California Green Regulations Discussion

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CALIFORNIA GREEN REGULATIONS

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Table of Contents

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:

Article X

6xxx.x Applicability

This section applies to all chemical and chemical ingredients contained in consumer products italic text(both consumer and product needs to be defined, for there is great confusion at this point as to exclusions) manufactured in, imported into, distributed in, or sold or offered for sale in California. What about by-products resulting from secondary processing? What about other regulations which already impact the specific chemicals and their ingredients? Does this regulation supercede all others? Is there a minimum concentration cutoff for consideration? Where do REACH regulations fit into this?

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”. Are nano materials included or should they be addresses differently?

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

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

(c) “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, potential users to be identified, and identification of specific products that may contain the chemical in question;
(4) Minimum data sets (pre-determined by whom?)to provide a thorough understanding of the potential risks associated with use of the chemical in question, including any adverse health, safety or environmental effects and exposure potential for a reasonable foreseeable end use, including exposure potential for any sensitive subpopulations, such as children, the elderly or others whose biological systems have been compromised. The minimum data sets should be aligned with the data sets required by other state regulations.
(5) The manufacture shall notify DTSC any time changes occur in production volumes or use patterns for the chemical in question, or the extent or diversity of uses expands.
(6) The manufacture shall notify DTSC any time that new information becomes available regarding any potential health, safety or environmental impacts of the chemical in question.

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

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

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

6xxxx.x Special Provision for Existing Chemicals

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A. Chemical of Concern in a Product

California is required to develop a process to identify and prioritize “chemicals of concern” in consumer products in California.
There are several steps to accomplish the state’s goal: 1) identifying “chemicals of concern”: 2) identifying what products containing those chemicals may present concerns for safety; 3) identifying whether there are suitable alternatives and 4) making final determinations on risk management actions. Ideally this will be an integrated, stepwise risk-based process to look at chemicals with hazards of concern and at their uses in products that have exposure scenarios of concern to identify priorities for alternative analysis and then, where warranted, risk management action as identified in AB 1879.

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

“Consumer products” are broadly defined under AB 1879 and SB 509, exempting only a few categories of products. This will help to maximize the potential for achieving the stated goals of the California Green Chemistry Initiative. The regulations should outline a reasonable, clearly defined approach for identifying, prioritizing, evaluating, and restricting chemicals where warranted in the whole of California commerce, not just a particular category of use. The following are important considerations:

  • The process needs to have an integrated way of considering chemicals with hazards in the context of their intended uses in products that have exposure scenarios of concern and to then identify priorities for action by California.
  • The priority setting process and risk management decisions need to consider factors which are frequently used to limit human exposure to chemical ingredients, e.g. the type and design of both products and packaging; directions for use and label warnings; protective equipment during product use, directions for disposal.
  • The process and outcome should be oriented to identifying real priorities of concern to public health and the environment—the important few, vs. the trivial many.
  • In moving from initial priorities to final determinations, DTSC should engage with producers and users of priority chemicals to acquire information and expertise that is available.
  • Also, in moving from initial priorities to final determinations, exposure assessments should be done to allow California to identify those products containing the priority chemicals that contribute significantly to exposure (based not only on concentration of the chemical in the product but also the intended use of a product and resulting routes of exposure including ingestion, inhalation, and dermal.)
  • In performing exposure assessment, these should focus on intentional ingredients looking at exposure pathways that result for intended use.

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.).

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

California needs to operate a transparent and timely process for this effort that includes several opportunities for input by stakeholders. This input could lead to both additions and deletions from preliminary findings. California should undertake a first round in the process, then allow parties to comment with rationale for additions/deletions and level of priority. California can then consider and update its findings. The state could consider multiple iterations for this as was done in Canada, enabling very useful input from stakeholders. However, the process needs to be arranged in an efficient manner to ensure the overall process is timely and minimize the potential for diverting state resources such as a nomination process might do.

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?

