratory test method used, including the data quality assurance criteria and reporting limits;

(F) The results of all analytical laboratory tests performed on the batch for which the certificate is issued (in numerical form, where applicable) and a comparison with the established acceptance criteria (limits);

(G) The date or dates on which the test or tests were performed; and

(H) The signature of an authorized representative of the laboratory, and the contact information for that individual.

(c) Documentation demonstrating that the instituted control measures are able to control the contaminant, as appropriate for the category described in section (4) of this rule, including but not limited to, the quantification of the degree of contaminant control occurring because of contaminant control measures instituted.

(8) In addition to meeting one of the requirements of section (6) of this rule a manufacture must document and describe, in its exemption request, whether the manufacturer’s or the manufacturer’s supplier’s manufacturing control process, include any of the following:

(a) Procedures to ensure the quality and purity of feedstock, whether raw or recycled;

(b) Contract specifications for manufacturing process parameters, for example material purity, drying and curing times when relevant to the presence of high priority chemicals in the finished children’s product components;

(c) Periodic testing that is for the presence and amount of HPCCCH in the finished children's product, including documentation of how tests were conducted and applicable lab results from an accredited third-party laboratory that meets the standards in subsection (7)(a) of this rule;

(d) Procedures and approaches to audit the methods used by contractors or suppliers to control a HPCCCP present as a contaminant in a children’s product; and

(e) Education and outreach to members of a supply chain about the importance to the manufacturer of controlling the amount of HPCCCH in supplied materials through activities such as discussions with suppliers, oral presentations, written materials or webinars.

(9) The Authority, upon receipt of an exemption request will date stamp the document. Once date stamped the Authority must approve or deny an exemption request within 180 days.

(a) If the Authority does not approve or disapprove the exemption request within 180 days the manufacturing control program exemption is deemed approved.

(b) If the Authority approves the exemption the Authority will notify the manufacturer of the approval, in writing.

(c) If an exemption request is disapproved, the Authority will provide written notice to the manufacturer of the disapproval and the reason for the disapproval.

(10) If the Authority disapproves an exemption request, the manufacturer may submit a revised exemption request for consideration within 180 days after the Authority’s notice of disapproval.

(11) If the exemption request is denied a second time, the manufacturer will have 90 days from the date of the written notification of disapproval to submit a notification in accordance with OAR 333-016-2060.

(12) A manufacturer who has been denied an exemption request a second time may submit a new exemption request under section (3) of this rule during future biennial notice periods.

(13) At any time the Authority may request additional information from a manufacturer requesting an exemption, and may specify the time period by which the manufacturer must provide the requested information

(14) A manufacturer or trade association may request an amendment of an MCP previously approved by the Authority. A request must be made at least 30 days before the next biennial notice period. Such amendments are limited to the following:

(a) The addition of product categories to an MCP provided that the HPCCCH in the manufacturing of products in these added categories is monitored and controlled, at all stages, with the specific mechanisms, tests and processes itemized in the approved MCP.

(b) Changes in the specific mechanisms, tests and processes identified in an approved MCP that are used to control an HPCCCH.

(c) The inclusion of additional members for specific product categories on an MCP approved by the Authority provided those members use all specific mechanisms, tests and processes itemized on the approved MCP for those product categories.

(15) The Authority may impose an MCP review fee under OAR 333-016-2080(1)(b)(B) for review of a request to amend an approved MCP.

(16) Within 90 days the Authority will inform the holder of the approved exemption request if the proposed amendment to the MCP still meets the standards for exemption as described in these rules.

(17) Trade associations seeking to include additional members on an MCP approved by the Authority in accordance with subsection (14)(c) of this rule shall submit a new exemption request as specified in section (3) of this rule. A request to add a member manufacturer to an approved MCP must include the product categories for which each member manufacturer is seeking exemption from these rules.

(18) A trade association must notify the Authority within 90 days of the date it determines a manufacturer member listed on an approved MCP is no longer party to an approved MCP.

(19) An approved MCP is only valid for the manufacturer that submitted it for approval. If a manufacture with an approved MCP merges with or is acquired by another business entity the new controlling entity must send a notice to the Authority within 90 days confirming that the specific mechanisms, tests and processes itemized in the previously approved MCP will continue to be utilized, or the exemption will be considered by the Authority to be invalid.

Statutory/Other Authority: ORS 413.042, 431A.258 & 431A.268
Statutes/Other Implemented: ORS 431A.258 & 431A.268
History:
PH 9-2021, amend filed 02/28/2021, effective 03/01/2021
PH 5-2017, f. 1-31-17, cert. ef. 2-1-17
PH 34-2016, f. & cert. ef. 12-1-16

333-016-2080
Fees

(1) The following fees are established:

(a) Notification. A nonrefundable fee of $250 for the notification of each HPCCCH reported to the Authority under OAR 333-016-2060(1).

(b) Exemption request made under OAR 333-016-2070(3) or an amendment to an exemption request under OAR 333-016-2070(14)(b):

(A) A non-refundable fee of $1,500; and

(B) $200 per hour for review of an MCP.

