WSR 10-22-017

PROPOSED RULES

DEPARTMENT OF ECOLOGY


[ Order 09-04 -- Filed October 22, 2010, 8:44 a.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 09-11-127.

Title of Rule and Other Identifying Information: Chapter 173-334 WAC, Children's safe products -- Reporting rule.

As signed into law, the Children's Safe Product Act (CSPA) manufacturers of children's products to report the presence of chemicals of high concern to children (CHCCs) to the department. The purpose of the rule is to clarify the following: The process to be used to update the reporting list for CHCCs, definitions of several key terms, and the reporting process.

Hearing Location(s): Ecology Headquarters Building, 300 Desmond Drive S.E., Lacey, WA 98503, on December 9, 2010, at 7:00 p.m.

Date of Intended Adoption: March 15, 2011.

Submit Written Comments to: John R. Williams, Jr., P.O. Box 47600, Olympia, WA 98504-7600, e-mail john.williams@ecy.wa.gov, fax (360) 407-6102, by December 31, 2010.

Assistance for Persons with Disabilities: Contact Michelle Payne, (360) 407-6129, by November 10, 2010, TTY 711 or (877) 833-6341.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: As signed into law, the CSPA requires manufacturers of children's products to report the presence of CHCCs to the department. The purpose of the rule is to clarify the following: The process to be used to update the reporting list for CHCCs, definitions of several key terms, and the reporting process.

Reasons Supporting Proposal: The rule will make it easier for the regulated community to comply with the reporting requirements established by chapter 70.240 RCW.

Statutory Authority for Adoption: Children's Safe Product Act (CSPA), RCW 70.240.040.

Statute Being Implemented: Children's Safe Product Act (CSPA), chapter 70.240 RCW.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Washington state department of ecology, governmental.

Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: John R. Williams, Jr., Waste 2 Resources, Headquarters, (360) 407-6940.

A small business economic impact statement has been prepared under chapter 19.85 RCW.

Small Business Economic Impact Statement

Note: Due to size limitations relating to the filing of documents with the code reviser, the small business economic impact statement does not contain the appendices that further explain Washington state department of ecology's (ecology) analysis. Additionally, it does not contain the raw data used in this analysis, or all of ecology's analysis of this data. However, this information is being placed in the rule-making file, and is available upon request. A full analysis of compliance costs is available in the associated cost-benefit analysis for this rule.

Executive Summary: Ecology is proposing to adopt a new chapter called the children's safe products reporting rule (chapter 173-334 WAC). The CSPA law requires ecology to identify high priority chemicals that are of high concern for children. This includes chemicals that have been:

Found through biomonitoring studies that demonstrate the presence of the chemical in human umbilical cord blood, human breast milk, human urine, or other bodily tissues or fluids.

Found through sampling and analysis to be present in household dust, indoor air, drinking water, or elsewhere in the home environment.

Added to or is present in a consumer product used or present in the home.

Ecology estimated the direct compliance costs of the proposed rule, over twenty years, and assuming product testing (the most expensive option) is used, to be between $44.7 million and $69.5 million.

Ecology analyzed the degree of disproportionate impact of the proposed rule on small businesses (those with fifty or fewer employees; versus the largest ten percent of businesses in likely impacted industries), and has concluded that a disproportionate impact is likely. But it should be emphasized that only business [businesses] falling within the definition of a manufacture [manufacturer] as define [defined] in the law would be required to report. And that would apply to retailers only if they are the importer in the United States and no other party reports on their behalf.


Based on the statutory authority created by the law, ecology could have done the following: Required reporting for hundreds of CHHCs [CHCCs], based the reporting trigger on detection limit, implemented the reporting requirement for all products and all manufactures [manufacturers] six months from the date the rule was adopted, required the reporting to be done at the individual SKU number. Instead ecology chose options, within the scope of the authorizing statute, to reduce this disproportionate burden.
Phasing in timelines for first reporting based, in-part, on business size. The first date for any reporting for those manufactures [manufacturers] with gross sales in the less than one hundred thousand dollars is five years from the date the rule is adopted. And these initial reports are only for those products intended to be stuck in the child's mouth, rubbed on the child's skin, and all products for children three and under.
Requiring reporting at the product category level based on the GS1 global product classification (GPC) standard. As a result the reporting burden is reduced to one report per product category, so a reporting entity which sales [sells] only two categories of products would only have to make two reports, one for the chemicals in each category.
Providing multiple examples of how a manufacture [manufacturer] can determine what if any CHHCs [CHCCs] are in there [their] products. Testing is not required by the law or the rule.
Requiring reporting at the "brick" or "class" level of the GS1 GPC standard.
Allowing multiple courses of determining CHCC content, rather than requiring only testing.

