California Green Regulations Discussion

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CALIFORNIA GREEN REGULATIONS

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California Health and Safety Code Section
Sample proposed outline of regulations to implement California’s green chemistry program

Please make changes, revisions, edits or add questions as necessary:

Article X

6xxx.x Applicability

This section applies to all chemical and chemical ingredients contained in consumer products italic text(both consumer and product needs to be defined, for there is great confusion at this point as to exclusions) manufactured in, imported into, distributed in, or sold or offered for sale in California. What about by-products resulting from secondary processing? What about other regulations which already impact the specific chemicals and their ingredients? Does this regulation supercede all others? Is there a minimum concentration cutoff for consideration? Where do REACH regulations fit into this? Many chemical manufacturers already have this information (DuPont is one that comes to mind). They look for cheaper, less hazardous feedstocks all the time. Handling hazardous materials, with the Process Safety regulations and Local Emergency Planning requirements, is expensive and the prudent manufacturer is always looking for opportunities to reduce these costs. Why not approach the manufacturers? I would echo the comment about REACH - the EU already has this in place. Why reinvent the wheel?

6xxxx.x Enforcement

Any failure to comply with any of the provisions of this article is a violation and may be subject to fines and penalties.

6xxxx.x Trade Secret

Anti Rayap | Pest Control

(a) Any person providing information to DTSC pursuant to this article may, at the time of submission, identify certain portions of the information submitted to DTSC as a “trade secret” or “confidential business information”. DTSC may only release that information to the public providing that certain conditions are met, and DTSC notifies the person that submitted the information accordingly, as specified in section 25257 of the Health and Safety Code, and in paragraphs (b) through (k) below.

(b) Any manufacturer claiming trade secret or confidential business information for information submitted to DTSC must provide justification for that claim at the time the information is submitted to DTSC.

(c) All information pertaining to the identification of a specific chemical or chemical ingredient, and the health and safety and hazard characteristics of that specific chemical or chemical ingredient, is not eligible for designation as “trade secret information”.

(d) The identification of any person or persons submitting information to DTSC regarding specific chemicals or chemical ingredients in consumer products is not eligible for designation as “trade secret information”.

(e) Information not identified as a trade secret pursuant to subdivision shall be available to the public unless exempted from disclosure by other provisions of law. The fact that information is claimed to be a trade secret is public information.
(f) Upon receipt of a request for the release of information that has been claimed to be a trade secret, DTSC shall immediately notify the person who originally submitted the information. Based on the request, the DTSC shall determine whether or not the information claimed to be a trade secret is to be released to the public.

(g) DTSC shall make the determination specified in paragraph (f) no later than 60 days after the date DTSC receives the request for disclosure, but not before 30 days following the notification of the person who submitted the information.

(h) If DTSC decides that the information requested pursuant to this subdivision should be made public, DTSC shall provide the person who submitted the information 30 days’ notice prior to public disclosure of the information, unless, prior to the expiration of the 30-day period, the person who submitted the information obtains an action in an appropriate court for a declaratory judgment that the information is subject to protection under this section, or for a preliminary injunction prohibiting disclosure of the information to the public, and promptly notifies DTSC of that action.

(i) This section does not authorize any person to refuse to disclose to the DTSC information required to be submitted to the DTSC pursuant to this article.
Konsultan Pajak
(j) This section does not prohibit the exchange of a properly designated trade secret between public agencies, if the trade secret is relevant and necessary to the exercise of the agency’s jurisdiction and the public agency exchanging the trade secrets complies with this section. An employee of the DTSC that has access to a properly designated trade secret shall maintain the confidentiality of that trade secret by complying with this section.

6xxxx.x Definitions

For the purposes of this article, the following terms have the meanings indicated:

(a) Chemical is any chemical or substance that ends up in a consumer product incidentally, including chemicals present only in “trace amounts”. Are nano materials included or should they be addresses differently?

Chemicals in "trace amounts" needs to be better defined. Is this determined by the limit of accuracy of the analytical instrument used to find the material? Sometimes, trace chemicals can vary from time to time depending on the batch of material used in the product, particularly those imported from Asia, where supply is not consistent. There need to be specific definition of lower limits of concentration for all chemicals, below which reporting is not necessary. This lower limit can be determined by human health studies, or data already available. What if the trace amounts in the product exceed normal background levels?

(b) Chemical ingredient is any chemical or substance that is contained in a consumer product and that was intentionally added to the consumer product or part of a consumer product during any stage of the manufacturing process.

(c) "Consumer Product" definition needed

(d) “Existing chemical” is any chemical or chemical ingredient that is contained in any quantity in any consumer product manufactured in, imported into, distributed, sold or offered for sale in California after January 1, 2010as of January 1, 2010.

(e) “New chemical” is any chemical or chemical ingredient that was not in commerce in California, and/or was not used in any consumer products imported into, distributed, sold or offered for sale in California before January 1, 2010, but that is contained in any quantity in any consumer products that are manufactured in, imported into, distributed, sold or offered for sale in, California after January 1, 2010.

6xxxx.x Special Provision for New Chemicals

(a) Any manufacturer who plans to use a “new” chemical in any consumer products that will be manufactured in, imported into, distributed, sold or offered for sale in, California shall provide a notification to DTSC at least 60 days prior to beginning manufacture of that product. The notification shall include, but not be limited to:
(1) The CAS number for the chemical or chemicals in question;
(2) Any common names for the new chemical or chemicals in question;
(3) Information on the planned or foreseeable use in consumer products, including quantity to be used, potential users to be identified, and identification of specific products that may contain the chemical in question;
(4) Minimum data sets (pre-determined by whom?)to provide a thorough understanding of the potential risks associated with use of the chemical in question, including any adverse health, safety or environmental effects and exposure potential for a reasonable foreseeable end use, including exposure potential for any sensitive subpopulations, such as children, the elderly or others whose biological systems have been compromised. The minimum data sets should be aligned with the data sets required by other state regulations.
(5) The manufacture shall notify DTSC any time changes occur in production volumes or use patterns for the chemical in question, or the extent or diversity of uses expands.
(6) The manufacture shall notify DTSC any time that new information becomes available regarding any potential health, safety or environmental impacts of the chemical in question.

(b) If the information required in (a)(4) is not available as of the date of the notification submitted to DTSC, the manufacturer shall submit to DTSC, via certified mail, return receipt requested, a detailed plan and a schedule for acquiring the required data.

(c) (1) The plan and schedule specified in (b) shall be subject to approval by DTSC. DTSC shall review the plan and schedule within 30 days of receipt, and shall either approve or deny the plan.
(2) The manufacturer shall not use the chemical in question in any consumer products that are manufactured in, imported into, distributed, sold or offered for sale in, California until the manufacturer receives approval for the plan from DTSC. Does this still apply if the chemical ingredients are presently in use? Are you suggesting that all manufacturing simply stop until DTSC provides permission?
(3) DTSC may require the manufacture to collect and submit to DTSC any other information or data DTSC deems necessary to evaluate the potential health, safety or environmental impacts of the chemical in question according to a scheduled specified by DTSC.
(4) If the plan specified in (b) is approved, the manufacturer will be notified by DTSC in writing. The manufacturer shall submit the required data to DTSC as specified in the plan and schedule. In the meantime, the manufacture may begin using the chemical in consumer products.
(5) If the manufacture fails to adhere to the schedule for data collection and submission as specified in the plan, the manufacturer shall immediately stop using the chemical in question in consumer products, and shall not distribute in, import into, manufacture in, sale or offer for sale in, California, any consumer products containing the chemical in question, until the manufacturer submits the required data to DTSC, and receives written approval from DTSC to continue using the chemical in question.
(6) If the plan specified in (b) is not approved, DTSC will notify the manufacturer in writing, and may request specific revisions to the plan. The manufacturer shall revise the plan, and shall resubmit the plan to DTSC for approval as specified in (c)(1). The manufacturer shall not begin distributing in, importing into, manufacturing in, or offering for sale in, California, any consumer products containing the chemical in question until the manufacture’s revised plan is approved by DTSC.

(d) For the purposes of complying with the minimum data set requirement specified in (a)(4), and the plan and schedule for acquiring data specified in (b), different manufacturers may cooperate and collaborate with one another to generate and submit the required plan and data to DTSC.

6xxxx.x Special Provision for Existing Chemicals

(a) DTSC may request from any manufacturer who uses an existing chemical in any consumer products that is, or will be, manufactured in, imported into, distributed, sold or offered for sale in, California the following information:
(1) The CAS number for the chemical or chemicals in question;
(2) Any common names for the new chemical or chemicals in question;
(3) Information on the planned or foreseeable use in consumer products, including quantity to be used, and identification of specific products;
(4) Minimum data sets to provide a thorough understanding of the potential risks associated with use of the chemical in question, including any adverse health, safety or environmental effects and exposure potential, including exposure potential for any sensitive subpopulations, such as children and others with compromised immune systems.
(5) The manufacture shall notify DTSC any time changes occur in production volumes or use patterns for the chemical in question, or the extent or diversity of uses expands.
(6) The manufacture shall notify DTSC any time that new information becomes available regarding any potential health, safety or environmental impacts of the chemical in question.

