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UNOFFICIALTEXT OF PROPOSED REGULATIONS --- POST-HEARING CHANGESJanuary 2013This version reflects post-hearing changes to the text as originally proposed. All of the text is
new language to be added to the California Code of Regulations.
NOTE: This “clean” version of the revised proposed regulations, which does not indicate
which text has been added / deleted, is being made available as a courtesy copy only. It is not
the official version of the post-hearing changes. The official version is provided separately,and shows deleted text with strikeouts and added text with underlines. Also, for ease ofreading and referencing the proposed regulations, line numbers and table of content page
numbers are added, but are not part of the actual regulatory text.

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DIVISION 4.5, TITLE 22, CALIFORNIA CODE OF REGULATIONSCHAPTER 55. SAFER CONSUMER PRODUCTS
Amend the Table of Contents by adding chapter 55, articles 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11,
and sections 69501, 69501.1, 69501.2, 69501.3, 69501.4, 69501.5, 69502, 69502.1, 69502.2,
69502.3, 69503, 69503.1, 69503.2, 69503.3, 69503.4, 69503.5, 69503.6, 69503.7, 69504,
69504.1, 69505, 69505.1, 69505.2, 69505.3, 69505.4, 69505.5, 69505.6, 69505.7, 69505.8,
69506, 69506.1, 69506.2, 69506.3, 69506.4, 69506.5, 69506.6, 69506.7, 69506.8, 69506.9,
69506.10, 69507, 69507.1, 69507.2, 69507.3, 69507.4, 69507.5, 69507.6, 69508, 69509,
69509.1, 69510, and 69511 through 69599 to division 4.5 of title 22 of the California Code ofRegulations, to read:
Table of Contents***
Chapter 55. Safer Consumer Products
Article 1.! General ................................................................................................................... 5!
§ 69501. ! Purpose and Applicability. ................................................................................... 5!
§ 69501.1.! Definitions............................................................................................................ 5!
§ 69501.2.! Duty to Comply and Consequences of Non-Compliance. ................................. 16!
§ 69501.3.! Information Submission and Retention Requirements. ..................................... 19!
§ 69501.4.! Chemical and Product Information. ................................................................... 19!
§ 69501.5.! Availability of Information on the Department’s Website. .................................. 21
Article 2.! Process for Identifying Candidate Chemicals................................................... 23!
§ 69502.! General. ............................................................................................................ 23!
§ 69502.1.! Applicability. ...................................................................................................... 23!
§ 69502.2.! Candidate Chemicals Identification. .................................................................. 23!
§ 69502.3.! Candidate Chemicals List. ................................................................................. 26
Article 3.! Process for Identifying and Prioritizing Product-Chemical Combinations .... 27!
§ 69503.! General. ............................................................................................................ 27!
§ 69503.1.! Applicability. ...................................................................................................... 27!
§ 69503.2.! Product-Chemical Identification and Prioritization Factors. ............................... 27!
§ 69503.3.! Adverse Impact and Exposure Factors. ............................................................ 28!
§ 69503.4.! Priority Product Work Plan. ............................................................................... 30!
§ 69503.5.! Priority Products List. ........................................................................................ 31!
§ 69503.6.! Initial Priority Products List. ............................................................................... 32!
§ 69503.7.! Priority Product Notifications. ............................................................................ 33

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Article 4.! Petition Process for Identification and Prioritization of Chemicals andProducts.......... ........................................................................................................................ 33!
§ 69504.! Applicability and Petition Contents. ................................................................... 34!
§ 69504.1.! Merits Review of Petitions. ............................................................................... 34
Article 5.! Alternatives Analysis .......................................................................................... 35!
§ 69505.! Guidance Materials. .......................................................................................... 35!
§ 69505.1.! Alternatives Analysis: General Provisions. ........................................................ 36!
§ 69505.2.! Removal/Replacement Notifications in Lieu of Alternatives Analysis. ............... 37!
§ 69505.3.! Alternatives Analysis Threshold Notification in Lieu of Alternatives Analysis. ... 41!
§ 69505.4.! Alternatives Analysis Process and Options. ...................................................... 42!
§ 69505.5.! Alternatives Analysis: First Stage. ..................................................................... 45!
§ 69505.6.! Alternatives Analysis: Second Stage. ................................................................ 46!
§ 69505.7.! Alternatives Analysis Reports. ........................................................................... 48!
§ 69505.8.! Department Review and Determinations for AA Reports and Work Plans. ....... 53
Article 6. ! Regulatory Responses........................................................................................ 55!
§ 69506.! Regulatory Response Selection Principles. ....................................................... 55!
§ 69506.1.! Applicability and Determination Process. .......................................................... 56!
§ 69506.2.! Supplemental Information and Regulatory Response Revisions. ...................... 58!
§ 69506.3.! Product Information for Consumers. .................................................................. 59!
§ 69506.4.! Use Restrictions on Chemicals and Consumer Products. ................................. 60!
§ 69506.5.! Product Sales Prohibition. ................................................................................. 60!
§ 69506.6.! Engineered Safety Measures or Administrative Controls .................................. 62!
§ 69506.7.! End-of-Life Management Requirements. ........................................................... 62!
§ 69506.8.! Advancement of Green Chemistry and Green Engineering. ............................. 65!
§ 69506.9.! Exemption from Regulatory Response Requirements. ...................................... 65!
§ 69506.10.!Regulatory Response Report and Notifications. ................................................ 66
Article 7.! Dispute Resolution Processes ........................................................................... 68!
§ 69507. ! Dispute Resolution. ........................................................................................... 68!
§ 69507.1.! Informal Dispute Resolution Procedures. .......................................................... 68!
§ 69507.2. ! Appeal to the Director. ....................................................................................... 68!
§ 69507.3. ! Formal Dispute Resolution Procedures. ............................................................ 69!
§ 69507.4. ! Time Lines for Requests for Review. ................................................................. 69!
§ 69507.5. ! Contents of Requests for Review. ..................................................................... 70!
§ 69507.6. ! Department Procedures for Requests for Review. ............................................ 70
Article 8.! Audits ................................................................................................................... 71!
§ 69508.! Audit of Materials Submitted to the Department and Regulatory Responses. ... 71

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Article 9.! Trade Secret Protection ...................................................................................... 71!
§ 69509.! Assertion of a Claim of Trade Secret Protection................................................ 71!
§ 69509.1.! Department Review of Claims of Trade Secret Protection. ............................... 73
Article 10.! Severability .......................................................................................................... 74!
§ 69510.! Severability. ....................................................................................................... 74
Article 11.! [Reserved] ............................................................................................................ 74!
§§ 69511 -- 69599. [Reserved] ........................................................................................... 74!

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Add chapter 55 to division 4.5 of title 22 of the California Code of Regulations, to read:
Chapter 55. Safer Consumer Products
Article 1.

General§ 69501. Purpose and Applicability.
(a)
Safer Consumer Product Regulations. This chapter specifies the process for
identifying and prioritizing Priority Products and their Chemicals of Concern, and identifying
and analyzing alternatives to determine how best to eliminate or reduce potential exposures to,or the level of potential adverse impacts posed by, the Chemical(s) of Concern in Priority
Products. This chapter also specifies the regulatory responses that will be imposed byoperation of article 6 or that may be required by the Department following completion of analternatives analysis.
(b)Applicability and Non-Duplication.
(1)
Except as provided in paragraphs (2) and (3), this chapter applies to all consumer
products placed into the stream of commerce in California.
(2)This chapter does not apply to any product that is exempted from the definition of“consumer product” specified in Health and Safety Code section 25251.
(3)(A) This chapter does not apply to a consumer product that the Department determines
is regulated by one or more federal and/or California State regulatory program(s), and/or
applicable treaties or international agreements with the force of domestic law, that, in
combination:
1.
Address the same potential adverse impacts, potential exposure pathways, andpotential adverse waste and end-of-life effects that could otherwise be the basis for the productbeing listed as a Priority Product; and2.
Provide a level of public health and environmental protection that is equivalent to or
greater than the protection that would potentially be provided if the product were listed as a
Priority Product.
(B)
The Department may re-evaluate a determination previously made pursuant to thisparagraph and rescind the determination if the Department finds that the facts and/or
assumptions upon which the determination was based were not, or are no longer, valid.
(c)Harmonization. Nothing in these regulations authorizes the Department tosupersede the requirements of another California State or federal regulatory program.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25251, 25252, 25253, and 25257.1, Health and Safety Code.
§ 69501.1. Definitions.
(a)Terminology. When used in this chapter, the following terms, unless specified
otherwise, have the meanings specified in this section:

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(1)“AA Reports” means Preliminary and/or Final AA Reports, draft and/or final Abridged
AA Reports, and/or AA Reports submitted for previously completed AAs, whichever isapplicable.
(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 ofRegulations, 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; or8.
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 theambient 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 ecologicalcommunities; 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; orDepartment of Toxic Substances Control

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(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 publichealth 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. Publichealth includes occupational health.
(7) “Adverse soil quality impacts” means any of the following effects on soil function orproperties:(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 orchanging 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 ormore 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 ofsolid 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.

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(9)“Adverse water quality impacts” means any of the following adverse effects on thebeneficial 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 Codesection 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 establishedand 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 publishedunder the California Safe Drinking Water Act (commencing with Health and Safety Codesection 116270).
(10) “Alternative” means any of the following:(A)
Removal of Chemical(s) of Concern from a Priority Product, with or without the useof one or more replacement chemicals;(B)
Reformulation or redesign of a Priority Product and/or manufacturing process toeliminate 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 thepotential adverse impacts and/or potential exposures associated with the Chemical(s) ofConcern 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 the Practical Quantitation Limit for a
Chemical of Concern that is present in a Priority Product solely as a contaminant.

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(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 achemical 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
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 bioaccumulation, 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:
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; andDepartment of Toxic Substances Control

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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; 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; 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 orleased by someone other than the manufacturer, importer, distributor, assembler, or retailer ofthe 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 promotecertain chemical or physical changes during manufacturing, and the incidental retention of aresidue is not desired or intended.

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(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 toprovide a specific characteristic, appearance, or quality.
(C)“Processing agent” means a chemical used in a product manufacturing process topromote 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 otherholiday 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 theend of the useful life of the product, whichever occurs first.
(31)"Environment" means the land, air, water, soil, minerals, flora, and fauna.

(32)
(A)
(B)
(C)
(D)
(E)
(F)
(G)
(H)

“Environmental fate” means all of the following:
Aerobic and anaerobic half-lives;
Aqueous hydrolysis half-life;
Atmospheric oxidation rate;
Bioaccumulation;
Biodegradation;
Mobility in environmental media, as specified in section 69405.6;
Persistence; andPhotodegradation.

(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 thefollowing requirements:(A)
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(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 forpurposes 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 requirementsof this chapter. “Importer” does not include a person that imports a product solely for use inthat 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 otherdepiction of specific pieces of knowledge.
(41) “Legal requirements” means specifications, performance standards, and/or labelingrequirements 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 andrecycling, and end-of-life disposal.
(43) “Manufacture” means to make or produce. “Manufacture” does not include acts thatmeet the definition of “assemble.”(44) “Manufacturer” means any person who manufactures a product that is subject to therequirements of this chapter, or any person that controls the manufacturing process for, or has
the capacity to specify the use of chemicals in, such a product.

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(45)(A) “Materials and resource consumption” means the consumption of renewable andnonrenewable 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 thatis 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 insubparagraph (B), but the resource is consumed at a rate that exceeds the rate at which it isreplaced such that its continued use will drive the resource to exhaustion.
(46)“Persistence” means environmental persistence, 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 ofchapter 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 producthas 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 similarelectronic 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 chemicalthat can be reliably measured within specified limits of precision and accuracy using routine
laboratory operating procedures.
(53) “Priority Product” means a product identified and listed as a Priority Product by the
Department under section 69503.5.
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(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 ofa chemical into the environment.
(57) “Reliable information” means information that is trustworthy based on the following:(A)
The level of rigor attendant to the generation of the information, including, where
relevant, the use of quality controls;(B)
The degree to which the information has been independently reviewed by qualified
disinterested parties;(C)
The degree to which the information has been independently confirmed,
corroborated, or replicated; and/or(D)With respect to a scientific study, the fact that the study meets both of the following
criteria:
1.
The study was:a.
Published in a scientifically peer reviewed report or other literature;b.
Published in a report of the United States National Academies;c.
Published in a report by an international, federal, state, or local agency that
implements laws governing chemicals; and/ord.
Conducted, developed, submitted, prepared for, or reviewed and accepted by aninternational, federal, state, or local agency for compliance or other regulatory purposes.
2.
The study design was appropriate to the hypothesis being tested, and sufficient tosupport 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, orplaces of employment;
3.
Accumulative or persistent in the environment; or
4.
Accumulative in aquatic, avian, animal, or plant species.
(B)
Biomonitoring data from one of the following sources that show the chemical to bepresent in human organs, tissues, or fluids:
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1.
California Environmental Contaminant Biomonitoring Program; and/or
2.
United States Centers for Disease Control and Prevention’s National Health andNutrition Evaluation Survey biomonitoring data.
(C)
Evidence that a chemical exhibits the hazard trait for any of the following:
1.
Bioaccumulation;
2.
Persistence; or3.
Lactational or transplacental transfer, as specified in section 69405.5.
(D)
Exposure or environmental modeling that indicates either 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 tothe 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 present at a lower concentration in the Priority Product relative toother chemicals in the Priority Product other than the Chemical(s) of Concern.
(60)
(A)
(B)
(C)
(D)

“Responsible entity” means any of the following:
Manufacturer;
Importer;
Assembler; orRetailer.

(61) “Retailer” means a person to whom a product that is subject to the requirements ofthis chapter is delivered or sold for purposes of sale or distribution by that person to a
consumer.
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(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 Chemical(s), Chemical(s) of Concern,
and/or replacement chemicals, whichever is/are applicable.
(63) “Sales outlet” means any place at which consumer products are sold, supplied, oroffered 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 persons at greater risk of adverse healtheffects 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 dueto 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 andimplement an alternative product or replacement chemical.
(66)"Trade secret" means “Trade secret” as defined in Civil Code section 3426.1(d).

(77) “Useful life” means the period of time during which a product can be used asintended, expressed in terms of a single use, number of applications, or days, months, or
years of use.
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 through 3426.11, inclusive, Civil Code.
§ 69501.2. Duty to Comply and Consequences of Non-Compliance.
(a)Duty to Comply.
(1)(A) A manufacturer has the principal duty to comply with requirements applicable to a
responsible entity. In the event a manufacturer does not comply, it shall be the duty of theimporter, if any, to comply if the Department provides notice to the importer under subsection(c)(1). A retailer or assembler is required to comply with the requirements applicable to a
responsible entity only if the manufacturer and the importer have failed to comply and theDepartment provides notice to the retailer or assembler of such non-compliance by posting theinformation on the Failure to Comply List.

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(B)
Notwithstanding subparagraph (A), the provisions of sections 69505.2 and 69505.3
may only be fulfilled by the manufacturer.
(C)
The Department may not require any responsible entity other than the manufacturer
to comply with a regulatory response under sections 69506.6 through 69506.8. However, if
the manufacturer fails to comply and the Department provides notice under subparagraph (A),the importer shall cease to place the product into the stream of commerce in California andeach retailer and assembler shall cease ordering the product, no later than ninety (90) days
after the Department has provided such notice.
(2)
Except for the requirement to submit a notification under sections 69503.7, 69505.2,
or 69505.3, the requirements of this chapter applicable to a responsible entity may be fulfilled
by a consortium, trade association, public-private partnership, non-profit organization, or otherentity acting on behalf of, or in the stead of, the responsible entity.
(b)
Retailer and Assembler Options.
A retailer or assembler who has received a notice from the Department under subsection(a)(1)(A) is not responsible for complying with the requirements specified in the notice if:(1)
The manufacturer or importer complies with the requirement specified in the
Department’s notice within ninety (90) days after the Department issues the notice; or(2)
The retailer or assembler complies with both of the following requirements:(A)
The retailer or assembler ceases ordering the product no later than ninety (90) days
after the Department has provided notice under subsection (a)(1)(A); and(B)
No later than ninety (90) days after the Department has provided notice undersubsection (a)(1)(A), the retailer or assembler submits a Product Cease Ordering Notification
informing the Department that the retailer or assembler has ceased ordering the product, andprovides the following information to the Department:
1.
The name of, and contact information for, the retailer or assembler, whichever isapplicable;
2.
The name of, and contact information for, the manufacturer(s) and importer(s);3.
Identification and location of the retailer’s sales outlets where the product is sold,
supplied, or offered for sale in California, if applicable;
4.
The name of, and contact information for, the person immediately upstream from theretailer or assembler, as applicable, in the supply chain for the product;
5.
Information describing the product, and the brand name(s) and product name(s)under which the retailer’s or assembler’s product is placed into the stream of commerce in
California, and, if the product is a component of one or more assembled products, adescription of the known product(s) in which the component is used;
6.
The length of time the retailer or assembler estimates will be needed to exhaust theremaining inventory of the Priority Product; and7.
A statement certifying that the retailer or assembler will not re-initiate ordering the
product unless and until information posted on the Department’s website indicates that the
non-compliance has been remedied.
(c)Failure to Comply List.