Ecology estimated that the costs and payments created by the proposed rule will likely reduce employment in the state by up to 0.5 positions over twenty years, across the state economy, for all sizes of business. This accounts for the flow of compliance expenditures through the economy as earnings, wages, and further spending.

Section 1 - Background: Ecology is proposing the Children's safe products -- Reporting rule (chapter 173-334 WAC) as part of the rule making it is allowed to perform by law in chapter 70.240 RCW (Children's Safe Products Act; CSPA). This law was passed in 2008, and specifically allows ecology to, "adopt rules as necessary for the purpose of implementing, administering, and enforcing this chapter."

Based on research and analysis required by the Regulatory Fairness Act, RCW 19.85.070, ecology has determined the proposed rule has a disproportionate impact on small business (those employing fifty or fewer employees). Therefore, ecology included cost-minimizing features in the rule where it is legal and feasible to do so.

The CSPA law requires ecology to identify high priority chemicals that are of high concern for children. This includes chemicals that have been:

Found through biomonitoring studies that demonstrate the presence of the chemical in human umbilical cord blood, human breast milk, human urine, or other bodily tissues or fluids.
Found through sampling and analysis to be present in household dust, indoor air, drinking water, or elsewhere in the home environment.
Added to or is present in a consumer product used or present in the home.

In July 2009, ecology published a report (ecology publication number 09-07-014) describing the work done by ecology and the state department of health (DOH) to comply with CSPA requirements, address concerns raised by stakeholders, and implement direction from the governor.1 This included discussion of the process the agencies used to determine chemicals of concern that are being proposed as part of this rule making.

The majority of the CSPA law delineates requirements for manufacturers and sellers of children's products, including:


Prohibition on the manufacturing and sale of children's products containing lead, cadmium, or phthalates above the limits established in the law. At this time the agency feels federal programs have substantially preempted our agency for the enforcement of these limits. So this rule only addresses the reporting requirement.
Notification to ecology that a children's product contains a high priority chemical.
Actions that must be taken by - and penalties for - manufacturers in violation of the law.

Ecology conducted a stakeholder process and pilot rule phase to determine the content of the proposed rule. Both the pilot phase and the stakeholder process helped ecology identify possible compliance difficulties for the regulated community without diminishing the effectiveness of the rule. These processes were also used to get other input from the public, business, environmental interests, and health interests might have toward rule making.

Baseline: As there is no current state-level CSPA or similar rule, there is technically no baseline rule for comparison. There are no existing federal or Washington state requirements intended explicitly for children's products as under this rule. There are, however, a number of partially overlapping requirements and mitigating factors, including:


Washington's toxics in packaging law (chapter 70.95G RCW, Toxics in packaging) requires manufacturers to have practices that may include contract specifications, quality control mechanisms, and/or testing protocols to determine the amount of a chemical in product materials.
Manufacturers must have procedures in place to test for lead under the federal Consumer Product Safety Improvement Act of 2008 (CPSIA). Some chemicals are restricted in cosmetic products under FDA regulations.
Interstate toxics rules allowing manufacturers to employ economies of scale in producing a homogeneous product across multiple markets.
Manufacturers who sell children's products in Maine are subject to similar reporting requirements for priority chemicals (Me. Rev. Stat. Ann. tit. 38, 1691-1699-B). The state of California has several reporting requirements applicable to manufacturers of children's products, including required reporting on use of specific ingredients in cosmetics (Cal. Health & Safety Code 111791-111793.5).
Manufacturers who do business in California are also required to label products if exposure to certain chemicals from those products exceeds levels known to cause cancer or reproductive harm (California Proposition 65).
The European Union, for instance, enforces chemical limits in children's products through its Toy Directive (88/378/EEC) and Cosmetics Directive (76/768/EEC). Many companies have preexisting restricted substance lists (RSLs) to describe and codify procedures to meet chemical limits in a variety of product lines for sale in various countries.

