PROPOSED RULES
Supplemental Notice to WSR 11-01-105.
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) requires manufacturers of children's products to report the presence of chemicals of high concern to children (CHCC) to the department. The purpose of the rule is to clarify the following: The process to be used to update the reporting list for CHCC, definitions of several key terms, and the reporting process.
Hearing Location(s): Ecology Headquarters Building, 300 Desmond Drive S.E., Lacey, WA 98503, on June 8, 2011, at 7:00 p.m.
Date of Intended Adoption: July 8, 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 June 15, 2011.
Assistance for Persons with Disabilities: Contact Michelle Payne, (360) 407-6129, by May 27, 2011, 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 CHCC to the department. The purpose of the rule is to clarify the following: The process to be used to update the reporting list for CHCC, definitions of several key terms, and the reporting process. Ecology made a number of changes to proposed rule language in response to comments received during the first comment period, which closed January 7, 2011. This new language is being proposed for additional public comment.
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: CSPA, RCW 70.240.040.
Statute Being Implemented: 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.
The CSPA law requires ecology to identify high priority CHCC. 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, other bodily tissues or fluids.
Found through sampling and analysis to be present in: Household dust, indoor air, drinking water, elsewhere in the home environment. Added to, or 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 $22.4 million and $34.8 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 businesses falling within the definition of a manufacturer as defined in the law would be required to report. 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 possible CHCC if they are added intentionally to a children's product. Based the reporting trigger on detection limit. Implemented the reporting requirement for all products and all manufacturers six months from the date the rule was adopted. Required the reporting to be done at the individual stock-keeping unit (SKU) number.
Instead, ecology chose options, within the scope of the authorizing statute, to reduce this disproportionate burden, including: Phasing in timelines for first reporting based, in-part, on business size. The first date for any reporting for those manufacturers with gross sales 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 most likely to cause harm because they are designed to be placed in the child's mouth or rubbed on the child's skin, or are mouthable products intended for use by children three and under.
Requiring reporting at the product category level based on the GS1 global product classification (GPC) standard. This standard is already in use globally and provides a standardized system for classifying consumer products. As a result the reporting burden is reduced. A manufacturer that produces ten individual products that fall into two product categories will have eighty percent fewer reports to make if all else is equal. Providing multiple examples of how a manufacturer can determine what if any CHCC are in their products. Testing is not required by the law or the rule.
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, through a redistribution of jobs across industries resulting from respending of wages in the economy. This estimated job impact accounts for the flow of compliance expenditures through the economy as earnings, wages, and further spending by those receiving transfers in the form of payments or wages resulting from actions taken to comply with the proposed rule.
Section 1 - Background: Ecology is filing a supplemental proposal of 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 (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 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 CHCC. 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, other bodily tissues or fluids. Found through sampling and analysis to be present in: Household dust, indoor air, drinking water, elsewhere in the home environment. Added to or 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. Implement direction from the governor.1
This included discussion of the process the agencies used to determine chemicals of concern 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 believes federal programs have substantially preempted our agency for the enforcement of these limits. Therefore, the proposed rule only addresses the notification requirements.
Notification to ecology that a children's product contains an intentionally added high priority CHCC.
Notification to ecology that a children's product is contaminated with a (not intentionally added) CHCC at a level exceeding one hundred ppm, unless the manufacturer determines that the presence of any CHCC has been minimized through use of an appropriate due diligence program.
Actions that must be taken by - and penalties for - manufacturers in violation of the law.
Pilot Phase: Ecology conducted a stakeholder process and pilot rule phase to determine the content of the proposed rule. The pilot phase and the stakeholder process helped ecology:
Identify possible compliance difficulties for the regulated community without diminishing the effectiveness of the rule.
Get other input from the public, business, environmental interests, and health interests on the 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:2
Washington's toxics in packaging law (chapter 70.95G RCW, Toxics in packaging). This law 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.
Federal Consumer Product Safety Improvement Act of 2008 (CPSIA). This law requires manufacturers to have a process in place to test their products for some chemicals. Also some chemicals are restricted in cosmetic products under Food and Drug Administration (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.
