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CALIFORNIA GREEN REGULATIONS

California Health and Safety Code Section 25252
Sample proposed outline of regulations to implement California’s green chemistry program

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

Identification and prioritization of chemicals of concern. California should just adopt the R-phrase classification system already in place elsewhere under the "Globally Harmonized system of Classification and Labeling of Chemicals", see:

http://www.unece.org/trans/danger/publi/ghs/ghs_rev02/English/01e_part1.pdf

Identification and Prioritization of Chemicals and Chemical Ingredients of Concern in Consumer Products
Possible Regulations for Consideration

Article X
6xxxx.x Applicability
This section applies to all chemical and chemical ingredients contained in consumer products manufactured in, imported into, distributed in, or sold or offered for sale in California.

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
(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.
(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”.

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.

(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) “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.
(d) “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, and identification of specific products that may contain the chemical in question;
(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 or environmental effects and exposure potential, including exposure potential for any sensitive subpopulations, such as children.
(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 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.
(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 begin using the chemical in consumer products.
(4) 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.
(5) 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 or environmental effects and exposure potential, including exposure potential for any sensitive subpopulations, such as children.
(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 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.
(4) 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.
(5) 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 and 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;
• 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; and
• Substance with other potential anticipated negative or adverse impacts to human health and 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 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;
(5) base prioritization on actual exposure of citizens to specific chemicals based on any available biomonitoring data generated by any authoritative body;
(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.

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, 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.

Summary From Safer Alternatives Workshop
Identification and Prioritization of CoCs
Feb 18, 2009, Berkeley, CA

BREAKOUT GROUP #1:
Rule for Process to Identify and Prioritize Chemicals of Concerns in Consumer Products

First Easel Page

Identify Chemicals of Concern
• Human health criteria
• Environmental criteria
• How to create a fluid list—cast wide net to define more tangible prioritization criteria
• What constitutes scientific evidence?
• Who decides? OEHHA?
• Some things in the law are not optional
• Requirement on number of studies?
• Hazard criteria

Second Easel Page

10,000 X INVENTORY

1,000 X List of lists (California-specific hazard traits)

Priority chemicals
100 X in California

10 – 100 X Action chemicals
in California (PBTs, CMRs in California)

• Health and environmental importance of hazard
• Volume and use characteristics
• Occupational
• Ubiquitous

  • toxicological and environmental end-points and other relevant data (Clearinghouse)

BREAKOUT GROUP #1:
Rule for Process to Identify and Prioritize Chemicals of Concerns in Consumer Products

Third Easel Page

Chemical of concern:
• Definition should work for SB 509 and AB 1879
• Hazard trait, toxicological, and environmental end-points—other relevant data (Clearinghouse process)
• What do you do with a false negative?
• Use list as guide and inform what will be a chemical of concern

Prioritization:
• What is adequate data to move forward?
• What do you do when no information is available for a chemical?

Chemical of concern:
• Based on hazard traits, toxicological and environmental end-points and other relevant data as determined by the Clearinghouse process
• Use the existing lists of chemicals evaluated by those traits but not limited to the chemicals on those lists

Fourth Easel Page

Identify Chemicals of Concern:
• Emerging contaminants
• All CAS chemicals—probably too much
• TSCA inventory (85,000 chemicals) as possible start
• High production volume (HPV) chemicals
• Do not have use information nor authority
• List of lists
• European Union “Substitute It Now (SIN)” list
• California cannot recreate all of the lists
• European Union SIN list—90% easy; 10% differing considerations
• High production volume as a criterion—is it used in products?
• Toxic Clearinghouse: can that law be used to obtain use data? (Probably not)
• Can DTSC act as a moderator with reliance on broad community to provide chemicals? Setup website and have input from groups and public, with rules, for selecting chemicals of concern
• What are criteria for chemicals of concern?

BREAKOUT GROUP #1:
Rule for Process to Identify and Prioritize Chemicals of Concerns in Consumer Products

Fifth Easel Page

Chemical of concern:
• List of lists plus criteria characteristics OR
• Criteria that put chemical on list(s)
• Agency will also solicit input from public via web-based tool (Wiki, etc.) and evaluate?
• List of lists—are there criteria missing? Or, are existing lists sufficient?
• AOEC list: respiratory sensitive/irritant/toxicity chemicals associated with occupational exposure
• Define chemical of concern by criteria or hazard characteristics
• Characteristics:
• Certain ones will be included
• What are the bright line end-points that make a chemical of concern
• Adaptive implementation—we do not know everything now

Sixth Easel Page

Prioritization:
• CMRs, PBTs, genetic mutation, endocrine disruptors
• Tie to use?
• Is it even used?
• High product volume as a factor—first actionable list
• Hazard plus exposure—not just high production volume
• It also has to do with the cumulative effect
• Use aspects of chemical (table versus sun tan lotion)
• Acute versus long-term impacts (example, water quality)
• First Order—PBTs: environment and human
• If information becomes available about toxicity [for] high exposure chemicals—push to top priority
• Occupational exposure? If consumer products
• Ubiquitous chemicals used identified as chemical of concern
• Use in interfering with ability to comply with the law
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?
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.

