Effective Date of Rule: Thirty-one days after filing.
Purpose: This rule is a new rule, chapter 173-333 WAC, Persistent bioaccumulative toxins, that establish ecology's process and procedures to address the subject of persistent bioaccumulative toxic substances. The 2004 legislature, and Governor Locke, in Executive Order 04-01, with continued support from Governor Gregoire, directed the department of ecology to establish, through rule, specific criteria for use in identifying persistent, toxic chemicals (PBTs) that pose human health or environmental impacts in Washington state, and a clear process for developing chemical action plans to address those impacts.
Statutory Authority for Adoption: Chapter 276, Laws of 2004 PV and chapter 70.105 RCW, Hazardous waste management.
Adopted under notice filed as WSR 05-23-008 on November 3, 2005.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 16, Amended 0, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 16, Amended 0, Repealed 0.
Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 16, Amended 0, Repealed 0.
Date Adopted: January 12, 2006.
Jay J. Manning
PERSISTENT BIOACCUMULATIVE TOXINS
WAC 173-333-100 Introduction. Persistent, bioaccumulative toxins (PBTs) are chemicals that pose a unique threat to human health and the environment in Washington state. They remain in the environment for long periods of time, are hazardous to the health of humans and wildlife, can build up in the food chain, and can be transported long distances and readily move between air, land and water media.
Because of the unique threat that these PBTs pose, special attention is necessary to identify actions that will reduce and eliminate threats to human health and the environment. While ecology addresses PBTs through existing regulatory and nonregulatory programs, there remains a need for multimedia, cross-program measures that will reduce and phase-out releases and uses of PBTs over time.
The goal of this chapter is to reduce and phase-out PBT uses, releases and exposures in Washington. Ecology recognizes that many factors will influence whether and when this goal can be attained and that those factors will often vary depending on the PBT and the uses of the PBT. These factors include environmental and human health benefits, economic and social costs, technical feasibility, availability of safer substitutes, and consistency with other regulatory requirements. This chapter establishes a process that ecology will use to evaluate and identify actions that should be taken for particular PBTs. This process is designed to enhance actions being taken under other environmental laws and regulations.
(1) Establish criteria ecology will use to identify persistent bioaccumulative toxins that pose human health or environmental threats in Washington state;
(2) Establish a list of persistent bioaccumulative toxins;
(3) Establish procedures ecology will use to review and periodically update the list;
(4) Establish criteria for selecting persistent bioaccumulative toxins and metals of concern for which ecology will prepare chemical action plans;
(5) Define the scope and content of chemical action plans and establish the process ecology will use to prepare those plans; and
(6) Define the processes ecology will use to coordinate the implementation of this chapter with the department of health and other agencies.
(2) This chapter provides for public involvement opportunities to allow interested persons to participate in the ecology processes for identifying PBTs and developing recommendations on measures to address uses and releases of PBTs.
(2) Public involvement. Ecology will provide opportunities for public involvement during the decision-making processes for identifying PBTs and preparing a CAP.
(3) Clear documentation. Ecology will provide clear and understandable descriptions and rationale for decisions implementing this chapter.
(4) Predictability. Ecology will implement this chapter in ways that allow stakeholders, interest groups, and the public to plan their participation in decision-making processes and future responses to recommendations that result from those processes.
(5) Coordination. Ecology will coordinate with federal and state agencies, local governments, tribes, and other interested parties in the development and implementation of CAPs and when revising the PBT list.
(6) Rule amendments. When amending any portion of this rule, Ecology will follow the requirements of the Administrative Procedure Act (APA), chapter 34.05 RCW.
WAC 173-333-200 Definitions. For the purposes of this chapter, the following definitions shall apply:
"Administrative Procedure Act" or "APA" means the Washington Administrative Procedure Act, chapter 34.05 RCW.
"Bioaccumulation" means the process by which substances increase in concentration in living organisms as they take in contaminated air, water, soil, sediment or food because the substances are very slowly metabolized or excreted.