These factors will likely mitigate some of the compliance costs for a subset of businesses covered by the proposed rule.

The baseline also includes the explicit provisions of the authorizing statute. These are excepted from this analysis. For further discussion, see analytic exceptions, below in this chapter.

Changes under Ecology's Proposed Rule: The proposed rule sets out requirements for:


Annual notification of ecology by manufacturers of children's products containing CHCCs, with pertinent firm, product, and CHCC quantity information as established by statute.
Timing of first reporting is phased in according to the product tier and size of manufacturer. Product tiers (1 - 4) represent the level of contact with a child intended for types of products, based on levels of the GS1 GPC standard. It is an industry standard for product classification.
Enforcement priorities and penalties.

Analytic Exemptions: Ecology excluded from analysis the following elements, explicitly dictated or defined in the children's safe products statute (chapter 70.240 RCW):

Definitions, including:

o Children's cosmetics
o Children's jewelry
o Children's product
o Cosmetics
o High priority chemical
o Manufacturer
o Phthalates
o Toy
o Trade association
o Very bioaccumulative
o Very persistent

Prohibition of the manufacturing and sale of children's products containing lead, cadmium, or phthalates.
Explicit reporting requirements, including:
The name of the chemical used or produced and its chemical abstracts service registry number.
A brief description of the product or the product component containing the substance.
A description of the function of the chemical in the product.
The amount of the chemical used in each unit of the product or product component. The amount may be reported in ranges, rather than the exact amount.
The name and address of the manufacturer and the name, address, and phone number of a contact person for the manufacturer.
Any other information the manufacturer deems relevant to the appropriate use of the product.
Notification of sellers and distributors.
Civil penalty.

Section 2 - Analysis of Compliance Costs for Washington Businesses:

Analytic Approach: Ecology analyzed the costs and benefits of the proposed rule qualitatively, and quantified the impacts where possible. Ecology only analyzed those aspects of the proposed rule that were left to ecology's discretion in the rule-making process. In the case of the proposed rule, many of its elements were dictated explicitly by law, as is the general idea of manufacturer reporting.

One must keep in mind, however, that ecology only had particular discretion on reporting ranges, and the phasing-in of first reporting time. Every chemical on the reporting list meets the standards set by the authorizing law. Ecology chose fifty-nine chemicals from an initial list of two thousand prospective chemicals. Ecology believes the content of the list of CHCCs is sufficiently dictated by statute, so that the chemicals on the final list were not entirely left to ecology's discretion. However, ecology also believes it is to the public and state's advantage to present the estimated costs of testing and reporting, to provide additional information to manufacturers and the public regarding compliance with the authorizing statute.

Section 3 - Quantification of Costs and Ratios:

Quantified Costs of Ecology's Proposed Rule: Ecology estimated the quantitative costs of complying with the proposed rule, including those elements dictated by the authorizing law, based on:


The number of businesses expected to comply.
The number of chemicals that require testing or business practice or business chain knowledge.
The estimated costs of testing or business practices and reporting.

These estimates are conservatively high, and do not account for economies of scale, nonreporters, or interstate/international regulatory consistency. Moreover, as a means of estimating CHCC content and reporting into a range, testing is not specifically required by the proposed rule or the law. Other options for gauging CHCC content include supply-chain knowledge and knowledge of the manufacturing process.

Ecology assumed that known businesses operating in Washington state manufacturing or importing toys and games, children's clothing, and baby supplies and accessories may have to comply with the law. These businesses fall into multiple NAICS2 categories, including:

3399 (Other Miscellaneous Manufacturing; includes toys, games, baby products).
4243 (Apparel, Piece Goods, and Notions Merchant Wholesalers; includes children's clothing).
3256 (Soap, Cleaning Compound, and Toilet Preparation Manufacturing; includes baby care).
3371 (Household and Institutional Furniture and Kitchen Cabinet Manufacturing; includes baby furniture).