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(1)(A) If the Department determines that one or more requirements of this chapter have notbeen complied with for a specific product, the Department shall issue a notice of noncompliance to the manufacturer and the importer(s) for the product.
(B)
A notice of non-compliance must include a description of the nature of the noncompliance, the steps necessary to achieve compliance, and the Department’s intent to placeinformation concerning the determination of non-compliance on the Failure to Comply List on
its website.
(2)
If the non-compliance has not been remedied to the satisfaction of the Department
within forty-five (45) days after the issuance of the notice of non-compliance, the Department
shall post information concerning the determination of non-compliance on the Failure toComply List on its website. The Department shall post this information on the Failure toComply List not later than ninety (90) days after issuing the notice of non-compliance.
(3)
Paragraph (2) does not apply if there is a pending dispute under article 7 concerning
the notice of non-compliance.
(4)
The Department shall post and maintain on its website a Failure to Comply List that
includes the following information for each product covered by a notice of non-compliance:(A)
Information identifying and describing the product, and the brand name(s) andproduct name(s) under which the product is placed into the stream of commerce in California,
and, if the product is a component of one or more assembled products, a description of the
known product(s) in which the component is used;(B)
The requirement(s) of this chapter, and the applicable due date(s), that are the basis
for the notice of non-compliance;(C)
A statement placing retailers and, if applicable, assemblers on notice undersubsection (a)(1)(A) of the failure to comply by the manufacturer(s) and importer(s), including
identification of the requirement with which the retailer and, if applicable, assembler shallcomply and the timeframe for compliance, which shall be no less than ninety (90) days after
the notice is posted on the Department’s website;(D)
The Chemical(s) of Concern and any other Candidate Chemical(s) known to the
Department to be present in the product;(E)
The name of and, if known, the contact information for any person(s) listed on the
product label as the manufacturer, importer, or distributor;(F)
The name of, and contact information for, any manufacturer or importer that has
been noticed by the Department, under paragraph (1);(G)
The name of, and contact information for, retailers and, if applicable, assemblers
known to the Department who have not fully complied with the requirements of subsection (b);and(H)
The date the product is first listed on the Failure to Comply List.
(5)
The Department shall remove a product and the associated information from the
Failure to Comply List if the Department determines that the condition of non-compliance has
been fully remedied.

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(6)
The Department shall remove information concerning a retailer or an assembler fromthe Failure to Comply List if the Department determines that the retailer or assembler has fullycomplied with subsection (b).
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252 and 25253, Health and Safety Code.
§ 69501.3. Information Submission and Retention Requirements.
(a)
Signatures. All documents required to be submitted to the Department under thischapter must be signed by the responsible individual in charge of preparing or overseeing the
preparation of the information, and by the owner, or an officer of the company, or an
authorized representative.
(b)
Format. All documents submitted to the Department must be in English, and mustbe generated and submitted in a manner and in an electronic format specified by the
Department.
(c)Certification Statement. All documents required to be submitted to the Department
under this chapter must include the following certification statement, signed by the owner or an
officer of the entity submitting the document, whose responsibilities include productdevelopment, product safety, or related responsibilities pertinent to the documents listed in thisparagraph, and by the responsible individual in charge of preparing, or overseeing the
preparation of, the information:“I certify that this document and all attachments were prepared or compiled under mydirection or supervision to assure that qualified personnel properly gathered and evaluated theinformation submitted. Based on my inquiry of the person(s) directly responsible for gathering
the information, the information submitted is, to the best of my knowledge and belief, true,
accurate, and complete. I am aware that submitting false information or statements is aviolation of law.”(d)
Due Dates. All provisions in this chapter requiring a document to be submitted to
the Department within a specified time frame means that the document must be postmarked or
submitted electronically by the end date of that time frame.
(e)Document Retention. A person who is subject to a requirement to obtain or prepare
information, but who is not required to submit the information to the Department or has not yet
been requested to submit the information to the Department, shall retain the information for aperiod of three (3) years following the date the person was required to obtain or prepare theinformation.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252 and 25253, Health and Safety Code.
§ 69501.4.

Chemical and Product Information.

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(a)(1) Information Gathering. The Department shall seek to obtain and/or review
information that it determines is necessary to implement this chapter using one or more of thefollowing approaches:(A)
Obtain and/or review information in the public domain that is readily available in a
usable format, without a subscription or other charge;(B)
Obtain and/or review information in the public domain that is readily available in a
usable format, with a subscription or other charge, to the extent resources are available to pay
the required costs;(C)
Request one or more product or chemical manufacturers, importers, assemblers,
and/or retailers to make existing information available to the Department, in accordance with aschedule specified by the Department; and/or(D)
Request one or more product or chemical manufacturers, importers, assemblers,
and/or retailers to generate new information and provide it to the Department, in accordancewith a schedule specified by the Department.
(2)
For purposes of this section, the terms “manufacturer”, “importer”, “assembler”, and“retailer”, mean the manufacturer, importer, assembler, and retailer of any product or chemical,
not just those products or chemicals subject to the requirements of this chapter.
(b)
Information Requests. The Department may request that information be madeavailable to it under this section by either or both of the following methods:(1)
Correspondence sent to an individual person electronically or by United States mail;and/or(2)
Information call-ins that, unless otherwise specified, apply to all manufacturers,
importers, assemblers, and retailers, as applicable, of a specific chemical or product or groupof chemicals or products. The Department shall post information call-ins on its website, andprovide notice to individuals on the electronic mailing list(s) established by the Department
related to this chapter.
(c)Response Status List.
(1)
The Department shall maintain and post on its website a Response Status List. The
Response Status List shall be used to provide notice that a person, who has been requested toprovide information to the Department under this section, or someone acting on behalf of or in
the stead of that person, has done one of the following:(A)
Made the information requested under this section available to the Department
within the time specified by the Department;(B)
Failed to make the information requested under this section available to the
Department by the due date specified by the Department; or(C)
Demonstrated to the Department’s satisfaction that it does not have and is unable toproduce the requested information.
(2)
The information posted on the Response Status List shall include identification of theperson and the chemical or product that is the subject of the request.
(3)
The Department shall update information on its website upon determining that aperson has taken action to change its status under paragraph (1).

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(d)Safer Consumer Products Partner Recognition List. The Department may maintainand post on its website a Safer Consumer Products Partner Recognition List identifying
persons that have voluntarily provided the Department with information that advances thequest for safer consumer products. Persons identified on this list may include, but are notlimited to, persons that have done the following:(1)
Voluntarily completed an alternatives analysis on a consumer product that has notbeen listed as a Priority Product; and/or(2)
Voluntarily provided information that is helpful to the Department in implementing
this chapter.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252 and 25253, Health and Safety Code.
§ 69501.5. Availability of Information on the Department’s Website.
(a)Website Postings Requiring Noticing. The Department shall post on its website, andupdate as appropriate, all of the information listed below. The Department shall also provide
notice of the availability of the information, including the availability of updates to theinformation, to individuals on the electronic mailing list(s) that the Department establishes
related to this chapter.
(1)
The Failure to Comply List.
(2)
Requests for information made under section 69501.4.
(3)
Proposed and final Candidate Chemicals and Priority Products lists and revisions to
the lists, supporting rationale and documentation, copies of all written comments received
during the public comment periods for the proposed lists, and copies of written responses the
Department provides to the comments.
(4)
Petitions designated as complete under section 69504(c), and notices of decisionand statements of basis prepared by the Department under section 69504.1(d).
(5)
A list of due date extension requests approved for submission of AA Reports.
(6)
AA Report notices of public review periods, notices of compliance, notices of
deficiency, notices of disapproval, and notices of ongoing review.
(7)
Proposed and final regulatory response determination notices issued by the
Department, copies of all written comments received during the public comment period for a
proposed regulatory response determination, and copies of written responses the Department
provides to the comments.
(8)
A list of regulatory response exemption requests submitted to the Department, andcopies of all notices issued by the Department granting, denying, or rescinding a regulatory
response exemption.
(9)
Copies of all disputes and Requests for Review filed with the Department underarticle 7, and copies of all Department decisions, and notices of ongoing review, issued in
response to disputes and Requests for Review.
(b)
Additional Website Postings. The Department shall also post on its website, andupdate as appropriate, all of the following information:
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(1)
The Response Status List prepared under section 69501.4(c).
(2)
Any Safer Consumer Products Partner Recognition List prepared under section
69501.4(d).
(3)
As the following information becomes available, the Department shall add it to thePriority Products list, posted on the Department’s website, for each product that is a Priority
Product, and maintain and update this information for as long as the Priority Product continues
to be placed into the stream of commerce in California:(A)
Brand name(s) and product name(s) for the product, and, if the product is acomponent of one or more assembled products, a description of the known product(s) in which
the component is used;(B)
Product manufacturer(s) and importers, except for those manufacturers that havesubmitted a timely and compliant Confirmation Notification under section 69505.2;(C)
Other responsible entities for the product, except for the responsible entities thathave complied with the requirements of section 69501.2(b);(D)
The identity of the person who will fulfill the requirements of article 5, as reflected in
the Priority Product Notification;(E)
The due dates for, and dates of receipt of, each applicable AA Report and each
Alternate Process AA Work Plan; and(F)
Lists of, and copies of, all of the following that have been submitted to the
Department for each product, including the date of receipt:
1.
Priority Product Notifications;
2.
Alternatives Analysis Threshold Notifications, and notifications submitted to the
Department under subsections (c) and (d) of section 69505.3, and notices issued by the
Department under section 69505.3(e);3.
Chemical Removal Intent and Confirmation Notifications;
4.
Product Removal Intent and Confirmation Notifications;
5.
Product-Chemical Replacement Intent and Confirmation Notifications; and6.
Product Cease Ordering Notifications submitted to the Department under section
69501.2(b)(2).
(4)
Guidance documents prepared by the Department under section 69505(a).
(5)
AAs made available by the Department under section 69505(b).
(6)
A list of all AA Reports and Alternate Process AA Work Plans submitted to the
Department under article 5, the executive summary for each document, the date of receipt,
and a full or redacted copy of each document, including both the originally submitted document
and the document approved by the Department, if different.
(7)
A list and copies of all notices issued by the Department and all documents
submitted to the Department under section 69506.5.
(8)
Copies of, or links to, product stewardship plans, substitute end-of-life management
programs, exemptions from end-of-life management program requirement, and copies ofannual end-of-life program reports.

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(9)
Regulatory response notifications submitted to the Department under subsections(a) and (c) of section 69506.10, and the Regulatory Response Summary prepared andupdated by the Department under section 69506.10(d).
(10) Findings of audits conducted by the Department under section 69508.
(c)
Website Posting Date. All information posted on the Department’s website under
this chapter must include the date the document or information is first posted and the date(s) of
any revised postings.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252 and 25253, Health and Safety Code.
Article 2.

Process for Identifying Candidate Chemicals§ 69502.
General.
This article identifies Candidate Chemicals that can be considered under article 3 fordesignation as a Chemical of Concern, and specifies the process by which the Department
may identify additional Candidate Chemicals. The Department may use, but is not limited tousing, information obtained and/or reviewed under section 69501.4 to perform its duties under
this article.
NOTE: Authority cited: Sections 25252 and 58012, Health and Safety Code. Reference:
Section 25252, Health and Safety Code.
§ 69502.1. Applicability.
This article applies to all chemicals that exhibit a hazard trait and/or an environmental or
toxicological endpoint, and that are present in products that are placed into the stream ofcommerce in California.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252 and 25257.1, Health and Safety Code.
§ 69502.2. Candidate Chemicals Identification.
(a)Candidate Chemicals List. As of the effective date of these regulations, a chemical
is identified as a Candidate Chemical if it exhibits a hazard trait and/or an environmental or
toxicological endpoint, and meets one or both of the following criteria:(1)
The chemical is on one or more of the lists specified below:(A)
Chemicals known to cause cancer and/or reproductive toxicity that are listed under
Health and Safety Code section 25249.8 of the California Safe Drinking Water and Toxic
Enforcement Act of 1986;(B)
Chemicals classified as carcinogens, mutagens, and/or reproductive toxicantsCategories 1A and 1B in Annex VI to Regulation (European Commission) 1272/2008;

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(C)
Chemicals included as endocrine disruptors in the candidate list of Substances ofVery High Concern in accordance with Article 59 of Regulation (European Commission)
1907/2006;(D)
Chemicals for which a reference dose or reference concentration has beendeveloped based on neurotoxicity in the United States Environmental Protection Agency’s
Integrated Risk Information System;(E)
Chemicals that are identified as “carcinogenic to humans”, “likely to be carcinogenic
to humans”, or Groups A, B1, or B2 carcinogens in the United States Environmental Protection
Agency’s Integrated Risk Information System;(F)
Chemicals that are identified as “known to be” or “reasonably anticipated to be” ahuman carcinogen in the 12th Report on Carcinogens, United States Department of Healthand Human Services, Public Health Service, National Toxicology Program;(G)
Chemicals included as persistent, bioaccumulative and toxic, or very persistent andvery bioaccumulative in the candidate list of Substances of Very High Concern in accordancewith Article 59 of Regulation (European Commission) 1907/2006;(H)
Chemicals that are identified as Persistent, Bioaccumulative, and Inherently Toxic tothe environment by the Canadian Environmental Protection Act Environmental Registry
Domestic Substances List;(I)
Chemicals classified as respiratory sensitizers Category 1 in Annex VI to Regulation(European Commission) 1272/2008;(J)
Groups 1, 2A, and 2B carcinogens identified by the International Agency for
Research on Cancer;(K)
Neurotoxicants that are identified in the Agency for Toxic Substances and Disease
Registry’s Toxic Substances Portal, Health Effects of Toxic Substances and Carcinogens,
Nervous System;(L)
Persistent Bioaccumulative and Toxic Priority Chemicals that are identified by theUnited States Environmental Protection Agency’s National Waste Minimization Program;(M)
Reproductive or developmental toxicants identified in Monographs on the Potential
Human Reproductive and Developmental Effects, National Toxicology Program, Office of
Health Assessment and Translation;(N)
United States Environmental Protection Agency’s Toxics Release Inventory
Persistent, Bioaccumulative and Toxic Chemicals that are subject to reporting under theEmergency Planning and Community Right-to-Know Act section 313; and/or(O)
Washington Department of Ecology’s Persistent, Bioaccumulative, Toxic Chemicals
identified in the Washington Administrative Code, title 173, chapter 173-333.
(2)
The chemical is one or more of the following types of chemicals:(A)
Chemicals for which Notification Levels, as defined in Health and Safety Codesection 116455, have been established by the California Department of Public Health;(B)
Chemicals for which primary Maximum Contaminant Levels have been establishedand adopted under section 64431 or section 64444 of chapter 15 of title 22 of the California
Code of Regulations;

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(C)
Chemicals identified as Toxic Air Contaminants under sections 93000 and 93001 of
title 17 of the California Code of Regulations;(D)
Chemicals that are identified as priority pollutants in California Water Quality Control
Plans under section 303(c) of the federal Clean Water Act and in section 131.38 of title 40 of
the Code of Federal Regulations, or identified as pollutants by California or the United States
Environmental Protection Agency for one or more water bodies in California pursuant tosection 303(d) of the federal Clean Water Act and section 130.7 of title 40 of the Code ofFederal Regulations;(E)
Chemicals that are identified with non-cancer endpoints and listed with an inhalationor oral Reference Exposure Level by the California Office of Environmental Health Hazard
Assessment under Health and Safety Code section 44360(b)(2);(F)
Priority Chemicals that are identified under the California Environmental
Contaminant Biomonitoring Program;(G)
Chemicals that are identified on the Centers for Disease Control and Prevention’s
Fourth National Report on Human Exposure to Environmental Chemicals and Updated Tables;
and/or(H)
Chemicals that are identified on Part A of the list of Chemicals for Priority Action,
Oslo and Paris Conventions for the Protection of the Marine Environment of the North-East
Atlantic.
(b)
Additions to the Candidate Chemicals List. In addition to the chemicals identified as
Candidate Chemicals under subsection (a), the Department may identify as Candidate
Chemicals those chemicals that exhibit one or more hazard traits and/or environmental or
toxicological endpoints by considering the following factors for which reliable information isavailable:(1)
Adverse Impacts.
(A)
The Department shall evaluate the potential for the chemical to contribute to or
cause adverse impacts, considering one or more of the following factors:
1.
The chemical’s hazard trait(s) and/or environmental or toxicological endpoint(s);2.
The chemical’s aggregate effects;
3.
The chemical’s cumulative effects with other chemicals with the same or similar
hazard trait(s) and/or environmental or toxicological endpoint(s);4.
The chemical’s physicochemical properties;
5.
The chemical’s environmental fate;6.
The human populations, and/or aquatic, avian, or terrestrial animal or plantorganisms for which the Candidate Chemical(s) has/have the potential to contribute to or
cause adverse impacts; and/or
7.
The potential for the chemical to degrade, form reaction products, or metabolize intoanother Candidate Chemical or a chemical that exhibits one or more hazard traits and/or
environmental or toxicological endpoints.
(B)
The Department shall give special consideration to the potential for the chemical tocontribute to or cause adverse impacts for:1.
Sensitive subpopulations;
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2.
Environmentally sensitive habitats;3.
Endangered and threatened species listed by the California Department of Fish andWildlife; and4.
Environments in California that have been designated as impaired by a California
State or federal regulatory agency.
(C)
The Department shall also give special consideration to the potential for thechemical to contribute to or cause widespread adverse impacts.
(D)
The Department may also evaluate and consider, based on reliable information,
structurally or mechanistically similar chemicals for which there is a known toxicity profile.
(2)
Exposures. The Department shall consider potential exposures to the chemical,
based on both of the following:(A)
Reliable information regarding potential exposures to the chemical; and(B)
Reliable information demonstrating the occurrence, or potential occurrence, of
exposures to the chemical.
NOTE: Authority cited: Sections 25252 and 58012, Health and Safety Code. Reference:
Sections 25252 and 25257.1, Health and Safety Code.
§ 69502.3. Candidate Chemicals List.
(a)
Informational List. The Department shall post an informational list of the chemicals
identified as Candidate Chemicals under section 69502.2(a) on the Department’s website
within thirty (30) days after the effective date of these regulations. The Department shallperiodically update the list to reflect changes to the underlying lists and sources from which it isdrawn, using the procedures specified in subsections (c) and (d).
(b)
Revisions to the List. The Department may make additions to, or deletions from, theCandidate Chemicals list using the factors specified in section 69502.2(b) and the procedures
specified in subsections (c) and (d).
(c)
Public Notice of Proposed List Revisions. The Department shall make proposed
revisions to the Candidate Chemicals list available on its website for public review andcomment, along with supporting documentation, including the Department's rationale and abibliography of the supporting information and information sources, prior to finalizing therevisions to the Candidate Chemicals list. The Department shall hold one or more public
workshop(s) to provide an opportunity for comment on the proposed revisions to the list. The
Department shall send to individuals on the electronic mailing list(s) that the Department
establishes related to this chapter, and post on its website, a notice regarding the availability ofthe proposed revisions to the list and supporting documentation. The notice must include:(1)
The last day for the public to submit written comments on the proposed revisions to
the Candidate Chemicals list. The last day for submission of public comments shall be no
sooner than forty-five (45) days from the date the notice of availability of the proposed
revisions is posted on the Department’s website or the date the notice is sent to individuals on
the electronic mailing list(s) that the Department establishes related to this chapter, whicheveris the later date.
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(2)
The method(s) for submitting comments to the Department.
(3)
The date, time, and location of the public workshop(s).
(d)
Website Posting of Final List Revisions. The Department shall post the final
revisions to the Candidate Chemicals list on its website after review of public comments. The
Department may respond to some or all public comments received.
NOTE: Authority cited: Sections 25252 and 58012, Health and Safety Code. Reference:
Sections 25252 and 25257, Health and Safety Code.
Article 3.