(b) If the information required in (a)(4) is not available as of the date of the notification submitted to DTSC, the manufacturer shall submit to DTSC, via certified mail, return receipt requested, a detailed plan and a schedule for acquiring the required data.

(c) (1) The plan and schedule specified in (b) shall be subject to approval by DTSC. DTSC shall review the plan and schedule within 30 days of receipt, and shall either approve or deny the plan.
(2) The manufacturer may continue to use the chemical in question in any consumer products that are manufactured in, imported into, distributed, sold or offered for sale in, California while the plan is being reviewed by DTSC.
(3) DTSC may require the manufacture to collect and submit to DTSC any other information or data DTSC deems necessary to evaluate the potential health and safety or environmental impacts of the chemical in question according to a scheduled specified by DTSC.
(4) If the plan specified in (b) is approved, the manufacturer will be notified by DTSC in writing. The manufacturer shall submit the required data to DTSC as specified in the plan and schedule. In the meantime, the manufacture may continue using the chemical in consumer products.
(5) If the manufacture fails to adhere to the schedule for data collection and submission as specified in the plan, the manufacturer shall immediately stop using the chemical in question in consumer products, and shall not distribute in, import into, manufacture in, sale or offer for sale in, California, any consumer products containing the chemical in question, until the manufacturer submits the required data to DTSC, and receives written approval from DTSC to continue using the chemical in question.
(6) If the plan specified in (b) is not approved, DTSC will notify the manufacturer in writing, and may request specific revisions to the plan. The manufacturer shall revise the plan, and shall resubmit the plan to DTSC for approval as specified in (c)(1). DTSC may, at any time, order the manufacture to stop distributing in, importing into, manufacturing in, or offering for sale in, California, any consumer products containing the chemical in question until the manufacture’s revised plan is approved by DTSC.

(d) For the purposes of complying with the minimum data set requirement specified in (a)(4), and the plan and schedule for acquiring data as specified in (b), different manufacturers may cooperate and collaborate with one another to generate and submit the required plan and data to DTSC.

6xxxx.x Identification of Chemicals or Chemical Ingredients of Concern

Any new or existing chemical that is contained in a consumer product that is manufactured in, imported into, distributed in, or sold or offered for sale in, California, and is any one or more of the following, is hereby designated a chemical or chemical ingredient of concern:

• Any new or existing chemical substance for which there is not adequate data available to make a determination that the chemical or chemical ingredient does not pose any threat to human health, safety or the environment.
• Any substances which appear on any “list” published by any government, authoritative body, or nongovernmental organization, and that are deemed by DTSC to be chemicals of concern with respect to HSC 25252 based on available scientific information. (DTSC would have sole discretion to make this determination. This would provide DTSC with the flexibility to adopt chemicals appearing on new, relevant “lists” (e.g., the SIN List ), as they are published, without the need to conduct additional rulemaking; Many of these list do not align and, in some cases, conflict, so how will this decsision be made?
• Substances for which there is scientific evidence of potential serious adverse effects to human health or the environment;
• Potentially harmful substances to which humans have been shown to be exposed through the California Environmental Contaminant Biomonitoring program , or other relevant biomonitoring studies, such as the CDCs NHANES surveys ;
• Chemicals already regulated in consumer products and/or packaging sold in California based on factors such as toxicity (e.g., cadmium, mercury, lead, and hexavalent chromium);
• Chemicals known to the State of California to cause cancer or reproductive harm under Proposition 65 ;
• Substances with any of the hazard traits and environmental and toxicological end-points that specified by OEHHA pursuant to 25256.1;
• Substances identified by IARC as carcinogenic to humans (i.e., group 1 substances) ;
• Persistent, bioaccumulative and toxic substances on the U.S. EPA’s “PBT List , ”;
• Substances designated as “higher hazard substances” by TURA ;
• Substances on the Washington State PBT List ;
• Substances classified as potentially very persistent and very bioaccumulative (vPvBs) in accordance with the criteria set out in Annex XIII of the EU REACH (Registries, Evaluation, and Authorization of Chemicals) Regulation ;
• Substances with evidence of potential endocrine disrupting effects (i.e., identified as category 1 in the priority list of substances established under the EU’s Community Strategy for Endocrine Disruptors”) ;
• Substances classified as mutagenic category 1 or 2 in accordance with EU Directive 67/548/EEC ;
• Substances classified as toxic for reproduction category 1 or 2 in accordance with EU Directive 67/548/EEC;
• Substances that are, or potentially give rise to, air pollutants, including ozone forming compounds, particulate matter, toxic air contaminants, and greenhouse gases;
• Substances that have the potential to contaminate surface water, groundwater, and soil;
• Substances which, during manufacturing, give rise to hazardous byproducts and waste materials that require treatment and/or disposal;
• Substances shown to potentially adversely impact worker safety and or public health (this depends upon dose—how is this actually considered then, for a "hazard" does not equate to "risk"; and
• Substance with other potential anticipated negative or adverse impacts to human health, safety or the environment.
• Any substances that would be, or would be presumed to be, a hazardous waste when discarded.

6xxxx.x Prioritization of Chemicals or Chemical Ingredients of Concern

(a) DTSC shall designate chemicals or chemical ingredients of concern, identified as described in section 6xxxx.x (above), as either “higher priority” or “lower priority”. Any chemical or chemical ingredient of concern may be designated as a “higher priority” based on any of the criteria specified in paragraph (b) below.

(b) DTSC may, at its discretion:
(1) adopt chemical prioritization or ranking schemes established by, and priorities assigned to specific chemicals by, any other authoritative bodies, or nongovernment entities;
(2) base prioritization on the volume of the chemical or chemical ingredient of concern used in California, or the volume contained in products distributed in, imported into, or sold in, California;
(3) base prioritization on the potential for exposure (occupational, community, use, disposal?) to the chemical or chemical ingredient of concern in a consumer product;
(4) base prioritization on the potential effects of the chemical or chemical of concern on sensitive subpopulations, including, but not limited to, infants and children, the elderly and those with compromised biological systems;
(5) base prioritization on actual exposure of citizens to specific chemicals based on any available biomonitoring data generated by any authoritative body (this is a shotgun approach);
(6) base prioritization on any available information suggesting that a chemical or chemical ingredient of concern may pose potential risk to human health or safety, or the environment;
(7) base prioritization on evidence of potential adverse environmental impact;
(8) base prioritization on a lack of data necessary to characterize a chemical or chemical ingredient of concern; or
(9) base prioritization on any one, or a combination of all, of the options listed in (b)(1) thru (8) above in assigning priority to specific chemicals or chemical ingredients of concern.

(c) Additional factors that DTSC may consider in assigning a priority to specific chemicals or chemical ingredients of concern include, but are not limited to:
(1) any credible, peer-reviewed scientific research, evidence from a preponderance of past experience, or any other credible evidence, suggesting that the chemical has potential adverse health or environmental impacts;
(2) existing knowledge of adverse environmental impact, or information regarding accumulation/persistence in the environment, based on past experience or peer-reviewed scientific research; and/or,
(3) any scientific evidence that otherwise provides indications that there are reasonable grounds for concern, and that sufficient early action should be taken to address emerging concerns and limit or prevent potentially dangerous effects on the environment, or human, animal, or plant health.

6xxxx.x Supply Chain Information Dissemination Requirements and Sales Prohibitions

(a) Any manufacturer who manufactures, imports, distributes, sales, or offers for sale, in California, any product containing a chemical or chemical ingredient that has been designated as a chemical or chemical ingredient of concern and prioritized by DTSC, must provide any importer, distributor, wholesaler, retailer, or other authorized agent, who sells or offers for sale, or otherwise places into commerce, that product, in California, with documentation identifying all the chemical or chemical ingredients of concern contained in the product, their respective priority as assigned by DTSC, and their respective concentrations in that product.

(b) If a manufacturer fails to provide the documentation specified in (a) to any importer, distributor, wholesaler, or retailer, or other authorized agent, who sells or offers for sale, or otherwise places into commerce, a product manufactured by that manufacturer and containing on or more chemicals or chemical ingredients of concern, as identified and prioritized by DTSC, the sale or offering for sale of that product in California is hereby prohibited until such time as the manufacturer provides the required documentation.

(c) Any importer, distributor, wholesaler, retailer, or other authorized agent of a manufacturer, who receives the documentation specified in (a) must maintain that documentation for each particular product for a period of 3 years following the last date that a particular product was handled by that importer, distributor, wholesaler, or retailer, and must make the documentation available to DTSC within 30 days of receipt of a written request for the information from DTSC.

