Section 69501.1 - Definitions(a) Terminology. When used in this chapter, the following terms, unless specified otherwise, have the meanings specified in this section: (1) "AA Reports" means Preliminary AA Reports, Final AA Reports, Abridged AA Reports, and/or AA Reports submitted for previously completed AAs, whichever is applicable. As applicable, "AA Report" also includes the AA Report Addendum for a Final AA Report or Abridged AA Report.(2) "Adverse air quality impacts" means indoor or outdoor air emissions of any of the air contaminants listed below that have the potential to result in adverse public health, ecological, soil quality, or water quality impacts: (A) California Toxic Air Contaminants as specified in title 17, California Code of Regulations, sections 93000 through 93001;(B) Greenhouse gases, which means any of the following gases:7. Sulfur hexafluoride; or8. Gases that exhibit the global warming potential hazard trait, as specified in section 69405.4;(D) Particulate matter that exhibits the particle size or fiber dimension hazard trait, as specified in section 69405.7;(E) Chemical substances that exhibit the stratospheric ozone depletion potential hazard trait, as specified in section 69405.8;(G) Tropospheric ozone-forming compounds, including compounds that exhibit the ambient ozone formation hazard trait, as specified in section 69405.1.(3) "Adverse ecological impacts" means any of the following direct or indirect effects on living organisms and/or their environments: (A) Adverse effects to aquatic, avian, or terrestrial animal or plant organisms or microbes, including: 1. Acute or chronic toxicity;2. Changes in population size, reductions in biodiversity, or changes in ecological communities; and3. The ability of an endangered or threatened species to survive or reproduce;(B) Adverse effects on aquatic and terrestrial ecosystems including:1. Deterioration or loss of environmentally sensitive habitats;2. Impacts that contribute to or cause vegetation contamination or damage; and3. Adverse effects on environments that have been designated as impaired by a California State or federal regulatory agency;(C) Biological or chemical contamination of soils; or(D) Any other adverse effect, as defined in section 69401.2(a), for environmental hazard traits and endpoints specified in article 4 of chapter 54.(4) "Adverse environmental impacts" means any of the following: (A) Adverse air quality impacts;(B) Adverse ecological impacts;(C) Adverse soil quality impacts;(D) Adverse water quality impacts; or(E) Exceedance of an enforceable California or federal regulatory standard relating to the protection of the environment.(5) "Adverse impacts" means adverse public health impacts and/or adverse environmental impacts.(6) "Adverse public health impacts" means any of the toxicological effects on public health specified in article 2 or article 3 of chapter 54, or exceedance of an enforceable California or federal regulatory standard relating to the protection of public health. Public health includes occupational health.(7) "Adverse soil quality impacts" means any of the following effects on soil function or properties: (A) Compaction or other structural changes;(C) Loss of organic matter; or(D) Soil sealing, meaning covering surface soil with a layer of impervious material or changing the nature of the soil so that it behaves as an impermeable medium.(8) "Adverse waste and end-of-life effects" means the waste materials and byproducts generated during the life cycle of a product, and the associated adverse effects due to one or more of the following: (A) The volume or mass generated;(B) Any special handling needed to mitigate adverse impacts;(C) Effects on solid waste and wastewater disposal and treatment, including operation of solid waste and wastewater handling or treatment facilities, and the ability to reuse or recycle materials resulting from the treatment of solid waste and/or wastewater;(D) Discharge(s) or disposal(s) to storm drains or sewers that adversely affects operation of wastewater or storm water treatment facilities; or(E) Release(s) into the environment, as a result of solid waste handling, treatment, or disposal activities, or the discharge or disposal to storm drains or sewers, of chemicals contained in the product.