Based on Washington employment security department information, there are currently about two hundred seventy-six such businesses in the state. Ecology was also able to categorize most of these businesses roughly into size categories by employment and, to a lesser degree, annual earnings. Ecology believes these businesses represent the majority of the businesses that will need to comply with the proposed rule. Some retailers who act as importers or distributors for products made by companies with no presence in the United States may also need to report, but ecology assumes this number will be minimal.

Ecology assumed that any given business would maintain at least existing business practices and standards, but ecology assumed conservatively (attempting to overestimated [overestimate] costs, as to calculate a conservative net benefit of the proposed rule) that a business might choose to test for a maximum of ten CHCCs.

Based on surveys of current testing costs, ecology estimated that this cost of knowing the level of CHCC content in children's products for some manufacturers would be in the range of approximately $1 thousand - $10 thousand per year for all the CHCCs in their products. This value was based on a range of existing, approved analytical methods. It is possible that new test methods could need to be developed. Ecology multiplied these values to calculate a total conservatively high3 testing cost of the proposed rule and CSPA law of $2.8 million - $27.6 million the first year, followed by $2.8 million annually in subsequent years, when testing has been established.

The above calculations generated at total likely present value4 cost of compliance, over twenty years, with the combined CSPA rule and CSPA law, of $44.7 million to $69.5 million. Requirements set forward in the latter of these, the CSPA law, are exempt from inclusion in this analysis, but ecology included this total cost in this analysis because the contribution of ecology reducing the possible list of CHCCs (to only those meeting the requirements set forth in the authorizing law) was not separable from the overall impacts of the law.

The costs estimated by ecology work under the assumption that costs are for a typical business, and are constant across them, on average. Obviously, the costs per-business range of $10 thousand to $100 thousand divided by smaller numbers of employees will be larger, as it will [be] divided by each $100 of sales recorded (for which records are much more sparse). For fifty employees or fewer, this is at least $200 - $2 thousand per employee. For the largest ten percent of likely affected businesses, this is at most nine - ninety cents per employee.

Section 4 - Actions Taken to Reduce the Impact of the Rule on Small Business:

Based on the statutory authority created by the law, ecology could of [have] done the following: Required reporting for hundreds of CHHCs [CHCCs], based the reporting trigger on detection limit, implemented the reporting requirement for all products and all manufactures [manufacturers] six months from the date the rule was adopted, required the reporting to be done at the individual SKU number. Instead ecology chose options, within the scope of the authorizing statute, to reduce this disproportionate burden.
Phasing in timelines for first reporting based, in-part, on business size. The first date for any reporting for those manufactures [manufacturers] with gross sales in the less than one hundred thousand dollars is five years from the date the rule is adopted. And these initial reports are only for those products intended to be stuck in the child's mouth, rubbed on the child's skin, and all products for children three and under.
Requiring reporting at the product category level based on the GS1 GPC standard. As a result the reporting burden is reduced to one report per product category, so a reporting entity which sales [sells] only two categories of products would only have to make two reports, one for the chemicals in each category.

Providing multiple examples of how a manufacture [manufacturer] can determine what if any CHHCs [CHCCs] are in there [their] products. Testing is not required by the law or the rule.

Section 5 - The Involvement of Small Business in the Development of the Proposed Rule:

Amendments: While multiple attempts were made to get small business involvement during both the pilot and advisory group phases, the actual input provided by them was little to none. One Washington small businesses [business] (Find it Games) said they were willing to participate on the advisory group but even after multiple efforts to get their input none was provided. Also another small business joined the pilot phase (Four Seasons) but they also did not provide any input. We assume that this was due to the need for small business to attend to the daily requirements of running their business. Hopefully their membership in trade organizations, for example TIA, JPMA, AAFA, and others resulted in their concerns being represented. It should be noted that Grant Nelson (AWB) was copied of multiple e-mails which were sent to the participants of pilot and that some of these even outline topics that agency was seeking input on.