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.
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?
These factors have to be weighed appropriately and in context of the compound or chemical in question and its intended use. It would seem intuitively obvious that any review would utilize credible volumes, and realistic exposures based on credible activity scenarios. .
1. How should these be weighed or balanced?
As stated above, no single factor should be considered any more important than the other. It would depend upon the consumer product involved and the recommended uses of the product. What are sources of this type of information? How could this information be obtained?
Manufacturers and distributors would be the primary source of this information as they would have the information on intended use and exposures.
2. What additional factors (if any) should be considered?
3. 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.

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
3. 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)
II. ALTERNATIVES ANALYSIS: What must be included in this analysis? Who performs it? How quickly must it be performed?
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?
2. Who should perform the lifecycle analysis? The manufacturer in cooperation with the appropriate state agencies.
3. What should be the scope of the analysis, and should there be any limitations on the scope of the analysis?
o a. full lifecycle of the product from extraction of raw materials through use of the product and then disposal or reuse? This option would seem to yield the most complete response but it would be costly and take a significant amount of time.
o b. the product lifecycle from design and manufacture (production) to retail sale and use? This may be a default option that balances completeness of an answer with time available to do the work.
o c. other? Given the complexity of the analysis, a specific scope cannot be accurately defined. However, if an analysis cannot be done as in (a) above [Full Lifecycle], then a scientifically sound, technically accurate analysis using a subset of those factors could result in a reasonable approach.
4. What are the essential components of the lifecycle analysis? These are defined in the statute – the question is moot. See, for example, Section IIA above (#3,#6, #7, #8, #11).
5. Should the assessment have a specified time limitation? This question is vague. Is the intent to identify the duration of the analysis (e.g., how long an analysis should take to be completed?) or the scope of the analysis (e.g., “ given the product or compound’s use in the economy and public exposure, over what period should data on exposure, risk hazard, etc. be considered?). It would seem that these issues need to be addressed on a case by case basis. .
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? All these factors must be considered. No a-priori weighting can be determined before an analysis is conducted. Each factor should be considered in the context of the consumer product involved.
7. How should the analysis address and include both internal and external costs? This question needs to be clarified.. What are internal costs to which the question is referring? What are external costs? If the question is referring to production and marketing costs information for the product, the State needs to recognize that such data may be competitively sensitive and the DTSC may be required to protect that data as confidential business information. This issue will require careful consideration as the DTSC proceeds.
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? Life cycle analysis cannot be undertaken for individual chemicals. The sheer volume of potential applications would render this task unmanageable. As the statute directs, it must be undertaken on a product application-specific basis. There are potentially significant economic implications if the state conducts lifecycle analyses. Peer-reviewed data is essential. 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 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?

1. What criteria should be considered to determine the appropriate regulatory response? DTSC must contemplate a range of options as envisioned by the legislation. This range must encompass the gamut of possible regulatory actions – from doing nothing to ban of the compound or chemical of concern. Clearly, this hierarchical approach to regulation must be supported by impartial criteria defined when an investigation is deemed warranted.
For example, if an analysis shows that the compound of concern does not pose a health or environmental risk, then no action would be required. If, on the other hand, an alternatives analysis and life-cycle analysis shows that a compound poses a health or environmental risk when used as intended, then the DTSC would be wise to seek means to reduce the risk to acceptable levels through a regulatory process.
2. At what point in the alternatives analysis or based on what information in the analysis is it appropriate for the State: Clearly, no action by DTSC would be appropriate until the completion of the alternatives or life-cycle analysis. Any such outcome as defined (in A-F below) can only be determined upon completion of an analysis when all data have been received and peer-reviewed. The stringency in regulatory action (again in A-F[G] below) must be mirrored by the strength of conclusions drawn from the alternatives analysis.
o A - to find a ban of the chemical of concern in the product is appropriate? “When the state determines that the product containing the chemical of concern cannot be used safely.”
o B – to require labeling or other types of consumer product information? How about “When the state determines that the product containing the chemical of concern cannot be used safely without further warnings:?
o C – to place restrictions in use of the product? When the state determines that the product containing the chemical of concern cannot be used safely without additional restriction on its use
o D – to require end of life management such as extended producer responsibility? Please define as this question is unclear.
o E – to require funding of research and development of potentially safer substitutes? We are not aware of any situation where funding of research and development could be mandated under current statutes.
o F – to place technology-forcing regulations into place to phase out harmful ingredients and/or phase-in safer ingredients?
o G - No regulatory action When the state has not determined that the product containing the chemical of concern cannot be used safely.
3. What other regulatory responses are appropriate based on information in the alternatives analysis? The Option for no regulatory action is also likely. This option has been added (to 2 above).

