WSR 17-07-131 PROPOSED RULES DEPARTMENT OF ECOLOGY [Order 16-08—Filed March 22, 2017, 11:20 a.m.]
Original Notice.
Preproposal statement of inquiry was filed as WSR 16-17-039.
Title of Rule and Other Identifying Information: Children's safe products—Reporting rule (CSPA reporting rule), chapter 173-334 WAC as authorized by the Children's Safe Products Act (CSPA) (chapter 70.240 RCW). This rule requires manufacturers to annually report the presence of chemicals of high concern to children (CHCC) in children's products to ecology. The CSPA reporting rule identifies the CHCCs and details the process for manufacturers to report to ecology.
Hearing Location(s): Ecology Headquarters Building, Room ROA-36, 300 Desmond Drive S.E., Lacey, WA 98503, combined with a webinar on April 25, 2017, at 10:00 a.m. PST. Presentation, question and answer session followed by the formal public hearing.
Webinar: Ecology is also offering this hearing via webinar. Webinars are an online meeting forum that you can attend from any computer using internet access.
Comments: Ecology will accept comments at the Lacey location and through the webinar.
To join the webinar click on the following link for more information and instructions: Webinar registration.
Date of Intended Adoption: September 1, 2017.
Submit Written Comments to: Kara Steward, P.O. Box 47600, Olympia WA 98504-7600, email kara.steward@ecy.wa.gov, fax (360) 407-6715, by May 12, 2017.
Assistance for Persons with Disabilities: Contact Ecology's ADA coordinator, Hanna Waterstrat, hanna.waterstrat@ecy.wa.gov, voice (360) 407-7668, relay service 711, TTY 877-833-6341.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The 2016 Washington state legislature's amendment of chapter 70.240 RCW identified six flame retardants to be considered for inclusion on the CHCC's list in the CSP [CSPA]-reporting rule (chapter 173-334 WAC). Ecology and the Washington department of health used the CHCC criteria to evaluate these six flame retardants and other chemicals. The rule amendment proposes to add the six flame retardants, add fifteen other chemicals and delist three chemicals from the CHCC list in the rule (WAC 173-334-130). Ecology also proposes changes to streamline the rule.
Reasons Supporting Proposal: See Purpose of the Proposal above for this information.
Statute Being Implemented: Chapter 70.240 RCW.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Department of ecology, governmental.
Name of Agency Personnel Responsible for Drafting: Kara Steward, Ecology Headquarters, (360) 407-6250; Implementation and Enforcement: Tina Schaefer, Ecology Headquarters, (360) 407-6786.
A small business economic impact statement has been prepared under chapter 19.85 RCW.
Small Business Economic Impact Statement
This small business economic impact statement (SBEIS) presents the:
A small business is defined by the Regulatory Fairness Act (RFA) (chapter 19.85 RCW) as having fifty or fewer employees. Estimated costs are determined as compared to the existing regulatory environment - the regulations in the absence of the rule. The SBEIS only considers costs to "businesses in an industry" in Washington state. This means that impacts, for this document, are not evaluated for nonprofit or government agencies.
The existing regulatory environment is called the "baseline" in this document. It includes only existing laws and rules at federal and state levels.
This information is excerpted from ecology's complete set of regulatory analyses of the proposed rule. For complete discussion of the likely costs, benefits, minimum compliance burden, and relative burden on small businesses, see the regulatory analyses (Ecology publication no. 17-04-019., March 2017).
COMPLIANCE REQUIREMENTS OF THE PROPOSED RULE, INCLUDING PROFESSIONAL SERVICES:
Baseline: The baseline for our analyses generally consists of existing rules and laws, and their requirements. This is what allows us to make a consistent comparison between the state of the world with and without the proposed rule amendments.
For this proposed rule making, the baseline includes:
Proposed rule amendments: The proposed rule amendments that differ from the baseline and are not specifically dictated in the authorizing statute or elsewhere in law or rule include:
Adding nineteen chemicals to the CHCC list:
Baseline: The existing CHCC list in chapter 173-334 WAC does not include the proposed additions.