"Bioaccumulation factor" or "BAF" means the ratio of the concentration of a chemical in an organism to the concentration of the chemical in the surrounding environment. The BAF is a measure of the extent to which the organism accumulates the chemical as a result of uptake through ingestion as well as contact from contaminated media, such as water.
"Bioconcentration factor" or "BCF" means the ratio of the concentration of a chemical in an aquatic organism to the concentration of the chemical in water. The BCF is a measure of the extent of chemical partitioning between an aquatic organism and water.
"Carcinogen" means a chemical or chemical group that has been identified as "carcinogenic to humans" or "likely to be carcinogenic to humans" by the Environmental Protection Agency, as a Group 1, 2A or 2B carcinogen by the International Agency for Research on Cancer or as a "known to be a human carcinogen" or "reasonably anticipated to be a human carcinogen" by the National Toxicology Program.
"Chemical" means a naturally occurring element, mixture, or group of organic and inorganic compounds that is produced by or used in a chemical process.
"Chemical action plan" or "CAP" means a plan that identifies, characterizes and evaluates uses and releases of a specific PBT, a group of PBTs or metals of concern and recommends actions to protect human health or the environment.
"Chemical group" means a grouping of chemicals which share a common chemical structure and common toxicological properties.
"Credible scientific information" means information that is based on a theory or technique that is generally accepted in the relevant scientific community or has been collected or derived using standard or generally accepted methods and protocols and appropriate quality assurance and control procedures.
"Cross-media transfer of chemicals" means the movement of a chemical from one medium, such as air, water, soil, or sediment, to another.
"Degradation" means the processes by which organic chemicals are transformed into derivative chemicals and ultimately broken down.
"Developmental or reproductive toxicant" means a chemical or chemical group identified as posing developmental or reproductive hazards by the National Toxicology Program or chemicals or chemical groups with sufficient evidence of a developmental or reproductive hazard in humans or experimental animals consistent with the United States Environmental Protection Agency's Guidelines for Reproductive Toxicity Risk Assessment and Guidelines for Developmental Toxicity Risk Assessment as set forth in 61 FR 56274 et seq. and 56 FR 63798 et seq., respectively.
"Ecology" means the department of ecology.
"Environment" means any plant, animal, natural resource, surface water (including underlying sediments), ground water, drinking water supply, land surface (including tidelands and shorelands) or subsurface strata, or ambient air.
"Environmental half-life" means the time required for the concentration of a chemical to diminish to half its original value. The environmental half-life of a chemical is a measure of a chemical's persistence in the environment.
"Feasible" means reasonably capable of being accomplished or brought about or capable of being utilized or dealt with successfully.
"High-exposure populations" means groups of people that have a higher potential for exposure than the general population.
"Log-octanol water partition coefficient" or "Log Kow" means the ratio of a chemical's concentration in the octanol phase to its concentration in the aqueous phase of a two-phase octanol/water system as expressed in a logarithmic format.
"Media" or "medium" means a component of the environment (air, water, soil or sediment) in which a contaminant is measured and an organism lives its life, and from which an organism can accumulate contaminants.
"Neurotoxicant" means a chemical or chemical group with sufficient evidence of a neurotoxic hazard in humans or experimental animals consistent with the United States Environmental Protection Agency's Guidelines for Neurotoxicity Risk Assessment as set forth in 63 FR 26926 et seq.
"No observed effect concentration" or "NOEC" means the highest concentration of a chemical evaluated in an aquatic toxicity test that does not cause a statistically and biologically significant difference in effects compared with controls.
"Persistent bioaccumulative toxin" or "PBT" means a chemical or chemical group that meets or exceeds the criteria for persistence, bioaccumulation and toxicity criteria established in WAC 173-33-320.
"Persistence" means the tendency of a chemical to remain in the environment without transformation or breakdown into another chemical form. It refers to the length of time a chemical is expected to reside in the environment and be available for exposure.
"Reference dose" means a numerical estimate of a daily exposure to the human population, including sensitive subgroups such as children, that is likely to be without harmful effects during a lifetime.