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? This question is ambiguous. What requirement is the DTSC referring to? Testing for certain toxic substances, drugs, etc. is already required by the Toxic Substances Control Act (TSCA) and by the Food and Drug Administration. If the state is asking whether the manufacturer of a new consumer product should be required to prove to the satisfaction of the state that all alternatives for the chemical components of its product have been evaluated, the answer is “no”. This would chill the introduction of new, useful products for California consumers and could deprive them of less expensive alternatives to products with which the new product would compete.
If the state is asking whether the manufacturer of a new consumer product containing a chemical of concern should be required to prove to the satisfaction of the state that all alternatives have been considered and that the product does not generate an unacceptable risk to safety or health when used as recommended, the answer should still be “no”.
The existence of these green chemistry laws will discourage any manufacturer from marketing a new product in California that might be banned due to the presence of a chemical of concern if the manufacturer also has not tested the product to ensure that its use not generate an unacceptable risk to safety or health.
1. Should reporting be required? If so, who should submit what information to whom, when, and for what purposes? Reporting is already required – DTSC could be an additional recipient of information.
2. Should a manufacturer be required to provide a certification to a distributor or retail seller of their products? No for many of the reasons provided above. What would the manufacturer be certifying? What would a retail seller do with all these ‘certifications”? How would the DTSC ensure that no fraudulent “certifications” entered the retail sector?
3. Should review or auditing be required? If so, who should review submittals? What criteria should be applied to that review or audit? This question is also vague. What is the “review” to which the question is refering? An “audit” of what? What is the purpose of the review or the auditing? Does this question also imply the possibility of random product testing?
4. 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? We are not aware that any such standard with respect to alternatives analysis or life cycle analysis exists currently. As indicated above, the existence of these green chemistry laws will discourage any manufacturer from marketing a new product in California that might be banned due to the presence of a chemical of concern if the manufacturer also has not tested the product to ensure that its use not generate an unacceptable risk to safety or health. No additional requirements should be placed on manufacturers. If they are, California residents will be denied access to such products because their production and marketing in the state will be more expensive than a manufacturer can tolerate. What other considerations should inform the state’s compliance and enforcement of this statute? None at this time

II. ALTERNATIVES ANALYSIS: What must (this is not a must it is a may) be included in this analysis? Who performs it? How quickly must (this is not a must it is a may) it be performed?

DTSC has it wrong. The intent of the legislation is (for DTSC) to develop tools that producers may use when developing their products. These tools (for the producers of goods) were intended to be voluntary (by the Legislature) - not manadatory. Proper use of the tools by a producer would ensure that the product would not contain a chemcial of concern/pose a problem. Hence, producers who voluntary practiced green chemistry (i.e., who used the tools) would know they were not at risk of producing a product identified as containing a chemical of concern. Only through this voluntary approach can DTSC givegreen chemistry its true meaning as a change in the way the world designs goods. A mandatory alternatives analysis approach is just the same old-fashioned, antiquated regualtory appraoch DTSC has always used.

If DTSC develps the tolls properly and they work, only those producers who don't use them would pose a concern for enfkorcement. Hence, by using the voluntary apporach combined with the real world verifiable concern approach above, DTSC will only need enforce against true problem products.

It does not appear as if the legislation gives DTSC the authority to make this alternative analysis requirment mandatory. The law only authorizes DTSC develop it. Perhaps, when done, if the legislatuures likes the tools that DTSC develops, then, maybe it will be required by statute.

It would be inconsistent with the law and with the fundmental principles of "green chemistry" to make the alternative analysis mandatory. Clearly the law envisions a prohibitoin on sale as a mandatory response, but even then the requirment to do teh alternative analysis is not mandatory.

The fundamental idea behind the statute is to provide the processes (the tools) to industry to avoid producing products that need regualtory intervention. DTSC's proposed approach of creating (via regulation) a robust and ever-reaching regualtory program to regualte products that requires alternatives analysis, like the IRS requires filing taxes, is exactly opposite the ultimate end-goal envisioned by "green chemistry." The ultimate end goal is the products are bieng made safe without regualtory intervenetion; DTSC must keep its eye on that vision.

The alternatives analsyis tools must be made readily available, by DTSC, for voluntary use. Only this voluntary approach will lead to safer products. If DTSC mandates the alternatives analysis, producers will simply leave the California market and/or sell from outside the state (e.g. via the internet.)

Workshop comments, Berkeley 2/19/09
BREAKOUT GROUP #2: Rule for Process for Alternatives Analysis
Alternatives:
• No alternatives? What is the process if there are no alternatives?
• Is the alternative better or worse? Should the regulation compel someone to choose an alternative?
• What is the definition of “safer alternative” in a specific application or product?

• [One] size does not fit all; should there be different criteria for use?
• What does “safer” mean? How should this be defined?

Purpose and Regulatory Outcome:
1. Provide manufacturers with information for improvement/look for better alternative
2. Inform the regulatory response

How to identify?
• Chemical
• Use
• Alternative

How does regulation impact industry?
For example, Design for the Environment (DfE) assessment—flame retardant review; does not come up with specific regulatory position
• How often will list/process be revisited?
• New versus old?
• Grandfather?
• How much data is available?
• Re-assessment timeline?

Proposition 65 – should this be a model?
• Calculation of risk/exposure
• Allows for lesser amount of data

Results of assessments
• Post online
• Allow for public comment
• Feasible?

Alternatives assessment: use to help to inform the regulatory body

Regulatory action and assessment are not inextricably linked, or should they be?

Chemicals of concern
• No alternative?
• What happens next?
• Inform the regulatory response

1) Identify Chemical of concern
2) Identify Green alternative
3) What is the Next step?

Process in Regulation:

Alternative [to chemical of concern]

1. What are the Data requirements
2. Reliable and reproducible results and methods
Who decides what is needed versus functionality?