Proposed: The proposed rule amendments add the following chemicals (with associated CAS numbers) to the CHCC list.
Chemicals added as CHCCs under the proposed rule amendments
Expected impact: Manufacturers of children's products containing the added chemicals would need to report information about these chemicals in their products.
This will likely result in additional costs of identifying the concentration of these chemicals in their products (using new testing, knowledge of product manufacturing processes, or testing for compliance with other regulations) and reporting this additional information.
This will likely also result in informational benefits for these nineteen chemicals, including increasing consumer awareness and government decision making, reducing potential health impacts and litigation, and improving industry understanding of the presence of CHCCs across the supply chain.
Adding two chemicals present as mixtures:
Baseline: The existing CHCC list in chapter 173-334 WAC does not include the proposed additions.
Proposed: The proposed rule amendments add the following mixture chemicals (with associated CAS numbers) to the CHCC list.
Chemicals present in mixtures added as CHCCs under the proposed rule amendments
Expected impact: Manufacturers of children's products containing the added chemicals would need to report information about these chemicals in their products.
This is not likely to result in additional costs of identifying the concentration of these chemicals in children's products because these chemicals are present in mixtures with two of the proposed chemicals identified in section 2.3.1. Testing products for short-chain chlorinated paraffins (CAS 85535-84-8) would also identify the presence of chlorinated paraffins (CAS 108171-26-2). Testing products for Tris(4-tert-butylphenyl) phosphate (CAS 78-33-1) would also identify the presence of butylated triphenyl phosphate (CAS 220352-35-2).
This will likely result in informational benefits for these two chemicals, including increasing consumer awareness and informing government decision making, reducing potential health impacts and litigation, and improving industry understanding of the presence of these CHCCs across the supply chain.
Changing some grouped CHCCs to individual listings:
Baseline: The existing CHCC list in chapter 173-334 WAC includes CAS number 104-40-5: "4-Nonylphenol; 4-NP and its isomer mixtures including CAS 84852-15-3 and CAS 25154-52-3."
Proposed: The proposed rule amendments separate the above single chemical listing into three individual chemical listings.
Chemicals listed as separate CHCCs under the proposed rule
Expected impact: Because the baseline rule only listed a single CAS number for the grouped CHCC chemicals (despite listing them separately in the chemical description), manufacturers have likely been testing for and reporting only the one chemical identified by the CAS number 104-40-5.
Listing the three chemicals separately, by individual CAS numbers, will likely result in manufacturers of children's products needing to identify two additional chemicals in their products (using new testing, knowledge of product manufacturing processes, or testing in compliance with other regulations), and reporting this information.
This will likely also result in informational benefits for the two chemicals listed separately in the proposed rule. Benefits could include:
Removing three chemicals from the CHCC list:
Baseline: The existing CHCC list in chapter 173-334 WAC includes the chemicals below.
Chemicals removed from the CHCC list under the proposed rule
Proposed: The proposed rule amendments remove the above chemicals from the CHCC list. The updated rule language identifies these three chemicals as removed from the CHCC list in 2017, the expected adoption year of the proposed rule.
Expected impact: Manufacturers of children's products containing the chemicals removed from the CHCC list would no longer need to report on these chemicals in their products.
This will likely result in a cost-savings (benefit), as the three chemicals proposed for removal would no longer need to be tested or reported by manufacturers. These chemical[s] no longer meet the criteria used to identify CHCCs for this rule, based on updated scientific information. We note that ecology has identified the removal of CHCCs as incurring a cost in past rule revisions, but this was for a chemical that was only identified as less toxic.
Setting single annual reporting dates:
Baseline: The existing rule (chapter 173-334 WAC) contains phased-in reporting deadlines that include mid-year reporting in February for specific categories of manufacturers for certain types of products, as well as reporting in August for all other manufacturers for all other products.