(c) Request for waiving requirement to remove or substitute chemicals:

(A) A non-refundable fee of $1,500; and

(B) $200 per hour for review of an Alternatives Assessment or a Quantitative Exposure Assessment.

(d) Request to substitute chemicals:

(A) A non-refundable fee of $1,500; and

(B) $200 per hour for review of a Hazard Assessment conducted with an alternative methodology under OAR 333-016-3030(4).

(e) A non-refundable fee of $1,500 for a request to be exempt from removal or substitution requirements under OAR 333-016-3015.

(2) The Authority will not accept an exemption request per OAR 333-016-2070(3) and (14)(b) or OAR 333-016-3015; a waiver to remove or substitute chemicals; a request to substitute chemicals; or a request to be exempt from removal or substitution requirements under OAR 333-016-3015 unless the non-refundable fee under this rule is submitted along with the request.

(3) Prior to reviewing a request for a waiver, chemical substitution, exemption OAR 333-016-2070 and (14)(b) or a Hazard Assessment conducted with an alternative methodology under OAR 333-016-3030(4), the Authority will send the applicant an estimate for the cost of the review. Unless the applicant informs the Authority in writing within seven business days of the date the fee estimate was sent, objecting to the estimate, the Authority will consider the estimate to be acceptable and will send an invoice to the applicant once the review of complete.

(4) If an applicant objects to the estimate within seven business days the Authority will not review the request and the applicant may do one of the following:

(a) Submit a second version of the initial request within 30 calendar days of the date the applicant submitted its objection to the Authority, in which case no additional application fee is required; or

(b) Submit a new request and $1,500 non-refundable fee, if more than 30 days has passed since the applicant submitted its objection to the Authority; or

(c) Comply with OAR 333-016-3010(3) or 333-016-2060.

(5) If a second version of the initial request is submitted under section (4)(a) of this rule or if a new request is submitted under (4)(b) of this rule, the Authority will provide a new estimate of the cost of the review. The Applicant will have seven calendar days to respond by either accepting or declining the estimate. If the estimate is declined or a response is not received within seven business days, the Authority will consider the request for a waiver, chemical substitution, exemption under OAR 333-016-2070(3) and (14)(b), or Hazard Assessment conducted with an alternative methodology under OAR 333-016-3030(4) to be incomplete and the request will not be reviewed. The Authority will not accept a third version of the initial request or another 'new request' and the manufacturer of the children's products for which the exemption, waiver or substitution request was made must comply with the applicable Oregon Administrative Rules.

(6) If in the course of its review the Authority expects the actual number of hours to exceed the estimate by more than 15 percent the Authority will stop the review and send a new estimate to the applicant. Within seven business days from the date the new estimate was sent the applicant must do one of the following:

(a) Accept the revised estimate by agreeing to pay for the new estimated amount; or

(b) Decline the new estimate and the Authority will consider the request for a waiver, chemical substitution, or exemption incomplete, and the request will not be reviewed. The Authority will invoice the Applicant for the actual hours spent on the review.

(7) The process delineated in Sections 3 through 6 of this rule also applies to revised requests for a waiver, chemical substitution, an exemption under OAR 333-016-2070(3) and (14), or a Hazard Assessment conducted with an alternative methodology under OAR 333-016-3030(4) .

(8) An applicant must pay its review fees within 30 days of receipt of the invoice.

Statutory/Other Authority: ORS 413.042 & 431A.270
Statutes/Other Implemented: ORS 431A.270
History:
PH 9-2021, amend filed 02/28/2021, effective 03/01/2021
PH 253-2018, amend filed 09/11/2018, effective 10/01/2018
PH 5-2017, f. 1-31-17, cert. ef. 2-1-17

333-016-3010
Removal or Substitution of High Priority Chemicals

(1) On or before the date on which a manufacturer of a children’s product must submit the third biennial notice required under OAR 333-016-2060 for a HPCCCH that is present in a children’s product, the manufacturer must remove or make a substitution, or seek a waiver under OAR 333-016-3040 if the HPCCCH is present in a children’s product that is:

(a) Mouthable;

(b) A children’s cosmetic; or

(c) Made for, marketed for use by or marketed to children under three years of age.

(2) A manufacturer with 25 or fewer employees may apply for a two-year extension of the date specified in ORS 431A.260 to meet the requirements of these rules. To apply for an extension a manufacturer must submit a request for an extension. A request for an extension must:

(a) Be received by the Authority on or before the date on which the manufacturer of a children’s product is obligated to submit the third biennial notice required under ORS 431A.260.

(b) Include documentation that the manufacturer had an average of 25 or fewer employees on its payroll during the third biennial notice period and the number of employees currently employed by the manufacturer.

(3) A manufacturer that has previously reported a HPCCCH to the Authority and later removes the HPCCCH from a children’s product sold or offered for sale in Oregon and does not substitute another chemical or is no longer manufacturing such a product, must submit notice to the Authority that the manufacturer is no longer using the chemical or a substitute chemical or manufacturing the product. The notice must be submitted no later than the last day (December 31st) of the third biennial notice period. The notice shall include:

(a) The product category of the children’s product;

(b) The brand names under which it is sold in Oregon and the model numbers of the children’s product associated with those brand names; and

(c) Universal Product Code or Stock Keeping Unit codes, style codes or other mechanisms sufficient to identify product models sold in Oregon, which have been assigned by the manufacturer.