Massachusetts Toxics Use Reduction Act (TURA) as a model?
• Similar outcome?

DTSC should:
• Mandate a process
• Report information and allow public input
• Work to identify alternatives (using existing alts assessment tools, like the Green/Blue database, DfE, etc.)

DTSC should Focus on functional groupings rather than chemical by chemical

DTSC should Include lifecycle considerations

The process should be:
• Open process
• Use Web 2.0
Identify best practices and Identify alternatives

DTSC
• Re-think the role of DTSC
• Instead of making list
• Facilitate that information is reliable

The process should include the following steps:
1. Identify new alternatives versus existing
Identify a Sufficient data set
Identify Hazard/safety/cost/efficacy/availability
2. Review and comparison of data
3. Public transparency, using Matrix pages?

Clarifications:
Definitions needed:
1. “Consumer product”
2. What is “safer”?
3. Define need

  • Have a workshop where DTSC brings in outside people to learn good/bad and to learn about different alternatives assessment models

=> TURA, DfE, Green/Blue, etc.

How do we deal with data gaps in the analysis?

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.

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

The presence of a chemical of concern.

  1. Who should perform the analysis?

Manufacturers should be required to hire independent experts to perform the analysis. Similar to a an EIR.

These analyses must be reviewed by an independent governmental entity to verify that the data being provided is accurate and complete.

  1. What must be included in this analysis?

The Alternatives Assessment approach should encompass a process that uses open source evaluation approaches to compare evaluation aspects such as economic feasibility, technical performance, and health and environmental impacts. The process should be self-implementing, and incorporate life cycle thinking to result in decision points that feed into appropriate regulatory options.

The alternative assessment process should consider factors when comparing different alternatives. These factors can help determine how best to limit exposure or reduce the level of hazard posed by a chemical of concern, as specified in the statute. The comparative assessment process should also consider the availability of potential alternatives, potential hazards of those alternatives and critical exposure pathways. The process and/or factors could be different depending upon whether existing alternatives are being compared or the comparison is among potential or design alternatives.

The alternatives assessment process should use information gathered for chemicals of concerns and combine the life cycle assessment tools with other alternatives assessment evaluations to arrive at results that will help determine which of the array of regulatory options will be most effective.

  1. What lifecycle based algorithms are available to be adapted for use in the analysis?
  2. 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?
  3. What factors should be considered in assessing performance of a chemical in a product?
  4. How should “necessity” be assessed or weighted in the analysis?

Similar to EU RoHS, a chemical that is present for reasons of health and safety, or if the chemical of concern is needed to "comply with consumer, health, or safety requirements that are required by the Underwriters Laboratories, the federal government, or the state law."

The American Conference of Governmental Industrial Hygienists has approximately 50 "Adopted Biological Exposure Determinants which have some limited application here.

  1. How are possible hazards, risks, or exposure pathways of any alternative evaluated?
  2. What other considerations should inform the alternatives analysis?
  3. Should the state adopt a formula to balance or weigh the mandatory and other factors? If so, what would that formula look like?
  4. What data is available or should be required for and how would that data be used in evaluating:
  • 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?
  • k. public health impacts?
  • l. environmental impacts? and,
  • m. economic impacts?

B. Process for Lifecycle Analysis

Framework for evaluation of potential alternatives

Preamble
What follows is a description of a comprehensive, practical, and flexible Framework to evaluate a product’s life-cycle and to assess changes when addressing a chemical of concern. The primary goal is to identify potential regrettable chemical substitutions or product reformulations when analyzing ways to reduce the impact of a chemical of concern. What is needed is a systematic and disciplined process to identify the potential impacts from any change with respect to the original product. Once identified, these potential impacts can be the focus of reduction individually or the alternative abandoned if the trade-offs appear significant.

The Framework should offer guidance on the key questions an organization should consider to make sound evaluations and management decisions. The ability to develop products and incorporate alternative chemicals into products is advancing rapidly, but the understanding of the potential environmental, health, and safety effects of changes — and of the most effective ways to manage such effects — has proceeded at a slower pace. Therefore it is especially important to understand and minimize the impacts of changes with the life cycle perspective in mind to establish corresponding controls for exposure and release.

The objective is to develop a framework that can promote responsible development of products, facilitate public acceptance, and support the development of a practical model for reasonable government policy on chemical safety. It is anticipated that the information produced can help inform product-development decisions by identifying opportunities to “design out” impacts. This Framework draws on principles from life-cycle assessment, that is the process of systematically and comprehensively evaluating the full environmental, health, and safety impacts of a product over the course of its life. The Framework is not intended to be a full-scale life-cycle assessment. However, use of life-cycle assessment tools may be warranted for certain aspects and certain situations to better quantify specific impacts.