(d) No importer, distributor, wholesaler, retailer, or other authorized agent of a manufacturer, shall place any product containing a chemical or chemical ingredient of concern as identified and prioritized by DTSC into commerce in California unless the importer, distributor, wholesaler, retailer, or other authorized agent of a manufacturer obtains and maintains from the manufacturer the documentation specified in paragraph (a), and makes that information available to DTSC within 30 days of the date of any written request for the information. What happens to existing chemicals of concern that are already in commerce?

6xxxx.x Lists of Chemicals and Chemical Ingredients of Concern

(a) DTSC shall develop and maintain a list of all chemicals and chemicals ingredients that have been identified as chemicals of concern pursuant to section(s) 6xxxx.x above. DTSC shall indicate on the list which chemicals have been designated “high priority” and which have been designated “low priority”, and shall make the list publicly available.

DTSC should also publish a list of safe alternate chemicals (very difficult to do because this is a function of operations, use, etc. It is important to have folks on DTSC staff who are knowledgeable (have actually worked in industry) who understand the reality of decisions made here. This is not an academic exercise alone!) and update the list as new information comes in from producers.

(b) DTSC may alter, revise, add chemicals to, delete chemicals from, or otherwise change, the list developed pursuant to paragraph (a) above any time that new information becomes available, and DTSC determines, at its discretion, that the new information is adequate to justify changing, altering, or revising the list. How does all this impact the manufacturing process? For example, if new info comes in suggesting that a recommended green chemical is now a potential hazard, does manufacturing halt? Does DTSC have final word? What is process for making a determination and what is companion action?

I. REGULATORY “TRIGGER”: When is the Requirement to Do an Alternatives Analysis Triggered?

A. Chemical of Concern in a Product

California is required to develop a process to identify and prioritize “chemicals of concern” in consumer products in California.

1. What factor(s) should be considered to identify a product sold in California containing a chemical of concern?

We need to first define chemicals of concern (COC), and then consider types of applications/uses of such products that pose highest potential risk, based upon characteristics of the use and the particular hazard trait(s) of concern for that chemical. For example, if there is no exposure potential for the particular trait of concern for a given product, it should not be considered. As an initial matter, if a COC is used in the manufacturing process, but is no longer in the actual product sold in California, the product should not be considered for inclusion.
In addition to consideration of chemical hazard data (TIC, etc.), the statute calls for consideration of “the potential for exposure to the chemical in a consumer product”, i.e., the screening process must establish a plausible exposure pathway as a precondition of listing. For example, while biomonitoring data might establish exposure to a COC, unless there is evidence that the COC is likely to be released from the subject product during manufacturing, use, or end of life management (considering applicable exposure control technologies), there is no identifiable exposure pathway to the product and no basis for listing the product. Absent this determination, one can argue that most products containing chemicals for which hazard/toxicity data exists, and that are found in meaningful volumes in state commerce (a crude surrogate for potential exposure), should be listed. This approach would result in indiscriminant listings (analogous to Prop 65) that would quickly overwhelm DTSC’s capacity to conduct the product
reviews required by AB 1879 – a setback for public health and environmental protection. Thus the goal of the screening criteria is to focus the regulatory review on particular products that are likely to pose significant human health and ecological risks.
The chemical of concern definition needs to take into consideration:
• Volume of a COC in a product.
• Volume of sales of a product containing a COC.
• Control technologies and physical methods in place to limit exposure to a COC.
• Formulation of a product and factors that balance or negate toxicity and exposure concerns.
• Designated use for a product.
• Potential for exposure.
• Protective equipment recommended or required for a products use.
• Determination if a sensitive subpopulation comes in contact with a product and if so, how.

2.Should the process allow for chemicals to be “nominated” by external parties for consideration?

The process for identifying COC should use science-based criteria to select chemicals which should be reviewed and aired for public comment. Individual chemical selections must be open for public comment and an appeals process must be established. Those in the best position to identify and assess potential chemicals for inclusion in the process are state scientists, with the support of the advisory panel. This will ensure that the state’s limited resources are wisely managed. .

DTSC is delegated responsibility for implementing this program and , as stated above, is in the best position to identify and review chemicals. If a decision is made to allow individuals to submit chemicals or products for inclusion, the information package must be robust and vetted by a recognized expert (consultant). It should be like the “Whistle Blower” provision under OSHA and Prop 65.

3.Which “endpoints” (toxicity, risk, hazard, other) or other attributes should trigger designation as a chemical of concern?

Exposure at any level does not automatically mean the chemical is of concern and a hazard does not automatically imply unacceptable risk. A full safety assessment of a chemical looking at the toxicity, exposure and ultimately the risk for a product’s uses should be considered.

4.What relationship should exist (if any) between this process and the Toxics Information Clearinghouse?

The State should be able to use information in the Toxic Information Clearinghouse as this data will have been vetted/approved for use.

5.How should data gaps (absence of endpoint or other information) influence state action? What should the state do where uncertainty exists? How should “quality” of data affect this determination?

Data gaps with respect to defining Chemicals of Concern may be different than data gaps with respect to product containing that chemical. There needs to be a strong reason to suspect the “Chemical” may be of concern versus a specific trait, in order to justify spending resources to “fill the gap” (cannot fill all gaps for all chemicals). Filling data gaps needs to be prioritized by risk. Data gaps for the highest priority risks with greatest uncertainty should be addressed first, to optimize limited state resources.
Under AB 1879, the State clearly has the responsibility to fill the data gaps through their own research and data submitted by the manufacturer of the chemical. If sufficient data does not exist to satisfy the screening criteria in #2, DTSC should work cooperatively with affected manufacturers pursuant to H&SC 57019 (AB 289), to fill identified data gaps.
The State should develop surrogate measures or methods to extrapolate from known data points. For instance, if no information exists on a particular chemical, but information is available for similar chemicals, or similar structured chemicals, methods should be available to use the known information in the absence of chemical specific data. There are several well-validated Quantitative Structure Activity Relationship (QSAR) models available to maximize read-across data from structurally similar compounds. (See OECD and EPA models.)
The quality of data is paramount. It needs to be relevant and of the highest quality. The actions taken by DTSC can have severe economic impacts and should only be taken when the data is clear.

6.Who should make the determination regarding a product containing a chemical of concern?

As stated above, the legislature delegated that responsibility to DTSC. DTSC is in the best position to evaluate and make decisions with respect to the risks associated with procucts containing chemicals of concern based on the best scientific knowledge available. DTSC scientists should make determinations through a safety-based assessment process with mandated consultation with product manufacturers.

7.How frequently should products with a chemical of concern be reviewed, updated, or changed?

Not more than once every 5 years or even longer unless some there is a product reformulation or new, significant information comes out concerning either the trait in question or its use/exposure potential in the product.

8.Can a chemical identified as a chemical of concern later be “de-selected” based on new or additional information or by filling data gaps?

Definitely YES. If the process is based on data, then data should dictate the selection or de-selection of a chemical of concern. It is not consistent to say that a chemical can be added based on objective criteria, but not removed based on the same criteria. Science is ever evolving and failure to consider significant new data, regardless whether it is positive or negative, would impact the integrity of the system.

9.How should this process link to the evaluation of safer alternatives? (See II below.)

The presence of a chemical of concern should trigger the requirement for an alternatives analysis to be performed. This could be refined and narrowed by coupling the presence of the chemical with a factor related to the likelihood of exposure, release during use, or release at the end of life.
Actions should not be taken versus any product or application without at least an equivalent assessment of likely implications for alternatives and a sense of their potential impacts – sufficient to get at least a strong indication that we are not pulling another MTBE.

**B. Factors for Prioritization

California is required to consider three explicit factors in prioritizing products containing chemicals of concern; they are: (i) the volume of a chemical in commerce in the state, (ii) the potential for exposure from use of a consumer product, and (iii) potential effects on sensitive subpopulations (including infants and children).**

1.How should the state consider these factors?

A background report should review existing government prioritization schemes to identify strengths, uncertainties and weaknesses of existing programs including (at a minimum) EPA’s HPV program, Canada’s Chemicals Management Plan and EU’s REACH program.

Screen out those products where there is no potential for exposure. Review the types of exposures and the risks from those exposures.

Note that the latter (iii) needs to account for the product and exposure potential, not just the potential effects of the chemical of concern in isolation. In a sense the “potential effects” should be considered as a surrogate for risk.

CSPA (from the Wiki): California should consider these three factors as part of a tiered screening process to identify chemicals of concern. The first tier should be screening based on human health (e.g. carcinogenicity, Mutagenicity, reproductive toxicity, etc.) and environmental (e.g. persistence, bioaccumulation, toxicity) factors; the human health screen could include effects on sensitive subpopulations. The second tier should be volume of a chemical in commerce. Finally, individual exposure scenarios should be developed for each chemical that is screened out to identify those uses with the highest exposure.