In addition, a listserv provided the public and small businesses, among others, with up-to-date information on the proposed rule. Also a press release and focus sheet were release [released] at the start of the pilot phase.

Section 6 - The SIC Codes of Impacted Industries:

Ecology assumed that known businesses operating in Washington state manufacturing or importing toys and games, children's clothing, and baby supplies and accessories may have to comply with the law. These businesses fall into multiple NAICS5 categories, including:

3399 (Other Miscellaneous Manufacturing; includes toys, games, baby products),
4243 (Apparel, Piece Goods, and Notions Merchant Wholesalers; includes children's clothing),
3256 (Soap, Cleaning Compound, and Toilet Preparation Manufacturing; includes baby care), and
3371 (Household and Institutional Furniture and Kitchen Cabinet Manufacturing; includes baby furniture).

Based on Washington employment security department information, there are currently about two hundred seventy-six such businesses in the state. Ecology was also able to categorize most of these businesses roughly into size categories by employment and, to a lesser degree, annual earnings. Ecology believes these businesses represent the majority of the businesses that will need to comply with the proposed rule. Some retailers who act as importers or distributors for products made by companies with no presence in the United States may also need to report, but ecology assumes this number will be minimal.

Section 7 - Impacts on Jobs:

Ecology used the Washington state office of financial management's 2002 Washington input-output model (OFM-IO) to estimate the proposed rule's first-round impact on jobs across the state. This methodology estimates the impact as reductions or increases in spending in certain sectors of the state economy flow through to purchases, suppliers, and demand for other goods. Compliance costs incurred by an industry, or industries, are entered in the OFM-IO model as decreases in spending and investment.

Ecology calculated that between approximately zero and 0.5 jobs are likely to be permanently lost under the proposed rule. Ecology was not able to estimate the second-round impacts of the proposed rule, which include the earned income of secondary parties and reduce overall job impacts. This result does, however, account for the labor income earned during efforts to research and report CHCC content.


1 The governor expressed that ecology and DOH should rely on safety testing conducted in the European Union and California, to the extent they provide a reasonable assurance of safety, in order to help establish a degree of consistency for the industry.

2 North American Industry Classification System (see http://www.census.gov/eos/www/naics/index.html) .

3 Assuming all covered businesses must test to determine whether and what to report.

4 Accounting for expected inflation, using US Treasury I-Bonds (see http://www.treasurydirect.gov/indiv/research/indepth/ibonds/res_ibonds_iratesandterms.htm).

5 North American Industry Classification System (see http://www.census.gov/eos/www/naics/index.html).

A copy of the statement may be obtained by contacting John R. Williams, Jr., P.O. Box 47600, Olympia, WA 98504-7600, phone (360) 407-6940, fax (360) 407-6102, e-mail john.williams@ecy.wa.gov.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting John R. Williams, Jr., P.O. Box 47600, Olympia, WA 98504-7600, phone (360) 407-6940, fax (360) 407-6102, e-mail john.williams@ecy.wa.gov.

October 22, 2010

Polly Zehm

Deputy Director

OTS-3630.4

Chapter 173-334 WAC

CHILDREN'S SAFE PRODUCTS - REPORTING RULE


NEW SECTION
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.

Reporting the presence of a CHCC does not establish that the product is harmful to human health. 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. The CSPA specifies both the characteristics of these chemicals and the notice requirements.

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NEW SECTION
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 is required;

(2) Establish what manufacturers of children's products must do to comply with the notice requirements created by the CSPA; and

(3) Clarify the enforcement processes the department of ecology will use if manufacturers fail to provide notice as required.

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NEW SECTION
WAC 173-334-030   To whom does this chapter apply?   This chapter applies to manufacturers of children's products.

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NEW SECTION
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.

"Department of health" means the Washington state department of health.

"Product category." For those products intended for children three years of age and under, 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. For all other children's products, product category means the "class" level within the hierarchy of GS1 Global Product Classification (GPC) standard.

"Product component" means a uniquely identifiable piece, substrate, or coating (including ink or dye) that is intended to be included as a part of a finished children's product.