With the considerations outlined above in mind, the basic elements that a framework should contain are:
• The Framework should require developing informational profiles (or “base sets”) regarding the properties, hazards, and exposures associated with a given chemical of concern and its application in a product, in order to identify opportunities and guide decisions toward safer substitutes or alternative product formulations.
• In particular, the Framework should include developing life-cycle profiles that provide more information on physical-chemical properties, eco-toxicity, and environmental fate than has typically been the case.
• The Framework should be information-driven; but not implicitly assume the risk or safety of any material.
• The Framework should allow users to address areas of incomplete or uncertain information by using reasonable assumptions and appropriate practices. Where there is little or no information to guide decisions on the potential for a particular hazard or exposure, the Framework should promote using “reasonable worst-case assumptions” or, alternatively, using comparisons to other materials or processes that have been better characterized along with management practices appropriate to those options.
• The Framework should be designed to encourage replacing assumptions with real information and refining management practices accordingly. Further, the Framework should describe a system to guide information generation and update assumptions, decisions, and practices with new information as it becomes available.
• The Framework should be designed to be flexible and robust, but that comes with an obligation for users to be transparent and accountable in its implementation.
• Finally, the Framework should serve as a tool to organize, document, and communicate what information is available about the product; to acknowledge where information is incomplete; to explain how information gaps are addressed; and to justify the rationale behind the user’s alternative decisions and actions.

Framework Overview
A Framework is described below which, is meant to facilitate evaluation, selection, and communication of product redesign and safer substitutes for chemicals of concern. The Framework provides a template for organizing all the information, capturing overall evaluations of that information, and recording consequent decisions. It is designed for iterative use as development advances and new information becomes available. The framework consists of six distinct steps to guide a process for evaluation and management that is practical, transparent, comprehensive, and flexible.

Step 1. Describe the Product and it’s Application.
This first step is to develop a description of the product and its intended uses, based
on information in the possession of the manufacturer and others. These descriptions set up the more thorough reviews, and provide context for the product’s functional unit and useful lifetime, consistent with life-cycle assessment methodology. This is important if any change in the product formulation, performance, useful lifetime or end-of-life management results from addressing the chemical of concern.

Step 2. Profile the Life-cycle(s).
The second step defines a process to develop three sets of profiles: the chemical of concern’s properties, inherent hazards, and associated exposures throughout the product life-cycle. The user takes into account the product’s full life-cycle from raw material sourcing, through production and use, to end-of-life disposal or recycling, including transportation and energy consumption for each life cycle phase. In so doing, the user considers how the product’s properties, hazards, and exposures may change during the life-cycle (for example, because of physical interactions during use, or from chemical changes that may occur as it breaks down after disposal). The step includes 3 base sets of information defined below to guide the development of these profiles. Various conditions will influence how fully a user may complete the base sets, or whether a user may incorporate additional information into the profiles.

The properties profile identifies and characterizes a physical and chemical properties throughout the product life-cycle such as: product function or performance, useful life, materials and resource consumption, production, in-use, and transportation energy inputs, and waste and end-of-life disposal.

The impact profile identifies and characterizes the chemical of concern’s potential safety, health, and environmental hazards during the product life-cycle such as: water quality impacts, energy efficiency, emissions of air pollutants, including ozone forming compounds, particulate matter, toxic air contaminants, and greenhouse gases, and other anticipated environmental impacts such as contamination of surface water, groundwater, and soil.

The exposure profile identifies and characterizes the opportunities for human or environmental exposure to the chemical of concern including exposure both through intended use and by accidental release. This includes public health impacts, including potential impacts to sensitive sub-populations, such as infants and children as well as others.

All three profiles work together, for example, exposure information may suggest which impacts are most important to investigate. Similarly, the properties may suggest which exposure scenarios are most likely.

Step 3. Evaluate impacts and assess management options
In this step, all the information generated in the profiles is reviewed in order to identify and
characterize the nature, magnitude, and probability of impacts presented by a particular product and its anticipated application. In so doing, the user considers gaps in the profiles, prioritizes those gaps, and determines how to address them — either by generating information or by using, “reasonable worst case” assumptions. The user then evaluates the available options for managing the identified impacts and recommends a course of action to evaluate each from the life cycle perspective. Options should include engineering controls, protective coatings, better end of life management, and product or process modifications including using alternative chemicals in place of the chemical of concern.

Step 4. Decide, Document, and Act.
In this step, the user evaluates alternative chemicals in lieu of the chemical of concern or if other changes in formulation or product construct control the chemical of concern’s impacts. The steps above, starting from 1 need to be repeated for the contemplated changes including the complete life cycle impacts of an alternative chemical or other changes due to reformulation or product life time, etc. The results can be used to compare to the original product profile to identify the benefits and downsides to the contemplated changes. The impacts identified in the alternatives assessment can also each be independently reviewed and targeted for reduction (these may include actions such as air pollution control at production facilities or water conservation measures, etc). The overarching goal being to identify the significant potential impacts of a change and avoid regrettable substitutions across the product life cycle including that of an alternative chemical. In general, “significant” means serious enough to potentially require a revision in the risk-evaluation or risk management procedures for the product. Examples include:
• A change in production, processing, or use patterns for the product that would alter the life-cycle exposure profile developed in Step 2.
• The acquisition of new data relevant to the risk evaluation for the product or chemical application, such as results from Step 3.

Economic impacts should also be evaluated for the preferred alternatives. This assessment should be complementary to the life cycle steps outlined above and also include the costs external to a traditional cost benefit assessment. External costs include those borne by the commons or by society such as the monetary costs of air pollution to ecosystem degradation, human health related costs due to air or water pollution, etc.