Volume should be considered in connection with routes of exposure. In relation to consumer products, in addition to volume and potential for exposure, DTSC must consider control technologies, product packages, and formulation attributes that limit exposure to chemicals of concern. DTSC must also consider label instructions and the intended use of a product when making prioritization decisions.

Initial prioritization should be performed in equal partnership among government, industry and academia with complete transparency.

Volume and potential exposure must be considered together and given equal weight. Sensitive populations must be more clearly defined in scientific terms and actual negative health responses in relation to a chemical in order for this consideration to be used for decisions.

116365.2. (a) In conducting the periodic review and revision of public health goals pursuant to paragraph (1) of subdivision (e) of Section 116365, the Office of Environmental Health Hazard Assessment may give special consideration to those contaminants that, on the basis of currently available data or scientific evidence, cause or contribute to adverse health effects in members of subgroups that comprise a meaningful portion of the general population, including, but not limited to, infants, children, pregnant women, the elderly, individuals with a history of serious illness, or other subgroups that are identifiable as being at greater risk of adverse health effects than the general population when exposed to the contaminant in drinking water.

(b) In preparing and publishing risk assessments pursuant to subparagraph (C) of paragraph (1) of subdivision (c) of Section 116365 that involve infants and children, the office shall assess all of the following, to the extent information is available:

(1) Exposure patterns, including, but not limited to, patterns determined by relevant data, among bottle-fed infants and children that are likely to result in disproportionately high exposure to contaminants in comparison to the general population.

(2) Special susceptibility of infants and children to contaminants in comparison to the general population.

(3) The effects on infants and children of exposure to contaminants and other substances that have a common mechanism of toxicity.

(4) The interaction of multiple contaminants on infants and children.

+++ 2.How should these be weighed or balanced?

Use volume as a filter first, then exposure—consecutive? Again, a main theme here should be to make the most efficient use of very, very limited resources. Cannot afford to grant everything an equal priority—need simple measures to at least triage.

Volume and potential exposure must be considered together and given equal weight. Sensitive populations must be defined scientifically for actual health impacts on a population for each product and chemical before they are considered.

After volume, screen chemicals in the following order:

• Receptors: sensitive subpopulations such as children should be focused upon first.

• Bioavailability: If a chemical does not physically reach receptors or the target organ, then it cannot exert effect.

• Biopersistence: Chemicals that bioaccumulate or are biomagnified in the environment and/or organisms should be considered first.

• Effect: Most serious effects should be prioritized first, e.g. cancer and reproductive/developmental toxicity.

Data from the Toxics Information Clearing House could inform the latter three screening steps (bioavailability, biopersistence and effect). The Clearinghouse should be a comprehensive repository of existing data gathered from other government agencies and the primary scientific literature, subject to data quality review. In addition, a chemical-specific data call-in could be announced with clearly defined data quality criteria, to capture most current information from any stakeholder. Data failing quality criteria would not be considered.

+++ 3.What are sources of this type of information? How could this information be obtained?

The production volumes of some materials are already reported to various state agencies. Manufacturers are aware of their products intended uses and could supply exposure pathways and may have some data on these pathways.

All publically available information from authoritative governmental bodies should be considered. Also voluntary submissions from companies should be considered under CBI protections.

+++ 4.What additional factors (if any) should be considered?

Nature of the hazard and risk. A high-dose only threshold effect should not be equated with an effect that could occur in real-world exposures.

Perhaps some sense of potential aggregate harm “threats of serious or irreversible damage”.

In addition to volume and hazard the route of exposure and duration of exposure should be considered. Also, confidentiality of data needs to be addressed.

The control technologies and physical methods in place to limit exposure to a chemical of
concern.

The formulation of a product and factors that balance or negate toxicity and exposure concerns The designated use for a product.

Protective equipment recommended or required for a product’s use.

**+++ 5.Should the state consider information—or the absence of information—about:

a. Emission, effluent, discharge, release and waste stream data?**

Only to the extent that it would help clarify potential exposure/risk (e.g. a chemical in a waste stream at a business does not necessarily mean that a nearby resident is exposed).

With a volume screen, you would likely get that via TRI reporting and, to the extent that it’s relevant as a significant route of exposure for problem trait of problem chemical, yes.

For chemicals, DTSC should work with industry members to identify existing data and research needs. For specific consumer products, DTSC must work with industry members, under a CBI process, to determine proprietary data and research needs. In the absence of data, industry should be able to utilize consortium processes and collective data development agreements to provide information needed to help make individual product determinations.

b. Biomonitoring data?

Don’t see how they could not consider this data. Any consideration needs to consider levels
detected and potential risk, not just yes/no on whether a measurable quantity was detected.

c. Environmental monitoring data (water quality, air quality)

d. Disease registry data?

Yes, if relevant to the trait of concern for the chemical of concern.

e. Other information?

C. Available Information for Others

California is required to reference and use—to the maximum extent feasible—available
information from other nations, governments, and authoritative bodies.

+++ 1.Are there other models for identifying and prioritizing chemicals in consumer products that
California could consider?

Other models include TSCA inventory registration as well as the Canadian Domestic
Substances list. However, when looking at existing programs DTSC needs to take into account
the programs strengths, uncertainties, and weaknesses. Additionally, DTSC also needs to
taken into consideration programs and regulations that are currently in place for specific product
categories such as the European Union’s Restriction on Hazardous Substances Directive
(RoHS).

+++ 2.What are the limitations of these other models?

All existing models are limited by the data that is used to support the decisions. DTSC needs to
continue to work with other governments to promote expanded research for toxicity and green
chemistry.

**II. ALTERNATIVES ANALYSIS: What must be included in this analysis? Who

performs it? How quickly must it be performed?**

A. Process for Alternatives Assessment

California is required to develop a process that provides for the evaluation of chemicals
of concern and their potential alternatives in consumer products.

GENERAL QUESTIONS FROM GCA:

What is the definition of “consumer product”? Without a clear and concise definition, many of
the answers to these questions cannot accurately be answered. Does the definition include
chemicals of concern only when there is the potential for exposure to the end-user/consumer?
During manufacture? End of life of the product? How does this mesh with Extended Producer
Responsibility proposals?

How would this alternatives analysis apply to products under formulation, before the product is
released into the market? How will confidential business information concerning a product
under formulation be protected?

+++ 1.What triggers the requirement to do an alternatives analysis?

An alternatives analysis should be conducted once a chemical of “potential” concern is
designated as a chemical of concern in clearly-defined consumer products through
manufacture, use and end of life of product, based on level of toxicity, volume of the product
being used, potential for exposure and use of the product. Thus additional data has already
been collected on the chemical of concern and a simplified life cycle analysis (LCA) has been
conducted for its presence in consumer products and whether alternatives are or may be
available.

There must be a clear demonstration of adverse impact on human health or the environment
from exposure to a chemical in a product and use, and verified commercial information
indicating alternatives may exist.

The presence of a chemical of concern should not necessarily trigger an alternatives analysis.

The nature of the product must pose a risk.

+++ 2.Who should perform the analysis?

State Scientists should lead this effort in collaboration with manufacturers and academia using a
state “facilitated” approach. Collaboration with industry is critical. The analysis should not be
restricted to just chemical substitution or reformulation. The State may wish to consider the use
of an independent third party to perform the analysis.

+++ 3.What must be included in this analysis?

Alternatives should be assessed in the same way as chemicals of concern to ensure the
comparison is apples to apples using the factors outlined in the law.

The analysis should also be consistent with ISO 14044 series standards. Importantly, the
simplified LCA’s should not be used as a basis of comparison or decision, but rather provide
some of the information needed to arrive at a decision. However, it may not be possible to
complete and LCA for all of the factors in S. 25253 given existing technologies.

This process should not be used to eliminate product forms.

+++ 4.What lifecycle based algorithms are available to be adapted for use in the analysis?

A simplified approach to Life Cycle Analysis (LCA) should be conducted. LCA is really designed
for products, not individual chemicals.

+++ 5.How does the state ensure that the alternatives which are evaluated include reformulation, safer chemical substitution, engineering alternatives (such as changing product fabrication to eliminate the chemical of concern) and other appropriate options?

The focus should be on problem products, with the aim to find alternative formulations. In most
cases the manufacturer may not be able to provide such information. This process must be a
collaborative one with State scientists, product manufacturers and chemical/alternative chemical
manufacturers.

+++ 6.What factors should be considered in assessing performance of an alternative?

There are five key factors that should be considered when assessing the performance of an
alternative. The alternative should:

1. Be technologically feasible.
2. Deliver equivalent or better value in cost and performance.
3. Provide an improved profile for health and environmental issues.
4. Account for economic and social considerations; and
5. Hove potential to result in lasting change.