"Sensitive population group" means groups of people that exhibit a different or enhanced response to a chemical than most people exposed to a similar level of the chemical because of genetic makeup, age, nutritional status or exposure to other toxic substances.
"Toxicity" means the degree to which a substance or mixture of substances can harm humans, plants or wildlife.
THE PBT LIST AND CRITERIA AND PROCEDURES FOR REVISING THE LIST
WAC 173-333-300 What is the purpose of the PBT list? (1) Purpose. The purpose of the PBT list is to identify toxic chemicals that require further action because they remain ("persist") in the environment for long periods of time where they can bioaccumulate to levels that pose threats to human health and environment in Washington.
(2) Intended uses of the PBT list. Ecology will use the PBT list in the following ways:
(a) Chemical action plans. To select chemicals for chemical action plan development.
(b) Ambient monitoring. To help guide decisions on the design and implementation of ecology programs for characterizing chemical concentrations in the ambient environment.
(c) Biomonitoring. To encourage and inform the department of health regarding their efforts to monitor chemicals in human tissue.
(d) Public awareness. To promote greater public awareness on the problems associated with PBT chemicals, the uses and sources of individual PBTs and steps that individuals and organizations can take to reduce PBT uses, releases and exposure.
(e) Voluntary measures. To help identify opportunities for government agencies, businesses and individuals to implement voluntary measures for reducing and phasing out PBT uses and releases.
(3) Relationship to actions addressing chemical uses and releases. Ecology has determined that the chemicals on the PBT list pose a potential threat to human health and the environment in Washington.
(a) Ecology's decision to include a particular chemical on the PBT list does not represent a final determination that all uses and releases of that chemical should be reduced and phased-out. Any recommendations on uses and releases of a particular chemical will be made in the CAP process.
(b) Ecology will not use the PBT list as the sole basis for establishing discharge monitoring requirements that are not required under current permits. Ecology will evaluate and, if necessary, prepare recommendations for additional monitoring requirements when preparing chemical action plans (WAC 173-333-420 and 173-333-430).
(2) PBT list. Ecology has determined that the following chemicals or chemical groups meet the criteria specified in WAC 173-333-320.
|Chemicals listed in alphabetical order||CAS Number|
|Short-chain chlorinated paraffins||85535-84-8|
|Chemical groups listed in alphabetical order|
|Perfluorooctane sulfonates (PFOS)|
|Polycyclic aromatic hydrocarbons (PAHs)|
|Polybrominated dibenzodioxins and furans|
|Polybrominated diphenyl ethers|
|Polychlorinated biphenyls (PCBs)|
(2) Metals of concern. Ecology has identified the following metals of concern based on a determination that these metals pose threats to human health and the environment in Washington.
|Metals of Concern||CAS Number|
(4) Revising the metals of concern list. Ecology will evaluate the relationship between the metals of concern list and PBT list in WAC 173-333-310 following the completion of the EPA's inorganic metals assessment framework process.
(2) Criteria for identifying PBTs. A chemical or group of chemicals will be included on the PBT list if ecology determines it meets each of the following criteria:
(a) Persistence. The chemical or chemical group can persist in the environment based on credible scientific information that:
(i) The half-life of the chemical in water is greater than or equal to sixty days; or
(ii) The half-life of the chemical in soil is greater than or equal to sixty days; or
(iii) The half-life of the chemical in sediments is greater than or equal to sixty days; and
(b) Bioaccumulation. The chemical or chemical group has a high potential to bioaccumulate based on credible scientific information that the bioconcentration factor or bioaccumulation factor in aquatic species for the chemical is greater than 1,000 or, in the absence of such data, that the log-octanol water partition coefficient (log Kow) is greater than five; and
(c) Toxicity. The chemical or chemical group has the potential to be toxic to humans or plants and wildlife based on credible scientific information that:
(i) The chemical (or chemical group) is a carcinogen, a developmental or reproductive toxicant or a neurotoxicant;
(ii) The chemical (or chemical group) has a reference dose or equivalent toxicity measure that is less than 0.003 mg/kg/day; or
(iii) The chemical (or chemical group) has a chronic no observed effect concentration (NOEC) or equivalent toxicity measure that is less than 0.1 mg/L or an acute no observed effect concentration (NOEC) or equivalent toxicity measure that is less than 1.0 mg/L.