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

The process should be risk-based prioritization considering both hazard and use/exposure information. To ensure that priority setting is focused on the “important few”, the selection criteria should include 1) indicators of high potential for hazard, e.g. carcinogens, mutagens or reproductive toxicants (CMR), persistent, bioaccumulative and toxic (PBT) compounds and 2) indicators of high potential for exposure, e.g. production level, found in drinking water, air, used in consumer products, especially those intended for children, emission/discharge data, found in biomonitoring.
In final determinations, on a weight-of-evidence approach comparing hazard level to anticipated exposure levels must be made, not simply considering the “presence” of a chemical in any given medium such as drinking water, air, or biomonitoring information.

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.

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

The TIC is intended to be a decentralized web-based system to collect, maintain, and distribute data on chemical hazard traits, environmental and toxicological endpoints. Its usefulness is partially dependent on timing. If the TIC is set up and has gathered substantial information on hazards, uses, exposures, priorities and risk management from other authoritative bodies it could provide useful resource in establishing priorities. However, it should not be the only source of information.

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

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

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.

The degree of uncertainty is a relevant factor in priority setting, however there needs to be some reason for suspected concern. For initial round of prioritization, the state should identify potential priorities and rationale, identify important data gaps and invite the public to provide information to fill gaps needed for final determination. This could then be repeated with the public release of updated information to allow for further input.
The Canadian approach to chemical prioritization under the Canada Environmental Protection Act (CEPA) should be understood and considered by California. For example, in the initial data gathering, Canada used available data when possible, and inserted modeled data for persistence, bioaccumulation and aquatic toxicity when data was not available. During comment periods, stakeholders were invited to provide study data to replace model information.
The state should employ data quality standards as developed by the Organization for Cooperative and Economic Development (OECD) based on the Klimisch method and use a weight of evidence approach when multiple studies are available. For final determinations, per the Canadian approach, the relative uncertainty of and degree of confidence in exposure and effects databases that serve as the basis for decision-making in the assessment of high intrinsic toxicity or the adequacy of margins of exposure including appropriate safety factors should be explicitly delineated and must be consistent across screening assessments. Consideration must be given to aspects such as:

  • interspecies and intraspecies variation,
  • nature of the critical effect,
  • dose spacing in the critical study,
  • steepness of the dose-response curve,
  • extent of the database as the basis for characterization of hazard for all effects including that considered critical,
  • degree of protection provided by the critical effect level, and whether or not estimates of exposure are based on, for example, environmental monitoring or modeled data or higher-confidence internal doses (e.g., levels in blood).

5. 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.

A final determination of “high priority for risk management action” should be made by CalEPA/DTSC. As previously indicated, this should only occur after an iterative process and consultation with stakeholders and with the Green Ribbon Science Panel in arriving at final priority determinations.

For effective resource management, it may be appropriate for California to make choices not only on what action to take, but when. In some cases the state may put a ‘hold’ on action, pending further data collection, awaiting pending assessments/actions by other governments, etc.

7. 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.

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

Absolutely. Deselection for the list should be a potential outcome of the prioritization and assessment process. As directed in the legislation, if chemical ends up “not requiring any action” it should be delisted. Additionally, should future information indicate that listing/regulatory action was inappropriate, the actions should be reconsidered.

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.

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

Once a chemical and its use(s) have been determined to be high priority based on risk, the Alternative process should be triggered. No immediate risk management needs to be taken unless there is an “imminent risk”.

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.

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

B. Factors for Prioritization

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

In identifying priority chemicals the state should use a risk-based prioritization approach in which both hazard and use/exposure information are considered. AB 1879 suggests a few criteria, but additional criteria would benefit the overall Initiative. Focus should be indicators of high potential for hazard, e.g. CMR, PBT and on indicators of high potential for exposure, e.g. US EPA data on production level, found in drinking water, air, used in consumer products, especially those intended for children, emission/discharge data, and CDC biomonitoring information. In implementing the prioritization, the state should create an open and iterative process for involving the expertise and knowledge of stakeholders to contribute to the information used to make decisions. The process should also work to funnel or narrow the universe of chemicals from a large initial set to a final small set to concentrate on “the important few” versus the trivial many. This process will create a workable approach that produces highly evident results.

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.

California should employ risk-based prioritization in which both hazard and use/exposure information are considered.