Market considerations and performance are key considerations. Products must should perform
at the same or equivalent level as the original. All claims of equal performance must be
carefully substantiated, and the State should require the source of all claims to be identified, and
require the company making the claims to validate those claims. The State should be careful
not to allow those making claims to gain market share without validating claims.

Other factors to be considered are:

• Product applications and exposure patterns
• Recommended user precautions and other risk management for the chemical use
• Environmental exposure pathways
• Environmental fate
• Whether it is used in combination with other chemicals that reduce its risk
• Commercial availability of alternatives
• Cost factors
• Adaptability of chemical for intended use
• Formulation interaction considerations
• Unintended consequences to human health, impact on the environment, noise, and
resource utilization, including whether substantially more product must be used to
achieve the same performance of the original product negating any benefits.

The State should also consider current State requirements for California’s environmentally
preferable purchasing (EPP) program. Section 12400 requires the Department of General
Services, in consultation with CalEPA, to take into account a range of factors in making
procurement decisions, including “the needs of the purchaser”. Consumer preferences and
demands must be considered in evaluating the efficacy of alternatives. Section 12400 reads as
follows:

12400. For purposes of this chapter, “environmentally preferable purchasing” means the
procurement or acquisition of goods and services that have a lesser or reduced effect on
human health and the environment when compared with competing goods or services
that serve the same purpose. This comparison shall take into consideration, to the
extent feasible, raw materials acquisition, production, manufacturing, packaging,
distribution, reuse, operation, maintenance, disposal energy efficiency, product
performance, durability, safety, the needs of the purchaser, and cost.

Alternatives analysis must include performance testing. If a substitute chemical or technology
fails to meet product specifications (e.g. ASTM), then it should not be considered further
regardless of other attributes.

The alternatives analysis and factors needed to assess alternatives also will vary from product
to product. Is the chemical the active ingredient? Does it perform a specific function as a carrier
for the active ingredients? What properties cause companies/consumers to choose it or reject
it?

+++ 7.How should “necessity” be assessed or weighted in the analysis?

The concept of “weighting” factors is not in the statute. This should not be an issue. Necessity
is a subjective term; demand is dictated by the market not the government.

+++ 8. How are possible hazards, risks, or exposure pathways of any alternative evaluated?

These factors, again, should be evaluated for alternative the same way they would be evaluated
for chemicals of concern.

+++ 9.What other considerations should inform the alternatives analysis?

Products should be evaluated fully for their positive impacts on public health, human quality of
life, beneficial use, economic benefit, etc. The analysis must fully consider the negative impact
of chemical restrictions on the ability to produce a technologically and commercially viable
product. The analysis must also consider what behaviors/practices consumers might use to
substitute if a product is eliminated from the market or becomes so ineffective that it is no longer
valuable in the market place (i.e. the use of gasoline to replace less effective solvent products).

+++ 10. Should the state adopt a formula to balance or weigh the mandatory and other factors? If
so, what would that formula look like?

As previously stated, the statute does not require balancing or weighing of factors. This should
not be part of the alternatives analysis.

In addition, the State should use the factors specifically identified in the statute to ensure that
manufacturers have certainty as to what factors products and alternatives will be required to
address.

Any formulas developed would most likely not be able to work for all products as products, and
categories of products, will be impacted differently by the factors.

+++ 11. What data is available or should be required and how would that data be used in evaluating:
(a. through m.)?

Company data should be accepted for all elements and utilized as the primary sources of
information.

B. Process for Lifecycle Analysis

California is required to use lifecycle assessment tools in its alternatives analysis process. The law sets
forth thirteen required elements.

1. What models or examples of lifecycle analysis are currently being used?

A LCA generally extends from the creation of raw materials to final disposal of the product or
service residuals, and takes into account environmental emissions to air, water, and land. In
2000, the International Standards Organization (ISO) completed work on a series of standards
that have become the general benchmark for the technique, which usually includes four stages:
• Defining the goal, scope and boundaries of the assessment.
• "Life Cycle inventory" (LCI) - a database of energy/materials use and emissions, relative to
some "functional unit" (e.g., for a detergent, emissions per 1000 loads of laundry washed; for
an automobile, emissions per 1000 person-kilometers traveled).
• "Life Cycle impact assessment" (LCIA) - translation of inventory data into potential impacts on
the environment.
• "Interpretation" - sensitivity and uncertainty analyses. Only if a chemical receives the COC
designation should this third piece be conducted.
In short, the analysis should be consistent with ISO 14044 series standards. Importantly, the
simplified LCA’s should not be used as a basis of comparison or decision, but rather provide
some of the information needed to arrive at a decision.

2. Who should perform the lifecycle analysis?

An ISO certified lab. In addition, all affected stakeholders should be able to submit
recommendations, information, and data throughout the process.

3. What should be the scope of the analysis, and should there be any limitations on the scope of the
analysis?

a. full lifecycle of the product from extraction of raw materials through use of the product and
then disposal or reuse?
b. the product lifecycle from design and manufacture (production) to retail sale and use?
c. other?

LCAs must be comparative from product-to-product within a category. LCA must balance
available and reliable data for product life-cycle stages versus a desire to know impacts at every
stage. Each product category under consideration should form a consensus as to the life-cycle
stages evaluated and acceptable data.

Life Cycle Assessment has several limitations:

• It is not a substitute for safety or risk assessment, since it cannot produce specific data that
relates directly to human or ecological exposure, or toxicity (Owens, 1997a).
• Life Cycle data can be incomplete, and assumptions (for example, about boundaries) can be
unclear. This makes it difficult to compare products, especially using results from different
studies. Furthermore, in comparing products, Life Cycle Assessment will typically identify
trade-offs, not overall "winners and losers."
• There are often uncertainties about the reliability of results, or a lack of understanding about
the sensitivity of different lifecycle stages to change.
• Life Cycle Assessment does not provide a direct measure of impacts on the environment due
to the aggregation of emissions across different phases of a product's lifecycle. Instead it
provides, at best, a measure of potential impacts (Owens, 1997b).

Given these limitations, we believe that all users of Life Cycle Assessment, especially for public
purposes (e.g., to support environmental claims in the marketplace, or policy making), should
follow similar principles:

• Life Cycle Assessment should be used as a decision support tool and not as a decision
making tool.
• Methods should be based on the ISO 14040 standards. These procedures are internationally
recognized, and agreed by numerous experts in the field.
• Analyses should be publicly available and fully transparent, including the underlying
assumptions, data sources, results, and conclusions.
• Life Cycle Assessments should be peer reviewed (as recommended by ISO) and undergo a
thorough sensitivity analysis.
• There should be a thorough discussion whether identified differences between products or
activities are really meaningful, relative to other human activities.
• In situations where Life Cycle Assessment is to be used for setting public policy, all
stakeholders (including industry) should be involved in the design, execution, and
interpretation of lifecycle studies.

4. What are the essential components of the lifecycle analysis?

In 2000, the International Standards Organization (ISO) completed work on a series of standards
that have become the general benchmark for the technique, which usually includes four stages:

• Defining the goal, scope and boundaries of the assessment.
• "Life Cycle inventory" (LCI) - a database of energy/materials use and emissions, relative to
some "functional unit" (e.g., for a detergent, emissions per 1000 loads of laundry washed; for
an automobile, emissions per 1000 person-kilometers traveled).
• "Life Cycle impact assessment" (LCIA) - translation of inventory data into potential impacts on
the environment.
• "Interpretation" - sensitivity and uncertainty analyses.
Efficiency of use should be considered., both shelf life of product prior to first use and after
consumer purchases it. (i.e., if all of the product can be used before “going bad”).

5. Should the assessment have a specified time limitation?

This will depend on each product category. The economic impacts associated with the length of
the analysis (i.e., manufacturing, sales, etc.) must be included in making this determination.

6. How should criteria—such product useful life, in-use energy consumption, public health effects,greenhouse gas emissions, etc.—be balanced or weighed against each other?

This will depend on each product category.

7. How should the analysis address and include both internal and external costs?

Internal costs to a company should be considered first as these can be more easily identified.
External costs should be included when reliable and validated data can be used to provide
reasonable external costs. If such data, however, includes production and marketing costs
information for the product, the State needs to recognize that such data may be competitively
sensitive and that DTSC may be required to protect that data as confidential business
information.

8. Are there implications of conducting lifecycle analysis of particular chemicals versus specific
consumer product categories (i.e., specific chemical uses)? If so, what are these? How should
the state address these?

(LCA for a consumer product derived from chemicals will be exponentially more involved if a LCA
is required to assign costs to each chemical’s life-cycle included in products.
Data will need to be shared up and down the supply chain depending on the scope of the LCA in
question. To limit the amount of data that would need to be developed and to ensure that LCAs
are comparable, DTSC might consider setting limits to the beginning and ending life-cycle data
development requirements in each product category under consideration. Peer-reviewed data will
be essential in this process.