Process for Identifying and Prioritizing Product-Chemical Combinations§ 69503.
General.
This article specifies the process by which the Department shall identify and prioritize
products containing Candidate Chemicals. The Department may use, but is not limited tousing, information obtained and/or reviewed under section 69501.4 to perform its duties under
this article.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252 and 25253, Health and Safety Code.
§ 69503.1. Applicability.
Except as provided otherwise in section 69501(b), this article applies to all products that
contain one or more Candidate Chemicals and that are placed into the stream of commerce in
California.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25251, 25252, 25253, and 25257.1, Health and Safety Code.
§ 69503.2. Product-Chemical Identification and Prioritization Factors.
(a)
Key Prioritization Principles. Any product-chemical combination identified and listed
as a Priority Product must meet both of the following criteria:(1)
There must be potential public and/or aquatic, avian, or terrestrial animal or plantorganism exposure to the Candidate Chemical(s) in the product; and(2)
There must be the potential for one or more exposures to contribute to or causesignificant or widespread adverse impacts.
(b)
Identification and Prioritization Process. The Department may identify and list as a
Priority Product one or more product-chemical combinations that it determines to be of highpriority. The Department’s decision to identify and list a product-chemical combination as a
Priority Product shall be based on an evaluation of the product-chemical combination todetermine its associated potential adverse impacts, potential exposures, and potential adverse
waste and end-of-life effects by considering the factors described in paragraphs (1) and (2) for

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which information is reasonably available. The Department may additionally, in its discretion,
consider paragraph (3).
(1)(A) Adverse Impacts and Exposures. The Department shall begin the product-chemical
combination evaluation process by evaluating the potential adverse impacts posed by the
Candidate Chemical(s) in the product due to potential exposures during the life cycle of the
product. The Department’s evaluation of potential adverse impacts and potential exposures
shall include consideration of one or more of the factors listed in section 69503.3(a) and one ormore of the factors listed in section 69503.3(b). The listing of a product-chemical combination
as a Priority Product shall be based on one or more of the factors listed in section 69503.3(a)and one or more of the factors listed in section 69503.3(b), in addition to the other factors
specified in this section.
(B)
Adverse Waste and End-of-Life Effects. The Department may also consider productuses, or discharges or disposals, in any manner that have the potential to contribute to or
cause adverse waste and end-of-life effects associated with the Candidate Chemical(s) in the
product.
(C)
Availability of Information. The Department shall consider the extent and quality of
information that is available to substantiate the existence or absence of potential adverse
impacts, potential exposures, and potential adverse waste and end-of-life effects.
(2)
Other Regulatory Programs. The Department shall next consider the scope of other
California State and federal laws and applicable treaties or international agreements with theforce of domestic law under which the product or the Candidate Chemical(s) in the productis/are regulated and the extent to which these other regulatory requirements address, andprovide adequate protections with respect to the same potential adverse impacts and potential
exposure pathways, and adverse waste and end-of-life effects, that are under consideration asa basis for the product-chemical combination being listed as a Priority Product. If a product isregulated by another entity with respect to the same potential adverse impacts and potential
exposure pathways, and potential adverse waste and end-of-life effects, the Department may
list such a product-chemical combination as a Priority Product only if it determines that thelisting would meaningfully enhance protection of public health and/or the environment withrespect to the potential adverse impacts and/or exposure pathways that are the basis for thelisting.
(3)
Safer Alternatives. When deciding whether to list a product-chemical combination
as a Priority Product, the Department may also consider whether there is a readily available
safer alternative that is functionally acceptable, technically feasible, and economically feasible.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252, 25253, and 25257.1, Health and Safety Code.
§ 69503.3. Adverse Impact and Exposure Factors.
(a)Adverse Impacts.
(1)
In evaluating a product-chemical combination for possible listing as a Priority
Product, the Department shall evaluate the potential for the Candidate Chemical(s) to
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contribute to or cause adverse impacts, by considering one or more of the following factors forwhich information is reasonably available:(A)
The Candidate Chemical(s)’ hazard trait(s) and/or environmental or toxicological
endpoint(s);(B)
The Candidate Chemical(s)’ aggregate effects;(C)
The Candidate Chemical(s)’ cumulative effects with other chemicals with the sameor similar hazard trait(s) and/or environmental or toxicological endpoint(s);(D)
The Candidate Chemical(s)’ physicochemical properties;(E)
The Candidate Chemical(s)’ environmental fate;(F)
The human populations, and/or aquatic, avian, or terrestrial animal or plantorganisms for which the Candidate Chemical(s) has/have the potential to contribute to or
cause adverse impacts; and/or(G)
The potential for the Candidate Chemical(s) to degrade, form reaction products, or
metabolize into another Candidate Chemical or a chemical that exhibits one or more hazard
traits and/or environmental or toxicological endpoints.
(2)
The Department shall give special consideration to the potential for the Candidate
Chemical(s) in the product to contribute to or cause adverse impacts for:(A)
Sensitive subpopulations;(B)
Environmentally sensitive habitats;(C)
Endangered and threatened species listed by the California Department of Fish andWildlife; and(D)
Environments in California that have been designated as impaired by a California
State or federal regulatory agency.
(3)
The Department may also evaluate and consider, based on reliable information, theadverse impacts associated with structurally or mechanistically similar chemicals for which
there is a known toxicity profile.
(b)
Exposures. In evaluating a product-chemical combination for possible listing as a
Priority Product, the Department shall evaluate the potential for public and/or aquatic, avian, or
terrestrial animal or plant organism exposure(s) to the Candidate Chemical(s) in the product,by considering one or more of the following factors for which information is reasonably
available:(1)Market presence of the product, including:(A)
Statewide sales by volume;(B)
Statewide sales by number of units; and/or(C)
Intended product use(s), and types and age groups of targeted customer base(s).
(2)
The occurrence, or potential occurrence, of exposures to the Candidate Chemical(s)in the product.
(3)
The household and workplace presence of the product, and other products
containing the same Candidate Chemical(s) that is/are the basis for considering the listing of
the product-chemical combination as a Priority Product.
(4)
Potential exposures to the Candidate Chemical(s) in the product during the product’s
life cycle, considering:
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(A)
Manufacturing, use, storage, transportation, waste, and end-of-life management
practices and the locations of these practices;(B)
Whether the product is manufactured or stored in, or transported through, California
solely for use outside of California;(C)
Whether the product is placed into the stream of commerce in California solely forthe manufacture of one or more of the products exempted from the definition of “consumer
product” specified in Health and Safety Code section 25251;(D)
The following types of uses:
1.
Household and recreational use;
2.
Sensitive subpopulation potential use of, or exposure to, the product; and/or
3.
Workers, customers, clients, and members of the general public who use, orotherwise come in contact with, the product or releases from the product in homes, schools,
workplaces, or other locations;(E)
Frequency, extent, level, and duration of potential exposure for each use scenario
and end-of-life scenario;(F)
Containment of the Candidate Chemical(s) within the product, including potential
accessibility to the Candidate Chemical(s) during the useful life of the product and the potential
for releases of the Candidate Chemical(s) during the useful life and at the end-of-life;(G)
Engineering and administrative controls that reduce exposure concerns associatedwith the product; and/or(H)
The potential for the Candidate Chemical(s) or its/their degradation products to bereleased into, migrate from, or distribute across environmental media, and the potential for the
Candidate Chemical(s) or its/their degradation products to accumulate and persist in biologicaland/or environmental compartments or systems.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252, 25253, and 25257.1, Health and Safety Code.
§ 69503.4. Priority Product Work Plan.
(a)
Initial Work Plan. Within one (1) year after the effective date of these regulations,the Department shall issue a Priority Product Work Plan that, except as provided in section
69503.6, identifies and describes the product categories that the Department will evaluate to
identify product-chemical combinations to be added to the Priority Products list during the three(3) years following the issuance of the work plan. The work plan must include a generalexplanation of the decision to select the identified product categories for evaluation during thelife of the work plan.
(b)
Subsequent Work Plans. Subsequent work plans shall be issued by the Department
no later than one (1) year before the three-year expiration date of the current work plan, andshall become effective upon expiration of the current work plan.
(c)
Revisions to Work Plans. The Department may revise an adopted work plan toinclude one or more additional product categories if necessitated by either of the following:

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(1)
The Department is legally required to take action on a particular chemical or product,
or both, prior to the expiration of the work plan; and/or(2)
The Department grants a petition under section 69504.1.
(d)Public Input. Prior to issuing each work plan, the Department shall hold one or more
public workshop(s) to provide an opportunity for comment.
(e)Public Notice. The Department shall send to individuals on the electronic mailinglist(s) that the Department establishes related to this chapter, and post on its website, a noticeof the availability of each work plan and each revised work plan.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252, 25253, and 25257.1, Health and Safety Code.
§ 69503.5. Priority Products List.
(a)
Listing Process.
(1)
The Department shall use the procedures specified in this section and theidentification and prioritization criteria and process specified in sections 69503.2 and 69503.3
to identify and list product-chemical combinations as Priority Products.
(2)
The Priority Products list shall be established and updated through rulemaking
pursuant to the Administrative Procedure Act (commencing with Government Code section
11340). Except as provided in section 69503.6, the Department shall hold one or more public
workshop(s) to provide an opportunity for comment on candidate product-chemical
combinations prior to issuing a proposed Priority Products list.
(b)
List Contents. The Department shall specify in the proposed and final Priority
Products lists the following for each listed product-chemical combination:(1)(A) A description of the product-chemical combination that is sufficient for a responsible
entity to determine whether one or more of its products is a Priority Product.
(B)
If the product-chemical combination is a component of one or more assembled
products, a description of the known assembled product(s) in which the component is usedshall be included.
(2)(A) The Candidate Chemical(s) that is/are the basis for the product being listed as a
Priority Product and the hazard traits and/or environmental or toxicological endpoints
associated with those chemicals.
(B)
For purposes of this chapter, a Candidate Chemical that is the basis for a productchemical combination being listed as a Priority Product, as specified under paragraph (2)(A), is
designated as a Chemical of Concern for that product. All references in this chapter to theChemical(s) of Concern in an alternative product that is under consideration or is selected toreplace a Priority Product mean the chemical(s) that is/are the Chemical(s) of Concern for that
Priority Product.
(3)
The due date for submission of the Preliminary AA Report required under article 5.
The due date for the Preliminary AA Report shall be 180 days after the date the product islisted on the final Priority Products list, unless the Department specifies otherwise in the
Priority Products list.
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(c)Complex Durable Products.
(1)
For a complex durable product, the Department may not list as Priority Products
more than ten (10) components contained in that product in a three-year period.
(2)
For purposes of paragraph (1), “complex durable product” means a product thatmeets the following criteria:(A)
The product is assembled from 100 or more manufactured components;(B)
Manufacturers of the product routinely prepare information intended to be provided
to consumers that indicates that the product has a useful life, or an average useful life, of five(5) or more years; and(C)
The product is typically not consumed, destroyed, or discarded after a single use.
(3)
Paragraph (1) does not apply to either of the following types of products:(A)
Products designed or intended primarily for children twelve (12) years of age or
younger as determined by information made available to consumers or as determined bywhether the product is commonly recognized by consumers as being primarily intended for use
by a child twelve (12) years of age or younger; or(B)
Products intended to be worn or placed on the human body.
(d)
Revisions to the Priority Products List. The Department shall review and revise, as
appropriate, the Priority Products list at least once every three (3) years using the procedures
specified in this section.
(e)
Priority Product Notifications to the Department. Each responsible entity for a
product-chemical combination listed on the Priority Products list shall provide a Priority ProductNotification to the Department within sixty (60) days after the product-chemical combination islisted as a Priority Product, or sixty (60) days after the product-chemical combination is firstplaced into the stream of commerce in California, whichever is later, unless the Department
specifies a later due date in the Priority Products list. If applicable, the responsible entity may
concurrently submit a notification under section 69505.2 or section 69505.3, or such
notification may be submitted at a later date as provided in section 69505.2 or section 69505.3
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252 and 25253, Health and Safety Code.
§ 69503.6. Initial Priority Products List.
The following provisions apply only to the initial list of Priority Products:(a)Scope of Candidate Chemicals. In the initial list of Priority Products, the Department
may list a product as a Priority Product only if one or more Candidate Chemical(s) that is/arethe basis for listing the product meet one or more of the criteria specified in subsection (a)(1) ofsection 69502.2 and one or more of the criteria specified in subsection (a)(2) of section
69502.2. This subsection also applies to any revisions to Priority Products list adopted prior to
January 1, 2016.
(b)
Size of the List. The initial final list of Priority Products shall include no more than
five (5) Priority Products. The list may identify more than one Chemical of Concern for eachlisted product.
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(c)
Initial Proposed Priority Products List. The Department shall make the initial
proposed list of Priority Products available for public review and comment under section
69503.5 no later than 180 days after the effective date of these regulations.
(d)Procedural Exceptions.
(1)
Priority Product Work Plan. Section 69503.4 does not apply to the adoption of theinitial list of Priority Products.
(2)
Workshops. The provisions of section 69503.5(a)(2) requiring the Department tohold one or more public workshop(s) prior to issuing the proposed Priority Products list do not
apply to the initial list of Priority Products.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252 and 25253, Health and Safety Code.
§ 69503.7. Priority Product Notifications.
(a)Notifications to the Department. Within sixty (60) days after a product-chemical
combination is listed as a Priority Product, unless the Department specifies a later due date in
the Priority Products list, each responsible entity for a Priority Product shall notify the
Department that its product-chemical combination is a Priority Product. For a Priority Productthat is first manufactured or first placed into the stream of commerce in California after the dateof the Priority Product listing, the responsible entity shall provide the Priority ProductNotification within sixty (60) days after the product is first placed into the stream of commercein California. The notification must include:(1)
The responsible entity’s name and contact information, and a statement indicating
whether the responsible entity is the product manufacturer, importer, assembler, or retailer;(2)
The type, brand name(s) and product name(s) of the Priority Product, and, if the
product is a component of one or more assembled products, a description of the known
product(s) in which the component is used;(3)
If applicable, the name of, and contact information for, the person that will becomplying with the requirements of article 5 on behalf of or in the stead of the responsible
entity; and(4)
If applicable, an indication that a notification is being submitted under section
69505.2 or section 69505.3 concurrently with the Priority Product Notification, or will be
submitted later as provided in section 69505.2 or section 69505.3.
(b)
Non-Compliance. A responsible entity is not in compliance with subsection (a) if the
responsible entity fails to fully and timely meet the requirements specified in subsection (a).
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252 and 25253, Health and Safety Code.
Article 4.
Products

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§ 69504.
Applicability and Petition Contents.
(a)Petition Process. Except as provided in subsection (b), a person may petition the
Department to add to or remove from the Candidate Chemicals list one or more chemicals, orto add to or remove from the lists specified in section 69502.2(a) the entirety of an existingchemicals list. A person may also petition the Department to add to or remove from thePriority Products list a product-chemical combination. A petition must include:(1)
The name of, and contact information for, both of the following:(A)
The petitioner; and(B)
The person responsible for the petition contents, if different from the petitioner, andthe affiliation of this person with the petitioner;(2)
A description of the chemical and/or product-chemical combination that is the
subject of the petition;(3)
A description of the uses of the chemical and/or product-chemical combination;(4)
The basis for the petition, including an analysis of the basis for the existence orabsence of potential adverse impacts, potential exposures, and/or potential adverse waste andend-of-life effects associated with the chemical and/or product-chemical combination;(5)
Information supporting the petition; and(6)
The identity of any known manufacturers and importers of the chemical or productchemical combination.
(b)
Limitations on Petitions.
(1)
A person may not petition the Department to delist any chemical identified as a
Candidate Chemical under section 69502.2(a), unless that chemical is no longer listed on anyof the lists specified in section 69502.2(a).
(2)
A person may not petition the Department to remove an entire chemicals list fromthe lists specified in section 69502.2(a) until three (3) years after the effective date of theseregulations.
(3)
A person may not petition the Department to remove a product-chemical
combination from the Priority Products list until three (3) years after the date the productchemical combination was placed on the Priority Products list.
(c)Completeness Review. Within sixty (60) days after receiving a petition, theDepartment shall review the petition and shall designate the petition complete if it contains allof the items specified in subsection (a). If the Department determines that a petition isincomplete, the Department shall provide notice to the petitioner of this determination and shallspecify the basis for the determination. If the Department determines that a petition iscomplete, the Department shall provide notice to the petitioner that it will conduct a merits
review to determine whether to grant or deny the petition.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252 and 25253, Health and Safety Code.
§ 69504.1.

Merits Review of Petitions.