Proposed: The proposed rule amendments eliminate reporting deadlines and sets an annual reporting date of January 31.
Expected impact: The proposed rule amendments could result in minor benefits arising from removing the mid-year reporting dates, streamlining compliance with the rule and making it more consistent with similar reporting programs in other states, such as Oregon's January 1 reporting date.
Housekeeping:
Baseline: The baseline for housekeeping is the existing rule.
Proposed: The proposed rule amendments change the organization and contents of the rule language that are intended to streamline or clarify the rule, without material change to its requirements, including:
Expected impact: Housekeeping changes are not expected to affect rule requirements or how manufacturers comply with the rule.
COSTS OF COMPLIANCE: EQUIPMENT
Compliance with the proposed rule, compared to the baseline, is not likely to impose additional costs of equipment.
COSTS OF COMPLIANCE: SUPPLIES
Compliance with the proposed rule, compared to the baseline, is not likely to impose additional costs of supplies.
COSTS OF COMPLIANCE: LABOR
Compliance with the proposed rule, compared to the baseline, is not likely to impose additional costs of labor.
COSTS OF COMPLIANCE: PROFESSIONAL SERVICES
Total annual costs:
We estimated total annual costs of testing for nineteen proposed additional CHCCs, of approximately:
We estimated total annual costs of testing for separating one CHCC listing into three, of approximately:
These costs sum to approximate total annual costs of:
Total present value costs:
Over twenty years, the total present value costs of testing created by adding the proposed nineteen new chemicals to the CHCC list are estimated to be:
Over twenty years, the total present value costs of testing created by separating one nonylphenol CHCC listing into three CHCCs is estimated to be:
These costs sum to total twenty year present value costs of:
COSTS OF COMPLIANCE: ADMINISTRATIVE COSTS
Where applicable, ecology estimates administrative costs ("overhead") as part of the cost of labor and professional services, above.
COMPARISON OF COMPLIANCE COST FOR SMALL VERSUS LARGE BUSINESSES: Ecology calculated the estimated per-entity costs to comply with the proposed rule amendments, based on the costs estimated in Chapter 3. In this section, ecology summarizes compliance cost per employee at affected businesses of different sizes.
We used Washington employment security department data for employment distributions at the industry level. This data is reported at the facility level at businesses in Washington, and therefore is likely an underestimate of the number of employees at the highest owner-operator level of a company. The average affected small business likely to be covered by the proposed rule amendments employs between three and thirteen people, depending on which industry incurs compliance costs based on its specific product line in a given year. The largest ten percent of affected businesses employ an average of between eighty-nine and four thousand five hundred twenty-one people, depending on which industry incurs compliance costs based on its specific product line in a given year.
Based on total twenty year present value (PV) cost estimates from Chapter 3 and cost-savings estimates from Chapter 4, we estimated the following compliance costs per employee. The ranges depend on which specific industry incurs compliance costs, and whether its compliance is related to the nineteen chemicals proposed for addition to the CHCC list, the proposed individual listing of nonylphenols currently listed as a group, or the proposed removal of three chemicals from the CHCC list. Negative numbers indicate a reduction in compliance costs.
20-year PV change in compliance costs per employee
We conclude that the proposed rule amendments are likely to have disproportionate impacts on small businesses, and therefore ecology must include elements in the proposed rule to mitigate this disproportion, as far as is legal and feasible.
Note that these estimates are based on estimated testing for reporting, and testing is not required under the baseline or proposed rule amendments. Note also that reporting costs are driven by the authorizing statute, which specifically lists reporting requirements.
CONSIDERATION OF LOST SALES OR REVENUE: Businesses that would incur costs could experience reduced sales or revenues if compliance with this rule would significantly affect the prices of the goods they sell. The degree to which this could happen is strongly related to each business's production and pricing model (whether additional lump-sum costs significantly affect marginal costs), as well as the specific attributes of the markets in which they sell goods, including the degree of influence of each firm on market prices, as well as the relative responsiveness of market demand to price changes.