NOTE: Requirements for each product category LCA process must be reached through
consensus.

9. How should the lifecycle analysis and the alternatives assessment evaluations account for limited
or absent data? In other words, how should the assessments accommodate uncertainty?

Uncertainty cannot be used to negatively impact a LCA or Alternatives Assessment of a product
or chemical. Data needs must be prioritized for the impact that they might have on understanding
a chemical or product.
Uncertainty in a result is not the same as limited data. Uncertainty (used in this context) is
assumed to mean variability in calculations or outcomes. An analysis that is highly variable may
mean that the underlying data are highly variable, or factors have not been sufficiently
determined; or that the answer is not, in fact, reliably obtained given the methods. Limited data,
on the other hand, is a reflection of lack of study (e.g., the question has not been asked in the
past). Hence, limited data cannot be used as a basis for any policy decision or conclusion
relative to life-cycle analysis.
In either event, due to the significant consequences of state action in this area, the state should
not act unless its the underlying data and analysis conducted by the DTSC meets all the
applicable scientific and technical standards. In general, limited or less than reliable data cannot
be used as a basis for policy decisions given the wide-ranging consequences that these
decisions might have.

III. REGULATORY RESPONSE: What are the appropriate

regulatory outcomes based on the alternatives analysis?

The alternatives analysis, & subsequent regulatory actions, if any, should be focus on a clearly defined
consumer product(s) containing a specific chemical of concern. Transparency and public
information is a key goal of CA’s Green Chemistry program. Thus, consumers should be encouraged
to make market decisions in lieu of state government regulatory actions.
1. What criteria should be considered to determine the appropriate regulatory response?
AB 1879 provides an appropriate range of potential responses in light of the possible range of
outcomes. GCA has provided responses to questions in Section IIA above which specifically address
criteria for evaluating possible alternatives to clearly defined consumer products containing specific
chemicals of concern. Please refer to Section IIA responses for detailed information. Prior to taking
regulatory action, DTSC should also consider other statutes and regulations that apply, e.g. is the
chemical approved for certain uses by regulation?
2. At what point in the alternatives analysis or based on what information in the analysis is it
appropriate for the State:
No regulatory action should be taken by DTSC until after the LCA has been completed as part of the
alternatives analysis in accordance with HS 25253(a)(2), DTSC has submitted the LCA to the Council
in accordance with HS 25252.5 (a), the Council has completed its review of the LCA in accordance
with HS 25252.5(c), and DTSC has mitigated “significant adverse impacts” identified by the Council in
accordance with HS 25252.5(d). Action taken by DTSC prior to ALL of these steps being taken would
be inconsistent with the requirements of the statute.
A - to find a ban of the chemical of concern in the product is appropriate?
DTSC should only act to ban the use of a chemical of concern in a specific consumer product when
consumers who use the product as it is intended by the manufacturer cannot be protected from
unsafe levels of exposure to the subject chemical. If a ban is predicated on the basis of the existence
of an alternative then the alternatives analysis must conclude the alternative provides a significant
reduction in exposure to consumers, the alternative is available in commercial quantities, and that it
preserves the performance and economic viability of the consumer product.
Any ban on the use of a chemical of concern in a specific consumer product must take into
consideration the manufacturer’s ability to respond in a timely manner and actually reformulate or
redesign, or retool for the alternative. DTSC should be required to allow a sufficient period of time
prior to the requirement taking effect and must NOT require a manufacturer to withhold products from
the market that have previously been manufactured for sale in California.
B – to require labeling or other types of consumer product information?
When the alternatives assessment indicates that existing warnings and/or exposure mitigation
measures are inadequate to provide consumers protection, additional product information measures
may be necessary and appropriate. However, due to the multitude of consumers products in all
shapes and sizes, manufacturers must be afforded flexibility when it comes to meeting the
requirements for providing consumer product information. Labeling is but one means of providing
product information. The proliferation of labels is often more confusing than helpful to the
consumers. Communication of information to consumers should be streamlined.
C – to place restrictions in use of the product?
The act of restricting the use of a product is a very serious matter and should not be entered into
lightly. Any such action must be predicated on sound scientific evidence and its severity should be
measured to address only the immediate issues of concern. Placing restrictions on a consumer
product can result in a de facto ban. It can have the same effective impact as banning the use of a
chemical of concern in a product, or banning the product outright. Placing restrictions on the use of a
product should only be done when all other options have been exhausted.
D – to require end of life management such as extended producer responsibility?
This should NOT be imposed because consumers are not disposing of products in the method
required by law or recommended by the manufacturer. End of life management should only be
imposed when there is a need that cannot be met by current municipal solid waste systems. The
question itself is premature as there is no authority within the current legislation to initiate extended
producer responsibility. Industry supports targeted voluntary actions over mandatory programs.
E – to require funding of research and development of potentially safer substitutes?
Business and industry are driven by market forces and competition to continuously invent and
redesign products that are safer for public health and the environment, perform better, and are cost
competitive. Research and development into safer alternatives is the lifeblood of successful business.
The question itself is inappropriate as fails to recognize the competitive nature of the market and the
lack of authority within the current legislation to require such R&D.
F – to place technology-forcing regulations into place to phase out harmful ingredients and/or
phase-in safer ingredients?
“Safer” is a relative concept. It should not be presumed because a product is deemed “safer” that it is
without harm. Furthermore, because a party claims a new product is “safer” than another which it is
intended to replace via substitution or as an alternative does not mean that the original product is
itself harmful when used in accordance with the manufacturer’s instructions.
Products that are not shown to be problematic should not be regulated or forced out of the market
simply because of another company’s marketing campaign and desire to increase market share.
However, if the state should impose a regulatory constraint because of a chemical of concern
within that certain consumer product, it must be left to the product manufacturer(s) to
determine how best to comply. The state is ill equipped to dictate a specific remedy or
product formulation. Manufactures must be afforded the opportunity to determine what
modifications are needed for the product to comply with the regulation.
GCA believes that manufacturers should be favorably incentivized to develop and discover new
products that are sustainable and whose lifecycle analysis demonstrates actual improvements and not
simply marketing claims. DTSC should focus resources on validating claims and not on
extraneous technology-forcing regulations which in themselves could impede real development.
3. What other regulatory responses are appropriate based on information in the alternatives
analysis?
a) DTSC needs to develop a process by which manufacturers of consumer products that have been
regulated can petition to have the regulatory requirements removed based on new information or
other factors. DTSC should also be required to review the petition and respond in a timely manner,
i.e., 90 – 180 days
b) Other regulatory responses should strongly incentivize development of green chemistry
alternatives, rather than obstruct manufacture within the state and commerce across its borders.
c) Banning the use of a chemical of concern in a specific consumer product could require significant
investment on the part of the manufacturer, i.e., laboratory reformulation, physical plant equipment,
product performance testing, customer qualification testing, advertizing and market acceptance. In
consideration of this investment there needs to be a process by which the new product once fulfilling
the requirements as an alternative is not subject to further regulation for a pre-determined period of
time. Without such a provision, a product could be in a perpetual state of regulation and
reformulation and the manufacturer would have no likelihood of recouping its investment.

+ IV. COMPLIANCE, AUDITING AND ENFORCEMENT: A means of ensuring compliance with the law’s goal of moving toward safer alternatives for consumer products will be needed.

1. Should testing be required by manufacturers to demonstrate compliance as a precondition for selling or offering for sale? If so, who would conduct laboratory analytical testing of consumer products? Under what conditions?

We believe that testing to demonstrate compliance as a precondition to selling a product in the state is outside the scope of AB 1879 and SB 509. The question is also unclear as to what testing would need to be done or what compliance would be demonstrated.

2. Should reporting be required? If so, who should submit what information to whom, when, and for what purposes?

Reporting requirements are a regulatory action under the bill and only be imposed once the state meets all of the requirements necessary to move forward with regulatory actions.

3. Should a manufacturer be required to provide a certification to a distributor or retail seller of their products?

It is best to keep supply chain out of regulatory reporting. Downstream users can put raw material specifications in place to their upstream suppliers. Those specs are CBI and not for public distribution. Arrangements between manufacturers and retailers should be similarly CBI. We are also unclear about what certification would achieve.

4. Should review or auditing be required? If so, who should review submittals? What criteria should be applied to that review or audit?

Review and auditing requirements should avoid burdensome and costly bureaucratic processes and be targeted at specific regulatory actions undertaken by DTSC.

5. Should other party standards-setting and validation be used? For instance, if
manufacturers and producers were to conduct the lifecycle analysis and alternatives assessment, do standards exist to guide them? If so, what are these? If not, what would be required to be developed? By whom? How?

ISO Standards are available for LCA. California could hire a contractor to outline general approaches to be followed for CA application. Perhaps review contractor’s proposal on how to apply in CA situation by Green Ribbon Panel.
See Section #2 of the Wiki Questions.