(4) From the date that the notice under section (3) of this rule is submitted, the manufacturer has 90 calendar days to:

(a) Cease selling or offering for sale in Oregon the children’s product; and

(b) Provide notice to all known distributers and retailers to whom the product was distributed that the product may no longer be sold or offered for sale in Oregon. To identify affected units of such children’s products, the notice shall include Universal Product Code, Stock Keeping Unit codes, style codes or other mechanisms sufficient to identify the affected product models.

(5) Units identified in this rule may no longer be sold or offered for sale in Oregon.

(6) Manufacturers shall provide the Authority with the notice in subsection (4)(b) of this rule and a list of known distributers and retailers to whom notice was given.

(7) A manufacturer that intends to substitute a HPCCCH pursuant to ORS 431A.263 must comply with OAR 333-016-3030.

Statutory/Other Authority: ORS 413.042, ORS 431A.260 & ORS 431A.268
Statutes/Other Implemented: ORS 431A.260
History:
PH 9-2021, adopt filed 02/28/2021, effective 03/01/2021

333-016-3015
Exemptions from Removal or Substitution Requirements

(1) For purposes of this rule "children’s product" is a children’s product as defined in ORS 431A.253 that is:

(a) Mouthable;

(b) A children’s cosmetic; or

(c) Made for, marketed for use by or marketed to children under three years of age.

(2) A manufacturer is exempt from meeting the requirement of removal or substitution of a HPCCCH in a children’s product under ORS 431A.260 if one or more of the following is met:

(a) The children’s product contains a HPCCCH used in children’s products at levels that are at or below allowable levels for children’s products as established by the Consumer Product Safety Improvement Act of 2008, P.L. 110-314, 122 Stat. 3016, as in effect on July 27, 2015.

(b) A manufacturer is in compliance with a federal consumer product safety standard adopted under federal law that establishes allowable levels for children’s products of a high priority chemical of concern for children’s health used in children’s products.

(c) The State of Washington has granted an exemption for the removal or substitution of a HPCCCH in the same children’s product model for which the exemption is requested under OAR 333-016-3015.

(d) A children’s product has been tested under applicable EN-71 standards, by a laboratory that is accredited to conduct such testing under the current edition of ISO/IEC 17025 by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation mutual recognition arrangement.

(3) More than one product model may be submitted in a single exemption request.

(4) In order to be exempt under one or more of the categories in section (2) of this rule a manufacturer must submit an exemption request and the fees specified in OAR 333-016-2080(1)(e) and provide to the Authority written supporting documentation, an electronic copy of the certificate of conformity, if available, that is issued by the applicable authority or an authorized designate, and any other supporting documentation that provides evidence that the children’s product meets the applicable standards described in the applicable category including:

(a) For an exemption request under subsection (2)(a) of this rule, the citation for the section of the Consumer Product Safety Improvement Act of 2008, P.L. 110-314, 122 Stat. 3016, in effect on July 27, 2015, naming the HPCCCH.

(b) For an exemption request under subsection (2)(b) of this rule, a citation to the federal consumer product safety standard adopted under federal law that establishes an allowable level of a HPCCCH in children’s products, specific to allowable levels of the HPCCCH in children’s products.

(c) For an exemption request under subsection (2)(c) of this rule, a copy of the manufacturer’s request for exemption under the applicable State of Washington law and the exemption approval from that state.

(d) For an exemption request under subsection (2)(d) of this rule, an electronic copy of an actual certificate of conformity issued for the product or products for which exemption is being requested, establishing that the product or products meets current EN-71 standards applicable to the HPCCCH and product type for which an exemption is being sought.

(5) The specific children’s products for which exemption is being sought under section (2) of this rule must be identified by manufacturers as specified in OAR 333-016-3010(3)(a) through (c).

(6) This written documentation must be submitted in its entirely to the Authority on or before the date on which the manufacturer is required to submit the third biennial notice under ORS 431A.258 and OAR 333-016-2060.

(7) The Authority will approve or disapprove an exemption request made under section (2) of this rule in writing within 180 days from receipt of all of the documentation required in the rule, explaining the basis of the approval or denial.

(a) If the Authority does not approve or disapprove the exemption request made under section (2) of this rule within 180 days of its submission, the exemption is deemed approved.

(b) If disapproved, a manufacturer may not resubmit an exemption request.

(8) If a manufacturer is granted an exemption under subsection (2)(c) of this rule and subsequently the State of Washington withdraws the approval for the exemption, the manufacturer must immediately notify the Authority and come into compliance with ORS 431A.260 and these rules.

Statutory/Other Authority: ORS 413.042 & ORS 431A.260
Statutes/Other Implemented: ORS 431A.260
History:
PH 9-2021, adopt filed 02/28/2021, effective 03/01/2021

333-016-3020
Requirements for Chemical Substitution

(1) For purposes of this rule a "children’s product" is a children’s product as defined in OAR 333-016-3015(1) that is:

(a) Mouthable;

(b) A children’s cosmetic; or

(c) Made for, marketed for use by or marketed to children under three years of age.