Consistent with a transparent decision-making process, the user documents the decisions and their rationale and shares relevant information with interested stakeholders, both internal and external. The user may also decide that further information is needed and initiate action to gather it. And the user determines the timing and conditions that will trigger future updates and reviews of the risk evaluation and risk-management decisions for the chemical containing product.

Through repeated reviews as refinements are identified, the user updates and re-executes the evaluation, ensures that the alternative chosen will work as expected, and adapts those systems in the face of new information (e.g., regarding hazard data) or new conditions
(such as new or altered exposure patterns). Reviews may also be triggered by a number of
situations (changes in production or use, or new data on hazard or exposure, for example). As in Step 4, the user not only documents changes, decisions, and actions but also shares appropriate information with relevant stakeholders. Results of this assessment process may include product modifications, engineering or management controls, or decisions to change product formulation or to abandon the product. The current consensus in the literature for risk management is that the “most effective to least effective” controls for problem chemicals are the following: elimination, substitution, or reduction of the chemical, process, or condition that presents the hazard.

Addendum:
Description about applying life-cycle thinking to assess alternatives
The product life-cycle can be thought of as encompassing all the processes and activities that occur from initial extraction of material from the earth to the point at which any of the material’s residuals are returned to the environment. A description of life-cycle assessment and typical diagrams of a product life-cycle is shown at www.ami.ac.uk/courses/topics/0109_lct/ or www.epa.gov/ord/NRMRL/lcaccess/. Related concepts or approximate synonyms for the term “life-cycle” used in other contexts include “product trail” and “value chain.” We propose using life-cycle thinking, appropriately modified to account for the nature of chemicals in products and their applications, to systematically evaluate the safety of an alternative, whether it involves reformulation of the product or straight chemical for chemical switch-out. Assembling such a profile need not entail use of a formalized ISO methodology for life-cycle assessment (LCA), but should include the associated consideration of all material and energy inputs and outputs that LCA typically entails.

Here, the life-cycle concept is used as a means for organizing all relevant processes and activities to which a product is subjected. Those processes and activities can then be evaluated to determine whether they carry the potential for the release of, or exposure to, the chemical or any of its derivatives. That is, the life-cycle profiles developed in Step 2 will respectively assess the material’s physical-chemical properties; hazard; and nature, magnitude, and probability of exposure as a function of any given process or activity.

Three other considerations are important in defining the life-cycle profile of a material.
• First, it can actually have multiple life-cycles. For example, a product may be handled in several different ways after use, e.g., by recycling, incinerating, or landfilling. Or the raw materials used to make it may be acquired from different sources or processed somewhat differently. Thus the life-cycle can be as envisioned as a many-branched tree, with each branch representing a different application. Because knowledge of each application will reside upstream and downstream of the primary product producer, the responsible party may need to solicit guidance (based on the current state of knowledge) regarding potential limits on the material’s uses.
• Second, it is important to consider both established and reasonably anticipated activities or
processes to which the product may be subject over its life-cycle, and these may be either intended or unintended.
• Third, the life-cycle profile also serves as a useful means of identifying the different actors (typically, commercial entities) that are involved, as the linkages between them are important. While the product manufacturer typically decides on or influences activities (such as workplace-safety practices) “within its four walls,” such decisions can profoundly affect the options available to the other actors in the value chain. For instance, a decision to use a toxic heavy metal in a product may ultimately compromise the safety of, or limit the disposal or recycling options for, that product at the end of its service life. Thus to define and catalog the elements of a material’s life-cycle, the following breakdown should generally be followed:
a) Describe each known activity by life-cycle stage (e.g., those directly under a company’s
control); b) Project reasonably anticipated activities by life-cycle stage (e.g., those upstream or downstream of the company). Each known and projected activity can then be assessed in Step 2 for its potential to result in a material release or direct exposure. If such potential exists, further examination may reveal whether the material is released, or is likely to be released, and its subsequent fate and behavior.

Stages of the life-cycle profile
It is important to organize discrete activities according to the stage, or stages, of the life-cycle
in which they occur. A general description of the scope and boundaries of the various stages,
and their relevance to products, is provided below.
Materials Sourcing
This stage of the life-cycle profile encompasses activities for gathering the needed inputs; thus it
includes transport from points of acquisition to the point of processing. For a product, activities at this stage are relevant if an input is actually acquired to which there is potential exposure or if the specific sources of the starting materials influence the composition, properties, or behavior of the resulting product e.g., by affecting the extent of other chemicals and materials present.
Manufacturing
Three substages — materials manufacture, product fabrication, and filling/packaging — are
involved in the transformation of source materials into a product to be delivered to end-users.
• The Materials Manufacture phase entails all the activities involved in converting a
source material into a form that can be used to fabricate a finished product. The production
of intermediate chemicals or materials is normally included in this category, as is their transport. It is important that their associated processes, the differences between them, and the differences between the resulting products be cataloged in this sub-stage of the life-cycle profile.
• The product fabrication phase involves the processing of raw or manufactured materials
in order to create a product. A consumer product, to be distributed for retail sales, is often involved, but the product could also be an intermediate or component of a larger product for use by other industries.
Distribution
This stage includes all transportation required to deliver an intermediate product to industrial
users or a final product to manufacturing sites, retail outlets, or directly to the consumer.
Use/Reuse/Maintenance
This stage begins after the distribution of products or materials for their intended use; it includes
any process in which the product is reconditioned, maintained, or serviced to extend its useful life. Replacement or repair for example would be among the activities included here. Product storage, consumption, wear, weathering, or other kinds of degradation are also included in this stage.
Recycle/Waste Management
This stage begins after the product or material has served its intended purpose and will enter
either a new system (through recycling) or the environment (through the waste-management system). Post-use options such as recycling, composting, and incineration are included. Repair and recycling, which can entail separation and recovery of some components as well as the shredding and landfill disposal or incineration of others are types of activities associated with this stage. It would also include the treatment of wastes and the fate and behavior of materials released to the environment the down-the-drain release of a material used in a personal care product, for example, or the subsequent movement, reaction, and degradation of a material after landfilling.