The market for children's products is likely to vary in its elasticity. Toys and games, or kitchen/dining products, for example, are likely to have more substitutes, making it more difficult for manufacturers and sellers to pass compliance costs on to consumers through increased prices. Higher prices for toy and game products whose manufacturers incur additional compliance costs under the proposed rule amendments are more likely to result in consumers substituting other products, potentially affecting manufacturers' sales or revenue. Children's products with specific required attributes are likely to have more uniform product availability and limited substitutes (e.g., car seats). If manufacturers of such products incur compliance costs under the proposed rule amendments, it is likely relatively easier for them to pass costs on to consumers without having those consumers purchase another product instead. In which case, they would be less likely to see losses in sales or revenue.
Based upon the extent of disproportionate impact on small business identified in the statement prepared under RCW 19.85.040, the agency shall, where legal and feasible in meeting the stated objectives of the statutes upon which the rule is based, reduce the costs imposed by the rule on small businesses. The agency must consider, without limitation, each of the following methods of reducing the impact of the proposed rule on small businesses:
(a) Reducing, modifying, or eliminating substantive regulatory requirements;
(b) Simplifying, reducing, or eliminating recordkeeping and reporting requirements;
(c) Reducing the frequency of inspections;
(d) Delaying compliance timetables;
(e) Reducing or modifying fine schedules for noncompliance; or
(f) Any other mitigation techniques including those suggested by small businesses or small business advocates.
Ecology considered all of the above options, and included the following legal and feasible elements in the proposed rule amendments that reduce costs. In addition, ecology considered the alternative rule contents discussed in Chapter 6, and excluded those elements that would have imposed excess compliance burden on businesses.
The baseline and proposed rule amendments include elements that intend to reduce disproportionate burden on small businesses. This includes allowing multiple options for determining the CHCC content of children's products, including:
Because smaller businesses likely operate in smaller volumes, they may inherently incur lower compliance costs than estimated in this analysis. This would not be reflected in our ranges of single estimates applied to all sizes of manufacturer.
Ecology's scope for reducing burden on small businesses via the examples listed under the RFA (items (a) – (f) above) was limited by the authorizing statute, scope of the rule, and scope of this rule making:
SMALL BUSINESS AND LOCAL GOVERNMENT CONSULTATION: Ecology involved small businesses and local government in its development of the proposed rule amendments, using:
NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODES OF INDUSTRIES IMPACTED BY THE PROPOSED RULE: The proposed rule is likely to impact the following NAICS codes. These codes were selected based on products in which the proposed additions, separate listings, or removals of chemicals from the CHCC list are likely to be found.
NAICS codes of likely impacted industries
IMPACT ON JOBS: Ecology used the Washington state office of financial management's 2007 Washington input-output model to estimate the impact of the proposed rule amendments on jobs in the state. The model accounts for inter-industry impacts and spending multipliers of earned income and changes in output.
The proposed rule amendments will result in transfers of money within and between industries. Industries spending compliance costs on testing are assumed to transfer their expenditures to the income of the laboratory testing industry (NAICS 541380, Testing Laboratories). However, based on ecology experience, and to maintain conservative estimates, we assumed the labs used are outside of Washington. We therefore estimated jobs [job] impacts based only on changes to compliance costs, without transfers to another in state industry.
These prospective changes in overall employment in the state are the sum of multiple small increases and decreases across all industries in the state.
Under the estimated increased compliance costs created by the proposed rule amendments, the Washington economy could experience a loss of one to five jobs in each year (twenty to one hundred full-time employees, FTEs, over twenty years), depending on which industry experiences increased compliance costs.
Under the estimated reduced compliance costs created by the proposed rule amendments, the Washington economy could experience a gain of four to seventeen jobs in each year (eighty to three hundred forty FTEs over twenty years), depending on which industry experiences reduced compliance costs.