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(a)Process and Timing. The Department shall determine whether to grant or deny apetition in accordance with the criteria and processes specified in article 2 and/or article 3, asapplicable. The Department shall make its determination no later than the next regular updateof the Candidate Chemicals list or Priority Products list, as applicable. The Department shallgive high priority to reviewing petitions by federal and other California State agencies that
relate to the petitioning agency’s statutory and/or regulatory authorities.
(b)
Substantive Review. The Department’s merits review of each complete petition
shall, to the extent applicable, be based on:(1)
The comprehensiveness of the information submitted that pertains to the factors
specified in section 69502.2(b) and/or section 69503.2.
(2)
The quality of the information submitted.
(3)
The availability of information, other than that submitted with the petition, that
supports the petitioner’s claims that:(A)
The chemical does or does not exhibit one or more hazard traits and/or
environmental or toxicological endpoints; and(B)
An evaluation of the chemical and/or the product, based on the factors specified in
section 69502.2(b) and/or section 69503.2, as applicable, does or does not indicate potential
adverse impacts and potential exposures, and, if applicable, adverse waste and end-of-life
effects.
(4)
For a petition to remove a chemical from the Candidate Chemicals list, whether thechemical has changed status on any source list(s) that led to its inclusion on the Candidate
Chemicals list.
(5)
For a petition to remove an entire existing chemicals list from the lists specified in
section 69502.2(a), whether the entity responsible for the underlying list still conducts its
scientific assessments of chemicals in a manner that is substantially equivalent to, or as
rigorous as, the manner in which it conducted its scientific assessments at the time of the initialadoption of these regulations.
(c)Supplemental Information Requests. The Department may request that thepetitioner provide, within a specified timeframe, additional information to assist the merits
review.
(d)
Notice of Decision. After completing the merits review, the Department shall provide
a notice to the petitioner of its decision to grant or deny the petition that includes a statement
explaining the basis for the decision.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252 and 25253, Health and Safety Code.
Article 5.

Alternatives Analysis§ 69505.
Guidance Materials.
(a)Guidance Materials. Before finalizing the initial list of Priority Products, theDepartment shall make available on its website guidance materials to assist persons in
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performing AAs in accordance with this article. The Department shall periodically revise andupdate the guidance materials.
(b)
Sample Alternatives Analyses. The Department shall also post on its website
examples of AAs that are available in the public domain at no cost. The posting must indicate,for each AA, the name of the person or entity that prepared the AA.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Sections 25252 and 25253, Health and Safety Code.
§ 69505.1. Alternatives Analysis: General Provisions.
(a)Applicability. This article does not apply to a product for which the notification
requirements of section 69505.2 or section 69505.3 have been fully and timely met.
(b)
AA Requirements.
(1)
Except as otherwise provided in subsection (a) above and subsections (b), (c) and(d) of section 69505.4, a responsible entity for a Priority Product shall conduct an AA for the
Priority Product and shall comply with all applicable requirements of this article.
(2)
A responsible entity subject to the requirements of paragraph (1) shall prepare, sign,and submit to the Department AA Reports as follows:(A)
Except as provided in subsection (c), a responsible entity shall submit the
Preliminary AA Report to the Department no later than 180 days after the date the product islisted on the final Priority Products list posted on the Department’s website, unless the
Department specifies a different due date in the Priority Products list.
(B)
Except as provided in subsection (c), a responsible entity shall submit the Final AA
Report no later than twelve (12) months after the date the Department issues a notice ofcompliance for the Preliminary AA Report, unless the responsible entity requests and theDepartment approves an extended due date.
(C)
For a product that is first placed into the stream of commerce in California after thedate the product is listed on the Priority Products list, the due date for the Preliminary AA
Report shall be 180 days after the product is first placed into the stream of commerce in
California, unless the Department specifies a different due date in the Priority Products list.
(3)
The requirements of this article applicable to a responsible entity may be fulfilled
entirely or in part by the responsible entity, and/or entirely or in part by a person acting on
behalf of or in the stead of the responsible entity. This paragraph does not apply to sections
69505.2 and 69505.3.
(c)
AA Report Due Date Extension.
(1)
A responsible entity may request, and the Department may grant, a one-time
extension of up to ninety (90) days to the submission deadline for the AA Report or Alternate
Process AA Work Plan if the extension request is based on circumstances that could notreasonably be anticipated or controlled by the responsible entity. The extension request must
be received at least sixty (60) days before the applicable due date.
(2)
The extension request must include:(A)
The name of, and contact information for, the person filing the extension request;
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(B)
The name of, and contact information for, the responsible entity(ies) on whose
behalf the AA Reports will be submitted;(C)
If different from subparagraphs (A) and (B), the name of, and contact information for,the manufacturer(s) and importer(s) of the product;(D)
Information identifying and describing the responsible entity’s Priority Product, andthe brand name(s) and product name(s) under which the Priority Product is placed into thestream of commerce in California, and, if the Priority Product is a component of one or more
assembled products, a description of the known product(s) in which the component is used;(E)
The due date for the AA Report;(F)
The amount of additional time requested; and(G)
The reason the extension is needed, including an explanation as to why thecircumstances necessitating the extension could not reasonably be anticipated or controlled by
the responsible entity.
(3)
The Department shall approve or deny the extension request in whole or in part andprovide notice to the person submitting the extension request of the decision within thirty (30)days of receipt of the extension request. Failure by the Department to issue a decision within
thirty (30) days does not constitute an approval of the extension request.
(d)Consideration of Information and Public Comments.
(1)
A responsible entity conducting an AA shall consider all relevant information madeavailable on the Department’s website, including any relevant public comments, and any
additional information or technical assistance the Department may provide regarding
alternatives analysis. The responsible entity shall summarize these efforts in the Final AA
Report or final Abridged AA Report, whichever is applicable.
(2)
The Department shall post on its website a notice regarding the availability for public
review and comment of each Preliminary AA Report, draft Abridged AA Report, and Alternate
Process AA Work Plan submitted to the Department. The notice shall include the time period,
not to exceed forty-five (45) days, during which the public may submit comments, and themethod(s) for submitting comments. Any public comments on these documents must be
submitted to the entity that submitted the document to the Department with a copy submitted
simultaneously to the Department.
(e)Compliance Status. Notwithstanding any other provision of this chapter, failure of
the Department to make a compliance determination for an AA Report within the applicable
timeframe specified in section 69505.8, or failure of the Director or the Department to respondto an appeal or Request for Review submitted under article 7 within sixty (60) days, shall notcause an AA Report to be deemed compliant with this article.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Sections 25252 and 25253, Health and Safety Code.
§ 69505.2. Removal/Replacement Notifications in Lieu of Alternatives Analysis.
(a)Applicability.

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(1)(A) The requirements of this article do not apply to a responsible entity’s Priority Productif the manufacturer of the Priority Product submits one of the following notifications to the
Department no later than the due date for submitting the Preliminary AA Report:
1.
A Chemical Removal Intent and/or Confirmation Notification that complies withsubsections (b) and (c);2.
A Product Removal Intent and/or Confirmation Notification that complies withsubsections (b) and (d); or
3.
A Product-Chemical Replacement Intent and/or Confirmation Notification thatcomplies with subsections (b) and (e).
(B)
If only a Chemical Removal, Product Removal, or Product-Chemical Replacement
Intent Notification is submitted to the Department by the date specified in subparagraph (A),within ninety (90) days of the submission date, or by the due date for the Preliminary AA
Report, whichever is later, the manufacturer shall submit one of the following to the
Department:
1.
A removal or replacement Confirmation Notification; or
2.
A Preliminary AA Report, draft Abridged AA Report, or Alternate Process AA Work
Plan.
(2)(A) If a Preliminary AA Report, draft Abridged AA Report, or Alternate Process AA Work
Plan has already been submitted to the Department, the requirements of this article pertaining
to performance of a second stage AA and submission of a Final AA Report, or submission of a
final Abridged AA Report, do not apply if one of the notifications specified in paragraph (1)(A)is submitted to the Department prior to the due date for submitting the Final AA Report or final
Abridged AA Report, whichever is applicable.
(B)
If only a Chemical Removal, Product Removal, or Product-Chemical Replacement
Intent Notification is submitted to the Department by the date specified in subparagraph (A),the manufacturer shall submit a removal or replacement Confirmation Notification, or a Final
AA Report or final Abridged AA Report, by the later of the following dates:
1.
Ninety (90) days after the Intent Notification is submitted; or2.
The due date for the Final AA Report or final Abridged AA Report, whichever isapplicable.
(3)
A manufacturer is not in compliance with section 69505.1(b), if the manufacturer
submits a notification under this section, in lieu of submitting the otherwise required AA
Report(s), and that notification is not submitted by the applicable due date or does not fully
meet the applicable content requirements specified in subsections (b) through (e).
(b)
Content Requirements for Intent and Confirmation Notifications. Chemical Removal,
Product Removal, and Product-Chemical Replacement Intent and Confirmation Notifications
must include:(1)
The name of, and contact information for, the person submitting the notification.
(2)
The name of, and contact information for, any known responsible entity(ies).
(3)
If different from paragraphs (1) and (2), the name of, and contact information for, themanufacturer(s) and importer(s) of the product.

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(4)
The name of, and contact information for, all persons in California, other than the
final purchaser or lessee, to whom the manufacturer directly sold the Priority Product within theprior twelve (12) months.
(5)
Identification and location of the manufacturer’s retail sales outlets where the
manufacturer sold, supplied, or offered for sale the Priority Product in California, if applicable.
(6)
Information identifying and describing the Priority Product and the reformulated
product, if applicable, and the brand name(s) and labeling information under which the Priority
Product and the reformulated product, if applicable, are/were placed into the stream ofcommerce in California, and, if the product is a component of one or more assembled
products, a description of the known product(s) in which the component is used.
(7)
The intended uses, and targeted customer base(s), for the Priority Product and thereformulated product, if applicable.
(8)
The measures the manufacturer will take, or has taken, to:(A)
If applicable, provide information regarding the reformulated product to persons
selling or distributing the Priority Product in California; and(B)
Cease fulfilling orders for the Priority Product from persons selling or distributing thePriority Product in California.
(9)
For Chemical Removal Notifications and/or Product-Chemical Replacement
Notifications, the Chemical(s) of Concern that will be, or have been, removed from the product,
and, as applicable the following information:(A)
Information explaining the rationale and the factors considered in deciding toreformulate the product;(B)
Laboratory analytical testing methodology and quality control and assurance
protocols used or that will be used to confirm that the Chemical(s) of Concern have been
removed;(C)
Information demonstrating that the Chemical(s) of Concern has/have been removed
from the product that was a Priority Product;(D)
The name of the replacement chemical(s), the concentration of each replacement
chemical in the reformulated product, and the hazard traits and/or environmental or
toxicological endpoints known to be associated with the replacement chemical(s);(E)
Laboratory analytical testing methodology and quality control assurance protocols
used or that will be used to measure the concentration of the replacement chemical(s) in the
product; and(F)
Information demonstrating that the replacement chemical(s) meet one of thefollowing criteria:
1.
The replacement chemical(s) is/are not on the list of Candidate Chemicals; or
2.
The replacement chemical(s) is/are Candidate Chemical(s) that are already in use to
manufacture the same product, in lieu of the Chemical(s) of Concern, by the same or adifferent responsible entity. For purposes of this subsection, “same product” means a productthat has the same product description as, or similar product description to, the Priority Product;
has the same intended use(s) and targeted customer base(s) as the Priority Product; andfulfills the functional, performance, and legal requirements of the Priority Product.
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(10) The certification statement specified in subsection (c), (d) or (e), as applicable.
(c)
Chemical Removal Notification Certification Statements. Chemical Removal Intent
and Confirmation Notifications must include whichever of the following certification statements
is applicable:(1)
Chemical Removal Intent Notifications must include a statement certifying that the
manufacturer intends to do all of the following within ninety (90) days of the date thenotification is submitted to the Department:(A)
Remove the Chemical(s) of Concern from the Priority Product without the use of one
or more replacement chemicals or otherwise adding other chemicals to the product;(B)
Provide information regarding the reformulated product to persons selling or
distributing the Priority Product in California;(C)
Cease fulfilling orders for the Priority Product from persons selling or distributing thePriority Product in California; and(D)
Submit a Chemical Removal Confirmation Notification to the Department for the
Priority Product.
(2)
Chemical Removal Confirmation Notifications must include a statement certifying
that:
(A)
The Chemical(s) of Concern has/have been removed from the product that was a
Priority Product without the use of one or more replacement chemicals or otherwise adding
other chemicals to the product;(B)
Information regarding the reformulated product has been provided to persons sellingor distributing the Priority Product in California; and(C)
The manufacturer has ceased fulfilling orders for the Priority Product from persons
selling or distributing the Priority Product in California and will not resume doing so.
(d)Product Removal Notification Certification Statements. Product Removal Intent andConfirmation Notifications must include whichever of the following certification statements is
applicable:(1)
Product Removal Intent Notifications must include a statement certifying that the
manufacturer intends to do both of the following within ninety (90) days of the date thenotification is submitted to the Department:(A)
Cease fulfilling orders for the Priority Product from persons selling or distributing thePriority Product in California; and(B)
Submit a Product Removal Confirmation Notification to the Department for the
product.
(2)
Product Removal Confirmation Notifications must include a statement certifying thatthe manufacturer has ceased, and will not resume, fulfilling orders for the Priority Product frompersons selling or distributing the Priority Product in California.
(e)Product-Chemical Replacement Notification Certification Statements. ProductChemical Replacement Intent and Confirmation Notifications must include whichever of thefollowing certification statements is applicable:

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(1)
Product-Chemical Replacement Intent Notifications must include a statement
certifying that within ninety (90) days of submission of the notification to the Department, themanufacturer intends to:(A)
Remove the Chemical(s) of Concern from the Priority Product;(B)
Provide information regarding the reformulated product to persons selling or
distributing the Priority Product on California;(C)
Cease fulfilling orders for the Priority Product from persons selling or distributing thePriority Product in California; and(D)
Submit a Product-Chemical Replacement Confirmation Notification to the
Department for the Priority Product.
(2)
Product-Chemical Replacement Confirmation Notifications must include a statement
certifying that:(A)
The Chemical(s) of Concern has/have been removed from the product that was a
Priority Product;(B)
The replacement chemical(s) meet the criteria specified in subparagraph 1. orsubparagraph 2. of subsection (b)(9)(F);(C)
Information regarding the reformulated product has been provided to persons sellingor distributing the Priority Product on California; and(D)
The manufacturer has ceased fulfilling orders for the Priority Product from persons
selling or distributing the Priority Product in California and will not resume doing so.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Sections 25252 and 25253, Health and Safety Code.
§ 69505.3. Alternatives Analysis Threshold Notification in Lieu of Alternatives
Analysis.
(a)
Notification Requirements. This article does not apply to a responsible entity’s
Priority Product for which the manufacturer submits an Alternatives Analysis Threshold
Notification to the Department concurrently with the Priority Product Notification, or by the due
date for the Preliminary AA Report for the Priority Product. Each notification must include:(1)
The name of, and contact information for, the person submitting the notification;(2)
The name of, and contact information for, any known responsible entity(ies);(3)
If different from paragraphs (1) and (2), the name of, and contact information for, themanufacturer(s) and importer(s) of the Priority Product;(4)
A statement certifying that the Chemical(s) of Concern are present in the
manufacturer’s Priority Product only as contaminants and the concentration of each Chemicalof Concern does not exceed the Alternatives Analysis Threshold for that chemical;(5)
Identification of the PQL for each Chemical of Concern in the Priority Product, andthe information and method used to determine the PQL;
(6)
The source of the Chemical(s) of Concern in the Priority Product;(7)
Information identifying and describing the Priority Product, the brand name(s) andlabeling information under which the Priority Product is placed into the stream of commerce in
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California, and, if the Priority Product is a component of one or more assembled products, adescription of the known product(s) in which the component is used;(8)
Laboratory analytical testing methodology and quality control and assurance
protocols used to measure each Chemical of Concern in the Priority Product, and identificationof the testing laboratory; and(9)
A demonstration and certification that the manufacturer meets and will continue tomeet the criteria and conditions that are the basis for the exemption in this section.
(b)
Burden of Proof. The manufacturer bears the burden of proof to demonstrate thatthe concentration of the Chemical(s) of Concern in its Priority Product does not exceed theapplicable PQL.
(c)
Notification Revisions. If any of the information listed in subsection (a) changes
significantly, the manufacturer shall submit to the Department a revised Alternatives Analysis
Threshold Notification within thirty (30) days of the change.
(d)Change in Product’s Exemption Status. If the Priority Product no longer meets thecriteria for an Alternatives Analysis Threshold exemption, the manufacturer shall notify the
Department of this change within thirty (30) days of the change, and shall submit to the
Department a Preliminary AA Report or an applicable Intent and/or Confirmation Notification
under section 69505.2 within 180 days of the change.
(e)
Determination of Exemption Eligibility. The exemption in subsection (a) does not
apply if the Department notifies the person who submitted the Alternatives Analysis Threshold
Notification that the information contained in the notification is inaccurate or inadequate tosupport an Alternatives Analysis Threshold exemption.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Sections 25252 and 25253, Health and Safety Code.
§ 69505.4. Alternatives Analysis Process and Options.
(a)
AA Stages.
(1)
An AA must be conducted in two stages.
(2)
The responsible entity shall initially complete the first stage of the AA, and submit a
Preliminary AA Report that complies with sections 69505.1(b)(2)(A) and 69505.7.
(3)
The responsible entity shall next complete the second stage of the AA, and submit a
Final AA Report that complies with sections 69505.1(b)(2)(B) and 69505.7.
(b)
Abridged AA Reports. After completing the first four (4) steps of the first stage of theAA pursuant to subsections (a) through (d) of section 69505.5, a responsible entity that
determines a functionally acceptable and technically feasible alternative is not available may
prepare and submit draft and final Abridged AA Reports, in lieu of the Preliminary and Final AA
Reports, if:(1)
The responsible entity summarizes in the Abridged AA Report the first stage AA
findings in compliance with the applicable requirements of section 69505.7;(2)
The responsible entity identifies the factors relevant for comparison of the Priority
Product and the alternatives under consideration as specified in section 69505.6(a), andDepartment of Toxic Substances Control