See Appendix B for a full listing of existing interstate and international rules that will likely mitigate the compliance costs created by the proposed rule.
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 revised proposed rule sets out requirements for:
Manufacturers or importers to notify ecology on an annual basis about:
All children's products they manufacture or import for sale in Washington state that contain intentionally added CHCCs. The notice must include information about the firm, the category of the product, and the amount (in categories) of CHCC in the product.
All children's products they manufacture or import for sale in Washington contaminated with greater than one hundred ppm of CHCCs, or be able to demonstrate that the presence of any CHCC has been minimized through use of an appropriate due diligence program.
The timing of first reporting phased in according to the product tier and size of manufacturer. Product tiers (1 - 4) represent the level of contact a child is likely to experience with various types of products. Product categories are based on levels of the GS1 GPC standard - an industry standard for product classification.
Enforcement processes 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: Children's cosmetics, children's jewelry, children's product, cosmetics, high priority chemical, manufacturer, phthalates, toy, trade association, very bioaccumulative, 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.
Ecology only has 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 sixty-six chemicals from an initial list of two thousand prospective chemicals. Ecology believes the content of the list of CHCC 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 supply 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 NAICS3 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 state 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 businesses operating in Washington state that will need to comply with the proposed rule. Ecology could not confidently determine the degree to which many of these businesses were:
Direct producers.
Assemblers of parts manufactured by other firms.
Importers.
Distributors.
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.
To maintain the most conservative estimate of net benefit (by overestimating costs to compensate for uncertainty), ecology assumed all of these businesses would behave as though they had little or no process knowledge - as is likely for importers or distributors only. In reality, the majority of businesses will have some (if not complete) control or knowledge of the manufacturing process and content of their children's products. This is achieved through direct control or contracting. Ecology also expects that many businesses will already have contracted process knowledge to mitigate liability in the event of product recall.
Therefore, ecology assumed that any given business would maintain at least existing business practices and standards, and that a business might choose to test for a maximum of ten CHCC. This is likely an overestimate of costs, but as discussed in the above paragraph, ecology chose the most cautious approach to dealing with the limited knowledge of the scope of each business's process and chemical knowledge.
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 high4 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 if necessary. This is if all covered businesses perform testing.
Sensitivity Analysis: Those businesses that have directly or indirectly sufficient information about the manufacturing process to know the intentionally added chemicals, and the quality assurance to minimize contamination with other chemicals will not need to test. This is more likely for manufacturers than for importers or distributors. If half of the covered businesses test, or if all businesses must test for only five chemicals because they don't have sufficient process knowledge or exhibit due diligence, then costs fall to $1.4 million - $13.8 million the first year, followed by $1.4 million in subsequent years.
It is also unlikely that the proposed rule will require the creation of new tests for all possible unknown contaminants, for all covered businesses. If ecology assumes that no new tests will need to be created for contaminants at or above a concentration of one hundred ppm, then the costs fall to $2.8 million annually.
The above calculations generated at total likely present value (PV)5 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 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.
If only half of businesses need to perform testing, only five (rather than ten) chemicals require testing for contamination, on average, then the PV falls to $22.4 million - $34.8 million.
If no new testing methods need to be created for the one hundred ppm level, then the PV falls to $44.7 million in the all tests for all businesses scenario.
Overall, ecology considered the central range of these scenarios as a reasonable estimate of overall costs: $22.4 million - $34.8 million.
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 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 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, including:
Phasing in timelines for first reporting based, in-part, on business size. The first date for any reporting for those manufactures 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 3 and under.
Requiring reporting at the product category level based on the GS1 GPC standard. This standard is already in use globally and provides a standardized system for classifying consumer products. As a result the reporting burden is reduced. A manufacturer that produces ten individual products that fall into two product categories will have eighty percent fewer reports to make if all else is equal.
Providing multiple examples of how a manufacture [manufacturer] can determine what if any CHHCs [CHCC] are in their products. Testing is not required by the law or the rule.