A copy of the statement may be obtained by contacting Kara Steward, P.O. Box 47600, Olympia, WA 98504-7600, phone (360) 407-6250, fax (360) 407-6715, email kara.steward@ecy.wa.gov.
A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Kara Steward, P.O. Box 47600, Olympia, WA 98504-7600, phone (360) 407-6250, fax (360) 407-6715, email kara.steward@ecy.wa.gov.
March 20, 2017
Polly Zehm
Deputy Director
AMENDATORY SECTION (Amending WSR 11-16-008, filed 7/21/11, effective 8/21/11)
WAC 173-334-010 Introduction.
Under the Children's Safe Product Act (CSPA), chapter 70.240 RCW, manufacturers of children's products are required to notify the department of ecology when a chemical of high concern to children (CHCC) is present in their products or, if the product contains more than one component, each product component.
The presence of a CHCC in a children's product does not necessarily mean that the product is harmful to human health or that there is any violation of existing safety standards or laws. The reported information will help fill a data gap that exists for both consumers and agencies.
The CSPA requires the department of ecology in consultation with the department of health to identify a list of chemicals for which manufacturers of children's products are required to ((provide notice)) report. The CSPA specifies both the characteristics of these chemicals and the ((notice)) reporting requirements.
AMENDATORY SECTION (Amending WSR 11-16-008, filed 7/21/11, effective 8/21/11)
WAC 173-334-020 What is the purpose of this chapter?
The purpose of this chapter is to:
(1) Establish the list of chemicals for which manufacturer ((notice)) reporting is required;
(2) Establish what manufacturers of children's products must do to comply with the ((notice)) reporting requirements created by the CSPA; and
(3) Clarify the enforcement processes the department of ecology will use if manufacturers fail to ((provide notice)) report as required.
AMENDATORY SECTION (Amending WSR 11-16-008, filed 7/21/11, effective 8/21/11)
WAC 173-334-040 What definitions apply to terms used in this chapter?
"Chemical Abstracts Service number" means the number assigned for identification of a particular chemical by the Chemical Abstracts Service, a service of the American Chemical Society that indexes and compiles abstracts of worldwide chemical literature called Chemical Abstracts.
"CHCC list" means the reporting list of chemicals that the department has identified as high priority chemicals of high concern for children.
"Child" means an individual under twelve.
"Children's product" has the same meaning as defined in RCW 70.240.010.
(a) For the purposes of this rule, children's products only include products that are sold, or are to be offered for sale, to consumers in the state of Washington.
(b) In addition to the exemptions specified in RCW 70.240.010, for the purposes of this rule, "children's product" does not include over the counter drugs, prescription drugs, food, dietary supplements, packaging, medical devices, or products that are both a cosmetic and a drug regulated by the Food and Drug Administration.
(c) A product label that includes usage instructions for use of a product that apply to children does not in and of itself establish that the product is a children's product.
"Contaminant" means trace amounts of chemicals that are incidental to manufacturing. They serve no intended function in the product component. They can include, but are not limited to, unintended by-products of chemical reactions during the manufacture of the product component, trace impurities in feed-stock, incompletely reacted chemical mixtures, and degradation products.
"De minimis level" means for a chemical that is an intentionally added chemical, a concentration below the practical quantification limit; or for a chemical that is a contaminant, a concentration below 100 parts per million.
"Department of health" means the Washington state department of health.
"Intentionally added chemical" means a chemical in a product that serves an intended function in the product component.
"Internal component" means a children's product component that during reasonably foreseeable use and abuse of the product would not come into direct contact with the child's skin or mouth.
"Manufacturer" means the producer, importer, or wholesale domestic distributor of a children's product and is more specifically defined in RCW 70.240.010. For the purposes of this rule, a retailer of a children's product is not a manufacturer unless it is also the producer, manufacturer, importer, or domestic distributor of the product.
