Or. Admin. Code § 333-016-2010

Current through Register Vol. 63, No. 12, December 1, 2024

Section 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.

Or. Admin. Code § 333-016-2010

PH 29-2015, f. 12-29-15, cert, ef.1/1/2016; PH 9-2021, amend filed 02/28/2021, effective 3/1/2021; PH 56-2023, amend filed 12/15/2023, effective 1/1/2024

Statutory/Other Authority: ORS 413.042 & ORS 431A.253 - 431A.280

Statutes/Other Implemented: ORS 431A.253 - 431A.280