(d) Additional criteria applicable to metals. The chemical or chemical group is a metal and ecology determines that it is likely to be present in forms that are bioavailable.
(3) Degradation products. Ecology will consider both the parent chemical and its degradation products when making decisions on whether a chemical meets the criteria in subsection (2) of this section. If a parent chemical does not meet the criteria in this section but degrades into chemicals that do meet the criteria in subsection (2) of this section, the parent chemical may be considered for inclusion on the PBT list and in the development of a CAP. Alternately, ecology may decide not to include the parent chemical on the PBT list, but consider it during the development of a CAP for derivative chemicals.
(2) Criteria for removing a chemical from the PBT list. Ecology will remove a chemical or chemical group from the PBT list if the department determines that credible scientific information developed subsequent to the listing decision provides evidence that the chemical or chemical group does not meet the PBT criteria in WAC 173-333-320(2).
(2) Reviewing and updating the PBT list. Ecology will periodically review and update WAC 173-333-310. The frequency of review will be determined by credible scientific information available on individual chemicals or chemical groups, rule-making petitions submitted to ecology, and available agency resources. Ecology will comply with the requirements for reviewing and responding to rule-making petitions in the Administrative Procedure Act, chapter 34.05 RCW.
(3) Public notification. If ecology makes a preliminary determination that a chemical should be added or removed from the PBT list, the department will prepare a technical discussion paper that summarizes the scientific information supporting the addition or removal of a chemical and notify the public through an announcement posted on the ecology web site and published in the Washington State Register.
(4) Amending the PBT list. If ecology makes a final determination that a chemical or chemical group should be added or removed from the PBT list, the department will initiate actions to amend WAC 173-333-310 through formal rule making.
CHEMICAL ACTION PLANS (CAPs)
WAC 173-333-400 What is a chemical action plan (CAP)? (1) A chemical action plan (CAP) is a plan that identifies, characterizes and evaluates uses and releases of a specific PBT, a group of PBTs or metals of concern and recommends actions to protect human health or the environment.
(2) For the purposes of this section, the term PBT refers to both the chemicals on the PBT list (WAC 173-333-310) and the chemicals on the metals of concern list (WAC 173-333-315).
(2) Evaluation factors.
(a) Ecology will consider the following factors when preparing the multiyear schedule:
(i) Relative ranking. The relative ranking assigned to each PBT based on ecology's evaluation of information on PBT characteristics, uses of the chemical in Washington, releases of the chemical in Washington, the levels of the chemical present in the Washington environment, and levels of the chemical present in Washington residents.
(ii) Opportunities for reductions. Whether there are opportunities for reducing or phasing out uses, production or releases of the PBT in Washington. In reviewing available information, the agencies shall consider whether more than one PBT is present in particular products, generated in particular processes or released from particular sources (co-occurring chemicals).
(iii) Multiple chemical releases and exposures. Scientific evidence on the combined effects of exposure to one or more PBTs and other substances commonly present in the Washington environment.
(iv) Sensitive population groups and high-exposure populations. Scientific evidence on the susceptibility of various population groups including the timing of the exposure and the cumulative effects of multiple exposures.
(v) Existing plans or regulatory requirements. Whether there are existing plans or regulatory requirements that reduce and phase out uses and releases of a particular PBT or group of PBTs.
(b) Ecology will not prepare CAPs if the department determines:
(i) All uses and releases of the PBT are prohibited under other state and federal laws or regulations;
(ii) There is credible scientific information to support a conclusion that the PBT is not used, released or present in Washington; or
(iii) There are no available opportunities for reducing or phasing out the uses, releases or exposures of the PBT beyond levels required under other federal or state laws or regulations.