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NEW SECTION
WAC 173-334-050   What is the purpose of the CHCC list?   The CHCC list identifies the chemicals to which the CSPA notice requirements apply. A manufacturer must notify the department in accordance with this rule if a chemical on the CHCC list is present in a children's product component. The current CHCC list is set forth in WAC 173-334-140.

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NEW SECTION
WAC 173-334-060   What schedule will the department follow to revise the CHCC list?   (1) The department will add chemicals to, or remove chemicals from, the CHCC list by amending this rule in accordance with the requirements of the Administrative Procedure Act, chapter 34.05 RCW.

(2) The department intends to revise the CHCC list on a regular basis. The department will routinely revise the CHCC list no more frequently than once every two years, and no less frequently than once every five years.

(3) If the directors of the department of ecology and the department of health both agree that a given chemical should be added to, or removed from, the CHCC list outside of the routine revision schedule described above, the CHCC list may be revised on a schedule the directors determine to be appropriate, in accordance with the requirements of the Administrative Procedure Act.

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NEW SECTION
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) Meets the toxicity, persistence, or bioaccumulativity criteria of the CSPA, as specified in RCW 70.240.010(6); and

(b) Meets the exposure criteria of the CSPA, as 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 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 the criteria required for inclusion on the list.

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NEW SECTION
WAC 173-334-080   How will the department decide to remove a chemical from the reporting list?   (1) The department will remove a chemical from the CHCC list if the department determines that credible peer-reviewed scientific information demonstrates that the chemical does not meet the required criteria for being on the CHCC list.

(2) A person may submit a petition to remove a chemical from the CHCC list. For consideration by the department the petition must contain peer-reviewed credible scientific information documenting why the chemical does not meet the criteria required for inclusion on the list.

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NEW SECTION
WAC 173-334-090   What must the manufacturer include in its notice to the department?   (1) The notice required by RCW 70.240.040 must be filed annually with the department for each CHCC by-product category and component. The notice 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 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 40 ppm (0.004%) but less than 200 ppm (0.02%);

(ii) Equal to or more than 200 ppm (0.02%) but less than 1000 ppm (0.1%);

(iii) Equal to or more than 1000 ppm (0.1%) but less than 10,000 ppm (1.0%);

(iv) Equal to or more than 10,000 ppm (1.0%) but less than 100,000 ppm (10%); or

(v) Equal to or more than 100,000 ppm (10%).

(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.

(2) 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.

(3) If a reporting party believes the information being provided is confidential business information (CBI), in whole or in part, it can 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.

(4) The department will make available the current version of the web form to be used for reporting on CHCCs. This same form can be used by the reporting manufacturer or trade organization to flag the submitted information they think should be treated as CBI. The web form must be used when providing notification.

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NEW SECTION
WAC 173-334-100   Who is required to provide notice to the department?   (1) The manufacturer of a children's product as defined in RCW 70.240.010, or a trade organization on behalf of its member manufacturers, must provide notice 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 with respect to a particular children's product.

Absent an agreement to the contrary among multiple persons or entities meeting the definition of manufacturer of a particular children's product, the following hierarchy will determine which person or entity is responsible for providing notice for the children's product:

(a) The person or entity that had the children's product designed or 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.

In no event may entities meeting the definition of manufacturer with respect to a particular children's product delegate notice responsibility to a person or entity with no presence in the United States.

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NEW SECTION
WAC 173-334-110   How often must notice be given?   Manufacturers must provide notice 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 173-334-120(2). If the reporting party determines that there has been no change in the information required to be reported since the prior annual notice, the party may submit a written statement indicating that the previous reported data is still valid, in lieu of a new duplicate complete notice.

If a CHCC is subsequently removed from the children's product component for which notice was given, the manufacturer may provide notice to ecology. Such updated notices will be documented in the department's records.

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NEW SECTION
WAC 173-334-120   When must manufacturers begin to provide notice?   (1) This section establishes when manufacturers must first provide notice to the department if a children's product contains a chemical on the CHCC list. The CSPA notice requirement will be phased in as provided in the schedule set out in subsection (2) of this section based on the manufacturer categories and children's product tiers established in subsections (3) and (4) of this section. Manufacturers conducting safer alternative assessments for CHCCs may obtain an extension of the first notice date as provided in subsection (5) of this section. After the first notice date, notice must be provided annually on the anniversary of the first notice.