(9) "Adverse water quality impacts" means any of the following adverse effects on the beneficial uses of the waters of the State, which include groundwater, fresh water, brackish water, marsh lands, wetlands, or coastal bodies or systems, as specified in Water Code section 13050(f) or adopted in a Water Quality Control Plan under article 3 of chapter 3 and/or article 3 of chapter 4 of division 7 of the Water Code: (A) Increase in biological oxygen demand;(B) Increase in chemical oxygen demand;(C) Increase in temperature;(D) Increase in total dissolved solids; or(E) Introduction of, or increase in, any of the following: 1. Priority pollutants identified for California under section 303(c) of the federal Clean Water Act;2. Pollutants listed by California or the United States Environmental Protection Agency for one or more water bodies in California under section 303(d) of the federal Clean Water Act;3. Chemicals for which primary Maximum Contaminant Levels have been established and adopted under section 64431 or section 64444 of chapter 15 of title 22 of the California Code of Regulations;4. Chemicals for which Notification Levels have been specified under Health and Safety Code section 116455; or5. Chemicals for which public health goals for drinking water have been published under the California Safe Drinking Water Act (commencing with Health and Safety Code section 116270).(10) "Alternative" means any of the following: (A) Removal of Chemical(s) of Concern from a Priority Product, with or without the use of one or more replacement chemicals;(B) Reformulation or redesign of a Priority Product and/or manufacturing process to eliminate or reduce the concentration of Chemical(s) of Concern in the Priority Product;(C) Redesign of a Priority Product and/or manufacturing process to reduce or restrict potential exposures to Chemical(s) of Concern in the Priority Product; or(D) Any other change to a Priority Product or a manufacturing process that reduces the potential adverse impacts and/or potential exposures associated with the Chemical(s) of Concern in the Priority Product, and/or the potential adverse waste and end-of-life effects associated with the Priority Product.(11) "Alternatives Analysis" or "AA" means an evaluation and comparison of a Priority Product and one or more alternatives to the product under article 5.(12) "Alternatives Analysis Threshold" means whichever of the following is applicable: (A) The Practical Quantitation Limit for a Chemical of Concern that is present in a Priority Product solely as a contaminant; or(B) The applicable concentration, if any, specified by the Department under section 69503.5(c).(13) "Alternatives Analysis Threshold Notification" means a notification submitted to the Department under section 69505.3.(14) "Aqueous hydrolysis half-life" means the time required for the concentration of a chemical to be reduced by one-half after being introduced into water.(15) "Assemble" means to fit, join, put, or otherwise bring together components to create, repair, refurbish, maintain, or make non-material alterations to a consumer product.(16) "Assembler" means any person who assembles a product containing a component that is a product subject to the requirements of this chapter.(17) "Atmospheric oxidation rate" means the rate of change or degradation of a chemical through the interaction with oxygen in the atmosphere.(18) "Bioaccumulation" means the bioaccumulation hazard trait, as specified in section 69405.2.(19) "Candidate Chemical" means a chemical that is a candidate for designation as a Chemical of Concern, and that is identified as a Candidate Chemical under section 69502.2.(20)(A) "Chemical" means either of the following:1. An organic or inorganic substance of a particular molecular identity, including any combination of such substances occurring, in whole or in part, as a result of a chemical reaction or occurring in nature, and any element, ion or uncombined radical, and any degradate, metabolite, or reaction product of a substance with a particular molecular identity; or2. A chemical ingredient, which means a substance comprising one or more substances described in subparagraph 1.(B) "Molecular identity" means the substance's properties listed below: 3. Chemical composition, including surface coating;8. Particle size, size distribution, and surface area;9. Physical form and shape, at room temperature and pressure;10. Physicochemical properties;12. Solubility in water and biologically relevant fluids;(21) "Chemical of Concern" means a Candidate Chemical that has been designated as a Chemical of Concern under section 69503.5(b)(2)(B).(22) "Chemical Removal Intent Notification" and "Chemical Removal Confirmation Notification" mean the notifications submitted to the Department under section 69505.2(a)(1)(A)1.(23)(A) "Component" means a uniquely identifiable homogeneous material, part, piece, assembly, or subassembly that is a necessary or intended element of a consumer product.(B) "Homogeneous material" means either of the following:1. One material of uniform composition throughout; or2. A material, consisting of a combination of materials, that cannot be readily disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding, or abrasive processes.