**6.What other considerations should inform the state’s compliance and enforcement of this statute?

Compliance and enforcement efforts should be targeted based on the regulatory actions imposed by DTSC.**

I. REGULATORY “TRIGGER”: When is the Requirement to Do an Alternatives Analysis Triggered?

A. Chemical of Concern in a Product

California is required to develop a process to identify and prioritize “chemicals of concern” in consumer products in California.

1. What factor(s) should be considered to identify a product sold in California containing a chemical of concern?

A clear definition of what the state believes characterizes a “chemical of concern”. Definition must include risk of a compound in intended use in commerce (including hazard and exposure). The definition should also address whether the compound is included on a reputable list by a qualified federal or state agency, or recognized authoritative body (e.g., EPA, FDA, NIOSH, OSHA, IARC, WHO, etc.).

Should the process allow for chemicals to be “nominated” by external parties for consideration? Parties other than agencies may suggest compounds for review to DTSC. However, only DTSC should be able to determine that a consumer product contains a chemical of concern after going through its normal review process. Absent a reliable, informed and responsible decision by the State Agency on the need for any further analysis, the potential for misuse of this process is great.

Any person wishing review of a chemical or a product containing a chemical of concern may submit it for consideration by DTSC. DTSC should make clear that the State is NOT entering the business of product formulation on a compound by compound basis. Only, upon evidence that a product is a concern, would DTSC then offer an analysis of alternatives -which may or may not include product re-formulation. What information should they be required to provide? Critical that DTSC be adequately staffed by knowledgable, experienced staff who appreciate the decisionmaking from aspects other than straight science. The DTSC process and activity needs to be calibrated periodically by external body to ensure it remains effective and value added. Accountability should come in at all levels—manufacturing, government, users.

1. Which “endpoints” (toxicity, risk, hazard, other) or other attributes should trigger designation as a chemical of concern?

Risk should be the primary consideration (a combination of hazard and exposure). We recognize that conducting complete risk assessments for each compound is impractical because of time or cost constraints, but using the concepts of risk, hazard and exposure must be considered by the State as part of this process (see Section on available information) For chemicals or compounds to be included on the list, there must exist a scientific or health based reason for the concern. Anecdotal evidence of a health or environmental effect should not, in and of itself, be sufficient to trigger investigation.
Information required for a review should include:

• Contact information
• Group representing (if any)
• Identification of the alleged chemical or product of concern
• Identification of the consumer products in which the alleged chemical of concern is a component
• Identification of the uses of the consumer product and an explanation as to why those uses constitute a basis for the DTSC to conduct a review
• Specification of the harm allegedly attributable to use of the consumer product containing the substance
• Specification of the exposure pathway
• Any potential interactions with other substances that cause the proponent to believe the consumer product should be reviewed.
• Potential commercially viable alternatives to compound or chemical of concern

2. What relationship should exist (if any) between this process and the Toxics Information Clearinghouse?

Since regulations have yet to be proposed, it can’t be determined at this point what relationship, if any, there should be between the two processes. However, since this process and the process for establishing the TIC are not the same, it should not follow a prori that the listing of a chemical on the TIL means that any consumer product containing that chemical should be subject to review by the DTSC. To the same extent, it should not necessarily follow that the components of any consumer product that is subject to action by the DTSC should automatically be subject to listing in the TIC

How should data gaps (absence of endpoint or other information) influence state action? What should the state do where uncertainty exists? How should “quality” of data affect this determination?

Any action taken by DTSC on a consumer product may result in very severe economic consequences for manufacturers, distributors or end users of the product, so the DTSC should take action only when it is absolutely convinced from reliable scientific data that action is necessary. For that reason, the quality of data upon which the DTSC results is critical. Data gaps, especially where there is an absence of endpoint or any other pertinent and refereed data, should not trigger regulatory action by DTSC. DTSC should not act based on assumptions or suppositions.

Data gaps should be supplemented with appropriate modeled data, and expert judgement based on chemical analogs. Where the models are inadequate and proper analogs cannot be found, then DTSC should determine which data are critical to decision making and then require reporting entity to provide the data. DTSC should prioritize endpoints that need data and should identify appropriate models and methods for using analogs. This will go a long way.

3. Who should make the determination regarding a product containing a chemical of concern?

It is not clear what the DTSC is asking for here, apart from the role it will have in reviewing products containing a chemical of concern. Certainly the manufacturer of a product that contains a product in which DTSC has shown an interest needs to be consulted, as the law requires that such manufacturer has determined through its own testing and procedures that the product or compound is safe for use as intended. To the extent that these procedures are non reopen the review. -regulatory, best practices should be documented and made generally available within and across industry sectors to enable widespread application at the product design and manufacturing stages.

Beyond the manufacturer, the DTSC should have a major role, along with other appropriate state agencies, in determining the use of, handling and ultimate disposition of compound or chemical.

1. How frequently should products with a chemical of concern be reviewed, updated, or changed?

Prior reviews of such products should be updated as reliable new scientific information become available. Anecdotal incidents concerning such products, by themselves, should not be grounds for further review. However, if a substance that has been reviewed by DTSC and found not to require any action when used as intended, that product should not be subject to a further review for a designated period of time, such as 60 months. If, in the ensuing period, reliable new scientific evidence surfaces, then the Agency should have the discretion, to initiate a new review.

2. Can a chemical identified as a chemical of concern later be “de-selected” based on new or additional information or by filling data gaps?

Yes, the status of a substance should be open for change upon receipt of credible, peer-reviewed data including any consumer product which currently or formerly contained that chemical.

How should this process link to the evaluation of safer alternatives? (See II below.)

The existence of what a proponent believes to be a “safer alternative” should not in and of itself trigger review of consumer products containing that chemical by the DTSC. As indicated above, action by the DTSC can have severe economic and other consequences for manufacturers and distributors of the products. The DTSC should therefore review consumer products as currently formulated and only consider what it believes are safer alternative component chemicals after it has concluded that the current formulation of the product makes the product one against which the DTSC has decided to take action. There is no discussion here on managing risk. Does this not exist as a viable option?

// in section I. REGULATORY “TRIGGER”: When is the Requirement to Do an Alternatives Analysis Triggered?//

B. Factors for Prioritization

California is required to consider three explicit factors in prioritizing products containing chemicals of concern; they are: (i) the volume of a chemical in commerce in the state, (ii) the potential for exposure from use of a consumer product, and (iii) potential effects on sensitive subpopulations (including infants and children).

1. How should the state consider these factors?

A background report should review existing government prioritization schemes to identify
strengths, uncertainties and weaknesses of existing programs including (at a minimum) EPA’s
HPV program, Canada’s Chemicals Management Plan and EU’s REACH program.
Screen out those products where there is no potential for exposure.
Review the types of exposures and the risks from those exposures.
Note that the latter (iii) needs to account for the product and exposure potential, not just the
potential effects of the chemical of concern in isolation. In a sense the “potential effects” should
be considered as a surrogate for risk.
CSPA (from the Wiki): California should consider these three factors as part of a tiered
screening process to identify chemicals of concern. The first tier should be screening based on
human health (e.g. carcinogenicity, Mutagenicity, reproductive toxicity, etc.) and environmental
(e.g. persistence, bioaccumulation, toxicity) factors; the human health screen could include
effects on sensitive subpopulations. The second tier should be volume of a chemical in
commerce. Finally, individual exposure scenarios should be developed for each chemical that
is screened out to identify those uses with the highest exposure.
Volume should be considered in connection with routes of exposure. In relation to consumer
products, in addition to volume and potential for exposure, DTSC must consider control
technologies, product packages, and formulation attributes that limit exposure to chemicals of
concern. DTSC must also consider label instructions and the intended use of a product when
making prioritization decisions.
Initial prioritization should be performed in equal partnership among government, industry and
academia with complete transparency.
Volume and potential exposure must be considered together and given equal weight. Sensitive
populations must be more clearly defined in scientific terms and actual negative health
responses in relation to a chemical in order for this consideration to be used for decisions.
116365.2. (a) In conducting the periodic review and revision of public health goals pursuant to
paragraph (1) of subdivision (e) of Section 116365, the Office of Environmental Health Hazard
Assessment may give special consideration to those contaminants that, on the basis of currently
available data or scientific evidence, cause or contribute to adverse health effects in members
of subgroups that comprise a meaningful portion of the general population, including, but not
limited to, infants, children, pregnant women, the elderly, individuals with a history of serious
illness, or other subgroups that are identifiable as being at greater risk of adverse health effects
than the general population when exposed to the contaminant in drinking water.
(b) In preparing and publishing risk assessments pursuant to subparagraph (C) of paragraph (1)
of subdivision (c) of Section 116365 that involve infants and children, the office shall assess all
of the following, to the extent information is available:
(1) Exposure patterns, including, but not limited to, patterns determined by relevant data,
among bottle-fed infants and children that are likely to result in disproportionately high exposure
to contaminants in comparison to the general population.
(2) Special susceptibility of infants and children to contaminants in comparison to the general
population.
(3) The effects on infants and children of exposure to contaminants and other substances that
have a common mechanism of toxicity.
(4) The interaction of multiple contaminants on infants and children.