Potential effects on sensitive subpopulations is an indication of potential hazard while volume and use in consumer products are indications of potential exposure. These are specifically stated in the law but there are other equally valuable factors that should be considered. The focus should be on indicators of high potential for hazard, e.g. CMR, PBT and on indicators of potential for exposure, e.g. production level, found in drinking water, air, used in consumer products, especially those intended for children, emission/discharge data, found in biomonitoring.

Accurate volume information at a state level will be difficult to develop without a large and burdensome data-collection process. Production volume has limited use in human health assessments for most consumer products. It can be important for environmental safety assessments. There are several ways to approximate volume information with sufficient accuracy when appropriate for initial screening and priority setting, without the need for a burdensome data call-in.

In making final determinations, the state must compare hazard data on the chemical with estimates of exposure from the use(s) to identify concern. An exposure assessment would estimate various exposure scenarios (e.g., ingestion, inhalation, dermal) based on expected use(s) of the chemical to establish what action the margins of exposure warrant on the potential risks of the priority chemical in its product uses.

2. How should these be weighed or balanced?

This might best be done in several iterative rounds as the Canadian CEPA system had done. A first round would be to order, via available data chemicals/uses according to an initial binning from high to low. Following public comments, a second round, focusing on the highest group, priorities could be refined and more detailed data needs established for finalizing high priority chemicals/uses.

As discussed in I.B.1.4, in making final determinations, the state should follow a scientific weight-of-evidence approach based on the entirety of available data to include:

  • The intrinsic toxicity; AND
  • The margin of exposure - is the margin of exposure sufficient to protect even the most sensitive subpopulations (e.g., infants, occupational, etc.); AND
  • The relative uncertainty – based on the available dataset.
  • This same prioritization process must be applied to any potential alternative as well;

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.

3. 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.

For hazard information there are many sources: US HPV and OECD HPV databases; NTP Report on Carcinogens and NTP_CERHR data; IARC monographs; US EPA IRIS database; Health and Environment Canada categorization databases; EU Annex 1 and ESIS databases; variety of online and published chemical hazard databases; producer GHS information; Proposition 65 data; REACH data when it becomes available.

For volume information the best source is US production level information and partial California information via US EPA’s 2006 IUR. There are also commercial databases for many chemicals and producer marketing information and websites.

For Use and Exposure information: US EPA’s 2006 IUR (use categories and use in products intended for children; EPA’s air and water (NCOD) monitoring databases; EPA’s TRI databases; CDC’s Biomonitoring data; sector trade associations; Economic surveys; producer marketing information/websites. In addition there are a number of sources to assist with developing exposure information. Some examples: US EPA’s Exposure Factors Handbook, EPA’s recently released exposure factors handbook for children, the Soap and Detergent Association’s Exposure and Risk Screening Methods for Consumer Product Ingredients.

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

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

This should be risk-based prioritization using both hazard and exposure considerations. Focus should be indicators of high potential for hazard, e.g. CMR, PBT and on indicators of high potential for exposure, e.g. production level, found in drinking water, air, used in consumer products, especially those intended for children, emission/discharge data, biomonitoring indicates potential exposure. The process should also consider risk management in place as a result of type and design of product and packaging.

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

Where information important to an identified potential concern or priority decision is absent, California should have a process and capability to request it. In some cases, California could also choose to use tools such as EPA models to develop estimates, to more timely move the priority process along towards determinations.

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

These can all be relevant to assessment of environmental risk and sometimes for human risk and may be useful in certain situations. Both Federal and California sources can contribute information to this. If available and of adequate quality, they should be used.

  • b. Biomonitoring data?

Biomonitoring data are point-in-time measurements that can potentially indicate an aggregate exposure. Given that adequate and sufficient information exist to interpret biomonitoring data (to link the detection to an exposure) biomonitoring can be useful in prioritization and in risk assessment. Biomonitoring data can be considered for use in priority setting based on clearly understood strengths and limitations of the data for a particular chemical; i.e., on a case-by-case basis. Final priority determinations and resulting risk management actions should not be taken based on presence alone, but based on a chemical’s potential for bioaccumulation, persistence, toxicity and the likelihood of harm. If available and of adequate quality, biomonitoring data should be used.