(3) Preliminary schedule. Ecology will prepare a preliminary schedule that will identify the PBTs for which CAPs will be developed for the multiyear schedule, the rationale for selecting these PBTs and a timeline for completing CAPs for these PBTs.
(4) Public notice and comment. Ecology will notify the public when it has prepared a preliminary schedule and provide an opportunity for public review and comment. Ecology will notify the public through an announcement published in the Washington State Register and posted on the ecology web site. Ecology will also send a written announcement to interested persons and organizations. Ecology will provide sixty days, from the date the notice is published in the Washington State Register for the public to review and submit comments on the preliminary selection.
(5) Final schedule. Ecology will review all public comments on the preliminary schedule prior to preparing a final schedule. Ecology will notify the public of the final decision through an announcement published in the Washington State Register and posted on the ecology web site. Ecology will also provide written notification to individuals or organizations who submitted comments on the preliminary schedule.
(6) Schedule updates. Ecology will review and, as appropriate, update the schedule for chemical action plans at least once every three years. In making such revisions, ecology will follow the process for preparing the schedule (including an opportunity for public review and comment) specified in this section.
(a) General chemical information. General information includes, but is not limited to, chemical name, properties, uses and manufacturers.
(b) Production, uses and releases. An analysis of information on the production, unintentional production, uses and disposal of the chemical. This will include estimates on the amount of each PBT used and released from all sources or activities in Washington and other man-made and naturally occurring sources that may contribute to exposures in Washington. Sources may include other chemicals or products that are known or suspected to degrade to the chemical included on the PBT list.
(c) Human health and environmental impacts. Information on the potential impacts on human health and the environment associated with the use and release of the PBT chemical. This will include consideration of available information on the levels of the PBT present in Washington's environment, potential for exposure, the likely fate and transport mechanisms, available body-burden data, toxicity effects, and the rates of diseases that have been associated with exposure to the particular PBT.
(d) Current management approaches. An evaluation of the regulatory and nonregulatory approaches that influence production, uses, releases and management of each PBT.
(e) Identification of policy options. A list of options for managing, reducing and phasing out the different uses and releases of the PBTs addressed in the CAP. The range of options for particular uses and releases will include:
(i) A no-action option;
(ii) An option that results in the phase out of PBT uses and releases;
(iii) An option to manage chemicals to reduce exposure; and
(iv) Other options, including the use of available substitutes, which will enable full consideration of the opportunities and constraints for reducing particular uses, releases and exposures.
(f) Recommendations. Recommendations for:
(i) Reducing and phasing-out uses and releases of the specific PBT or group of PBTs addressed in the CAP;
(ii) Managing products or wastes that contain the specific PBT or group of PBTs addressed in the CAP;
(iii) Minimizing exposure to the specific PBT or group of PBTs;
(iv) Switching to safer substitutes; and
(v) Encouraging the development of safer alternatives.
The recommendations will be based on an evaluation of the following factors:
(A) Environmental and human health benefits associated with implementing the action;
(B) Economic and social impacts associated with implementing the action;
(C) Feasibility of implementing the action;
(D) Availability and effectiveness of safer substitutes for uses of the PBT being addressed in the plan; and
(E) Consistency with existing federal and state regulatory requirements.
(g) Implementation steps. A description of the steps ecology will take to implement the CAP, including a description of:
(i) The existing resources and necessary additional budget ecology intends to use;
(ii) Potential funding sources for CAP implementation, including those that tie implementation costs to PBT sources and products;
(iii) How ecology intends to inform and educate affected persons about the CAP;
(iv) How ecology will promote, assist, and evaluate the effectiveness of voluntary actions;
(v) How ecology will collect additional information needed to evaluate the feasibility of potential actions; and
(vi) Any recommended regulatory actions and how ecology will pursue them.
(h) Performance measures. A description of interim milestones to assess progress and the use of objectively measurable outcomes, including recommendations for environmental and human health monitoring to measure levels of the chemical(s) (in the CAP) over time and whether the goals and purposes of the CAP are being achieved.