(2) The following table specifies when the first annual notice must be provided to the department in compliance with RCW 70.240.040. The due date will be determined by counting the number of months specified in the table, beginning with the first calendar month following the calendar month in which this rule is adopted. The notice will be considered delinquent if not received by the department by the first day of the month indicated.

Notice due dates from adoption date of rule, values are in months.


Manufacturer categories Product Tier 1 Product Tier 2 Product Tier 3 Product

Tier 4

Largest 12 18 24 case-by-case
Larger 18 24 36 case-by-case
Medium 24 36 48 case-by-case
Small 36 48 60 case-by-case
Smaller 48 60 72 case-by-case
Tiny 60 72 84 case-by-case

(3) For the purpose of this rule the department recognizes six categories of manufacturers. The categories of manufacturers are as follows:

(a) "Largest manufacturer" means any manufacturer of children's products with annual aggregate gross sales, both within and outside of Washington, of more than one billion dollars, based on the manufacturer's most recent tax year filing.

(b) "Larger manufacturer" means any manufacturer of children's products with annual aggregate gross sales, both within and outside of Washington, of more than two hundred fifty million but less than or equal to one billion dollars, based on the manufacturer's most recent tax year filing.

(c) "Medium size manufacturer" means any manufacturer of children's products with annual aggregate gross sales, both within and outside of Washington, of more than one hundred million but less than or equal to two hundred fifty million dollars, based on the manufacturer's most recent tax year filing.

(d) "Small manufacturer" means any manufacturer of children's products with annual aggregate gross sales, both within and outside of Washington, of more than five million but less than or equal to one hundred million dollars, based on the manufacturer's most recent tax year filing.

(e) "Smaller manufacturer" means any manufacturer of children's products with annual aggregate gross sales, both within and outside of Washington, of more than one hundred thousand but less than or equal to five million dollars, based on the manufacturer's most recent tax year filing.

(f) "Tiny manufacturer" means any manufacturer of children's products with annual aggregate gross sales, both within and outside of Washington, of less than one hundred thousand dollars, based on the manufacturer's most recent tax year filing.

(4) For the purpose of this rule the department recognizes four tiers of products. The tiers or products are as follows:

(a) Tier 1 - children's products intended to be put into a child's mouth (e.g., children's products used for feeding, sucking, some toys) or applied to the child's body (e.g., children's products used as lotions, shampoos, creams), or any children's product intended for children who are age three or under.

(b) Tier 2 - children's products intended to be in prolonged (more than one hour) direct contact with a child's skin (e.g., clothes, jewelry, bedding, car seats).

(c) Tier 3 - children's products intended for short (less than one hour) periods of direct contact with child's skin (e.g., many toys).

(d) Tier 4 - children's product components not intended for direct contact with the child's skin or mouth (e.g., inaccessible internal components for all children's products). Any reporting requirements for internal components will be based on a case-by-case evaluation by the department and may be required by amendment of these rules.

(5) If a manufacturer presents documentation to show that it is conducting safer alternative assessments for CHCCs contained in its children's products and that these assessments are intended to result in the elimination or significant reduction of CHCCs from the manufacturer's products, the department may extend by twelve months the reporting requirement for that manufacturer.

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NEW SECTION
WAC 173-334-130   How will this chapter be enforced?   (1) A manufacturer of children's products is responsible for knowing the amount of CHCCs in its children's products and their components. To control the amount of any chemical present in its final children's product the manufacturer has a duty to establish and conduct a reasonable manufacturing control program. At a minimum, a reasonable manufacturing control program would include those methods and procedures established in federal regulations for children's products and recognized industry best manufacturing practices, e.g., compliance with relevant International Standards Organization (ISO) requirements, American Society for Testing and Materials (ASTM) standards, or other widely established certification or standards programs.

(2) In deciding whether to impose penalties for failure to provide appropriate notice as described in WAC 173-334-090 through 173-334-120, the department may consider whether the manufacturer responsible for providing notice has exercised due diligence to ensure it knows the amount of the CHCCs in its children's product components. Actions demonstrating diligence 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.