3. How should these be weighed or balanced?

Use volume as a filter first, then exposure—consecutive? Again, a main theme here should be
to make the most efficient use of very, very limited resources. Cannot afford to grant everything
an equal priority—need simple measures to at least triage.
Volume and potential exposure must be considered together and given equal weight. Sensitive
populations must be defined scientifically for actual health impacts on a population for each
product and chemical before they are considered.
After volume, screen chemicals in the following order:
• Receptors: sensitive subpopulations such as children should be focused upon first.
• Bioavailability: If a chemical does not physically reach receptors or the target organ,
then it cannot exert effect.
• Biopersistence: Chemicals that bioaccumulate or are biomagnified in the environment
and/or organisms should be considered first.
• Effect: Most serious effects should be prioritized first, e.g. cancer and
reproductive/developmental toxicity.
Data from the Toxics Information Clearing House could inform the latter three screening steps
(bioavailability, biopersistence and effect). The Clearinghouse should be a comprehensive
repository of existing data gathered from other government agencies and the primary scientific
literature, subject to data quality review. In addition, a chemical-specific data call-in could be
announced with clearly defined data quality criteria, to capture most current information from
any stakeholder. Data failing quality criteria would not be considered.

2. What additional factors (if any) should be considered?

The Potential impact on the market should be considered along with the availability of substitutes for the consumer product involved. Factors including changes in cost and effectiveness must be included in the analysis. Should the state consider information—or the absence of information—about: Agencies can only act when there is credible evidence of a need for action. Hence, the absence of evidence must preclude agency action in this area.

• a. Emission, effluent, discharge, release, and waste stream data?
• b. Biomonitoring data? Note: This is an ancillary consideration after risk and exposure have been considered. Biomonitoring data alone does not imply risk.
• c. Environmental monitoring data (water quality, air quality)
• d. Disease registry data? It is not clear what this means. Statistical correlations between disease registry data and environmental monitoring data are often insufficient to draw conclusions about causation and thus should not be used as a trigger for alternatives analysis.
• e. Other information? Exposure information; method of exposure to compound or chemical; handling methodology, test methods used etc.

// in section I. REGULATORY “TRIGGER”: When is the Requirement to Do an Alternatives Analysis Triggered?//

C. Available Information for Others

California is required to reference and use—to the maximum extent feasible—available information from other nations, governments, and authoritative bodies.

1. Are there other models for identifying and prioritizing chemicals in consumer products that California could consider?

The European Union has developed and published hazard based classifications (R Phrases). Under the Globally Harmonized System for MSDSs (GHS) classifications are also currently being developed. DTSC could also make use of TSCA Section 8(e) submissions that are sent in to EPA. DTSC should, however, be aware that studies used by other agencies are not always conducted consistently nor result in consistent answers. Commentaries (e.g., peer review) on studies used by the DTSC should also be consulted

2. What are the limitations of these other models? Not aware of any for the TSCA model.

1. Are there tools beyond the traditional toxicological risk management paradigm?

Given the importance of this issue and the evolving process, any tools utilized must be scientifically sound and technically reliable so that California consumers can be assured of the accuracy and reliability of actions taken.

2. Do these other models prompt the use of safer alternatives?

To our knowledge, the availability and safety of chemical components is normally a consideration in determining consumer product composition, whether specifically called for in the model or not.

3. Are there other approaches for assessing potential danger, weighing uncertainty, or determining priority or action regarding chemicals in consumer products used in other fields (such as workplace safety, medicine, food safety, finance, other) that California could consider?

Federal and state regulatory programs treat hazard, uncertainty, risk and risk management differently depending upon the issue being discussed. For example, environmental programs look at environmental risk and uncertainty differently than those associated with food and drug. Hence, how one looks at risk assessment, risk analysis and risk reduction relates to the product involved, how the public might be exposed, and the inherent hazard of the product etc. The DTSC, because it cannot know how particular products containing the chemicals concern might relate to human exposure, must remain flexible on how to weigh factors in the assessment process.

4. Where other institutions have acted (for instance, to allow, limit, restrict, or ban a chemical or chemicals in products)?

Federal and State agencies have used discretion to restrict or ban use of a product containing a particular compound or chemical. Actions under TSCA, or by the USDA and FDA should be consulted to determine how decisions on handling such products and chemicals are made. It should be noted that protections that have resulted from these regulations have driven a myriad risk management decisions that fall short of outright bans, but do serve to improve public health protection..

II. ALTERNATIVES ANALYSIS: What must be included in this analysis? Who performs it? How quickly must it be performed?

A. Process for Alternatives Assessment

California is required to develop a process that provides for the evaluation of chemicals of concern and their potential alternatives in consumer products.

What triggers the requirement to do an alternatives analysis?

In general, there are several factors. The existence of what a proponent believes to be a “safer alternative” should not in and of itself trigger review of consumer products containing that chemical by the DTSC. As indicated above, action by the DTSC can have severe economic and other consequences for manufacturers and distributors of the products. The DTSC should therefore review consumer products as currently formulated and only consider what it believes are safer alternative component chemicals after it has concluded that the current formulation of the product makes the product one against which the DTSC has decided to take action. .The potential impact on the market should be considered, along with the availability of substitutes for the consumer product involved and the potential effect of action as to a consumer product because of a component that is a chemical of concern on other consumer products which happen to have that same chemical as a component.

1. In terms of the legislation, we understand that DTSC must first list a COC in a particular product pursuant to the criteria discussed in section 1. Upon listing and reliable evidence that suggest a risk is posed by a chemical when used as intended, the State could begin an analysis of alternatives.
2. Who should perform the analysis? DTSC in cooperation with consumer product manufacturers, distributors and users (a collaborative process critical)

What must be included in this analysis? A variety of factors such as i) how the compound is produced; ii) recommended or intended use of the product; ; iii) information on inherent hazard; iv) data on exposure to workers during product production and the public; v) risk associated with appropriate use; vi) potential impacts associated with a change in costs associated with the production, handling, distribution and sale of the product; vii) impact on associated with use of the product including impacts to air, water, and soil; viii)worker health and safety; ix) cost of production; x) availability of substitutes for the product; xi) the impact of the proposed DTSC action on the market; xii) the information that is to be provided to consumers about any change in the product.

4. What lifecycle based algorithms are available to be adapted for use in the analysis?

This question is vague and needs to be explained.

5. How does the state ensure that the alternatives which are evaluated include reformulation, safer chemical substitution, engineering alternatives (such as changing product fabrication to eliminate the chemical of concern) and other appropriate options? ?

This question is vague and ambiguous. But the state should certainly work closely with the manufacturer of any such consumer product on such issues.

6. What factors should be considered in assessing performance of a chemical in a product?

It is the performance of the product that is the consideration, not what the state believes may be the role of any chemical component in that product. . But in assessing product performance, the state should focus on the effectiveness of the product as currently formulated and whn used as directed.

7. How should “necessity” be assessed or weighted in the analysis? Necessity should be defined. The state should not be involved in determining the necessity of a product or compound. The marketplace ultimately determines the success of the product. The state’s role is to identify whether a compound is a concern and to act, as necessary, in accordance with its role as to such products, as specified under law.

8. How are possible hazards, risks, or exposure pathways of any alternative evaluated? They should be evaluated the same way as consumer products with their existing chemical components. But in particular, any variables which are unique to an alternatively formulated product must be expressly identified and considered.

9. What other considerations should inform the alternatives analysis?

None that we are aware of at this time.

10. Should the state adopt a formula to balance or weigh the mandatory and other factors? If so, what would that formula look like?

No. No single formula could adequately take into consideration all of the relevant factors to describe an alternatives analysis. If anything, a formula could set minimum criteria which would ensure that analysis would be scientifically sound, technically correct, and produce accurate, reliable, and repeatable results.

11. What data is available or should be required for and how would that data be used in evaluating: [ As stated above, these are not all the factors that should be considered. The availability of the types of data listed below and how it is used will depend upon the specific consumer product involved.

• a. product function or performance?
• b. useful life?
• c. materials and resource consumption?
• d. water conservation?
• e. water quality impacts?
• f. air emissions?
• g. production, in-use, and transportation energy inputs?
• i. energy efficiency?
• j. waste and end-of-life disposal (including impacts and opportunities for re-use or recycling)?
• k. public health impacts?
• l. environmental impacts? and,
• m. economic impacts (See answers to question #3 above)

in section II. ALTERNATIVES ANALYSIS: What must be included in this analysis? Who performs it? How quickly must it be performed?