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)

These can be relevant to assessment of environmental and human risk and may be useful in certain situations. If available and of adequate quality, they should be used.

  • 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. They may be useful only to the extent that the disease can be causally connected to exposure to/use of the particular chemical following accepted epidemiology scientific practice.

  • e. Other information?

AB 1879 contains significant provisions on Confidential Business Information. The Wiki outline does not cover the topic at all. This will be an important area to address in regulations.

Exposure information; method of exposure to compound or chemical; handling methodology, test methods used etc.

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

C. Available Information for Others

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

Available information from other nations, governments and authoritative bodies should be an important emphasis given limited resources. California needs some way to bring in other successful approaches, to evaluate and adapt them for the state’s situation. California should use the Green Ribbon Panel to review and comment on CalEPA insights from these sources.

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

To date, Canada has established the most efficient and effective process for doing this despite resource and information limitations. The clear focus of their legislation, single minded approach of the agencies, open and iterative process for involving stakeholders, prompt and timely capability of Canada’s data call-in process and high elected leadership support for the program have contributed to this success. There has been a very high focus to concentrate on “the important few” versus the trivial many and has led to a very workable approach producing highly evident results.

A process that emerged from a Canada/Mexico/US meeting in Montebello, the EPA Chemical Assessment and Management Program (ChAMP) program, holds a lot of promise, given strong support from agency leadership, EPA’s technical capability, more available US information and effective assessment tools. But this has been underway for just a short time, its priority in the new administration is not clear, it is voluntary and is hampered by EPA’s challenges in promptly getting adequate data for decisions.

In the 1990’s, Europe had a prioritization process but it operated very slowly with very few decisions and actions over a decade of effort. Frustration with that led directly to the development for and advocacy on REACH.

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.

3. 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. AB 1879 is focused on prioritizing, making decisions and taking control actions on priority chemicals to improve public health and the environment. There are no alternative science-based tools for accomplishing this purpose.

There are some approaches which only focus on the one-dimensional aspect of considering hazard in making decisions. These can be very short sighted in not also considering performance, cost, availability and long term sustainability. And, unless exposure is also considered, California resources will almost certainly be misdirected to chemicals that do not pose any risk.

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.

Actions by other states or countries may be useful to California’s consideration generally in understanding the objectives and criteria for decisions. For specific cases of chemicals and uses, California should consider bringing the relevant information from other jurisdictions into consideration, but follow the process that the state sets up so that the determinations are relevant to California.

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.

The product research and development paradigm is an excellent analog for the alternatives process. During R&D, improvement objectives are set, alternative approaches for achieving the improvement are identified, and alternatives are evaluated considering a number of factors—alternatives must:

  • Provide an improved profile for health and environmental issues;
  • Be technologically feasible and commercially available in sufficient quantity;
  • Deliver the same or better value in cost and performance;
  • Be accepted by the consumer
  • Account for economic and social considerations; and
  • Have potential to result in lasting change.

Alternatives analysis must be done from a broad lifecycle perspective to avoid the potential for unintended consequences that can occur from a narrow or hazard-only approach. The Green Chemistry Science Advisory Panel made many useful suggestions on the Alternatives question that should be considered in this process. One caution that must be noted: even under the most rigorous and detailed execution of lifecycle analysis, relatively large margins of error are typical due to assumptions and lack of precision in the input data. Additionally, different models may give different results. Thus, an analysis which suggests a 10% or even 20% improvement may in fact, not be meaningful,

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

Determinations by the state that a chemical and its use(s) are a risk to public health and/or the environment as an outcome of the priority chemical process.

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.

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. DTSC should facilitate but the process must include experts from the particular value chain—chemical producers and consumer product manufacturers and potentially trade associations with relevant expertise. This needs to be set up in a way to avoid anti-trust concerns and protect trade secrets.

US EPA’s Design for the Environment approach has been very constructive in providing a science-based approach to gaining insights on potential benefits and risks of competing alternatives for priority chemicals.