(24)(A) "Consumer product" or "Product" means any of the following: 1. A "consumer product" as defined in Health and Safety Code section 25251; or2. When applicable, a component of an assembled "consumer product."(B) "Consumer product" or "Product" does not mean a product that ceased to be manufactured prior to the date the product is listed as a Priority Product.(C) "Consumer product" or "Product" does not mean a product previously owned or leased by someone other than the manufacturer, importer, distributor, assembler, or retailer of the product.(25) "Contact information" means mailing and electronic addresses, headquarters location, phone number(s), title(s) if applicable, and website address.(26)(A) "Contaminant" means a chemical that is not an intentionally added ingredient in a product and the source(s) of the chemical in the product is/are one or more of the following:1. A naturally occurring contaminant commonly found in raw materials that are frequently used to manufacture the product;2. Air or water frequently used as a processing agent or an ingredient to manufacture the product;3. A contaminant commonly found in recycled materials that are frequently used to manufacture the product; and/or4. A processing agent, reactant, by-product, or intermediate frequently used to promote certain chemical or physical changes during manufacturing, and the incidental retention of a residue is not desired or intended.(B) "Intentionally added ingredient" means a chemical that is deliberately used in the manufacture of a product where the continued presence is desired in the final product to provide a specific characteristic, appearance, or quality.(C) "Processing agent" means a chemical used in a product manufacturing process to promote chemical or physical changes.(D) "Recycled material" means a material that has been separated from a waste stream for the purpose of recycling the material as feedstock.(27) "Day" means calendar day. Periods of time are calculated by excluding the first day and including the last; except that the last day is excluded if it is a Saturday, Sunday, or other holiday specified in Government Code section 6700.(28) "Department" means the Department of Toxic Substances Control.(29) "Economically feasible" means that an alternative product or replacement chemical does not significantly reduce the manufacturer's operating margin.(30) "End-of-life" means the point when a product is discarded by the consumer or the end of the useful life of the product, whichever occurs first.(31) "Environment" means the land, air, water, soil, minerals, flora, and fauna.(32) "Environmental fate" means all of the following:(A) Aerobic and anaerobic half-lives;(B) Aqueous hydrolysis half-life;(C) Atmospheric oxidation rate;(F) Mobility in environmental media, as specified in section 69405.6;(33) "Environmental or toxicological endpoint" means any environmental or toxicological endpoint specified in chapter 54.(34) "Failure to Comply List" means the list prepared by the Department under section 69501.2(c).(35) "Functionally acceptable" means that an alternative product meets both of the following requirements: (A) The product complies with all applicable legal requirements; and(B) The product performs the functions of the original product sufficiently well that consumers can be reasonably anticipated to accept the product in the marketplace.(36) "Hazard trait" means any hazard trait specified or defined in chapter 54.(37) "Hazard trait submission" means any health, safety, or environmental study of, or health, safety, or environmental information regarding, a chemical submitted to the Department under this chapter or article 14 of chapter 6.5 of division 20 of the Health and Safety Code. Precise chemical identity is part of any hazard trait submission, except as otherwise provided in section 69509(g).(38) "Import" means to bring, or arrange to bring, a product into the United States for purposes of placing the product into the stream of commerce in California. "Import" includes reimporting a product manufactured or processed, in whole or in part, in the United States. "Import" does not include ordering a product manufactured outside of the United States if the product is ordered from a person located in the United States.(39) "Importer" means a person who imports a product that is subject to the requirements of this chapter. "Importer" does not include a person that imports a product solely for use in that person's workplace if that product is not sold or distributed by that person to others.(40) "Information" means data, documentation, records, graphs, reports, or any other depiction of specific pieces of knowledge.(41) "Legal requirements" means specifications, performance standards, and/or labeling requirements that a chemical, product, or product packaging is required to meet under federal or California law.