June 2007
Adapted from Life Cycle Assessment: Inventory Guidelines and Principles (EPA 600/R-92/245). Cincinnati, Ohio: U.S.EPA, Office of Research and Development, Risk Reduction Engineering Laboratory, February 1993.

*
Notes from the 2/18 workshop LCA breakout table

Opening focus statement- What is the process –tool for lca?

Questions
Q-does lca apply to a chemical or products or use?
A- products
Q-can lca info factor into identifying the chemical of concern?
A –include this in the prioritization group discussions
Q- are there existing stds for lca?
A- yes -ISO stds but these are basically guidelines
Q- what are the criteria to consider in lca?
• exposure
• volume of use of CoC
• user (children, etc)

LCA, within alternatives assessment should consider:
Toxicity
• hazard exposure should be paramount since other drivers/requirements exist for energy efficiency, water, GW, etc
Function
GHG’s
Water
Air
Production
End of life/Disposal
Energy
Raw materials

LCA methods
Need process to determine product category of greatest concern with a given CoC
Time limits to complete study/AA
Steps for minimum lca requirements use existing LCA stds and simplify?
• Take a common sense approach to look at LCA criteria, no need to run every alternative thru full LCA; but needs to be multimedia and cradle to grave
• Should more heavily emphasize exposure
• Simplified LC thinking framework approach, or scorecard tool? Qualitative vs quantitative? Is qualitative too “fuzzy”? Are full LCA results actually definitive?
• Desired attributes at minimum? Can weight hazard/exposure more than others?
• How to deal with data gaps and alternative decision making

WiKi proposed language now has -to assess raw materials chemicals, water, energy
Then reassess with chemical switch out or other product changes using LC thinking.

Confusion about LCA in context, and the overall process encountered-
First a chemical is identified, then the product or product category, then alternatives analysis, then action. Same as flow chart in am presentations.

Outcome of LCA in AA- How to engage designers suppliers to redesign?

Really need disclosure of chemicals in products to begin with-
Screen using Clean Product Action hazard screen or other tools?

Who does the AA/LCA?
• Manufacturers of product or component
• Industry association
• Maker/marketer of alternative

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?
  2. Who should perform the lifecycle analysis?
  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?
  4. What are the essential components of the lifecycle analysis?
  5. Should the assessment have a specified time limitation?
  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?
  7. How should the analysis address and include both internal and external costs?
  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?
  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?

III. REGULATORY RESPONSE: What are the appropriate regulatory outcomes based on the alternatives analysis?

  1. What criteria should be considered to determine the appropriate regulatory response?
  2. At what point in the alternatives analysis or based on what information in the analysis is it appropriate for the State:
  • A - to find a ban of the chemical of concern in the product is appropriate?

If the use of a chemical is unsafe, it is appropriate for the state to restrict its use. In fact, if the department feels that enough infromation exists to justify a ban even before an alternatives analysis has been completed the department should act to protect the health of consumers.

How will issues of lower product quality and/or severe challenges associated with a re-vamped production process be addressed? If these issues are not adequately addressed, DTSC can not point to a successful substitution as having occurred.

The substitution of a chemical in process coul result in more than simply replacing one chemical with another. The change may create technical challenges in the process and may require the company to perform administrative changes also.

Will the process by which a ban is initiated be subject to exemptions? Historically, there are numerous exemptions that have been granted to regulations. I am hoping that specific, powerful corporations or industry groups would not be able to accomplish with consumer product chemical bans.

Are their provisions being considered for exemptions to be granted in the event the chemical substitution is extraordinarily expensive or extremely challenging from a technical standpoint?

  • B – to require labeling or other types of consumer product information?

Labeling or similar use instructions would be appropriate for cases where proper use results in a greater level of sustainability (e.g., greater benefit or lesser exposure to particular hazards). However, any labeling shouldn't interfere with other important safety labeling.

  • C – to place restrictions in use of the product?

Again, if the use of a chemical is unsafe, it is appropriate for those uses to be restricted.

  • D – to require end of life management such as extended producer responsibility?

End of life management are appropriate where there are potential outcomes resulting from proper or improper disposal. Products and chemicals which can result in human or environmental contamination as a result of improper disposal need to be managed. In order to encourage proper recycling of discarded consumer products containing hazardous materials like electronics, sales of these items should be taxed much like some containers are taxed at sale today, and these funds can be used to pay those who deliver the items to the proper recycling facilities (redemption value), and also to pay for the recycling process.