3. What must be included in this analysis?

Much of the public discussion and debate on alternatives focuses solely on reducing the hazard posed by a priority chemical. To be successful in achieving the goals of the Green Chemistry Initiative, the state must take a much broader approach. Of course, an acceptable alternative must provide an improved profile for health and/or the environment. However, it must also be technologically feasible and commercially available in sufficient quantity; deliver the same or better value in cost and performance; be accepted by the consumer; account for economic and social considerations; and, have the potential to result in lasting change.

Thus, information on product safety, performance, public health benefit, cost, commercial availability, quality, and feasibility, plus consumer acceptance and long term potential for use of the alternative must be analyzed in comparison with the priority chemical. The alternative must represent an improved profile for the hazard or risk concerns associated with the priority chemical while not introducing other concerns that could adversely shift the overall balance. An alternative must be workable, with means of adequate production to deliver an equal or better performing product at a competitive price and be accepted by consumers. Any alternatives that are seriously considered must have an expectation of being effective for a long period of time—industry should be able to make use of technologies for years, with later rounds of reformulation and capital investment beyond the immediate horizon.

Creating a consumer preferred formulation that performs well is complicated— simple “drop-in” alternatives are extremely unusual. Some factors to be considered are:

  • Overall product characteristic and performance requirements;
  • Physical properties of the alternative;
  • Formulation interaction with other ingredients and packaging;
  • Stability of the formula;
  • Shelf-life preservation;
  • Aroma;
  • Appearance;
  • Convenience and ease of product use and disposal.

Considerations for evaluating and improving product safety profile include:

  • Product applications and human exposure patterns;
  • Recommended packaging, user precautions and other risk management for use and disposal;
  • Environmental fate and exposure pathways; and
  • Whether it is used in combination with other chemicals that reduce its risk
  • Unintended consequences to human health, impact on the environment, and resource utilization, including whether substantially more product must be used to achieve the same performance of the original product negating any benefits.

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.

There are many models available which may or may not give different results. It is important that a consistent approach be used within each alternatives analysis.

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. DTSC must establish expectations for the alternatives process and carry them out through facilitation of each alternative effort.

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 when used as directed.

Performance of a chemical is product category and formulation specific. ASTM standards exist in some categories, and there may be guidance from trade and scientific organizations in certain product categories. This reinforces the need to have producers and users from affected value-chain engaged in the process.

There are several generic factors to be considered. Characteristics that a chemical may impart to the overall performance of a product may include its compatibility with other chemicals, its contribution to increased shelf-life and stability, its function to modulate absorption of key ingredients, and others. However, these determinations must be made on a case-by-case basis depending on the intended function of the chemical.

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. If the use of an ingredient in a product is safe, there should not be a need for a risk-benefit analysis. Consumers should continue to be allowed to decide whether a product or individual chemical in products is necessary. To be successful, the California program must operate in a way that it is not vulnerable to legal challenges based on restraint-of-trade or interstate commerce concerns.

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.

Alternatives must be evaluated to the same extent as the chemical it is being proposed to replace to avoid any regrettable substitutions. The hazards, exposure pathways, uses, and lifecycle impacts should all be factored into the evaluation. California must consciously evaluate “what could go wrong” with the alternative as part of the analysis to ensure identification of potential problems

9. What other considerations should inform the alternatives analysis?

At the end of the day, it will always be the consumer who finally determines the performance, value and acceptance of a product and its ingredients. Ideally, there should be a consumer acceptance evaluation phase to an alternatives process.

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.

These will most likely be a case-by-case judgments, not adaptable to a “formula”. Overall weight of evidence on priority chemicals/uses, their risks and a comparison with the available alternatives. The state’s final determination should be on whether to restrict or ban the use of a priority chemical. It should never mandate the use of a specific alternative(s), but leave those decisions to the users.

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.

These are excellent examples of lifecycle analysis factors. Lifecycle analyses have been done for some product categories but many have not been evaluated. Thus, availability of baseline lifecycle date and requirements can be vastly different per product category.

A simplifying approach in lifecycle analysis is to focus on what is changing and assess the impact of the change, vs assess the entire system. This can still be challenging and take significant effort, but can provide a practical approach for simplified analysis.