"Mouthable" means able to be brought to the mouth and kept in the mouth by a child so that it can be sucked and chewed. If the product can only be licked, it is not able to be placed in the mouth. If a product or part of a product in one dimension is smaller than five centimeters, it can be placed in the mouth.
"Practical quantification limit (PQL)" means the lowest concentration that can be reliably measured within specified limits of precision, accuracy, representativeness, completeness, and comparability during routine laboratory operating conditions. This value is based on scientifically defensible, standard analytical methods. The value for a given chemical could be different depending on the matrix and the analytical method used.
"Product category" means the "brick" level of the GS1 Global Product Classification (GPC) standard, which identifies products that serve a common purpose, are of a similar form and material, and share the same set of category attributes.
"Product component" means a uniquely identifiable material or coating (including ink or dye) that is intended to be included as a part of a finished children's product.
AMENDATORY SECTION (Amending WSR 11-16-008, filed 7/21/11, effective 8/21/11)
WAC 173-334-050 What is the purpose of the CHCC list?
The CHCC list identifies the chemicals to which the ((notice)) reporting requirements apply. A manufacturer must notify the department in accordance with WAC 173-334-080 if a chemical on the CHCC list is present in a children's product component. The current CHCC list is set forth in WAC 173-334-130.
AMENDATORY SECTION (Amending WSR 11-16-008, filed 7/21/11, effective 8/21/11)
WAC 173-334-070 How will the department identify chemicals for inclusion in the CHCC list?
(1) The department will consult with the department of health during the modification of the CHCC list.
(2) A chemical that the department determines to meet all of the following criteria may be included on the CHCC list:
(a) The toxicity, persistence, or bioaccumulativity criteria specified in RCW 70.240.010(((6))) (9); and
(b) The exposure criteria specified in RCW 70.240.030(1).
(3) The department will consider both the parent chemical and its degradation products when deciding whether a chemical meets the criteria of this section. If a parent chemical does not meet the criteria in this section but degrades into chemicals that do, the parent chemical may be included on the CHCC list.
(4) A person may submit a petition for consideration by the department to add a chemical to or remove a chemical from the CHCC list. The petition must provide the following information:
(a) Chemical Abstracts Service registry number;
(b) Chemical prime name; and
(c) Credible peer-reviewed scientific information documenting why the chemical meets or fails to meet the criteria required for inclusion on the list.
(5) The department shall review petitions in accordance with RCW 34.05.330, the Administrative Procedure Act.
AMENDATORY SECTION (Amending WSR 11-16-008, filed 7/21/11, effective 8/21/11)
WAC 173-334-080 What must the manufacturer include in its ((notice)) report to the department?
(1) The ((notice)) report required by RCW 70.240.040 must be filed annually with the department in accordance with the following:
(a) Each chemical on the CHCC list that is an intentionally added chemical present in a product component must be reported at any concentration above the PQL.
(b) Each chemical on the CHCC list that is a contaminant present in a product component must be reported at any concentration above 100 ppm. A manufacturer need not file a ((notice)) report with respect to any CHCC that occurs in a product component only as a contaminant if the manufacturer had in place a manufacturing control program and exercised due diligence to minimize the presence of the contaminant in the component.
(2) The ((notice)) report must include all of the following information:
(a) The name of the CHCC and its Chemical Abstracts Service registry number.
(b) The product category or categories in which it occurs.
(c) The product component or components within each product category in which it occurs.
(d) A brief description of the function, if any, of the CHCC in each product component within each product category.
(e) The total amount of the CHCC by weight contained in each product component in each children's product sold or offered for sale within each product category. The amount may be reported in ranges, rather than the exact amount. If there are multiple CHCC values for a given component in a particular product category, the manufacturer must use the largest value for reporting.