(42) "Life cycle" means the sum of all activities in the course of a consumer product's entire life span, including raw materials extraction, resource inputs and other resource consumption, intermediate materials processes, manufacture, packaging, transportation, distribution, use, operation and maintenance, waste generation and management, reuse and recycling, and end-of-life disposal.(43) "Manufacture" means to make or produce. "Manufacture" does not include acts that meet the definition of "assemble."(44) "Manufacturer" means any person who manufactures a product that is subject to the requirements of this chapter, or any person that controls the manufacturing process for, or specifies the use of chemicals to be included in, the product.(45)(A) "Materials and resource consumption" means the consumption of renewable and nonrenewable resources that are used for a consumer product throughout its life cycle.(B) Except as specified in subparagraph (C)2., a renewable resource is a resource that is capable of being replaced by natural processes at a rate equal to or faster than its consumption rate. Renewable resources include solar and wind energy, timber, agriculture, and water.(C) Both of the following are nonrenewable resources:1. An inherently finite resource that is formed over long periods of geologic time, including petroleum, coal, mined and recycled metals, minerals, and other finite resources; and2. A resource that meets the definition of a renewable resource, specified in subparagraph (B), but the resource is consumed at a rate that exceeds the rate at which it is replaced such that its continued use will drive the resource to exhaustion.(46) "Persistence" means the environmental persistence hazard trait, as specified in section 69405.3.(47) "Person" has the same meaning as in Health and Safety Code section 25118.(48) "Physical chemical hazards" means physical hazard traits specified in article 6 of chapter 54.(49) "Physicochemical properties" means the physicochemical properties specified in section 69407.2.(50)(A) "Placed into the stream of commerce in California" means that a consumer product has been sold, offered for sale, distributed, supplied, or manufactured in or for use in California as a finished product or as a component in an assembled product.(B) "Sold or offered for sale" means any transfer or offer to transfer for consideration of title or the right to use, by lease or sales contract, including, but not limited to, transactions conducted and offers made through sales outlets, catalogs, or the Internet or other similar electronic means.(51)(A) "Potential" means that the phenomenon described is reasonably foreseeable based on reliable information.(B) Subparagraph (A) does not apply to the use of the term "potential' in paragraph (2) above or section 69502.2(a)(1)(M).(52) "Practical Quantitation Limit" or "PQL" means the lowest concentration of a chemical that can be reliably measured within specified limits of precision and accuracy using routine laboratory operating procedures.(53) "Priority Product" means a product-chemical combination identified and listed as a Priority Product by the Department under section 69503.5.(54) "Product-Chemical Replacement Intent Notification" and "Product-Chemical Replacement Confirmation Notification" mean the notifications submitted to the Department under section 69505.2(a)(1)(A)3.(55) "Product Removal Intent Notification" and "Product Removal Confirmation Notification" mean the notifications submitted to the Department under section 69505.2(a)(1)(A)2.(56) "Release" means an intentional or unintentional liberation, emission, or discharge of a chemical into the environment.(57) "Reliable information" means a scientific study or other scientific information that meets the criteria in subparagraphs (A) and (B): (A) The study or other scientific information was:1. Published in a scientifically peer reviewed report or other literature;2. Published in a report of the United States National Academies;3. Published in a report by an international, federal, state, or local agency that implements laws governing chemicals; and/or4. Conducted, developed, submitted, prepared for, or reviewed and accepted by an international, federal, state, or local agency for compliance or other regulatory purposes.(B) With respect to a scientific study, the study design was appropriate to the hypothesis being tested, and sufficient to support the proposition(s) for which the study is presented to the Department.(58) "Reliable information demonstrating the occurrence, or potential occurrence, of exposures to a chemical" means any of the following that meet the definition of reliable information: (A) Monitoring data that shows the chemical to be any of the following:1. Present in household dust, indoor air, or drinking water, or on interior surfaces;2. Present in, or released from, products used in or present in homes, schools, or places of employment;3. Accumulative or persistent in the environment; or4. Accumulative in aquatic, avian, animal, or plant species.