(2) When a manufacturer of a children’s product that is sold or offered for sale in Oregon removes a HPCCCH as required in ORS 431.260 and intends to sell the product in Oregon with a substitute chemical, the manufacturer must provide or submit to the Authority no later than the last day (December 31st) of the third biennial notice period for the product:

(a) A Hazard Assessment (HA) that meets the requirements in OAR 333-016-3030; and

(b) The fees specified in OAR 333-016-2080.;

(3) The Authority must either approve or disapprove a HA within 180 days of the receipt of a HA and the information and fees required in section (2) of this rule.

(4) During its review of the HA the Authority may request additional information from the manufacturer at any time and must specify the time period by which the manufacturer must provide the requested information.

(5) If the Authority does not approve or disapprove the HA within 180 days from receipt of all of the information and fees required in section (2) of this rule the HA is deemed approved and the manufacturer may continue to sell or offer for sale in Oregon the children’s product for which the manufacturer submitted a HA.

(6) If the Authority approves the HA it will notify the manufacturer of the approval, in writing.

(7) If the Authority disapproves a HA it will provide written notice to the manufacturer of the disapproval and the basis for the disapproval.

(8) If the Authority disapproves a HA the manufacturer may submit a revised HA within 180 days after the date of the Authority’s notice of disapproval that meets the requirements of this rule. The payment of non-refundable fees in OAR 333-016-2080 is not required for a resubmitted HA.

(9) A revised HA is subject to the same requirements as an initial HA under this rule and the Authority will review and approve or disapprove a revised HA in the same manner as an initial HA.

(10) If the Authority disapproves an initial HA and no revised HA is submitted, the manufacturer has 90 calendar days to comply with OAR 333-016-3010(4) through (6).

(11) The Authority will not consider any additional information it did not request that has been provided by a manufacturer and received by the Authority more than seven business days after the revised HA conducted with an alternative hazard assessment methodology (OAR 333-016-3030(4)) is submitted to the Authority.

(12) A manufacturer may request a HA for one or more product models or styles.

(13) If a manufacturer requests a HA for more than one product model or style, the Authority may approve or disapprove a request in whole or in part, based on criteria established in these rules.

(14) Trade associations may submit a HA on behalf of specified member manufacturers if the following conditions are met for each HA submitted:

(a) The HA meets the requirements in OAR 333-016-3030.

(b) The fees are paid as specified in OAR 333-016-2080.

(c) The products are identified on which a HA has been conducted for each participating manufacturer as specified in OAR 333-016-3010(3)(a) through (c). This list of identified products shall include the name and contact information of a representative for each specified member manufacturer.

Statutory/Other Authority: ORS 413.042 & ORS 431A.263
Statutes/Other Implemented: ORS 431A.263
History:
PH 9-2021, adopt filed 02/28/2021, effective 03/01/2021

333-016-3030
Hazard Assessment for Substitute Chemicals

(1) A manufacturer must conduct a Hazard Assessment (HA) of the substitute chemical that includes:

(a) A report:

(A) By a Licensed GreenScreen Profiler using GreenScreen® for Safer Chemicals Hazard Assessment Guidance (GreenScreen methodology) that assesses the hazard level of the substitute chemical or chemicals; or

(B) Using an Authority approved methodology as described in section (4) of this rule.

(b) Information about each product model containing the HPCCCH and each final product model containing the substitute chemical that will enable the Authority to determine if the final children’s product is inherently less hazardous than before. The information provided shall include but is not limited to:

(A) A high-resolution image of the product model in JPEG or PDF form.

(B) Identification of products on which a HA is conducted by manufacturers as specified in OAR 333-016-3010(3)(a) through (c).

(C) A complete list of the product model’s components containing a HPCCCH at or above de minimis levels. For each component, the amount of HPCCCH in the component should be expressed as parts per million. The substitute chemical in each component of final product model should be expressed as parts per million. The HPCCCH and substitute chemical(s) shall be listed with their Chemical Abstract Numbers.

(2) The Authority will not approve a HA for a substitute chemical that has a hazard level score of 'high' or greater as determined by the GreenScreen methodology or Authority approved methodology for any of the following human health endpoints:

(a) Reproductive toxicity;

(b) Developmental toxicity;

(c) Endocrine activity; or

(d) Skin sensitization.

(3) For a HA submitted with an assessment from a Licensed GreenScreen Profiler:

(a) A HPCCCH is considered by the Authority to be comparable to a chemical that has a GreenScreen Benchmark score of 1.

(b) A substitute chemical is considered to be inherently less hazardous if it is assigned a GreenScreen Benchmark score of 2, 3 or 4, and is in compliance with section (2) of this rule.

(4) A manufacturer may request that the Authority approve an alternative methodology for conducting a HA that exists in the public domain, is hazard-focused, considers the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) categorization method of health hazard, and is comparable to the GreenScreen Guidance methodology of this rule, including having an equivalent or stricter health hazard criteria for the human health endpoints described below:

(a) Carcinogenicity;

(b) Genotoxicity and mutagenicity;

(c) Reproductive toxicity;

(d) Developmental toxicity;

(e) Endocrine activity;

(f) Acute toxicity;

(g) Systemic toxicity;

(h) Neurotoxicity;

(i) Skin sensitization;

(j) Respiratory sensitization;

(k) Skin irritation; or

(l) Eye irritation.