Allowing multiple courses for determining CHCC content, rather than requiring only testing.
Requiring reporting of contaminants in concentrations of one hundred ppm or higher, or demonstration of sufficient due diligence in production to minimize contaminant content.
Section 5: The Involvement of Small Business in the Development of the Proposed Rule Amendments: Advisory group meetings included representatives from Teaching Toys and Books, and from Find It Games. Small business industry groups were also represented.
Multiple attempts were made to involve small business in the pilot and advisory group phases but little actual input was provided. One Washington small business said they were willing to participate on the advisory group but after multiple efforts to get their input, none was provided. Another small business joined the pilot phase but they also did not provide any input. We assume that this was due to lack of resources. As a result, ecology relied upon input from trade organizations to represent concerns specific to small businesses. Industry associations include:
Toy Industry Association.
Juvenile Products Manufacturers Association.
American Apparel and Footware [Footwear] Association.
Others, to represent concerns specific to small businesses.
Ecology established a listserv (which has over two hundred members) to provide the public and small businesses, among others, with regular updates and information related to the proposed rule. Also a press release and focus sheet were issued at the start of the pilot phase.
| Trade Associations and Likely Testing Facilities Representing or Related to Small Businesses Covered by the Proposed Rule | |||
| Trade Associations | Chemical Companies, Consultants and Testing Labs | ||
| American Apparel & Footwear Association | AkzoNobel | Eastman | Perkins Coie |
| American Chemistry Council | Antheil Maslow & MacMinn, LLP | Exponent | RegNet |
| American Forest & Paper Association | Arnold & Porter LLP | Foresite Systems | SGS |
| Apparel and Footwear International RSL Management Group | Brush Wellman Inc. | ICQ | Stateside Associates |
| Association of Washington Business | Bureau Veritas | Insight Labs | |
| Fashion Jewelry and Accessories Trade Association | Cascadia Consulting Group | Intertek | |
| Grocery Manufacturers Association | Cascadia Law Group PLLC | Keller and Heckman LLP | |
| Juvenile Products Manufacturers Association, Inc. | ChemADVISOR | KSE FOCUS | |
| Personal Care Products Council | Compliance & Risks | Lab/Cor Materials, LLC | |
| Toy Industry Association™, Inc. | Consumer Testing Laboratories | MultiState Associates Inc. | |
| Washington Retail Association | Decernis | NVL Laboratories, Inc. | |
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 state 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 children's product businesses operating in Washington state that will need to comply with the proposed rule.
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 of 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. This result accounts for the labor income earned during efforts to research and report CHCC content. That income is respent by earners in the economy, providing income for other industries through retail purchases, wholesale, and so forth. Where jobs might be lost in the industries incurring additional process or testing expenditures, that money does not disappear, but rather is respent in the economy. The results of the IO model indicate a redistribution of jobs across industries, as shown in the table below.