(B) Biomonitoring data from one or both of the following sources that show the chemical to be present in human organs, tissues, or fluids: 1. California Environmental Contaminant Biomonitoring Program; and/or2. United States Centers for Disease Control and Prevention's National Health and Nutrition Evaluation Survey biomonitoring data.(C) Evidence that a chemical exhibits the hazard trait for any of the following:3. Lactational or transplacental transfer, as specified in section 69405.5.(D) Exposure or environmental modeling that indicates one or both of the following:1. Exposure point concentration(s) associated with adverse impacts; or2. Environmental accumulation of a chemical.(E) Monitoring data indicating the presence of a chemical or its degradation products in California solid waste, wastewater, biosolids, or storm water streams collected or managed by California State or local agencies in concentrations or volumes that: 1. Potentially contribute to or cause adverse impacts;2. Require the expenditure of public funds to mitigate potential adverse impacts associated with the chemical or its degradation products;3. Increase the costs of reusing or recycling materials containing the chemical or its degradation products;4. Interfere with the proper operation of solid waste, wastewater, or storm water treatment systems and result in the discharge of the chemical or its degradation products to the environment;5. Exceed regulatory thresholds for the chemical or its degradation products; or6. Result in violations of the permit issued to the facility responsible for managing solid waste, wastewater, biosolids, or storm water streams.(59) "Replacement Candidate Chemical" or "replacement chemical" means a Candidate Chemical or other chemical, whichever is applicable, that replaces, or is under consideration to replace, the Chemical(s) of Concern, in whole or in part, in an alternative to the Priority Product, and that is one of the following: (A) A chemical that is not present in the Priority Product; or(B) A chemical that is or would be present in the alternative at a higher concentration than in the Priority Product relative to other chemicals in the Priority Product other than the Chemical(s) of Concern.(60) "Responsible entity" means any of the following: (61) "Retailer" means a person to whom a product that is subject to the requirements of this chapter is delivered or sold for purposes of sale or distribution by that person to a consumer.(62) "Safer alternative" means an alternative that, in comparison with another product or product manufacturing process, has reduced potential adverse impacts and/or potential exposures associated with one or more Candidate Chemicals, Chemicals of Concern, and/or replacement chemicals, whichever is/are applicable.(63) "Sales outlet" means any place at which consumer products are sold, supplied, or offered for sale directly to consumers in California.(64) "Sensitive subpopulations" means subgroups that comprise a meaningful portion of the general population that are identifiable as being at greater risk of adverse health effects when exposed to one or more chemicals that exhibit a hazard trait and/or toxicological endpoint, including, but not limited to, infants, children, pregnant women, and elderly individuals. "Sensitive subpopulations" also include individuals at greater risk of adverse health effects when exposed to chemicals because they are either individuals with a history of serious illness or greater exposures to chemicals, or workers with greater exposures to chemicals due to the nature of their occupation.(65) "Technically feasible" means that the technical knowledge, equipment, materials, and other resources available in the marketplace are expected to be sufficient to develop and implement an alternative product or replacement chemical.(66) "Trade secret" means "Trade secret" as defined in Civil Code section 3426.1(d).(67) "Useful life" means the period of time during which a product can be used as intended, expressed in terms of a single use, number of applications, or days, months, or years of use.Cal. Code Regs. Tit. 22, § 69501.1
1. New section filed 8-28-2013; operative 10-1-2013 (Register 2013, No. 35). Note: Authority cited: Sections 25252, 25253 and 58012, Health and Safety Code. Reference: Sections 25251, 25252, 25253 and 25257, Health and Safety Code; Section 1060, Evidence Code; and Sections 3426- 3426.11, inclusive, Civil Code.
1. New section filed 8-28-2013; operative 10-1-2013 (Register 2013, No. 35).