(5) Prior to conducting a HA using a methodology other than the GreenScreen methodology a manufacturer must submit detailed information about the methodology it proposes to use and a detailed analysis comparing the methodology to the GreenScreen Guidance methodology.

(a) Requests to use a HA methodology other than the GreenScreen methodology must be made at least 90 business days before the date the manufacturer submits the Hazard Assessment.

(b) The Authority will review the request and within 60 business days respond in writing to the manufacturer either approving or denying the request.

(6) The Authority will accept a HA that demonstrates with scientifically supported objective data that the children’s product and any substituted chemical is inherently less hazardous than before the substitution was made.

(7) For purposes of this rule and OAR 333-016-3060, the Authority:

(a) Finds that the GreenScreen methodology is scientifically supported by objective data;

(b) Finds that an assessment by a licensed GreenScreen Profiler contains sufficient protocols and safeguards to ensure that the assessment is reliable; and

(c) Will consider an assessment conducted by a licensed GreenScreen Profiler using the GreenScreen methodology that shows a children’s product and any substitute chemical is inherently less hazardous than before the substitution was made, to be sufficient to approve a HA, assuming all other provisions of this rule and OAR 333-016-3030 have been met.

(8) A HA approved by the Authority may be used to apply to a new product if the composition of the new product is substantially similar to that specified in an approved HA and differs only in ways that do not affect the HPCCCH's behavior in the product. Differences may include, but are not limited to, packaging, size/volume, product name, and other minor aesthetic differences, and if all of the following are demonstrated for the new product:

(a) The chemical composition of the new product is substantially similar to those in an approved HA;

(b) There are not any HPCCCHs at or above de minimis levels in addition to those in a product that has an approved HA; and

(c) Neither the concentration of the HPCCCH nor its mobility from the new product has increased from those in the referenced product.

(9) To substantiate a claim that an HA approved by the Authority applies to a new product, manufacturers shall submit all of the following:

(a) A copy of the reference HA approved by the Authority;

(b) Documentation demonstrating compliance with section (8) of this rule, which must include the signature, on an application form provided by the Authority, of an authorized representative of the manufacturer bringing products into Oregon, with knowledge and authority to attest to the veracity of the information submitted under section (8) of this rule; and

(c) Identification of new affected products as specified in subsection (1)(b) of this rule.

Statutory/Other Authority: ORS 413.042, ORS 431A.263 & ORS 431A.265
Statutes/Other Implemented: ORS 431A.263 & ORS 431A.265
History:
PH 9-2021, adopt filed 02/28/2021, effective 03/01/2021

333-016-3040
Waiver from Removal or Substitution Requirement

(1) For purposes of applying for a waiver from the removal or substitution requirement in ORS 431A.260 "children’s product" is a children’s product that is:

(a) Mouthable;

(b) A children’s cosmetic; or

(c) Made for, marketed for use by or marketed to children under three years of age.

(2) A manufacturer may request a waiver from the requirement to remove or substitute a chemical under ORS 431A.260 for one or more product models or styles. An application for a waiver must include:

(a) A Quantitative Exposure Assessment (QEA) that meets the requirements of OAR 333-016-3050; or

(b) An Alternatives Assessment (AA) that meets the requirements of OAR 333-016-3060.

(3) An application for a waiver under this rule must be accompanied by the fees specified in OAR 333-016-2080 and the following information:

(a) The name, address, telephone number and other contact information for the manufacturer; and

(b) The information required in OAR 333-016-2060(4)(a) through (i) for each children’s product category or children’s cosmetics for which a waiver is being requested, based on the information reported in the most recent Biennial Notice Period.

(4) The Authority will not consider any additional information from the manufacturer it did not request, that is received by the Authority more than seven business days after a manufacturer submits a QEA, AA or an HA to the Authority.

(5) The Authority must either approve or disapprove a waiver request within 180 days of the receipt of a request and the fees required in sections (2) and (3) of this rule.

(6) During its review of the waiver request the Authority may request additional information from the manufacturer that submitted the request at any time and must specify the time period by which the manufacturer must provide the requested information.

(7) If the Authority does not approve or disapprove the waiver request within 180 days from receipt of the information and fees required in sections (2) and (3) of this rule the request is deemed approved and the manufacturer may continue to sell or offer for sale in Oregon the children’s product for which the manufacturer submitted an AA or QEA.

(8) If the Authority approves a waiver request the Authority will notify the manufacturer of the approval, in writing.

(9) If the Authority disapproves a waiver request it will provide written notice to the manufacturer of the disapproval and the basis for the disapproval.

(10) If the Authority disapproves a waiver request the manufacturer may submit a revised waiver request that meets the requirements of this rule within 180 days after the date of the Authority’s notice of disapproval. The payment of non-refundable fees in OAR 333-016-2080 is not required for a resubmitted waiver request.

(11) A revised waiver request is subject to the same requirements as an initial waiver request under this rule and the Authority will review and approve or disapprove a revised waiver request in the same manner as an initial request.