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

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

B. Process for Lifecycle Analysis

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

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

A LCA generally extends from the creation of raw materials to final disposal of the product or service residuals, and takes into account environmental emissions to air, water, and land. In 2000, the International Standards Organization (ISO) completed work on a series of standards that have become the general benchmark for the technique, which usually includes four stages:

  • Defining the goal, scope and boundaries of the assessment.
  • "Life Cycle inventory" (LCI) - a database of energy/materials use and emissions, relative to some "functional unit" (e.g., for a detergent, emissions per 1000 loads of laundry washed; for an automobile, emissions per 1000 person-kilometers traveled).
  • "Life Cycle impact assessment" (LCIA) - translation of inventory data into potential impacts on the environment.
  • "Interpretation" - sensitivity and uncertainty analyses.

In short, the analysis should be consistent with ISO 14044 series standards. Importantly, the simplified LCA’s should not be used as a basis of comparison or decision, but rather provide some of the information needed to arrive at a decision.

2. Who should perform the lifecycle analysis? The manufacturer in cooperation with the appropriate state agencies.

Undertaking the LCA should be the responsibility of the affected industry sector, facilitated and reviewed by CalEPA.

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? This option would seem to yield the most complete response but it would be costly and take a significant amount of time.
  • 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.
  • 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.

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

A simplified approach to Life Cycle Analysis (LCA) should be conducted. LCA is really designed for products, not individual chemicals. Thus, a targeted approach focusing exclusively on the chemical under review is necessary to maintain scope.

Life Cycle Assessment has several limitations:

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

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

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

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

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

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?

This is dependent on the product category being examined, thus must be considered on a case-by-case basis. 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.

Internal costs to should be considered first as these can be more easily identified. External costs should be included when reliable and validated data are available to provide reasonable 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?

LCA for a consumer product derived from chemicals will be exponentially more involved if a LCA is required to assign costs to each chemical’s life-cycle included in products.

Data will need to be shared up and down the supply chain depending on the scope of the LCA in question. To limit the amount of data that would need to be developed and to ensure that LCAs are comparable, DTSC might consider setting limits to the beginning and ending life-cycle data development requirements in each product category under consideration.

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

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.

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

Uncertainty cannot be used to negatively impact a LCA or Alternatives Assessment of a product or chemical. Data needs must be prioritized for the impact that they might have on understanding a chemical or product. There are always uncertainties in these analyses, which should be presented and explained. A useful way to present this can be with error bars to make the uncertainty more transparent.

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.

The specifics of reformulation response in the case of a restriction or ban should not be mandated, but must be left to manufacturers. Each company should determine appropriate formulation changes for its products.

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, unless an imminent risk is identified. 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.

  • 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.”
  • 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:?
  • 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. The risk assessment shows that a restriction that could be to “maintain product concentration below a certain level that would be safe for the product category”. It could also find that a product with a particular ingredient is not appropriate for use by children under a certain age, resulting in label warnings. Another example might be that a chemical would be restricted or banned from use in some product categories but allowed in others based on the assessment of hazard and exposure in those uses.
  • D – to require end of life management such as extended producer responsibility? Please define as this question is unclear.

Requiring extended producer responsibility for end of life management of products puts an undue burden on manufacturers, and is neither practical nor enforceable. Control of the ultimate disposal of a product is in the hands of the end-user. Additionally, end-of-life disposal options may vary according to municipal availability, such as for apartment complexes, which do not have multiple collection containers available. State and local consumer communications together with appropriate product labeling that suggest proper use, handling and disposal of a product are ways to support green habits for recycling, and composting, reusing or disposing spent products and their packaging.

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

When the risk assessment indicates a concern, but there are inadequate alternatives found in analysis.
We are not aware of any situation where funding of research and development could be mandated under current statutes.

  • F – to place technology-forcing regulations into place to phase out harmful ingredients and/or phase-in safer ingredients? This may be an action the state could consider for some of the scenarios in A – F and where an alternative is available meeting the criteria of the alternative analysis. However, the specifics of reformulation in response to a restriction or ban should not be mandated, but must be left to manufacturers. Each company should determine appropriate formulation changes for its products.
  • 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).