(i) Other. Other information that ecology determines is necessary to support the decision-making process.
(2) Regulatory consistency. When evaluating the consistency with existing federal and state regulatory requirements under subsection (1)(f)(iii)(E) of this section, ecology will:
(a) Ensure that the recommendations do not violate existing federal or state laws;
(b) Determine if the recommendations would impose more stringent performance requirements on private entities than on public entities, unless already required to do so by federal or state law, and if so, describe the justification for doing so; and
(c) Determine if the recommendations differ from federal regulations and statutes, and if so, explain why the difference is necessary and how ecology will coordinate with other federal, state, and local laws applicable to the same activity or subject matter.
(3) Economic analyses. In assessing economic impacts under subsection (1)(f)(iii)(B) of this section, ecology will identify costs of implementing the recommendations. This may include a qualitative and/or quantitative analysis of the probable benefits and costs of the CAP.
(2) Workplan/scoping. Once a chemical is selected for CAP development, ecology will initially plan and scope the CAP of the selected chemical based upon available information regarding the chemical's products, uses and releases; human health exposure and ecological hazards; environmental releases, fate, and transport; environmental concentrations and available substitutes; available options for managing uses and releases; estimated costs, benefits and effectiveness of alternate management options; and any other information ecology determines is necessary to support the CAP development process. Ecology will consult with the department of health regarding all portions of the CAP related to human health exposures.
(3) Advisory committee. Ecology will create an external advisory committee for each CAP that ecology develops. The purpose of the advisory committee is to provide stakeholder input and expertise.
(a) The advisory committee membership will include, but not be limited to, representatives from: Large and small business sectors, community, environmental and public health advocacy groups, local governments, and public health agencies. When appropriate, representatives from the following groups will also be invited to participate: Agricultural groups, worker safety advocacy groups, and other interested parties. Federally recognized tribal governments will also be encouraged to participate. In addition, representation from other state executive agencies may be requested to provide input and to represent agency interests in the CAP development process. Outside experts (if needed) may be requested to provide technical expertise.
(b) A neutral third-party facilitator may be hired to facilitate advisory committee meetings.
(c) The advisory committee will follow a consultative process, where ecology will draft the CAP in consideration of input from advisory committee members.
(d) All advisory committee meetings will be open to the public. Ecology will notify the public of advisory committee meetings through an announcement posted on the ecology web site and written notification to interested individuals and organizations.
(4) Information collection phase. Ecology will collect all necessary and up-to-date information regarding the selected chemical. CAP advisory committee members will be asked to contribute, and as appropriate, review information from ecology during this phase of CAP development. The department of health will be asked to review any information related to human health.
(5) Draft recommendations. Ecology will develop a draft CAP for advisory committee review and comment. Ecology will review all advisory committee comments and, as appropriate, revise the draft CAP prior to distributing it for public review and comment.
(6) Public review and comment. Ecology will notify the public when it has developed a draft CAP and provide an opportunity for public review and comment. The public comment period for each draft CAP will be a minimum of sixty days. Ecology will notify the public through an announcement posted concurrently on the ecology web site, a notice in the Washington State Register, and sent to interested persons and organizations. The comment period shall start from the date the notice is published in the Washington State Register. During the comment period, ecology will hold a minimum of two public meetings on the draft CAP. One meeting shall be held on the western side of the state, and one meeting shall be held on the eastern side of the state. Ecology may hold additional public meetings during the public comment period if determined necessary. Ecology will provide a response to all public comments.
(7) Final recommendations. Ecology will review and provide responses to all public comments on the draft CAP prior to issuing the final recommendations. Ecology will notify the public of the final recommendations through an announcement that will be published in the Washington State Register and posted on the ecology web site. Ecology will also provide written notification to individuals or organizations who submitted comments on the draft CAP.
(8) Coordination with other agencies. Ecology will coordinate with other government agencies and interested parties as appropriate on the implementation of the final CAP. Ecology will consult with the department of health on public information materials addressing food safety issues.