For the purpose of this rule, the reporting ranges are as follows:
(i) Equal to or more than the PQL but less than 100 ppm (0.01%);
(ii) Equal to or more than 100 ppm (0.01%) but less than 500 ppm (0.05%);
(iii) Equal to or more than 500 ppm (0.05%) but less than 1,000 ppm (0.10%);
(iv) Equal to or more than 1,000 ppm (0.10%) but less than 5,000 ppm (0.5%); or
(v) Equal to or more than 5,000 ppm (0.5%) but less than 10,000 ppm (1.0%); or
(vi) Equal to or more than 10,000 ppm (1.0%).
(f) The name and address of the reporting manufacturer or trade organization and the name, address and phone number of the contact person for the reporting manufacturer or trade organization. When a trade organization is the reporting party, the report must include a list of the manufacturers on whose behalf the trade organization is reporting, and all of the information that would otherwise be required of the individual manufacturers.
(g) Any other information the manufacturer deems relevant to the appropriate use of the product.
(3) Reporting parties are not required to include either:
(a) Any specific formula information; or
(b) The specific name and address of the facility which is responsible for the introduction of a CHCC into a children's product or product component.
(4) If a reporting party believes the information being provided is confidential business information (CBI), in whole or in part, it may request that the department treat the information as confidential business information as provided in RCW 43.21A.160. The department will use its established procedures to determine how it will handle the information.
(5) The department will ((make available the current version of the web form)) maintain an online reporting database to be used for reporting on CHCCs. This same ((form)) database may be used by the reporting party to flag the submitted information it thinks should be treated as CBI. ((The web form must be used when providing notification.))
(6) Any information that is not determined to be confidential business information will be available to the public. As resources allow, the department will post this information on the department's web site.
AMENDATORY SECTION (Amending WSR 11-16-008, filed 7/21/11, effective 8/21/11)
WAC 173-334-090 Who is required to ((provide notice)) report to the department?
(1) The manufacturer of a children's product, or a trade organization on behalf of its member manufacturers, must ((provide notice)) report to the department that the manufacturer's children's product component contains a chemical on the CHCC list.
(2) The definition of manufacturer in RCW 70.240.010 includes any person or entity that produces a children's product, any importer that assumes ownership of a children's product, and any domestic distributor of a children's product. However, it is only necessary for one person or entity to ((provide notice)) report with respect to a particular children's product.
The following hierarchy will determine which person or entity the department will hold primarily responsible for ensuring that the department receives a complete, accurate, and timely ((notice)) report for the children's product:
(a) The person or entity that had the children's product manufactured, unless it has no presence in the United States.
(b) The person or entity that marketed the children's product under its name or trademark, unless it has no presence in the United States.
(c) The first person or entity, whether an importer or a distributor, that owned the children's product in the United States.
AMENDATORY SECTION (Amending WSR 11-16-008, filed 7/21/11, effective 8/21/11)
WAC 173-334-100 ((What time period is covered by the notice?)) When must manufacturers report and for what time period?
((Manufacturers must provide notice as required by WAC 173-334-110 on an annual basis for children's products that have been manufactured for sale in Washington during the twelve-month period that precedes the applicable due date for first notices set out in WAC 173-334-110(2).)) (1) On January 31, 2019, and annually thereafter, a manufacturer of a children's product sold or offered for sale in Washington that contains a CHCC listed in WAC 173-334-130 in an amount above a de minimis level must submit the information detailed in WAC 173-334-080 to the department.
(a) The report submitted on January 31, 2019, applies to children's products sold or offered for sale in Washington between September 1, 2017, and December 31, 2018.
(b) A manufacturer of a children's product containing a CHCC above the de minimis level may request an extension for submission of the report required on January 31, 2019, if this would be the first report required by the manufacturer and the manufacturer will be reporting more than one product or chemical.
(c) Reports submitted on January 31, 2020, and annually thereafter, apply to children's products sold or offered for sale during the prior calendar year.