As a first step, California should work with industry and other stakeholders on voluntary programs and consumer education. This can often prevent many issues and unexpected outcomes. All potential outcomes identified in AB1879, taken after a deliberate and scientifically sound process with appropriate opportunity for notice-and-comment by stakeholders.

  • Not requiring any action.
  • Imposing requirements to provide additional information needed to assess a priority chemical and its potential alternatives.
  • Imposing requirements on the labeling or other type of information.
  • Imposing a restriction on the use of the chemical.
  • Prohibiting the use of the chemical in specific uses.
  • Imposing requirements that control access to or limit exposure to the chemical.
  • Imposing requirements to manage the chemical at the end of its useful life, including recycling or responsible disposal.
  • Imposing a requirement to fund green chemistry challenge grants where no feasible alternative exists.
  • Any other outcome the agency may determine.

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.

Many manufacturers currently disclose ingredients in their products and many more are moving to do so. This should eliminate the vast majority of issues. In the case of a priority chemical being intentionally formulated into a product in which the use is regulated or restricted, non-disclosure could represent mis-branding.

There are many current examples of restrictions, prohibitions, and expectations for product manufacturers. The majority of businesses obey the law in complying with those requirements, and will continue to do so with future requirements including those from the Green Chemistry Initiative. There are federal precautionary labeling requirements and any additional needs to provide that kind of information to consumers would be covered by those laws.

  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?

Formulation testing is an unnecessary, costly and inefficient burden. Testing at the product level must not be required; this is expensive, requires development of standards that don't exist (which will take years), and is only a snapshot in time. Manufacturing industries got out of the "inspect quality in" mindset in the 1980s; the right way to guarantee quality (defined as "conformance to specification" - in this case, "safe") is to design it in to the product development and manufacturing processes. Requiring manufacturers to be able, when and if asked, to show the trail of data as well the business processes they used to design and manufacture the product, as well as select suppliers and materials is sufficient to meet auditing and compliance requirements.

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?

New reporting requirements should not be required. Ongoing ingredient disclosure should handle this need.

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

It would be best to keep the supply chain out of regulatory reporting. As with all other regulatory compliance needs, downstream users can and usually do put raw material specifications in place to their upstream suppliers. Those specs are confidential business information and not for public distribution. Arrangements between manufacturers and retailers should be similarly confidential business information.

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

California should avoid burdensome and costly bureaucratic processes. Ingredient disclosure should minimize any concerns.

  1. Should other party standards-setting and validation be used?

For instance, if manufacturers and producers were to conduct the lifecycle analysis and alternatives assessment, do standards exist to guide them? If so, what are these? If not, what would be required to be developed? By whom? How?

ISO Standards are available for LCA. California could hire a contractor to help the state outline general approaches to be followed for CA application. The contractor’s proposal on how to apply LCA in the CA situation could be reviewed by the Green Ribbon Panel.

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

The State could create additional market-based incentives for compliance.

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? Where does Cal-OSHA fall into this? Occupational piece not discussed at all.
  • Some things in the law are not optional
  • Requirement on number of studies?
  • Hazard criteria. Is it not more appropriate to discuss risk potential? Just because something exists does not mean it is a problem.

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)
  • End use important too. Lack of alternatives should be considered.

// in section 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? What do you do with information that evolves and/changes?
  • Use list as guide and inform what will be a chemical of concern. How come we are not leveraging existing lists?

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. Should include potential end use, conditions of use, users, etc. Risk requires identification of other factors.
  • 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 (knowledgeable enough? Adequately staffed? Experienced enough?) 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?

// in section 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, email, 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? Critical that DTSC be adequately staffed by knowledgable, experienced staff who appreciate the decisionmaking from aspects other than straight science. The DTSC process and activity needs to be calibrated periodically by external body to ensure it remains effective and value added. Accountability should come in at all levels—manufacturing, government, users.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

B. Factors for Prioritization

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

1. How should the state consider these factors?

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. . State should use existing alternative life cycles already in use and not start from scratch in devising its own. What about federal EPA's alternatives life cycle model as a starting point? Other models exist as well.