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summarizes in the Abridged AA Report its findings with respect to section 69505.6(a) incompliance with the applicable requirements of section 69505.7;(3)
The responsible entity submits a draft Abridged AA Report by the due date specified
in section 69505.1(b)(2)(A), and submits a final Abridged AA Report by the due date specified
by the Department under section 69505.8(b)(4); and(4)
The responsible entity specifies in the implementation plan included in the draft andfinal Abridged AA Report the milestones and dates for implementation of proposed regulatory
responses, which shall, at a minimum, include the regulatory responses required under
sections 69506.3 and 69506.8.
(c)
Alternate Process AA.
(1)
A responsible entity may use an AA process that differs from the process specified
in sections 69505.5 and 69505.6, if:(A)
The responsible entity’s alternate process provides the information needed toprepare a Final AA Report that substantially complies with section 69505.7.
(B)
The responsible entity’s alternate process compares the Priority Product and thealternatives under consideration using, at a minimum, the same factors and, when applicable,
associated exposure pathways and life cycle segments specified in sections 69505.5 and69505.6.
(C)
The responsible entity submits an Alternate Process AA Work Plan to the
Department with sufficient information to demonstrate that the alternate process complies with
subparagraphs (A) and (B), and sufficient information for the Department to specify anappropriate due date for submittal of the Final AA Report.
1.
The Alternate Process AA Work Plan shall include the information specified insubsections (c), (d), and (e) of section 69505.7.
2.
If the Alternate Process AA Work Plan includes information for which trade secretprotection is claimed, the responsible entity shall also submit a redacted copy of the work planthat masks that information.
3.
The Alternate Process AA Work Plan shall be accompanied by an executive
summary organized in conformance with the organization of the work plan that is sufficient toconvey to the public a general understanding of the work plan, and that masks any information
for which trade secret protection is claimed. If the Department subsequently rejects a trade
secret claim, the responsible entity shall, at the Department’s request, submit a revised
executive summary within thirty (30) days of the request to add any information for which a
trade secret claim is rejected and which the Department specifies must be included in theexecutive summary.
(D)
The Alternate Process AA Work Plan is submitted to the Department no later thansixty (60) days after the product is included on the Priority Products list. For a product that isfirst placed into the stream of commerce in California after the date the product is included on
the Priority Products list, the Alternate Process AA Work Plan shall be due sixty (60) days after
the Priority Product is first placed into the stream of commerce in California.
(E)1. The responsible entity timely submits a Final AA Report to the Department that
substantially complies with section 69505.7.
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2.
The due date for the Final AA Report is eighteen (18) months after the date theDepartment issues a notice of compliance for the Alternate Process AA Work Plan, unless the
responsible entity requests and receives Department approval of an extended due date using
the procedures specified for Preliminary AA Reports in section 69505.7(k)(1)(B), or the
Department otherwise approves an extended due date under section 69505.8(b)(4)(A). If the
Department approves an extended due date, the responsible entity shall provide a yearlyprogress report until the Final AA Report is submitted. Each progress report must provide allof the information specified in subparagraphs 1. through 6. of section 69505.7(k)(1)(A).
(2)
If the Alternate Process AA Work Plan is disapproved by the Department under
section 69505.8(b)(3), the responsible entity shall submit a Preliminary AA Report to the
Department within 180 days after the Department issues the notice of disapproval.
(d)Previously Completed AAs. A responsible entity may comply with section
69505.1(b) by submitting to the Department a report for a previously completed AA for the
Priority Product, if the Department determines that the report is substantially equivalent to the
Final AA Report requirements of section 69505.7 and contains sufficient information for the
Department to determine any necessary regulatory response(s) under article 6. The
previously completed AA may be either an AA conducted or obtained by the responsible entity
or a publicly available AA.
(1)
A responsible entity submitting a report under this subsection shall submit the reportno later than the deadline for submitting a Preliminary AA Report, except that a one-time
extension may be requested under section 69505.1(c).
(2)
A responsible entity submitting an existing report under this subsection may
supplement the report with additional information to render the report substantially equivalent
to the Final AA Report requirements of section 69505.7.
(e)Revised Alternative Selection Decision.
(1)
If after submitting the Final AA Report, the responsible entity selects one or morealternatives that differ from the alternative(s) identified as the selected alternative(s) in the
Final AA Report, the responsible entity shall submit a revised Final AA Report to the
Department at least sixty (60) days prior to placing the newly selected alternative product(s)into the stream of commerce in California. The revised Final AA Report must explain the
differences from the original Final AA Report, identify the information used to support therevisions to the Final AA Report, and describe the rationale for selecting the different
alternative(s). The Department shall review and make a compliance determination withrespect to the revised Final AA Report in accordance with the procedures and criteria set forthin section 69505.8.
(2)
Paragraph (1) also applies if:(A)
The selection decision in the original Final AA Report was to retain the Priority
Product, and the responsible entity later decides to select an alternative to replace the Priority
Product; or(B)
The responsible entity later decides to retain the Priority Product in lieu of apreviously selected alternative product.

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(3)
The requirements of this subsection only apply for three (3) years after the date theoriginal Final AA Report is approved by the Department.
(f)
Reformulation. Except as provided in section 69505.2, if prior to submitting the Final
AA Report for a Priority Product the responsible entity removes, or reduces the concentrationof, the Chemical of Concern(s) and uses one or more replacement Candidate Chemical(s), theAlternatives Analysis evaluation and comparison shall include consideration of both the Priority
Product and the reformulated product.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Sections 25252, 25253, and 25257, Health and Safety Code.
§ 69505.5. Alternatives Analysis: First Stage.
The first stage of the AA shall include the five (5) steps described below:(a)Step 1, Identification of Product Requirements and Function(s) of Chemical(s) ofConcern.
(1)
The responsible entity shall identify the functional, performance, and legal
requirements of the Priority Product that must also be met by the alternatives underconsideration.
(2)
The responsible entity shall identify the role(s), if any, of the Chemical(s) of Concern
in meeting the Priority Product’s requirements identified under paragraph (1).
(3)(A) The responsible entity shall determine if the Chemical(s) of Concern or alternative
replacement chemical(s) is/are necessary to meet the Priority Product’s requirements identified
under paragraph (1).
(B)
If the responsible entity determines that neither the Chemical(s) of Concern nor
alternative replacement chemical(s) is/are necessary to meet the Priority Product’s
requirements identified under paragraph (1), the responsible entity shall evaluate removal of
the Chemical(s) of Concern from the Priority Product without the use of any replacement
chemical(s) as one of the alternatives to the Priority Product. Alternatively, the responsible
entity may submit Chemical Removal Intent and/or Confirmation Notifications to the
Department in lieu of completing the Alternatives Analysis and submitting the required AA
Reports.
(b)
Step 2, Identification of Alternatives.
(1)(A) In addition to any alternative identified under subsection (a)(3)(B), the responsible
entity shall identify and consider alternatives that meet the definition of “alternative” under
section 69501.1 and meet the Priority Product’s requirements identified under subsection(a)(1).
(B)
The responsible entity shall research and evaluate available information that
identifies existing possibly viable alternatives for consideration in the AA. This research andevaluation shall include, but is not limited to, information posted on the Department’s website.
The responsible entity shall consider any identified alternative in the AA, or explain in the AA
Report why such an alternative is not viable for consideration.

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(2)
Alternatives that do not involve the use of one or more replacement chemicals, orotherwise adding chemicals to the product, do not require compliance with subsection (c).
(c)
Step 3, Initial Evaluation and Screening of Alternative Replacement Chemicals.
(1)
For those alternatives under consideration that involve removing or reducing theconcentration of the Chemical(s) of Concern and using one or more alternative replacement
chemicals, or otherwise adding chemicals to the product, the responsible entity shall:(A)
Use available information on hazard traits and environmental and toxicological
endpoints and any other relevant information to identify the following for each alternative
replacement chemical under consideration:
1.
Adverse environmental impacts;
2.
Adverse public health impacts;
3.
Environmental fate;4.
Physical chemical hazards; and5.
Physicochemical properties.
(B)
Compare each of the alternative replacement chemicals under consideration with
the Chemical(s) of Concern in the Priority Product, using the information collected andevaluated under subparagraph (A).
(2)
The responsible entity may eliminate from further consideration in the AA any
alternative replacement chemical(s) that it determines has/have the potential to pose adverse
impacts equal to or greater than those posed by the Chemical(s) of Concern.
(d)
Step 4, Consideration of Additional Information.
In the first stage of the AA, the responsible entity may consider pertinent factors andinformation not specifically identified in this section. This may include, but is not limited to,consideration of the factors and information specified in section 69505.6. A responsible entity
may eliminate an alternative from further consideration based on the additional factors andinformation as long as the reason for its elimination is explained in the Preliminary AA Report
and there are alternatives remaining to be evaluated in the second AA stage.
(e)
Step 5, Preliminary AA Report Preparation.
(1)
The responsible entity shall prepare, for inclusion in the Preliminary AA Report, awork plan and proposed implementation schedule for completion of the second AA stage andpreparation and submittal of the Final AA Report.
(2)
The responsible entity shall prepare and submit to the Department a Preliminary AA
Report as specified in section 69505.7.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Sections 25252, 25253, and 25257, Health and Safety Code.
§ 69505.6. Alternatives Analysis: Second Stage.
After receiving approval of the Preliminary AA Report from the Department, the responsible
entity shall compare the Priority Product with the alternatives still under consideration. The
second stage of the AA shall include the five (5) steps described below:(a)Step 1, Identification of Factors Relevant for Comparison of Alternatives.
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(1)
A factor listed in paragraph (2)(A), in conjunction with an associated exposure
pathway and life cycle segment, if applicable, is relevant if:(A)
The factor makes a material contribution to one or more adverse public healthimpacts, adverse environmental impacts, adverse waste and end-of-life effects, and/or
materials and resource consumption impacts associated with the Priority Product and/or one ormore alternatives under consideration; and(B)
There is a material difference in the factor’s contribution to such impact(s) between
the Priority Product and one or more alternatives under consideration and/or between two or
more alternatives.
(2)
The responsible entity shall use available quantitative information and analytical
tools, supplemented by available qualitative information and analytical tools, to identify thefactors specified in subparagraph (A) and the associated exposure pathways and life cycle
segments, if applicable, that are relevant for the comparison of the Priority Product and thealternatives still under consideration after completion of the first AA stage. The factors
identified in subparagraphs (B) and (C) are relevant for all comparisons of the Priority Productand the alternatives.
(A)
Multimedia life cycle impacts for the Priority Product and alternatives underconsideration, and chemical hazards and adverse impacts for the Chemical(s) of Concern andany alternative replacement chemical(s) or other chemicals in the alternatives that differ fromthe chemicals in the Priority Product. This evaluation shall be based on available information,and shall include the following factors to the extent relevant:
1.
Adverse environmental impacts;
2.
Adverse public health impacts;
3.
Adverse waste and end-of-life effects;
4.
Environmental fate;
5.
Materials and resource consumption impacts;
6.
Physical chemical hazards; and7.
Physicochemical properties.
(B)
Product function and performance. The responsible entity shall identify the principal
manufacturer-intended use(s) or application(s), the functional and performance attributes, andthe applicable legal requirements for the Priority Product. The responsible entity shall, at aminimum, evaluate:
1.
The useful life of the Priority Product, and that of the alternatives underconsideration;
2.
The function and performance of each alternative relative to the Priority Product andother alternatives under consideration; and3.
Whether an alternative exists that is functionally acceptable, technically feasible, andeconomically feasible.
(C)
Economic impacts.
1.
The responsible entity shall evaluate, monetize, and compare for the relevant
exposure pathways and life cycle segments the following impacts of the Priority Product andthe alternatives:
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a.
Public health and environmental costs; andb.
Costs to governmental agencies and non-profit organizations that manage waste,
oversee environmental cleanup and restoration efforts, and/or are charged with protecting
natural resources, water quality, and wildlife.
2.
If the responsible entity’s alternative selection decision is to retain the Priority
Product based in whole or in part on internal cost impacts, this decision must be explained in
the Final AA Report. The Final AA Report must include a quantified comparison of the internal
cost impacts of the Priority Product and the alternatives, including manufacturing, marketing,materials and equipment acquisition, and resource consumption costs.
(3)
Exposure pathways. The responsible entity’s identification of relevant exposure
pathways shall consider both of the following:(A)
Chemical quantity information:
1.
Quantities of the Chemical(s) of Concern or alternative replacement chemical(s)necessary to manufacture the Priority Product and each alternative under consideration; and2.
Estimated volume and/or mass of the Chemical(s) of Concern or alternative
replacement chemical(s) that is/are or would be placed into the stream of commerce in
California as a result of the Priority Product and each alternative under consideration.
(B)
Exposure factors specified in section 69503.3(b).
(b)
Step 2, Comparison of the Priority Product and Alternatives.
The responsible entity shall use available quantitative information and analytical tools,
supplemented by available qualitative information and analytical tools, to evaluate andcompare the Priority Product and each of the alternatives under consideration with respect toeach relevant factor and associated exposure pathways and life cycle segments, if applicable,
identified under subsection (a). The responsible entity shall compare each alternative with thePriority Product and with each of the other alternatives under consideration.
(c)
Step 3, Consideration of Additional Information.
As part of the second stage of the AA, the responsible entity may also consider otherpertinent information not specifically identified in this section. This may include, but is not
limited to, reconsideration of the factors and information identified in section 69505.5.
(d)Step 4, Alternative Selection Decision.
The responsible entity shall select the alternative(s) that will replace the Priority Product,
unless the decision is to retain the existing Priority Product. The selection of an alternative or
the decision to retain the Priority Product shall be based on and supported by the comparative
analysis conducted under subsections (b) and (c).
(e)
Step 5, Final AA Report Preparation.
The responsible entity shall prepare and submit to the Department a Final AA Report as
specified under section 69505.7.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Sections 25252, 25253, and 25257, Health and Safety Code.
§ 69505.7.

Alternatives Analysis Reports.

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(a)General Requirements. All references in this section to “AA Reports” mean thePreliminary AA Report, Final AA Report, draft Abridged AA Report, and/or final Abridged AA
Report, as applicable, unless otherwise specified.
(1)
The Preliminary and Final AA Reports, and draft and final Abridged AA Reports,
must each include all of the applicable information specified in subsections (b) through (k).
(2)
The responsible entity shall include in the AA Reports sufficient information for the
Department to determine:(A)
Compliance with the substantive and administrative requirements of this article; and(B)
The appropriate due date for submission of the Final AA Report or final Abridged AA
Report, whichever is applicable, and the appropriate due date for any regulatory response(s)required under article 6.
(3)
The responsible entity shall identify and explain in the Final AA Report all differencesin the information and analyses presented in the Preliminary AA Report and the Final AA
Report. The responsible entity must identify in the Final AA Report the information sources
used to support changes from the Preliminary AA Report to the Final AA Report. This
information shall also be included in a final Abridged AA Report with respect to differences
between the draft and final Abridged AA Reports.
(4)
The responsible entity shall maximize the scope of information in the AA Report thatcan be made available to the public, while maintaining protection of legitimate trade secrets.
(A)
If the AA Report contains information claimed by the responsible entity to be a trade
secret, a separate publicly available AA Report shall be submitted to the Department thatmasks claimed trade secret information only to the extent necessary to protect its confidential
nature.
(B)
If the Department subsequently rejects a trade secret claim and/or the nature and/or
extent of masking, the responsible entity shall, at the Department’s request, submit a revised
publicly available AA Report and executive summary within thirty (30) days of the request to
add any information for which a trade secret claim or masking is rejected.
(b)
Executive Summary. AA Reports must include a publicly available executive
summary sufficient to convey a general understanding of the scope and results of the AA andthe rationale for the AA selection decision. The executive summary must be organized inconformance with the organization of the AA Report and must include for each section of the
AA Report a detailed summary of the information presented. Information for which trade
secret protection is claimed must not be included in the executive summary.
(c)Preparer Information. This section of the AA Report must include:(1)
The name of, and contact information for, the person submitting the AA Report;(2)
If applicable, the name of, and contact information for, all responsible entities on
whose behalf the AA Report is being submitted;(3)
The names of the parties that were involved in funding, directing, overseeing,
preparing, and/or reviewing the AA; and(4)
The method(s) for the public to submit comments on the Preliminary AA Report ordraft Abridged AA Report under section 69505.1(d)(2).