(2) If the reporting party determines that there has been no change in the information required to be reported since the prior annual ((notice)) report, the party ((may submit a written statement indicating that the previous reported data is still valid, in lieu of a new duplicate complete notice)) must copy the prior year's report and resubmit the same data into the online reporting database.
(3) If a CHCC is subsequently removed from the children's product component for which ((notice)) a report was given, the manufacturer may ((provide notice)) report to the department. Such updated ((notices)) reports will be documented in the department's records.
(4) Annual reporting for internal components will not be required, except by amendment of this rule.
AMENDATORY SECTION (Amending WSR 11-16-008, filed 7/21/11, effective 8/21/11)
WAC 173-334-120 How will this chapter be enforced?
(1) The department may collect children's products subject to possible reporting, and analyze their components for the presence of CHCCs. If the department finds that a children's product component contains a chemical on the CHCC list that the manufacturer either has not reported, or has reported at a lesser amount, the department will notify the manufacturer in writing. The department will then afford the manufacturer forty-five days from receipt of the department's notification to respond to the findings before the department takes further enforcement action.
In determining whether a violation of the CSPA or these rules has occurred, the department will consider the manufacturer's timely explanation as to why it did not report the presence or accurate amount of the CHCC in the product component. If the manufacturer asserts that the CHCC is present in the component only as a contaminant, and that the manufacturer did not report the CHCC's presence based on WAC 173-334-080 (1)(b), then the manufacturer must present evidence that it conducted a reasonable manufacturing control program for the CHCC contaminant and exercised due diligence as described in subsections (2) and (3) of this section.
If the manufacturer contests the department's findings regarding the presence or amount of the CHCC in the product component, the manufacturer may further analyze the component in question for presence of CHCC and provide the department with a copy of its own laboratory findings for the component.
(2) Manufacturing control program. A reasonable manufacturing control program must include industry best manufacturing practices for the minimization of the CHCC in the children's product. Those practices may include, but are not limited to, methods and procedures for meeting relevant federal regulations, International Standards Organization (ISO) requirements, American Society for Testing and Materials (ASTM) standards, and other widely established certification or standards programs.
(3) Due diligence. Actions demonstrating due diligence in ensuring the effectiveness of a manufacturing control program may include the use and enforcement of contract specifications, procedures to ensure the quality/purity of feedstock (whether raw or recycled), the use and enforcement of contract specifications for manufacturing process parameters (e.g., drying and curing times when relevant to the presence of high priority chemicals in the finished children's product components), periodic testing for the presence and amount of CHCCs, auditing of contractor or supplier manufacturing processes, and other practices reasonably designed to ensure the manufacturer's knowledge of the presence, use, and amount of CHCCs in its children's product components.
(4) If the department determines based on the process described in subsection (1) of this section, or on other grounds, that a manufacturer has violated a requirement of the CSPA or these rules, it may require the manufacturer to pay a civil penalty. A manufacturer of children's products in violation of this chapter is subject to a civil penalty not to exceed five thousand dollars for each violation in the case of a first offense. Manufacturers who are repeat violators are subject to a civil penalty not to exceed ten thousand dollars for each repeat offense. Penalties collected under this section must be deposited in the state toxics control account created in RCW 70.105D.070.
(5) A single violation consists of a manufacturer failing to provide the required ((notice)) report for the presence and accurate amount of each CHCC, in each applicable product category, in each applicable product component.
AMENDATORY SECTION (Amending WSR 13-21-123, filed 10/22/13, effective 11/22/13)
WAC 173-334-130 The reporting list of chemicals of high concern to children (CHCC list).
(1) The current list of CHCCs identifies the chemicals that must be reported to the department in accordance with WAC 173-334-080 if a chemical on the CHCC list is present in a children's product component.
(2) Changes to the list of CHCCs occurs only by amendment of this rule as required by WAC 173-334-060. The year a CHCC was added to the list by rule amendment is provided in the third column. Chemicals removed by rule amendment are identified at the end of this list.
REPEALER
The following section of the Washington Administrative Code is repealed:
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