| OFM-IO Model Results: Employment Impacts of the Proposed Rule | |||
| INDUSTRY | EMPLOYMENT IMPACT | INDUSTRY | EMPLOYMENT IMPACT |
| 1. Crop Production | 0.82 | 26. Furniture Product Manufacturing | -18.54 |
| 2. Animal Production | 1.38 | 27. Other Manufacturing | -88.80 |
| 3. Forestry and Logging | -0.48 | 28. Wholesale | -38.58 |
| 4. Fishing, Hunting, and Trapping | 0.20 | 29. Retail | 38.05 |
| 5. Mining | 0.08 | 30. Air Transportation | 0.48 |
| 6. Electric Utilities | 0.43 | 31. Water Transportation | 0.28 |
| 7. Gas Utilities | 0.10 | 32. Truck Transportation | 0.25 |
| 8. Other Utilities | 0.31 | 33. Other Transportation/Postal Offices | 1.08 |
| 9. Construction | 0.20 | 34. Support Activities for Storage, Transportation and Warehousing | -0.04 |
| 10. Food, Beverage and Tobacco Manufacturing | 1.46 | 35. Software Publishers & Internet Service Providers | 0.03 |
| 11. Textiles and Apparel Mills | -0.13 | 36. Telecommunications | 2.36 |
| 12. Wood Product Manufacturing | -1.12 | 37. Other Information | 2.81 |
| 13. Paper Manufacturing | -0.17 | 38. Credit Intermediation and Related Activities | 3.78 |
| 14. Printing and Related Activities | 0.20 | 39. Other Finance and Insurance | 3.31 |
| 15. Petroleum and Coal Products Manufacturing | 0.06 | 40. Real Estate and Rental and Leasing | 7.49 |
| 16. Chemical Manufacturing | -2.31 | 41. Legal/Accounting and Bookkeeping/Management Services | -1.21 |
| 17. Nonmetallic Mineral Products Manufacturing | -0.16 | 42. Architectural, Engineering, and Computing Services | 0.29 |
| 18. Primary Metal Manufacturing | -0.20 | 43. Educational Services | 5.62 |
| 19. Fabricated Metals Manufacturing | -0.406066466 | 44. Ambulatory Health Care Services | 13.60538787 |
| 20. Machinery Manufacturing | -0.090763608 | 45. Hospitals | 8.380215879 |
| 21. Computer and Electronic Product Manufacturing | -0.071740411 | 46. Nursing and Residential Care Facilities, Social Assistance | 14.89128539 |
| 22. Electrical Equipment Manufacturing | -0.005694654 | 47. Arts, Recreation, and Accommodation | 7.011931267 |
| 23. Aircraft and Parts Manufacturing | 0.00050651 | 48. Food Services and Drinking Places | 24.7220975 |
| 24. Ship and Boat Building | 0.099552202 | 49. Administrative/Employment Support Services | 1.578830241 |
| 25. Other Transportation Equipment Manufacturing | 0.020661761 | 50. Waste Management/Other, and Agriculture Services | 11.52590511 |
| Total | 0.55 | ||
2See Appendix B for a full listing of existing regulations that will likely mitigate the compliance costs created by the proposed rule.
3North American Industry Classification System (see http://www.census.gov/eos/www/naics/index.html).
4Assuming all covered businesses must test to determine whether and what to report.
5Accounting for expected inflation, using U.S. Treasury I-Bonds (see http://www.treasurydirect.gov/indiv/research/indepth/ibonds/res_ibonds_iratesandterms.htm).
6North 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.
May 3, 2011
Polly Zehm
Deputy Director
OTS-3630.6
CHILDREN'S SAFE PRODUCTS - REPORTING RULE
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. The CSPA specifies both the characteristics of these chemicals and the notice requirements.
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(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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"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.
"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.
"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.
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(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); 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.
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(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.
(c) A manufacturer need not file a notice 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 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 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 to be used for reporting on CHCCs. This same form 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.
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(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.
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 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.
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If a CHCC is subsequently removed from the children's product component for which notice was given, the manufacturer may provide notice to the department. Such updated notices will be documented in the department's records.
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(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 last 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 |
(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 mouthable 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).
(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 that during reasonable foreseeable use and abuse of the product would not come into direct contact with the child's skin or mouth (e.g., inaccessible internal components for all children's products). Any reporting requirements for Tier 4 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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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)(c), 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 for the presence and accurate amount of each CHCC, in each applicable product category, in each applicable product component.
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| 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 |
| 84-66-2 | Diethyl phthalate |
| 84-74-2 | Dibutyl phthalate |
| 84-75-3 | Di-n-Hexyl phthalate |
| 85-44-9 | Phthalic anhydride |
| 85-68-7 | Butyl benzyl phthalate (BBP) |
| 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 |
| 117-81-7 | Di-2-ethylhexyl phthalate |
| 117-84-0 | Di-n-octyl phthalate (DnOP) |
| 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 |
| 25637-99-4 | Hexabromocyclododecane |
| 26761-40-0 | Diisodecyl phthalate (DIDP) |
| 28553-12-0 | Diisononyl phthalate (DINP) |
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