(3) 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.

(4) 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 in an amount above the amount reported by the manufacturer or that the manufacturer has otherwise failed to provide appropriate notice as described in WAC 173-334-090 through 173-334-120, the department will inform the manufacturer in writing. The manufacturer shall have forty-five days from receipt of the department's notification of potential violation to further analyze the components in question for presence of CHCCs or to provide an explanation for the omission.

(5) A single violation consists of a manufacturer failing to provide the required notice for the presence of each CHCC, in each applicable product category, in each applicable product component. Unless otherwise warranted by egregious circumstances, the department's investigation prior to taking an enforcement action will include a request to the suspected violator for information regarding the suspected violation.

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NEW SECTION
WAC 173-334-140   The reporting list of chemicals of high concern to children (CHCC list).  


CAS Chemical
50-00-0 Formaldehyde
62-53-3 Aniline
62-75-9 N-Nitrosodimethylamine
71-36-3 n-Butanol
71-43-2 Benzene
75-01-4 Vinyl chloride
75-07-0 Acetaldehyde
75-09-2 Methylene chloride
75-15-0 Carbon disulfide
78-93-3 Methyl ethyl ketone
79-34-5 1,1,2,2-Tetrachloroethane
79-94-7 Tetrabromobisphenol A
80-05-7 Bisphenol A
84-75-3 Di-n-Hexyl Phthalate
86-30-6 N-Nitrosodiphenylamine
87-68-3 Hexachlorobutadiene
94-13-3 Propyl paraben
94-26-8 Butyl paraben
95-53-4 2-Aminotoluene
95-80-7 2,4-Diaminotoluene
99-76-3 Methyl paraben
99-96-7 p-Hydroxybenzoic acid
100-41-4 Ethylbenzene
100-42-5 Styrene
104-40-5 4-Nonylphenol; 4-NP and its isomer mixtures including CAS 84852-15-3 and CAS 25154-52-3
106-47-8 para-Chloroaniline
107-13-1 Acrylonitrile
107-21-1 Ethylene glycol
108-88-3 Toluene
108-95-2 Phenol
109-86-4 2-Methoxyethanol
110-80-5 Ethylene glycol monoethyl ester
115-96-8 Tris(2-chloroethyl) phosphate
118-74-1 Hexachlorobenzene
119-93-7 3,3'-Dimethylbenzidine and Dyes Metabolized to 3,3'-Dimethylbenzidine
120-47-8 Ethyl paraben
123-91-1 1,4-Dioxane
127-18-4 Perchloroethylene
131-55-5 Benzophenone-2 (Bp-2); 2,2',4,4'-Tetrahydroxybenzophenone
140-66-9 4-tert-Octylphenol; 1,1,3,3-Tetramethyl-4-butylphenol
140-67-0 Estragole
149-57-5 2-Ethylhexanoic Acid
556-67-2 Octamethylcyclotetrasiloxane
608-93-5 Benzene, pentachloro
842-07-9 C.I. Solvent Yellow 14
872-50-4 N-Methylpyrrolidone
1163-19-5 2,2',3,3',4,4',5,5',6,6'-Decabromodiphenyl ether; BDE-209
1763-23-1 Perfluorooctanyl sulphonic acid and its salts; PFOS
1806-26-4 Phenol, 4-octyl-
5466-77-3 2-Ethyl-hexyl-4-methoxycinnamate
7439-97-6 Mercury & mercury compounds including methyl mercury (22967-92-6)
7439-98-7 Molybdenum & molybdenum compounds
7440-36-0 Antimony & Antimony compounds
7440-38-2 Arsenic & Arsenic compounds including arsenic trioxide (1327-53-3) & dimethyl arsenic (75-60-5)
7440-43-9 Cadmium & cadmium compounds
7440-48-4 Cobalt & cobalt compounds
25013-16-5 Butylated hydroxyanisole; BHA
25154-52-3 Nonylphenol
25637-99-4 Hexabromocyclododecane

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Washington State Code Reviser's Office