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(d)
Responsible Entity and Supply Chain Information. This section of the AA Reportmust include:(1)
The name of, contact information for, and headquarters location of the
manufacturer(s) and importer(s), if applicable, and, if the AA Report is prepared on behalf of aconsortium of manufacturers or other persons in the Priority Product’s supply chain, a list of
the participants along with their contact information;(2)
The name of, and contact information for, any person(s) identified on the Priority
Product label as the manufacturer, importer, or distributor;(3)
The name of, and contact information for, all persons in California other than the
final purchaser or lessee to whom the manufacturer or importer directly sold the Priority
Product within the prior twelve (12) months; and(4)
Identification and location of the manufacturer’s and/or importer’s retail sales outlets
where the manufacturer and/or importer sold, supplied, or offered for sale the Priority Productin California, if applicable.
(e)Priority Product Information. This section of the AA Report must include:(1)
The brand name(s) and product name(s) under which the Priority Product is placed
into the stream of commerce in California;(2)
If the Priority Product is a component of one or more assembled products, adescription of the known product(s) in which the component is used;(3)
Identification of the Chemical(s) of Concern for the Priority Product;(4)
Any Material Safety Data Sheets related to the Priority Product; and(5)
The information specified in paragraphs (1) and (2) of section 69505.5(a).
(f)
Scope of Relevant Comparison Factors. The Final AA Report must identify which
factors and, when applicable, associated exposure pathways and life cycle segments were
determined to be relevant, under section 69505.6(a), for evaluation and comparison of thePriority Product and its alternatives. For each factor, and exposure pathway and life cycle
segment, if applicable, determined not to be relevant, the Final AA Report must explain therationale and identify, and explain the pertinent findings of, the supporting information for thisdetermination.
(g)
Scope and Comparison of Alternatives. The AA Reports must identify and describe
the alternatives chosen to be evaluated and compared, and explain the rationale for selecting
and screening out specific alternatives at each stage of the alternatives comparison process.
For any alternative that is screened out because it is determined that its adverse impacts areequal to or greater than those of the Priority Product, the responsible entity shall describe in
the AA Report the method used to determine equal or greater adverse impacts, including themethod used to compare the multiple factors associated with the impacts, and the rationale forany trade-offs made among the factors.
(1)
The Preliminary AA Report must include the information collected and thecomparison conducted under section 69505.5 for the Chemical(s) of Concern and thealternative replacement chemical(s). The information and comparison must be presented in amatrix, or other summary format, that provides a clear visual comparison among the chemicals
and their associated adverse impacts.
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(2)
The Final AA Report must include the information collected and the comparison
conducted under sections 69505.5 and 69505.6 for the Priority Product and its alternatives,
including:(A)
A matrix, or other summary format, that provides a clear visual comparison that
includes the information collected regarding the relevant comparison factors, and theirassociated relevant exposure pathways and life cycle segments, for the Priority Product andeach alternative considered, and the comparative results of evaluating this information; and(B)
Identification and description of how any relevant safeguards provided by otherfederal and California State regulatory programs were considered in the AA.
(3)
The responsible entity shall demonstrate in the Final AA Report that all of therequirements of section 69505.6 have been met.
(h)Methodology. The AA Report shall identify and describe the analytical tools,
models, and software used to conduct the AA, and discuss any of their limitations. The AA
Report shall also identify any published methodologies and/or guidelines used, and any
deviations from those methodologies and/or guidelines.
(i)
Supporting Information.
(1)
All information used as supporting information in performance of the AA andpreparation of the AA Reports must be cited in the AA Reports and made available to the
Department upon request. The AA Reports must include a brief summary of the information
reviewed and considered under section 69505.1(d)(1). Final AA Reports and final Abridged
AA Reports must include a summary of the public comments submitted under section
69505.1(d)(2), and a description as to how the comments are addressed in the report or an
explanation as to why the comments are not addressed in the AA Report.
(2)
The Final AA Report must identify information that is not currently available but, if itwere available, could be used to:(A)
Validate information used for purposes of sections 69505.5 and 69505.6; and/or(B)
Address any uncertainties in the analyses conducted under sections 69505.5 and69505.6.
(j)Selected Alternative(s).
(1)
The Preliminary AA Report must identify and describe the alternatives selected forfurther evaluation in the second stage of the AA, and explain the rationale for the selection
decision.
(2)
The Final AA Report must identify and describe the alternative(s), if any, selected toreplace the Priority Product. The description of the selection decision must include an analysis
that evaluates and compares the selected alternative(s) against the Priority Product and adetailed list and explanation of the reasons for the selection decision, or, alternatively, for thedecision not to select and implement an alternative to the Priority Product. The Final AA
Report must also include:(A)
The product function and performance information specified in section
69505.6(a)(2)(B) for the selected alternative(s). If no alternative is selected, this informationmust be provided for each alternative considered.

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(B)
An explanation of the rationale for retaining the Chemical(s) of Concern or using thealternative replacement chemical(s), if section 69505.5(a)(3)(B) applies, and one or more
selected alternatives retains the Chemical(s) of Concern or uses one or more replacement
chemicals.
(C)
A list of all chemicals known, based on available information, to be in the selected
alternative(s) that are Chemicals of Concern, that differ from the chemicals in the Priority
Product, or that are present in the selected alternative(s) at a higher concentration than in the
Priority Product relative to other chemicals in the Priority Product other than the Chemical(s) ofConcern. The following information, to the extent available, must be provided for thosechemicals:
1.
Environmental fate;
2.
Hazard trait and environmental and toxicological endpoint information that has notalready been provided to the Department under this chapter;3.
Information about the chemical purity, meaning the relative absence of extraneous
matter, and identification of known impurities and additives in the chemical;
4.
Physicochemical properties; and5.
Substance identification information, including all of the following that are applicable:a.
Chemical abstract services number;b.
Structural formula;c.
Molecular weight;d.
Synonyms;e.
International Union of Pure and Applied Chemistry name;f.
European Commission number;g.
Registry of Toxic Effects of Chemical Substances number;h.
International Union of Biochemistry and Molecular Biology number;i.
Japan Ministry of International Trade and Industry number;j.
Number assigned by the United Nations Experts on the Transport of Dangerous
Goods;k.
North America Department of Transportation number;l.
European Inventory of Existing Commercial Chemical Substances number;m.
European List of Notified Chemical Substances number;n.
European Commission Directive 67/548/EEC No Longer Polymers number; ando.
Other commonly recognized substance identification system numbers.
(k)
Next Steps.
(1)
Work plan. The Preliminary AA Report must include the work plan and proposed
implementation schedule for completion of the second AA stage required to be prepared under
section 69505.5(e)(1). The work plan must include a description of the process that will be
used to identify the factors and associated exposure pathways and life cycle segments that are
relevant for the comparison of the Priority Product and the alternatives under consideration, as
required under section 69505.6(a).
(A)
The work plan and implementation schedule must specify the proposed submission
date for the Final AA Report and must ensure that the Final AA Report or progress report, if
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applicable, will be submitted to the Department no later than twelve (12) months after the
Department issues a notice of compliance for the Preliminary AA Report. If the Department
approves an extended due date under section 69505.8(b)(4)(A), the responsible entity shallprovide a yearly progress report until the Final AA Report is submitted. The first yearlyprogress report shall be submitted no later than twelve (12) months after the Department
issues a notice of compliance for the Preliminary AA Report. Each progress report must
include:1.
Preparer information specified in subsection (c);2.
Priority Product information specified in subsection (e);3.
A summary of achievements since the last progress report;
4.
A summary and discussion of issues that have arisen and their resolutions;5.
A summary of work that is pending; and6.
An assessment of whether the milestones in the schedule set forth in the Preliminary
AA Report or Alternate Process AA Work Plan are anticipated to be completed on time andany contingency plans to ensure timely completion.
(B)
The responsible entity may request an extended due date for submittal of the Final
AA Report. Any requested extension shall not exceed twenty-four (24) months from the date
the Department issues a notice of compliance for the Preliminary AA Report, unless additionaltime is needed to conduct regulatory safety and/or performance testing on multiple alternativesprior to making an AA selection decision, in which case the requested extension shall not
exceed thirty-six (36) months. The extended due date request must include a detailed
explanation of why additional time is needed.
(2)
Implementation of selected alternatives. The Final AA Report must include a
detailed plan for implementing any selected alternative(s).
(A)
The implementation plan must include key milestones and dates for implementing
the selected alternative(s), if applicable, and identify steps that will be taken to ensurecompliance with applicable federal, state, and/or local laws.
(B)
The implementation plan may also include the identification of and implementationplan(s) for any regulatory response(s) that the responsible entity wishes to propose that would
best limit exposure to, or reduce the level of adverse impacts or adverse waste and end-of-life
effects posed by, any Chemical(s) of Concern or replacement Candidate Chemical(s) that will
be in the selected alternative(s) or the Chemical(s) of Concern that is/are in the Priority
Product if the decision resulting from the AA is to retain the Priority Product.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Sections 25252, 25253, and 25257, Health and Safety Code.
§ 69505.8. Department Review and Determinations for AA Reports and Work Plans.
(a)Review Criteria. In reviewing AA Reports and Alternate Process AA Work Plans forcompliance with the substantive and administrative requirements of this article, the Department
shall consider:(1)
Whether the AA Report or Alternate Process AA Work Plan was submitted timely;
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(2)
Whether, and to what extent, the responsible entity considered and addressed allapplicable provisions of this article pertaining to the preparation and submittal of an AA Report
or Alternate Process AA Work Plan, whichever is applicable;(3)
Whether, and to what extent, the responsible entity demonstrated that theconclusions of the AA were based on reliable information, when applicable; and(4)
Whether, and to what extent, the responsible entity demonstrated that theconclusions of the AA Report were determined using reliable information.
(b)
Preliminary AA Reports, Draft and Final Abridged AA Reports, and Alternate
Process AA Work Plans.
(1)Within sixty (60) days of receiving a Preliminary AA Report, draft or final Abridged
AA Report, or Alternate Process AA Work Plan, the Department shall review the report or work
plan for compliance with this article, and issue a notice of compliance, notice of deficiency,
notice of disapproval, or notice of ongoing review.
(2)
Notice of Deficiency.
(A)
The Department shall specify in a notice of deficiency the areas of deficiency, theinformation required to cure the deficiency(ies), and the due date for submitting the necessary
information, which may not exceed sixty (60) days from the date the notice of deficiency isissued. The responsible entity shall submit a revised report or work plan, whichever isapplicable, by the due date specified, and address the areas of deficiency.
(B)
Within thirty (30) days of receipt of the additional information requested in the noticeof deficiency, the Department shall issue a notice of compliance, a notice of disapproval, or a
notice of ongoing review for the report or work plan.
(3)
Notice of Disapproval. If the revised report or work plan does not fully address theidentified areas of deficiency, the Department shall issue a notice of disapproval. The
Department shall also issue a notice of disapproval if a revised report or work plan is not
submitted by the due date specified under paragraph (2)(A). If the report or work plan isdisapproved, the Department shall explain the basis for the disapproval. A disapproved reportor work plan is not in compliance with section 69505.1(b).
(4)
Notice of Compliance.
(A)
The Department shall specify in a notice of compliance for a Preliminary AA Report
or Alternate Process AA Work Plan the due date for submitting the Final AA Report. The
Department shall specify a due date twelve (12) months from the date the Department issues
the notice of compliance, except that the Department may specify an extended due date forsubmission of the Final AA Report if it determines based on information in the Preliminary AA
Report or Alternate Process AA Work Plan that more time is needed. The Department may
also specify an extended due date for submission of the Final AA Report if the responsible
entity submits a request under section 69505.7(k)(1)(B).
(B)
The Department shall specify in a notice of compliance for a draft Abridged AA
Report the due date for submitting the final Abridged AA Report, which shall be no later thanninety (90) days after the end of the public comment period the draft Abridged AA Report.
(c)Final AA Reports.

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(1)
Within sixty (60) days of receiving a Final AA Report, the Department shall review
the AA Report for compliance with this article, and shall issue a notice of compliance, notice of
deficiency, notice of disapproval, or notice of ongoing review.
(2)
Notice of Deficiency.
(A)
The Department shall specify in a notice of deficiency the areas of deficiency, theinformation required to cure the deficiency(ies), and the due date for submitting the necessary
information to complete the Final AA Report, which may not exceed sixty (60) days from thedate of the notice of deficiency. The responsible entity shall submit a revised Final AA Reportby the due date specified, and address all areas of deficiency. Pursuant to section 69505.1(c),the responsible entity may request, and the Department may approve, a one-time extension of
not more than ninety (90) days for submission of the revised Final AA Report to correct the
deficiencies.
(B)
Within sixty (60) days of receipt of the requested additional information, theDepartment shall issue a notice of compliance, a second notice of deficiency, or a notice ofongoing review.
1.
If the Department issues a second notice of deficiency, the Department may grantno more than thirty (30) days for submission of the requested information.
2.
Within sixty (60) days of receipt of the additional information requested in the second
notice of deficiency, the Department shall issue a notice of compliance, a notice of disapproval,
or a notice of ongoing review for the Final AA Report.
(3)
Notice of Disapproval. If the Final AA Report does not fully address the areas of
deficiency identified in the second notice of deficiency, the Department shall issue a notice ofdisapproval. The Department shall also issue a notice of disapproval if a revised Final AA
Report is not submitted by the due date specified under paragraph (2)(A) or paragraph(2)(B)1., whichever is applicable. If the report or work plan is disapproved, the Department
shall explain the basis for the disapproval. A disapproved Final AA Report is not in compliancewith section 69505.1(b).
(d)
Notice of Ongoing Review. The Department shall specify in a notice of ongoing
review the estimated date by which the Department expects to issue a notice of compliance ornotice of deficiency, which shall be based on its available resources and the complexity of the
AA Report under review.
(e)Issuance of Notices. All notices issued by the Department under this section shallbe issued to the person who submitted the AA Report, and a copy of the notice shall be sentby the Department to all persons identified in the AA Report under subsections (c)(2) and(c)(3) of section 69505.7.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Section 25253, Health and Safety Code.
Article 6.

Regulatory Responses§ 69506.

Regulatory Response Selection Principles.

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(a)
Need for Regulatory Response. The Department shall identify and require
implementation of one or more regulatory responses for Priority Products and/or selected
alternative products when the Department determines such regulatory responses arenecessary to protect public health and/or the environment. In selecting regulatory responses,
the Department shall seek to maximize the use of alternatives of least concern when suchalternatives are functionally acceptable, technically feasible, and economically feasible.
(b)
Inherent Protection Preference. In selecting regulatory responses, the Department
shall give preference to regulatory responses providing the greatest level of inherent
protection. For these purposes, “inherent protection” refers to avoidance or reduction ofadverse impacts, exposures, and/or adverse waste and end-of-life effects that is achieved
through the redesign of a product or process, rather than through administrative or engineering
controls designed to limit exposure to, or the release of, a Chemical of Concern or replacement
Candidate Chemical in a product.
(c)
Selection Factors. In selecting regulatory responses, the Department may consider
the following factors:(1)
Public health and environmental protection.
(A)
The degree to which, and speed with which, the regulatory response can address
the adverse impacts and/or adverse waste and end-of-life effects of the Chemical(s) ofConcern or replacement Candidate Chemicals in the selected alternative, or the Chemical(s) ofConcern in the Priority Product;(B)
The ability of end-users to understand and act upon any regulatory response
involving provision of information and/or directions with respect to the Priority Product; and(C)
Any adverse ecological impacts of the regulatory response on sensitive resources,
or unique or additional burdens that the regulatory response would impose upon sensitive
subpopulations.
(2)
Private economic interests of responsible entities.
(A)
Existing federal and/or California State regulatory requirements applicable to theChemical(s) of Concern or replacement Candidate Chemicals in the product;(B)
The cost to the responsible entity of the regulatory response(s) relative to the cost ofother possible responses; and(C)
The practical capacity of responsible entities to comply with regulatory response(s).
(3)
Government interest in efficiency and cost containment.
(A)
The management and clean-up costs imposed on public agencies by the ongoingsale of the Priority Product or a selected alternative;(B)
The Department’s administrative burden in overseeing implementation of theregulatory response(s); and(C)
The ease of enforcing the regulatory response(s).
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Section 25253, Health and Safety Code.
§ 69506.1.

Applicability and Determination Process.