(12) If the Authority disapproves a revised waiver request, or the Authority disapproves an initial request and the manufacturer does not submit a revised waiver request, the manufacturer has 90 calendar days to comply with OAR 333-016-3010(4) through (6).

(13) A manufacturer who has had an initial or revised waiver request disapproved who intends to remove the chemical or substitute a chemical may do so in compliance with these rules but may not sell or offer to sell the children’s products unless and until the HPCCCH that is the subject of a the notice requirement in ORS 431A.258 is removed and notice is given to the Authority or the Hazard Assessment for a substitute chemical has been approved by the Authority.

(14) The Authority will disapprove any waiver request from a manufacturer that submits fraudulent information.

(15) Trade associations may submit an application for a waiver on behalf of specified member manufacturers if the following conditions are met for each waiver submitted:

(a) The waiver application follows the requirements of section (2) of this rule.

(b) The fees are submitted as specified in OAR 333-016-2080.

(c) The products are identified on which a QEA or AA has been conducted for each participating manufacturer as specified in OAR 333-016-3010(3)(a) through (c). This list of identified products shall be listed by manufacturer and shall include the name and contact information of a representative for each specified member manufacturer.

(16) If a manufacturer requests a waiver for more than one product model or style, the Authority may approve or disapprove a request in whole or in part, based on criteria established in these rules.

Statutory/Other Authority: ORS 413.042, ORS 431A.263 & ORS 431A.265
Statutes/Other Implemented: ORS 431A.263 & ORS 431A.265
History:
PH 9-2021, adopt filed 02/28/2021, effective 03/01/2021

333-016-3050
Quantitative Exposure Assessment

(1) For purposes of this rule, "inaccessible" means a HPCCCH that cannot be absorbed, swallowed, mouthed, or inhaled through normal and reasonably foreseeable use and abuse of the product.

(2) A Quantitative Exposure Assessment (QEA) must demonstrate that a HPCCCH in a children’s product is not reasonably anticipated to result in exposure to a child based on an analysis of the leachability and bioavailability of the HPCCCH.

(3) A QEA may be done in two steps, as follows:

(a) A description of exposure scenario(s) that demonstrates that a HPCCCH in a children’s product is inaccessible to the consumer or otherwise could not reasonably be anticipated to be transferred to or into a child’s body through a completed exposure pathway because of leachability and bioavailability of a HPCCCH from the children’s product. Exposure scenarios must focus on the reasonably foreseeable use and abuse of the specified children’s product.

(b) If the manufacturer determines that the exposure scenarios, through reasonably foreseeable use and abuse of the specified children’s product, are reasonably anticipated to result in a completed exposure pathway to a child regardless of the amount of HPCCCH potentially transferred, the manufacturer shall submit information on the leachability and bioavailability of HPCCCH from a product, including measurements of the concentration of a HPCCCH in the simulated media such as saliva, sweat, or digestive fluid appropriate for the exposure scenarios, using analytical methods relevant to the chemical and the product. The manufacturer must also submit a copy of any analytical test results for the HPCCCH in each media tested that include:

(A) The specific analytical methods or source of information utilized to determine the concentration of the HPCCCH in media relevant for each exposure pathway.

(B) The detection limit for each HPCCCH for each analytical instrument used for the testing in each medium tested.

(c) If a manufacturer determines that, based on exposure scenarios, a HPCCCH is inaccessible or cannot reasonably be anticipated to be transferred to or into a child’s body through a completed exposure pathway because of leachability and bioavailability and only conducts the first step of the QEA as described in section (3)(a) of this rule, the manufacturer shall provide a detailed report and analysis to the Oregon Health Authority (Authority) that demonstrates to the Authority’s satisfaction, that a child would not be exposed to a HPCCCH.

(4) A QEA must include citations from scientific literature for any assertion made.

(5) Laboratory analysis done for purposes of a QEA must be conducted by a laboratory accredited to ISO/IEC 17025 as described in OAR 333-016-2070(7)(a).

(6) To enable accurate identification of children’s products on which a QEA is conducted, such products must be identified by manufacturers as specified in OAR 333-016-3010(3)(a) through (c).

(7) In order to be approved a QEA must demonstrate that HPCCCH concentrations measured in the media are less than or equal to the Practical Quantification Limit of the HPCCCH established in OAR 333-016-2035(2), Exhibit A, incorporated by reference.

(8) If the Authority determines that there are exposure scenarios for which a completed exposure pathway is possible through reasonably foreseeable use and abuse of the specified children’s product, it will deny the QEA. The manufacturer may resubmit a revised request along with a completed QEA.

(9) A QEA approved by the Authority may be used to apply to a new product if the composition of the new product is substantially similar to those specified in an approved QEA and differ only in ways that do not affect the HPCCCH's behavior in the product. Differences may include, but are not limited to, packaging, size/volume, product name, and other minor aesthetic differences. The use of a QEA approved by the Authority in this manner is permitted if all of the following are demonstrated for the new product:

(a) The chemical composition of the new product is substantially similar to those in an approved QEA;

(b) There are not any HPCCCHs at or above de minimis in addition to those in the product specified in the approved QEA; and

(c) Neither the concentration of the HPCCCH nor its mobility from the product has increased from those in the referenced product.

