California Code of Regulations › Title 22 - Social Security › Division 4.5 - Environmental Health Standards for the Management of Hazardous Waste › Chapter 55 - Safer Consumer Products › Article 1 - General › Section 69501.1 - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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:
1. Carbon dioxide;
2. Hydrofluorocarbons;
3. Methane;
4. Nitrogen trifluoride;
5. Nitrous oxide;
6. Perfluorocarbons;
7. Sulfur hexafluoride; or
8. Gases that exhibit the global warming
				  potential hazard trait, as specified in section
				  69405.4;
(C) Nitrogen oxides;
(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;
(F) Sulfur oxides; or
(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; and
3. 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; and
3. 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;
(B) Erosion;
(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;
				  or
5. 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; or
2. 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:
1. Agglomeration state;
2. Bulk density;
3. Chemical composition, including surface
				  coating;
4. Crystal
				  structure;
5.
				  Dispersability;
6. Molecular
				  structure;
7. Particle
				  density;
8. Particle size, size
				  distribution, and surface area;
9.
				  Physical form and shape, at room temperature and pressure;
10. Physicochemical properties;
11. Porosity;
12. Solubility in water and biologically
				  relevant fluids;
13. Surface
				  charge; and
14. Surface
				  reactivity.
(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; or
2. 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;
				  or
2. 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/or
4. 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;
(D)
				  Bioaccumulation;
(E)
				  Biodegradation;
(F) Mobility in
				  environmental media, as specified in section
				  69405.6;
(G) Persistence; and
(H) Photodegradation.
(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; and
2. 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/or
4.
				  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; or
4. 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/or
2.
				  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:
1.
				  Bioaccumulation;
2. Persistence;
				  or
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; or
2. 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; or
6. 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:
(A) Manufacturer;
(B) Importer;
(C) Assembler; or
(D) Retailer.
(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.