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(a)Applicability. This article applies to any product placed into the stream of commercein California that is:(1)
A Priority Product for which an alternative is not selected;(2)
An alternative selected under section 69505.6(d);(3)
A Priority Product that will remain in commerce in California pending development
and distribution of a selected alternative; or(4)
A Priority Product for which the AA Report is disapproved by the Department under
section 69505.8(c)(3).
(b)
Exceptions. This article does not apply to a Priority Product if the manufacturer
submits a Removal or Replacement Confirmation Notification that fully meets the applicable
content requirements specified in subsections (b) through (e) of section 69505.2 to the
Department prior to the due date for implementing any regulatory response that would
otherwise apply to the product.
(c)
Notice of Proposed Determination. After issuing a notice of compliance or a noticeof disapproval for a Final AA Report or a final Abridged AA Report, the Department shall issue
a notice of the Department’s proposed determination that one or more of the regulatory
responses specified in this article is/are required, or that no regulatory response is required.
The notice shall be issued no later than ninety (90) days after the Department issues the noticeof compliance or a notice of disapproval.
(d)Public Input. A notice issued pursuant to subsection (c) shall be sent to all known
responsible entities for the product, and shall be made available on the Department’s website,
for public review and comment. The proposed regulatory response determination notice shall
include the Department’s rationale for the proposed regulatory response(s). The Department
shall hold one or more public workshop(s) to provide an opportunity for comment on the
proposed regulatory response determination. The Department shall send to individuals on theelectronic mailing list(s) that the Department establishes related to this chapter, and post on its
website, a notice regarding the availability of the proposed regulatory response determination.
The notice must include:(1)
The last day for the public to submit written comments on the proposed regulatory
response determination. The last day for submission of public comments shall be no sooner
than forty-five (45) days from the date the notice of the availability of the proposed regulatory
response determination notice is posted on the Department’s website or the date the notice issent to individuals on the electronic mailing list(s) that the Department establishes related tothis chapter, whichever is later.
(2)
The method(s) for submitting comments to the Department.
(3)
The date, time, and location of any public workshop(s).
(e)
Notice of Final Determination. After review and consideration of public comments,
the Department shall post on its website and send to known responsible entities the final
regulatory response determination notice. The Department may respond to some or all publiccomments received.
(f)Contents of Notices. All proposed and final regulatory response determination
notices must include:
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(1)
A description of the required regulatory response(s), or a determination that noregulatory response is required, whichever is applicable;(2)
The rationale, information, and information sources supporting the Department’s
determination(s);(3)
The implementation due date(s) for the regulatory response(s), if applicable; and(4)
The Department’s determination as to whether or not the regulatory response(s)apply(ies) to either or both of the following:(A)
Priority Products ordered by a retailer prior to the effective date of the Priority
Product listing, and still for sale by the retailer as of the date of the final regulatory response
determination notice; and/or(B)
Priority Products manufactured after the effective date of the Priority Product listing,but before the date of the final regulatory response determination notice.
(g)
Implementation Due Date(s). In assigning a due date for implementation of one ormore regulatory responses, the Department shall consider the complexity of implementing theregulatory response(s).
(h)
Finality of Regulatory Response(s). Once a final regulatory response determination
notice has been issued, the Department shall not augment or revise the regulatory responses
for the affected product, except as provided otherwise in section 69506.2 and article 7.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Section 25253, Health and Safety Code.
§ 69506.2. Supplemental Information and Regulatory Response Revisions.
(a)Supplemental Information for Selection of Regulatory Response(s). Prior to
imposing any regulatory response for a product, the Department may require the responsible
entity to obtain or develop, and provide to the Department within a specified time frame, any
information supplementary to the AA Report that the Department determines is necessary to
select and ensure implementation of one or more regulatory responses.
(b)
Information-Generation for Revision of Regulatory Response(s).
(1)
When imposing one or more regulatory responses for a product, the Department
may include a requirement that the responsible entity provide information to the Department tofill one or more information gaps identified in the AA Report under section 69505.7(i)(2), if the
Department determines this information is necessary to re-evaluate one or more of the otherinitial regulatory responses.
(2)
Following receipt of information required to be provided under paragraph (1), theDepartment may, based on this new information, revise the initial regulatory response(s)imposed for the product in accordance with the procedures set forth in section 69506.1. Anyrevisions to the initial regulatory responses shall be noticed for public review and comment nolater than ninety (90) days after receiving the information required to be provided underparagraph (1).
(c)
Regulatory Response Revisions for Revised AA Reports. In addition to thecircumstances described in subsection (b), the Department may revise the initial regulatory
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response(s) imposed for a product in response to a revised AA Report submitted by a
responsible entity under section 69505.4(e), within ninety (90) days after issuing the notice ofcompliance or notice of disapproval for the revised AA Report.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Section 25253, Health and Safety Code.
§ 69506.3. Product Information for Consumers.
(a)Applicability. This section applies to:(1)
Priority Products for which an alternative is not selected;(2)
Priority Products that continue to be introduced into commerce in California pending
development and distribution of an alternative product for longer than twelve (12) months after
the Department issues a notice of compliance or a notice of disapproval for the AA Report; and(3)
Selected alternative products that retain the Chemical(s) of Concern, and/or containany replacement Candidate Chemical(s).
(b)
Required Information. Beginning no later than the date specified by the Departmentin the final regulatory response determination notice for the product, or when the product is firstplaced into the stream of commerce in California, whichever is later, and for as long thereafteras the product continues to be placed into the stream of commerce in California, theresponsible entity shall ensure that all of the following information is made available to theconsumer prior to product purchase:(1)
Manufacturer’s name and importer’s name, and/or the name of any other entity listedon the product label;(2)
Brand name(s) and product name(s), and a description of the product;(3)
A list of, and common names for, any Chemical(s) of Concern that remain in the
product and/or any replacement Candidate Chemical(s) and known hazards traits and/or
environmental or toxicological endpoints for those chemicals, based on available information;(4)
A statement informing consumers that the product must be disposed of or otherwise
managed as a hazardous waste at the end of its useful life, if applicable;(5)
Any safe handling and storage procedures and/or other information needed toprotect public health or the environment during the useful life of the product, including
precautions that consumers may take to prevent or limit exposure to the Chemical(s) ofConcern or replacement Candidate Chemical(s), and first aid and accidental releaseprocedures;(6)
Identification of any end-of-life management requirements specified by law, and any
existing end-of-life management program(s) for the product; and(7)
The manufacturer’s website address and the importer’s website address where theconsumer can obtain additional information about the product, the adverse impacts associatedwith the product as identified in the AA Report for the product, and proper end-of-life disposal
or management of the product.

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(c)Communication to Consumers. The responsible entity shall satisfy subsection (b) bymaking the required information available to consumers, in easily seen, legible, andunderstandable formats, by both:(1)
Posting the information in a prominent place on the manufacturer’s website and theimporter’s website; and(2)
Using one or both of the following means of informing consumers at the point of saleof the information specified in subsection (b):(A)
Providing the required information on the product packaging or in accompanying
written material that is accessible without breaking the product seal; and/or(B)
Posting the information in a prominent place at the point of retail display. For
products offered for sale online, the point of retail display is/are the web page(s) on which the
product is offered for sale.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Section 25253, Health and Safety Code.
§ 69506.4. Use Restrictions on Chemicals and Consumer Products.
The Department may impose restrictions on the use of one or more Chemicals of Concern
or replacement Candidate Chemicals in a selected alternative, or Chemicals of Concern in a
Priority Product for which an alternative is not selected, or restrictions on the use of the productitself, that the Department determines are necessary to reduce the potential for the product tocontribute to or cause adverse impacts and/or adverse waste and end-of-life effects. Use
restrictions may include one or more of the following:(a)Restrictions on the amount or concentration of the Chemical(s) of Concern or
replacement Candidate Chemical(s) permitted in a product;(b)
Restrictions on the settings in which a product may be sold or used;(c)
Restrictions regarding the form in which a product is sold;(d)Restrictions on who may purchase and/or use a product;(e)Requirements for training of product purchasers and/or users; and/or(f)
Any other use restriction that reduces the amount of any Chemical(s) of Concern or
replacement Candidate Chemical(s) in the product, or reduces the potential for the product tocontribute to or cause an exposure to the Chemical(s) of Concern or replacement Candidate
Chemical(s) in the product.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Section 25253, Health and Safety Code.
§ 69506.5. Product Sales Prohibition.
(a)
Existence of Safer Alternative(s). Except as provided in subsection (c), theDepartment may require a responsible entity to cease placing into the stream of commerce in
California a selected alternative product that contains one or more Chemical(s) of Concern or
replacement Candidate Chemical(s), or a Priority Product for which an alternative is not
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selected, if the Department determines and provides notice to the responsible entity under
section 69506.1 that a safer alternative exists that does not contain the Chemical(s) ofConcern or replacement Candidate Chemical(s) and that is functionally acceptable, technicallyfeasible, and economically feasible. In making this determination, the Department shallconsider the potential adverse impacts and potential exposure pathways associated with thealternative product or Priority Product, as applicable.
(b)
No Existing Safer Alternatives.
(1)
Except as provided in subsection (c), the Department may issue a notice, under
section 69506.1, that a product containing the Chemical(s) of Concern or replacement
Candidate Chemical(s) may no longer be placed into the stream of commerce in California,
notwithstanding the fact that there are no currently identified safer alternatives that arefunctionally acceptable, technically feasible, and economically feasible.
(2)
Prior to issuing a notice under paragraph (1), the Department shall request the
responsible entity to provide, within sixty (60) days, documentation that demonstrates to the
Department’s satisfaction both of the following:(A)
The overall beneficial public health and/or environmental impacts and/or social utilityof the product significantly outweigh the overall adverse impacts of the product; and(B)
Administrative and/or engineering restrictions on the nature and/or use of the
product will adequately protect public health and the environment.
(3)
The Department may issue a notice under paragraph (1) if the responsible entity
does not provide the requested documentation with sixty (60) days, or if the submitted
documentation does not make the required demonstrations to the Department’s satisfaction.
(c)
Exceptions. A responsible entity that receives a notice under subsection (a) or (b) is
not subject to the requirements of subsection (a) or (b) if all of the following requirements aremet:(1)
Within sixty (60) days after the notice is issued by the Department, the responsible
entity notifies the Department in writing of its intent to submit a revised AA Report that selects
an alternative that does not contain the Chemical(s) of Concern or the replacement Candidate
Chemical(s);(2)
The Department receives a timely revised AA Report that selects an alternative that
does not contain the Chemical(s) of Concern or the replacement Candidate Chemical(s) andthat complies with section 69505.7; and(3)
The product containing the Chemical(s) of Concern or the replacement Candidate
Chemical(s) is no longer placed into the stream of commerce in California by the responsible
entity, directly or indirectly, by the date specified by the Department in the final regulatory
response determination notice issued under section 69506.1.
(d)Extensions.
(1)
A responsible entity may request an extension to the due date for the revised AA
Report to be submitted under subsection (c), under the procedures specified in section
69505.1(c) or section 69505.7(k)(1)(B).
(2)
If the Department grants an extension, the responsible entity shall satisfy one of thefollowing requirements by the due date specified in the extension approval:
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(A)
A revised AA Report meeting the requirements of subsection (c)(2) shall be
submitted to the Department; or(B)
The product shall cease to be placed into the stream of commerce in California by
the responsible entity, directly or indirectly.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Section 25253, Health and Safety Code.
§ 69506.6. Engineered Safety Measures or Administrative Controls(a)Requirement for Controls. The Department may require a manufacturer to engineer
safety measures that integrally contain or control access to, and/or implement administrative
controls that limit exposure to, the Chemical(s) of Concern or replacement Candidate
Chemical(s) in a selected alternative, or the Chemical(s) of Concern in a Priority Product for
which an alternative is not selected, to reduce the potential for adverse impacts.
(b)
Criteria. Engineering or administrative controls may be required if one or more of
the following applies:(1)
Reliable information indicates the presence of the Chemical(s) of Concern or
replacement Candidate Chemical(s), or its/their degradate, metabolite, or reaction products, ina particular subpopulation that has one or more routes of exposure to the chemical(s);(2)
Reliable information indicates an elevated level of the Chemical(s) of Concern or
replacement Candidate Chemical(s) in an indoor building or other enclosed environment;
and/or(3)
Improper product handling increases the potential for release of, or exposure to, theChemical(s) of Concern or replacement Candidate Chemical(s).
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Section 25253, Health and Safety Code.
§ 69506.7. End-of-Life Management Requirements.
(a)Applicability. A manufacturer of a selected alternative, or a Priority Product for whichan alternative is not selected, that is sold or otherwise made available to consumers as afinished product and is required to be managed as a hazardous waste in California at the endof its useful life, shall comply with the requirements of subsection (c) except as otherwise
provided under subsections (d) and (e).
(b)
Manufacturer Collaboration Option. A manufacturer may individually fulfill therequirements of this section, or may join with other manufacturers to form a non-profit thirdparty product stewardship organization, funded by participating manufacturers, to fulfill therequirements of this section on behalf of the participating manufacturers.
(c)End-of-Life Program Requirements. No later than the date specified by the
Department in the final regulatory response determination notice for the product, or no later
than the date the product is first placed into the stream of commerce in California, whichever is

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later, the manufacturer shall establish and maintain an end-of-life management program for the
product. The program must comply with all of the following requirements:(1)
A comprehensive product stewardship plan must be developed and maintained,
after the plan is submitted to and approved by the Department. If the Department disapproves
the plan, it shall notify the manufacturer in writing, identify what is necessary to correct
deficiencies in the plan, and specify a due date for submission of a revised plan. If the plan is
not resubmitted by the due date or does not address all of the deficiencies, the plan will beconsidered to be non-compliant with this section.
(2)
Each product stewardship plan must include:(A)
A list of, and contact information for, participating manufacturers, importers, andother participating persons.
(B)
The scope of products and brands to be covered by the plan.
(C)
The roles and responsibilities for manufacturers, importers, assemblers, retailers,
consumers, and government throughout the life cycle of the product, and identification ofretailers and/or assemblers who have agreed to participate in the program.
(D)
Identification and description of collection systems that will be used.
(E)
End-of-life management information that describes the steps that will be taken to
ensure compliance with all applicable federal and California State and local laws, and that
addresses any adverse multimedia impacts.
(F)
Identification of anticipated resources needed to implement and sustain the plan,
which must ensure that the end-of-life management program is maintained for sufficient time to
be available at the end-of-life for the last covered product, and all previous covered products,that the manufacturer places into the stream of commerce in California. An estimate of theannual and total long-term program costs shall also be identified in the plan, along with theinformation, assumptions, calculations, and any models used to develop the cost estimate.
(G)
The funding mechanism to cover, but not exceed, the costs identified insubparagraph (F). This requirement shall be satisfied by whichever of the following means isapplicable:
1.
If the end-of-life management program will be administered by a non-profit thirdparty product stewardship organization pursuant to subsection (b), the plan shall describe how
the organization will collect operating revenues in an amount necessary to cover, but notexceed, the costs identified in subparagraph (F). This shall include the method andcalculations used to determine how much each participant will contribute.
2.
If an individual manufacturer is administering and funding its own end-of-life
management program, the manufacturer shall provide a financial guarantee that will ensurethat adequate funding is available to cover the costs identified in subparagraph (F).
(H)
Program performance goals, which shall be quantitative to the extent feasible, for:1.
Increasing the capture rate of covered products at the end-of-life; and2.
Increasing recyclability, and recycling rate.
(I)
A description of how each program goal will be achieved.
(J)
Public education, outreach, and communications plans.

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(K)
A description of public and stakeholder consultation activities during preparation of
the plan, which shall include, at a minimum, provision of thirty (30) days for the public tocomment on the proposed product stewardship plan through the manufacturer’s website. The
manufacturer shall transmit to the Department all comments received concurrent with submittalof the plan.
(L)
A description of public and stakeholder consultation activities for review andupdating of the plan, which shall occur no less frequently than annually.
(M)
Reporting and evaluation procedures.
(3)
The product stewardship program and plan for collecting and, if applicable, recycling
the product shall be developed in consultation with California retailers and owners/operators ofprospective collection sites. The collection program must include one or both of the following:(A)
Collection mechanisms; and/or(B)
If applicable, compensation to retailers and other persons who agree to administeror participate in the collection program.
(4)
The manufacturer shall provide its product stewardship plan to the Department forreview and approval, post a copy of the product stewardship plan on its own website, andprovide that link to the Department for posting on the Department’s website.
(5)
The manufacturer of a product subject to this section shall provide an annual reportto the Department. The annual report is due one (1) year from the date the end-of-life
management program is required to be implemented, and annually thereafter. The report must
include, by total tonnage:(A)
The quantity of products placed into the stream of commerce in California over theprevious one-year period; and(B)
The quantity of products recovered over the same one-year period.
(d)Alternative End-of-Life Programs. A manufacturer subject to this section may
request the Department’s approval to substitute an alternative end-of-life management
program that achieves, to the maximum extent feasible, the same results as the program
required by this section. A manufacturer may not propose an in-store take-back program aspart of an alternative program unless the manufacturer provides in the plan evidence that asufficient number of retailers have agreed in writing to participate to insure successful
implementation of the plan as proposed. A manufacturer may not substitute an alternative
end-of-life management program for the program specified in this section unless it receives
advanced written approval from the Department.
(e)Exemption from End-of-Life Program Requirements.
(1)
A manufacturer subject to this section may request an exemption from therequirement to provide an end-of-life management program by demonstrating to the
Department’s satisfaction in the AA Report that an end-of-life management program cannot
feasibly be implemented for the product.
(2)
A manufacturer subject to this section is not exempt from this section until it receives
written concurrence from the Department that an end-of-life management program cannot
feasibly be implemented for the product.

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NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Section 25253, Health and Safety Code.
§ 69506.8. Advancement of Green Chemistry and Green Engineering.
When a manufacturer concludes that no safer alternative to its Priority Product isfunctionally acceptable, technically feasible, and economically feasible, or a manufacturer
selects an alternative that reduces but does not eliminate the use of Candidate Chemicals in
the product, the Department may require the manufacturer to initiate a research anddevelopment project or fund a challenge grant pertinent to the Priority Product that uses green
chemistry and/or green engineering principles to do one or more of the following:(a)Design a safer alternative to the Priority Product;(b)
Improve the performance of a safer alternative to the Priority Product;(c)Decrease the cost of the safer alternative to the Priority Product; and/or(d)Increase the market penetration of a safer alternative to the Priority Product.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Section 25253, Health and Safety Code.
§ 69506.9. Exemption from Regulatory Response Requirements.
(a)
Exemption Requests. A product is exempt from sections 69506.3 through 69506.8,
if the responsible entity requests, and the Department grants, an exemption. A responsible
entity seeking an exemption shall submit an exemption request to the Department no later thansixty (60) days after the Department issues a final regulatory response determination notice forthe product.
(b)
Contents of Requests. An exemption request submitted under subsection (a) must
include:(1)
The name of, and contact information for, the person filing the exemption request;(2)
The name of, and contact information for, the responsible entity(ies) on whose
behalf the exemption request is being submitted;(3)
If different from paragraphs (1) and (2), the name of, and contact information for, themanufacturer(s) and importer(s) of the product;(4)
The name of, and contact information for, other responsible entities for the product,
to the extent known to the person submitting the exemption request;(5)
Information identifying and describing the product, and the brand name(s) andproduct name(s) under which the product is placed into the stream of commerce in California,
and, if the product is a component of one or more assembled products, a description of the
known product(s) in which the component is used; and(6)
Information that demonstrates to the Department’s satisfaction that one or both of
the following applies:(A)
The required or proposed regulatory response conflicts with one or more
requirements of another California State or federal regulatory program or applicable treaties or