(10) To substantiate a claim that a QEA approved by the Authority applies to a new product, manufacturers shall submit all of the following:

(a) A copy of the referenced QEA approved by the Authority;

(b) Documentation demonstrating compliance with section (9) of this rule, which must include the signature, on an application form provided by the Authority, of an authorized representative of the manufacturer bringing the product into Oregon, with the knowledge and authority to attest to the veracity of the information submitted under section (9) of this rule; and

(c) Identification of new affected products as specified in section (6) of this rule.

Statutory/Other Authority: ORS 413.042 & ORS 431A.265
Statutes/Other Implemented: ORS 431A.265
History:
PH 56-2023, amend filed 12/15/2023, effective 01/01/2024
PH 9-2021, adopt filed 02/28/2021, effective 03/01/2021

333-016-3060
Alternatives Assessment

(1) An Alternatives Assessment (AA) must evaluate the possibility of replacing chemicals in products or processes with an inherently safer alternative, in order to better protect and enhance human health.

(2) A manufacturer must conduct an AA by doing a Hazard Assessment (HA), Quantitative Exposure Assessment (QEA), technical feasibility assessment, and financial feasibility assessment, starting with an HA, except as specified in section (3) of this rule. The three remaining assessments may be conducted in any order.

(3) If, after HA and technical feasibility assessments are conducted, an alternate chemical substitute or substitutes is not found to be technically feasible, the financial feasibility assessment is not required.

(4) The HA for purposes of an AA must be conducted in accordance with OAR 333-016-3030.

(5) The QEA for purposes of an AA must be conducted in accordance with OAR 333-016-3050.

(6) To substantiate a claim that removal of a HPCCCH or substitution of a HPCCCH in a children’s product with a less hazardous chemical is not technically feasible, a manufacturer must provide to the Authority the following for each HPCCCH in a children’s product:

(a) A detailed analysis of the role of each HPCCCH in the product specified by function, its application in the product (in a material, component, or manufacturing process) and whether the HPCCCH or function is non-essential, substitutable, essential, or a contaminant;

(b) For HPCCCH roles labeled as substitutable or non-essential, an explanation with supporting evidence shall be provided that justifies retaining the HPCCCH in the children’s product;

(c) A detailed analysis of the role played by each HPCCCH if labeled as non-essential, substitutable, or essential in the product for the reliability, quality, useful life and acceptability to consumers of the product; and

(d) After an AA is conducted, a detailed explanation of why it not technically feasible for any identified alternate chemical substitutes to fulfill the roles specified in subsections (a) through (c) of this section.

(7) To substantiate a claim that removal or substitution of a HPCCCH is not financially feasible, a manufacturer must provide to the Authority a price comparison of the cost to produce the children’s product with an alternative chemical to the current cost to produce the product. The comparison must include:

(a) Direct costs along the value-chain, such as product reformulation;

(b) Retooling;

(c) Research or other capital investment costs;

(d) An evaluation of adequate supply to meet demand; and

(e) An evaluation of the potential reduction in price of the alternative chemical if the volume of the alternative chemical being purchased increases.

(8) An AA approved by the Authority may be used to apply to a new product if the composition of the new product is substantially similar to those specified in an approved AA and differ only in ways that do not affect the HPCCCH's behavior in the product. Differences may include, but are not limited to, packaging, size/volume, product name, and other minor aesthetic differences. The use of an AA approved by the Authority in this manner is permitted if all of the following are demonstrated for the new product:

(a) The chemical composition of the new product is substantially similar to those in an approved AA;

(b) There are not any HPCCCHs at or above de minimis in addition to those in a product specified in the approved AA; and

(c) Neither the concentration of the HPCCCH nor its mobility from the product has increased from those in the referenced products.

(9) To substantiate a claim that an AA approved by the Authority applies to a new product, manufacturers shall submit all of the following:

(a) A copy of the referenced AA approved by the Authority;

(b) Documentation demonstrating compliance with section (8) of this rule which must include the signature, on an application form provided by the Authority, of an authorized representative of the manufacturer bringing the product into Oregon with the knowledge and authority to attest to the veracity of the information submitted under section (8) of this rule; and

(c) Identification of the new affected products as specified in OAR 333-016-3010(3)(a) through (c).

Statutory/Other Authority: ORS 413.042, ORS 431A.263 & ORS 431A.265
Statutes/Other Implemented: ORS 431A.263 & ORS 431A.265
History:
PH 9-2021, adopt filed 02/28/2021, effective 03/01/2021

333-016-3070
Trade Secrets

(1) If a manufacturer submits information to the Authority in order to comply with these rules that the manufacturer believes is a trade secret, the manufacturer must mark the information "confidential – trade secret."

(2) If the Authority receives a public records request for information submitted by a manufacturer, it will review all documents submitted by the manufacturer to determine whether the documents contain trade secrets that would be exempt from disclosure under Oregon’s Public Records Act, ORS 192.501.

(3) For purposes of this rule "trade secret" has the meaning given that term in ORS 192.501.