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, the conditions of use, 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?

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

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

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

C. Available Information for Others

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

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

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

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

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

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

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

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

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

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

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

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

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

A. Process for Alternatives Assessment

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

What triggers the requirement to do an alternatives analysis?

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

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

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

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

This question is vague and needs to be explained.

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

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

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

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

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

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

9. What other considerations should inform the alternatives analysis?

None that we are aware of at this time.

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

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

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

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

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

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?
    • 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.
    • 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.
    • 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.

  • 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.”
  • 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:?
  • 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
  • D – to require end of life management such as extended producer responsibility? Please define as this question is unclear.
  • 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.
  • F – to place technology-forcing regulations into place to phase out harmful ingredients and/or phase-in safer ingredients?
  • 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.)

DTSC should be engaged in managing this process for the appropriate outcomes (greener products) and helping develop the tools for use by manufacturers and others. DTSC is simply a cluster of folks who have certain skill sets; their greatest contribution resides in defining the process and setting up the quality systems to ensure it goes as planned.

Workshop comments, Berkeley 2/19/09

It might be helpful if DTSC held a one day workshop which included industry and their safer alternative methodologies. Leverage learnings, not re-create them!

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. Thus far, the public input has been limited. Approximately 100 responses on wiki is not considered robust. An outreach process needs to be developed that encourages more input from an educated public.
  • Work to identify alternatives (using existing alts assessment tools, like the Clean Production Action Green Screen for Safer Chemicals and the CleanGredients database, US EPA DfE Formulator Program and the US EPA DfE Alternatives Assessment process used for the Flame Retardancy Partnerships, 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

  1. Review and comparison of data
  2. 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 http://www.ami.ac.uk/courses/topics/0109_lct/ or http://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.

Many manufacturers currently disclose ingredients in their products and many more are moving to do so. This should eliminate the vast majority of issues. In the case of a priority chemical being intentionally formulated into a product in which the use is regulated or restricted, non-disclosure could represent mis-branding.

There are many current examples of restrictions, prohibitions, and expectations for product manufacturers. The majority of businesses obey the law in complying with those requirements, and will continue to do so with future requirements including those from the Green Chemistry Initiative. There are federal precautionary labeling requirements and any additional needs to provide that kind of information to consumers would be covered by those laws.

  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?

Formulation testing is an unnecessary, costly and inefficient burden. Testing at the product level must not be required; this is expensive, requires development of standards that don't exist (which will take years), and is only a snapshot in time. Manufacturing industries got out of the "inspect quality in" mindset in the 1980s; the right way to guarantee quality (defined as "conformance to specification" - in this case, "safe") is to design it in to the product development and manufacturing processes. Requiring manufacturers to be able, when and if asked, to show the trail of data as well the business processes they used to design and manufacture the product, as well as select suppliers and materials is sufficient to meet auditing and compliance requirements.

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?

New reporting requirements should not be required. Ongoing ingredient disclosure should handle this need.

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

It would be best to keep the supply chain out of regulatory reporting. As with all other regulatory compliance needs, downstream users can and usually do put raw material specifications in place to their upstream suppliers. Those specs are confidential business information and not for public distribution. Arrangements between manufacturers and retailers should be similarly confidential business information.

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

California should avoid burdensome and costly bureaucratic processes. Ingredient disclosure should minimize any concerns.

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

ISO Standards are available for LCA. California could hire a contractor to help the state outline general approaches to be followed for CA application. The contractor’s proposal on how to apply LCA in the CA situation could be reviewed by the Green Ribbon Panel.

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

The State could create additional market-based incentives for compliance. In terms of compliance, the state should be responsible for setting up the process (criteria, model requirements), leaving the actual risk determinations up to manufacturer. The state should monitor the process to make sure it is functioning as planned. In other words, state is trying to assess whether manufacturers are reporting against a set of criteria, do they in fact perform alternative analyses when the risk is unacceptable, do they mitigate the exposure and risk? State should only be involved in actual determinations of risk on a random sample basis. All submittals by manufacturer to Cal-EPA should be submitted by highest operational manager.


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