  • E – to require funding of research and development of potentially safer substitutes?

Requiring funding for R&D of potentially safer substitutes is appropriate.

R&D should not be required. The producer should be allowed to discontinue the product in CA.

  • F – to place technology-forcing regulations into place to phase out harmful ingredients and/or phase-in safer ingredients?

If an ingredient is truly harmful, it should not be permitted to be used. If a safer ingredient is avialiable it should be substituted.

Somehow, the cost/benefit impact of changing to the "safer" ingredient needs to be comprehended. We're all in favor of safe products, but the degree of "safe" should be balanced against the cost.

  1. What other regulatory responses are appropriate based on information in the alternatives analysis?

DTSC may wish to consider the use of a "tax" in lieu of an out-right ban with corporations clamoring for exemptions.

Berkeley Workshop February 18, 2009
BREAKOUT GROUP #4:
Rule for Regulatory Response

First Easel Page

Consider EU REACH approach:
1. Manufacturers do assessment
2. Ends users collaborate [to give feedback to manufacturers and regulators]
3. Regulators impose rigor and enforce

“Ban” as regulatory response:

California should ban IF ALL of the following:

• Product contains a chemical of concern in the top five priority rank

• Any biomonitoring, ecological, epidemiological data shows presence and risk

• Use in product results in likely exposure for vulnerable population, such as infants (several participants pointed out that broader definition of vulnerable population exists in Clean Drinking Water Act and also in Health and Safety Code section 116365.28)

• The chemical of concern is not necessary because a functional [defined broadly] substitute(s) [that does not meet any of the above] is/are available

Second Easel Page

“Labeling” as regulatory response:

California should require labeling IF:
• Substance [chemical ingredient in product] is on the “ban” list [see above]
• Chemical of concern necessitates end of life management
(example, heavy metals in brake pads should carry some sort of label indicating proper end-of-life management so environmental harm/aquatic toxicity is prevented)
• “Presence” [of chemical of concern] would trigger label response
• Considerations:
 Level/concentration: “above a certain level” (such as a federal standard, FDA, Proposition 65 MADL/safe harbor number) would trigger label requirement
 What is exposure is limited or virtually non-existent?
 What if chemical is not intentionally added? (example, pollutant at very low concentration in water from public system used in manufacturing)
 “Exposures” defined by complex multi-media/human/environmental

Regulatory response criteria CAN stand apart from alternatives analysis/lifecycle

Third Easel Page

Commodity products

Pros/cons of regulated versus unregulated

Label On product/packaging
or
On website

Could a “good” label (absence of chemicals of concern) be used? [consensus is NO]

“End of Life” management as regulatory response:

 Take back program
 Recycling
 Demanufacturing/Destruction
 Reuse
 Others ??

California should require end-of-life management IF:
• Substance [chemical ingredient in product] is identified as a chemical of concern and as hazardous [see label above] which requires some sort of EOL management

“Manufacturer” take-back program IF:
• Chemical of concern presents harm at end of life and labeled as part of take-back program
• Responsible take-back program must include:
 Minimum percentage
 No dumping/export
 Etc.

Fourth Easel Page
• Exposure: Lead in child’s toy where no exposure (inside and not accessible) versus exposure
• From origin to end-of-life (i.e., computer disassembly)
• Use

Example,
No further action if lead in child’s toy is in compliance with federal CPSIA

• Manufacturer conducts critical anticipatory assessment and regulators make sure those are done
• Manufacturer required to submit data
• What about by-products and reaction products?

  • Consider problem set as functional groups or classes of:

— chemicals with similar functions (i.e., flame retardants)
— products (cleaners)
— users (children)

Fifth Easel Page
Regulatory Responses

• What does law apply to?
• Consumer products for sale/use in California
• Not limited to “made in California”
• What about a chemical ingredient that is not intentionally part of the product?
• Must differentiate size: small, medium, and large manufacturers have different capabilities

Sixth Easel Page
No Further Action response

Considerations:
• Specified conditions exist
• Kinds of products with that chemical
• Production volume

Focus on knowns given limited resources—start with ban
Level of toxicity, exposure, affected sub-populations (children)
Need an inventory
“hazard” is not the same as “risk”

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?

First and foremost, consumers have a right to expect that the products they purchase are safe. If a manufacturer sells an unsafe product, there are a number of statutes under which enforcement action can be taken. In addition, manufacturers might have civil liabilities as well.
With regard to "safer" alternatives, the conventional product must still be safe, but presumably, the "safer" product has a more favorable hazard profile, more favorable source materials or other attributes that make it more sustainable. As such, there should not be conventional mechanisms used to achieve compliance, but a market-based approach where it is in the business interest of the manufacturer to comply. (In a world of perfect markets where environmental costs are internalized, no enforcement would be necessary.)

  1. Should reporting be required? If so, who should submit what information to whom, when, and for what purposes?
  2. Should a manufacturer be required to provide a certification to a distributor or retail seller of their products?

A manufacturer must be required to post a certificate on its website, visible to anyone that wants that information.

  1. Should review or auditing be required? If so, who should review submittals? What criteria should be applied to that review or audit?
  2. 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?
  3. What other considerations should inform the state’s compliance and enforcement of this statute?

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