Statutory/Other Authority: ORS 192.501, ORS 413.042 & ORS 431A.253 - 431A.280
Statutes/Other Implemented: ORS 431A.253 - 431A.280
History:
PH 9-2021, adopt filed 02/28/2021, effective 03/01/2021

333-016-3080
Enforcement and Civil Penalties

(1) The Authority may impose a civil penalty on a manufacturer for a violation of any provision of ORS 431A.258, 431A.260 or 431A.263, or these rules. A civil penalty may not exceed:

(a) $2,500 for the first violation.

(b) $5,000 for the second and each subsequent violation.

(2) For purposes of assessing civil penalties under these rules a violation consists of a single course of conduct with regard to an entire children’s product line that is sold or offered for sale in Oregon.

(3)(a) If a manufacturer violates the notification requirement described in ORS 431A.258 the Authority shall provide the manufacturer with written notice informing the manufacturer of the violation and stating that the manufacturer may avoid a civil penalty for the violation by providing the proper notice required under ORS 431A.258 within 90 days.

(b) If the manufacturer fails to cure the violation within the first 90 days, the Authority may impose a civil penalty not to exceed $2,500.

(c) For a continuing violation, each 90-day period that the violation continues after the preceding imposition of a civil penalty is considered a separate offense subject to a separate civil penalty not to exceed $5,000. The Authority is not required to provide the manufacturer with an opportunity to cure the continuing violation before imposing the separate civil penalty.

(4)(a) If a manufacturer continues to sell or offers for sale a product for which a chemical was required to be removed under ORS 431A.260, and the manufacturer does not have a pending or an approved waiver or hazard assessment request, the Authority shall provide the manufacturer with written notice informing the manufacturer of the violation. The notice shall state that the manufacturer may avoid a civil penalty by:

(A) Ceasing to sell or offer the product for sale; and

(B) Contacting any known entities who are distributing or selling the product in Oregon, advising them that the product can no longer be sold in Oregon, and providing documentation of those notifications to the Authority in accordance with OAR 333-016-3010(4) through (6); or

(C) Submitting proof to the Authority that it is not in violation as alleged in the notice.

(b) If the manufacturer does not submit proof that it is in compliance or fails to cure the violation within 90 days, the Authority may impose a civil penalty not to exceed $2,500.

(c) For a continuing violation, each day that the violation continues after the preceding imposition of a civil penalty is considered a separate offense subject to a civil penalty not to exceed $5,000. The Authority is not required to provide the manufacturer with an opportunity to cure the continuing violation before imposing the separate civil penalty.

(5) If the Authority has reason to believe that a children’s product that contains a HPCCCH used in children’s products is being sold or offered for sale in Oregon in violation of ORS 431A.258, 431A.260 or 431A.263 the Authority may request that the manufacturer provide a statement of compliance on a form provided by the Authority. The manufacturer must submit the statement of compliance within 30 days after receipt of a request. To prove compliance with ORS 431A.258, 431A.260 and 431A.263, the manufacturer must provide the Authority with proof that:

(a) The children’s product does not contain the HPCCCH at or above de minimis levels; or

(b) The manufacturer has previously provided the Authority with notice as required by ORS 431A.258; or

(c) The manufacturer is providing notice as required by ORS 431A.258; or

(d) The manufacturer or trade association has provided the Authority with an exemption request approved by the Authority under ORS 431A.260; or

(e) The manufacturer possesses a hazard assessment for a substitution approved by the Authority for the HPCCCH and products in question under ORS 431A.263; or

(f) The manufacturer possesses a waiver for the HPCCCH and products in question approved by the Authority under ORS 431A.265.

(6) Providing a notice under subsection (5)(c) of this rule does not exempt the manufacturer from compliance with the timelines for removal or substitution under ORS 431A.260, OAR 333-016-3015, ORS 431A.263, or OAR 333-016-3030.

(7) In imposing a penalty under these rules the Authority must consider the following factors:

(a) The past history of the manufacturer in taking all feasible steps or following all feasible procedures necessary or appropriate to correct any violation.

(b) Any prior violations of statutes, rules, orders or permits pertaining to HPCCCH used in children’s products.

(c) The gravity and magnitude of the violation.

(d) Whether the violation was a sole event, repeated or continuous.

(e) Whether the violation was a result of an unavoidable accident, negligence or an intentional act.

(f) The violator’s cooperativeness and efforts to correct the violation.

(g) The economic and financial conditions of the manufacturer incurring a penalty.

(h) The manufacturer’s declaration that a HPCCCH used in a children’s product is present only as a contaminant, and the manufacturer is able to provide evidence that a manufacturing control program for the contaminant that meets or exceeds the minimum requirements for a manufacturing control program in OAR 333-016-2070, which was approved by the Authority, was in place prior to the violation and that the manufacturer has exercised due diligence.

(i) Civil penalties will be imposed in the manner provided in ORS 183.745.

(8) The Authority will enforce the reporting requirements against a manufacturer in the same order as the priority order for reporting in OAR 333-016-2060(11).

Statutory/Other Authority: ORS 413.042 & ORS 431A.275
Statutes/Other Implemented: ORS 431A.275
History:
PH 9-2021, adopt filed 02/28/2021, effective 03/01/2021