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international agreements with the force of domestic law in such a way that the responsible
entity cannot reasonably be expected to comply with both requirements; and/or(B)
The required or proposed regulatory response substantially duplicates one or more
requirements of another California State or federal regulatory program or applicable treaties orinternational agreements with the force of domestic law, without conferring additional publichealth or environmental protection benefits.
(c)
Departmental Notice. Within sixty (60) days of receiving an exemption request, theDepartment shall issue a notice to the person who submitted the request granting or denying
the exemption request. The Department shall send a copy of the notice to known responsible
entities for the product.
(d)Actions Following Exemption Denial. If the exemption request or the Department’s
granting of the exemption is based solely on the criteria specified in subsection (b)(6)(A), theDepartment may require implementation of a modified regulatory response that resolves theconflict that is the basis for the exemption.
(e)
Rescission of Exemption. The Department shall rescind an exemption granted
under this section if the Department determines that the facts and/or assumptions that the
Department relied upon in granting the exemption were not, or are no longer, valid. If the
Department rescinds an exemption, the Department shall provide notice to the person who
submitted the exemption request and known responsible entities for the product.
(f)
Contents of Notices. The Department shall include in all notices granting, denying,or rescinding an exemption under this section a statement of basis for its decision and a newdue date for compliance, if applicable.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Sections 25253 and 25257.1, Health and Safety Code.
§ 69506.10. Regulatory Response Report and Notifications.
(a)Notification to Supply Chain. A responsible entity subject to a regulatory responseother than one imposed under sections 69506.2 and 69506.8 shall ensure that a notification issent to all persons in California, other than the final purchaser or lessee, to whom theresponsible entity directly sells the product, and any other person other than the final
purchaser or lessee to whom the responsible entity directly sells the product if it is reasonably
foreseeable that the product will be placed into the stream of commerce in California, informing
those persons of the applicability of the regulatory response to the product. The notification
shall be sent, with a copy sent to the Department, no later than thirty (30) days after receivinga final regulatory response determination notice, under section 69506.1.
(b)Contents of Notifications. The notification required under subsection (a) shall
include:(1)
The name of, and contact information for, the person providing the notification;(2)
The name of, and contact information for, the responsible entity(ies) on whose
behalf the notification is being provided;

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(3)
If different from paragraphs (1) and (2), the name of, and contact information for, themanufacturer(s) and importer(s) of the product;(4)
Information identifying and describing the original Priority Product, and the selected
alternative, and the brand name(s) and product name(s) under which the product is placed into
the stream of commerce in California, and the name(s) of any persons identified as the
manufacturer, importer, and/or distributor on the product label; and, if the product is acomponent of one or more assembled products, a description of the known product(s) in which
the component is used; and(5)
A description of the required regulatory response(s) and the due date for
implementing the regulatory response(s).
(c)
Notifications to the Department. The responsible entity shall notify the Department
upon completing implementation of the required regulatory response(s) and, if applicable, uponcompleting development and introduction into the California marketplace of the selected
alternative(s). The notification must include information describing how the regulatory
response(s) was/were implemented. If requested by the Department, the responsible entity
shall provide periodic implementation status reports regarding the selected regulatory
response(s) and/or the development and introduction into the California marketplace of theselected alternative(s). The information provided to the Department under this subsection
shall also be posted on the website of the responsible entity.
(d)Regulatory Response Summary.
(1)
The Department shall prepare and post on its website, and update at least annually,a Regulatory Response Summary that identifies the regulatory response(s) for each selected
alternative to a Priority Product, or for the Priority Product, whichever is applicable. The
Regulatory Response Summary must contain all of the following for which information isavailable:(A)
The name of, and contact information for, the manufacturer(s) and importer(s);(B)
The names of, and contact information for, other known responsible entities;(C)
Information identifying and describing the original Priority Product, and the selected
alternative(s), if any, and the brand name(s) and product name(s) under which the product isplaced into the stream of commerce in California, and, if the product is a component of one ormore assembled products, a description of the known product(s) in which the component is
used;
(D)
The due date and actual date for completing development and introduction into the
California marketplace of the selected alternative(s), if any;(E)
The regulatory response(s), if any;(F)
The applicable section(s) in this article specifying the regulatory response(s);(G)
The implementation due date(s), and the actual implementation date(s), for the
regulatory response(s); and(H)
Other information provided to the Department under subsections (a) through (c).
(2)
The Department shall also include in the Regulatory Response Summary the
information specified in paragraphs (1)(A) through (1)(D) for each exemption granted by the
Department under section 69506.9.
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NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Sections 25253 and 25257, Health and Safety Code.
Article 7.

Dispute Resolution Processes§ 69507.
Dispute Resolution.
(a)Applicability. This article applies to any responsible entity that wishes to dispute a
decision made by the Department under this chapter that applies to the responsible entity,
except as otherwise provided in subsection (c).
(b)
Exhaustion of Administrative Remedies. The procedures set out in this article are
required for resolving disputes arising under this chapter. If the responsible entity fails tofollow the procedures specified in this article for disputes subject to this article, it waives its
right to further contest the disputed issue.
(c)Scope. Notwithstanding any other provision of this chapter, a decision made by the
Department under article 2, 4, or 9 is not subject to dispute resolution under this article.
(d)Automatic Stay. A requirement imposed by the Department under this chapter on a
responsible entity, and any posting concerning the requirement on the Failure to Comply list, isstayed during the pendency of an administrative dispute concerning the requirement.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252, 25253, and 25257.1, Health and Safety Code.
§ 69507.1. Informal Dispute Resolution Procedures.
(a)Request for Review. For a dispute regarding a decision made by the Department
under the provisions of this chapter other than article 6, a responsible entity may, within thirty(30) days following the mailing of the notice or the website posting of the Department’s
decision that is the basis of the dispute, whichever is later, request that the Department
informally resolve the dispute. The Department shall provide the responsible entity with anopportunity to resolve the dispute informally within thirty (30) days of receiving the request for
dispute resolution. If a request for informal dispute resolution is not received within thirty (30)days of the notice or website posting of the Department’s decision, the Department’s decision
is final and is not eligible for any dispute resolution procedures under this article.
(b)
Administrative Appeal. If the responsible entity disagrees with the Department’s
decision following completion of the informal dispute resolution process, the responsible entity
may appeal to the Director of the Department under section 69507.2.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252, 25253, and 25257.1, Health and Safety Code.
§ 69507.2.

Appeal to the Director.

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(a)Contents of Appeals. A responsible entity appealing the Department’s decision
following completion of the informal dispute resolution process shall submit information stating
the basis for seeking further review, and the reasons why the decision does not comply withthis chapter or is otherwise unreasonable. The responsible entity shall also provide:(1)
The original statement of dispute;(2)
Supporting information; and(3)
Copies of responses prepared by the Department.
(b)Deadline for Filing an Appeal. A responsible entity appealing a Department decision
shall file the appeal with the Department’s Director within thirty (30) days after completion of
the informal dispute resolution process under section 69507.1.
(c)
Decision on Appeal. The Director or designee shall issue a decision granting or
denying the relief sought, in whole or in part, or a notice of ongoing review, within sixty (60)days after receipt of the request under this section. If the relief sought is denied, the decisionby the Department must:(1)
Contain a short and plain description of the basis for denial of the request for further
administrative review; and(2)
Specify the date by which the responsible entity must comply with the requirementsof this chapter that were in dispute.
(d)Finality of Decision. A decision issued under subsection (c) is the Department’s final
decision and is not subject to additional administrative dispute resolution.
(e)Notice of Ongoing Review. The Department shall specify in a notice of ongoing
review the estimated date by which the Department expects to issue a decision granting or
denying the relief sought. The Department shall take into account its available resources andthe complexity of the issues raised in the appeal in estimating the date for issuance of the final
decision.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252, 25253, and 25257.1, Health and Safety Code.
§ 69507.3. Formal Dispute Resolution Procedures.
For all disputes regarding a decision made by the Department under article 6, theprocedures specified in sections 69507.4 through 69507.6 shall apply in lieu of the procedures
set forth in sections 69507.1 and 60507.2.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Sections 25253 and 25257.1, Health and Safety Code.
§ 69507.4. Time Lines for Requests for Review.
Within thirty (30) days of a responsible entity receiving a final regulatory response
determination notice from the Department under article 6, the responsible entity may submit a
Request for Review to the Department, requesting review of such determination. If a Request

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for Review is not filed within this time period, the Department’s determination is final and is not
eligible for any administrative dispute resolution procedures under this article.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Sections 25253 and 25257.1, Health and Safety Code.
§ 69507.5. Contents of Requests for Review.
A Request for Review filed under section 69507.4 must include a statement of the reasonssupporting the Request for Review, and, as applicable, a showing that the determination isbased on:(a)Erroneous facts, assumptions, approaches, or conclusions of law; and/or(b)
A policy judgment that the Department should, in its discretion, reconsider.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Sections 25253 and 25257.1, Health and Safety Code.
§ 69507.6. Department Procedures for Requests for Review.
(a)Decision Time Frame. Within sixty (60) days following the filing of a Request for
Review under section 69507.4, the Department shall issue an order either granting or denying
the Request for Review, or a notice of ongoing review.
(b)
Finality of Decision. An order denying review shall constitute the Department’s final
decision and shall not be subject to additional administrative dispute resolution. The decision
shall be effective on the date of the order. An order denying review must:(1)
Specify the date by which the responsible entity must comply with the requirementsof this chapter that were the subject of the Request for Review; and(2)Contain a short and plain description of the basis for the denial of further
administrative review.
(c)
Briefing Schedule. An order granting review must specify a schedule for briefing of
the issues by the responsible entity and the Department.
(d)Merits Decision. The Department shall issue an order specifying its decision on the
merits of the Request for Review, or a notice of ongoing review, within 180 days from the dateit grants the Request for Review.
(1)
If the final order upholds the Department’s decision under this chapter, the order isthe Department’s final decision and is not eligible for additional administrative dispute
resolution. An order upholding the Department’s original decision must specify the date bywhich the responsible entity must comply with the applicable requirements of this chapter.
(2)
If the final order grants the relief sought by the responsible entity, in whole or in part,the order must remand the decision that is the subject of the Request for Review to the
responsible program within the Department for re-evaluation by a specified date. The date forcompletion of the re-evaluation must be no more than ninety (90) days from the date of theorder. The order may also provide guidance or criteria for the re-evaluation.

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(e)
Notice of Ongoing Review. The Department shall specify in a notice of ongoing
review the estimated date by which the Department expects to issue an order undersubsection (a) or (d), whichever is applicable. The Department shall take into account its
available resources and the complexity of the issues raised in the Request for Review inestimating the date for issuance of the order.
(f)
Recusal of Staff. No Department staff that participated in the decision that is the
subject of the Request for Review filed under section 69507.4 may participate in decisionmaking or review of decisions made under this section.
(g)
Limits on Intra-Departmental Communications. No Department staff participating indecision-making or review of decisions made under this section may have communications
about the Request for Review with the Department staff that participated in the decision that is
the subject of the Request for Review filed under section 69507.4 unless the Department
simultaneously communicates with the responsible entity or its representative regarding theissues under discussion with Department staff.
NOTE: Authority cited: Sections 25253 and 58012, Health and Safety Code. Reference:
Sections 25253 and 25257.1, Health and Safety Code.
Article 8.

Audits§ 69508.
Audit of Materials Submitted to the Department and Regulatory Responses.
(a)
Audits. The Department may audit any information compiled, and/or submitted to
the Department, under this chapter. Information the Department may audit includes, but is not
limited to, AAs, AA Reports, information related to notifications submitted under this chapter,and implementation of regulatory responses.
(b)
Scope. The scope of any audit may include, but is not limited to, an examination of
one or more of the following:(1)
Compliance with article 5 requirements;(2)
Information quality and adequacy of analysis;(3)
Implementation of selected alternatives, if applicable; and/or(4)Compliance with the regulatory response(s) imposed under article 6, if any.
(c)Upon completion of an audit, the Department shall provide notice to the responsible
entity(ies) of the audit findings and the process to dispute audit findings.
NOTE: Authority cited: Sections 25253, and 58012, Health and Safety Code. Reference:
Article 8 of Division 4.5 of Chapter 20 and Section 25253, Health and Safety Code.
Article 9.

Trade Secret Protection§ 69509.
Assertion of a Claim of Trade Secret Protection.
(a)
Substantiation Requirements. A person who asserts a claim of trade secretprotection with respect to information submitted to the Department under this chapter willDepartment of Toxic Substances Control

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receive a written request from the Department to furnish the Department with all of thefollowing supporting information:(1)
The identity of the person asserting the claim;(2)
A brief description of the nature of the information for which trade secret protection is
being claimed;(3)
The extent to which the information is known by employees or others involved withthe facility or business of the person, and whether or not those individuals are bound by nondisclosure agreements;(4)
The extent to which the information is known outside of the facility or business of theperson, and whether or not individuals with such knowledge are bound by non-disclosureagreements;(5)
The measures taken to restrict access to and safeguard the information, andwhether or not the person plans to continue utilizing such measures;(6)
The estimated value of the information to the person and the person’s competitors;(7)
The estimated amount of effort and/or money expended by the person in developing
the information;(8)
The estimated ease or difficulty with which the information can be properly acquiredor duplicated by others, including for any chemical claimed as trade secret, an explanation of
why the chemical identity is not readily discoverable through reverse engineering;(9)
Copies of, or references to, any pertinent trade secret or other confidentiality
determinations previously made by the Department or other public agencies;(10) A description of the nature and extent of harm that could be caused if the information
were made public, including an explanation of the causal relationship between disclosure andthe harmful effects claimed;(11) The signature of the person's general counsel or other executive with knowledge ofthe preparation of the substantiating information, certifying as required by section 69501.3 andbased upon the knowledge and belief of the signatory, that:(A)
The substantiating information is true, accurate, and complete;(B)
The information for which trade secret protection is claimed is not otherwise publicly
available; and(C)
There is a reasonable basis to assert trade secret protection for the information soclaimed; and(12) Contact information for the individual to be contacted if any of the claimed
information is requested to be disclosed under the California Public Records Act (commencing
with Government Code section 6250).
(b)Streamlining of Submittal. The substantiating information required undersubsections (a)(1) through (a)(10) shall be provided for each individual trade secret claim,
although such information may be incorporated by reference to apply to multiple claims, as
appropriate. The requirements of subsections (a)(11) and (a)(12) may be met once for all
claims submitted at one time.
(c)Documentation. A person who asserts a claim of trade secret protection shall also
at the time of submission provide the Department with both of the following:
Department of Toxic Substances Control

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(1)
Except where expressly prohibited by federal law, or by a nondisclosure agreement
whose relevant text is provided to the Department, a complete copy of the documentation
being submitted, which shall include the information for which trade secret protection isclaimed; and(2)
A redacted copy of the documentation being submitted, which shall exclude theinformation for which trade secret protection is claimed.
(d)Marking of Documents. A person who asserts a claim of trade secret protection
shall make such assertion at the time of submission by marking the words "Trade Secret"conspicuously on each page containing the information for which trade secret protection isclaimed. If no claim of trade secret protection is made at the time of submission, theDepartment may make the submitted information available in full to the public without further
notice.
(e)Provision of Separate Copies. If the documentation supporting a claim of trade
secret protection contains information that is itself subject to a claim of trade secret protection,such supporting documentation shall be separately supplied in both complete and redacted
form as required by subsection (c), and marked as required by subsection (d), but shall notitself require further supporting documentation. Such documentation shall be separate fromdocumentation used to comply with other provisions of this chapter.
(f)
Hazard Trait Submissions. Except as specified in subsection (g), trade secretprotection may not be claimed for any hazard trait submission or for any chemical identity
information associated with a hazard trait submission.
(g)
Chemical Identity Masking When a Patent is Pending.
(1)
The precise identity of a chemical that is the subject of a hazard trait submission
may be temporarily masked only if that chemical is an alternative considered or proposed in an
Alternatives Analysis, and a patent application is pending for the chemical or its contemplated
use in the product. Such masking shall be authorized only until the patent application has
been granted or denied. The person claiming the trade secret shall notify the Department inwriting within thirty (30) days after the patent application has been granted or denied.
(2)
Any person temporarily masking the precise identity of a chemical under paragraph(1) shall provide the Department with a non-confidential description of the nature of thechemical that is as specific as possible, consistent with the claim of trade secret protection.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252, 25253, and 25257, Health and Safety Code.
§ 69509.1. Department Review of Claims of Trade Secret Protection.
(a)
Review of Support for Trade Secret Designation. Upon receipt of information
submitted under this chapter that contains information identified as being subject to trade
secret protection, or at any time thereafter, the Department may review the trade secret claim
and supporting information for compliance with the requirements of this article.
(b)
Additional Information Requirements.

Department of Toxic Substances Control

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(1)
If the Department determines that information provided in support of a request for
trade secret protection is incomplete or insufficiently responsive to permit a trade secrecy
determination, the Department shall:(A)
Provide notice to the submitter of the Department's finding of insufficiency, and thebasis therefor;(B)
Identify the specific area(s) for which additional information is needed; and(C)
Indicate the date by which the submitter must provide the requested information.
(2)
If the submitter fails to provide the information within the timeframe specified, theDepartment shall provide notice to the submitter by certified mail that the claim is out ofcompliance with this article, and that the information claimed to be trade secret will beconsidered a public record subject to disclosure by the Department thirty (30) days after such
notice is mailed. During this 30-day period, the submitter may seek judicial review by filing anaction for a preliminary injunction and/or declaratory relief.
(c)Notice to Submitter. If the Department determines that information provided insupport of a request for trade secret protection does not meet the substantive criteria for trade
secret designation, the Department shall provide notice to the submitter by certified mail of its
determination and that the information claimed to be trade secret will be considered a publicrecord subject to disclosure by the Department thirty (30) days after such notice is mailed.
During this 30-day period, the submitter may seek judicial review by filing an action for apreliminary injunction and/or declaratory relief.
(d)Judicial Review. If a person asserting a claim of trade secret protection initiates anaction for a preliminary injunction and/or declaratory relief under subsection (b)(2) or (c), theDepartment may not publicly release or disclose the information that is the subject of the claimof trade secret protection until resolution of any court challenge, including any appeals.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252, 25253, and 25257, Health and Safety Code.
Article 10.

Severability§ 69510.
Severability.
If any provision(s) of this chapter, or the application thereof to any person or circumstances,is held invalid, such invalidity shall not affect other provisions or applications of this chapterthat can be given effect without the invalid provision or application, and to that end theprovisions of this chapter are severable.
NOTE: Authority cited: Sections 25252, 25253, and 58012, Health and Safety Code.
Reference: Sections 25252 and 25253, Health and Safety Code.
Article 11.

[Reserved]§§ 69511 -- 69599. [Reserved]
Department of Toxic Substances Control

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