FAQ: Toxic-Free Kids Act

Frequently Asked Questions

1. For the $250.00 reporting fee, what is meant by "...per unique HPCCCH in a manufacturer’s biennial notice(s)"?
   
2. Does the TFKA require reporting of High Priority Chemical of Concern for Children's Health (HPCCCH) in areas of the product that are inaccessible to children?
3. What is the rationale for having to report all the HPCCCH in a product, regardless of location?
4. Is furniture marketed for children covered by the TFKA?
5. When reporting for Oregon, reporters are asked either for the number of products sold or offered for sale in Oregon in 2018 through 2019. I represent a manufacturer, and don’t know the answer. What should I do?
6. When you state the "number of Bricks sold or offered for sale..." are you referring to "styles" or "SKU" or the actual quantity of each style or SKU that were sold or offered for sale in Oregon?
7. For reporting to Oregon, what exactly is meant by "number" of bricks?
8. What does Oregon require as far as the Manufacturing Control Program is concerned?
9. Did I understand correctly that Oregon will require an Exception Request / Manufacturing Control Program (MCP) for a HPCCCH found as a contaminant in the final product?
10. Are Exception Requests / MCP’s available for HPCCCH that are intentionally added during the manufacturing process?
11. Are food and beverages and their packaging, which are regulated by U.S. Food & Drug Administration (FDA), exempt from the reporting requirements of the TFKA?
12. How do I know if my payment of my Biennial Notice fee has been made successfully?
13. How can I stay informed of important announcements and changes to the Toxic-Free Kids program?
14. Are HPCCCH and products containing them supposed to be reported annually? Does that mean that fees for Oregon are paid annually?
15. Oregon does not require products to be specified below their brick level, right?
16. Is there a second phase that is being planned to "restrict" these 68 chemicals as opposed to simply "reporting"?
17. This seems to be a voluntary reporting program. Will there eventually be limits put on these substances?
18. Reporting requirements under the TKFA seem similar to the state of Washington’s Children’s Safe Products Act. What are some important differences?
19. Will Oregon implement the PIN program like Washington state where a manufacturer/distributor can report on behalf of a retailer?
20. What strategies could businesses use to comply with these requirements to ensure their products do not contain any of the listed chemicals, and in turn, avoiding the need to report?

For the $250.00 reporting fee, what is meant by "...per unique HPCCCH in a manufacturer’s biennial notice(s)"?

This means that a fee of $250 is required for each chemical (HPCCCH) that is reported by a manufacturer, or a supplier reporting on the manufacturer's behalf, for a Biennial Notice due date. [See definition of 'manufacturer' in ORS 431A.253(7).] The fee amount stays the same regardless of the number of children's products (GS1 'bricks') containing that HPCCCH reported for that due date. If one of those 'bricks' contains an additional chemical(s), the fee would increase.

EXAMPLE: Tommy Tinkleberry Toys reports seven Product Bricks each containing 1,1,2,2-Tetrachloroethane for the January 1, 2020 due date, the fee would be $250. If one of those reported bricks also contained 2-Ethylhexanoic acid, the fee would be $500. HPCDS will automatically calculate the fees owed.

Does the TFKA require reporting of High Priority Chemical of Concern for Children's Health (HPCCCH) in areas of the product that are inaccessible to children?

Yes, if a product is made for, marketed for use by or marketed to children under 12 years of age, and contains a HPCCCH at or above de minimis levels in any part or component of the children’s product, it must be reported using the IC2 High Priority Chemicals Data System (HPCDS).

De minimis levels are as follows:

• Intentionally-added HPCCCH - De minimis is the practical quantification limit (PQL) for a specific HPCCCH as indicated in Oregon Administrative Rules OAR 333-016-2035 Exhibit A. The method used to detect the PQL for each HPCCCH is listed in the far right column.
• The HPCCCH as a “contaminant” - See the Oregon Revised Statute ORS 431A.253: Definitions. The de minimis level is at or above 100 ppm.

“Contaminant” means trace amounts of chemicals that are incidental to manufacturing and that serve no intended function in the product component, including but not limited to:

(a) Unintended by-products of chemical reactions during the manufacture of the product component;
(b) Trace impurities in feedstock;
(c) Incompletely reacted chemical mixtures; and
(d) Degradation products.

Oregon’s Toxic-Free Kids Act differs from Washington’s Children’s Safe Products Act in how we have chosen to deal with components that are not accessible to a child through normal and reasonably foreseeable use and abuse. While Washington does not require reporting of these components, Oregon’s law does.

Oregon’s law does not exempt a component based on its location in the product. If a HPCCCH is in any component/location of the final product, and at/above the applicable de minimis, it should be reported using the HPCDS before January 1, 2020.

What is the rationale for having to report all the chemicals in a product regardless of location?

The Toxic Free Kids Act does not make a distinction between "accessible" and so-called "inaccessible" components.The Oregon Legislature, when developing the Toxic-Free Kids Act, was looking at all the potential ways a child could be exposed to a HPCCCH from a children’s product. They felt that children can be both destructive and curious when it comes to children’s products, and that many component parts that seem to be hard to access may in actuality become accessible, especially to older children who can either break them open or take them apart and therefore potentially be exposed to the chemicals in these components.

4. Is furniture marketed for children covered by the TFKA?

The definition of “children’s product” in the Oregon Revised Statute ORS 431A.253 reads, in part:

(3)(a) “Children’s product” means:

(A) Any of the following products that are made for, marketed for use by or marketed to children under 12 years of age:
(i) A product designed or intended by the manufacturer to facilitate sucking, teething, sleep, relaxation, feeding or drinking.
(ii) children’s clothing and footwear.
(iii)car seats.
(iv)children’s cosmetics.
(v)children’s jewelry.
(vi)toys.

(B) Any component part of a product specified in subparagraph (A) of this paragraph.

Products intended to facilitate sleep or relaxation are part of the definition of “children’s product.” This means children’s beds, head boards for children’s beds and cribs, children’s stuffed chairs or other furniture for relaxing as well as other sleep-related products (sheets, pillows, blankets, etc.), should be reported if they contain High Priority Chemical of Concern for Children’s Health (HPCCCH) above de minimis levels.

Under the statute and Oregon Administrative Rules, children’s dressers, desks, nightstands, hard chairs, tables and any other furniture that does not facilitate sleep or relaxation, are not included in the definition of “children’s products.”

When reporting for Oregon, reporters are asked either for the number of products sold or offered for sale in Oregon in 2018 through 2019. I represent a manufacturer, and don’t know the answer. What should I do?

OHA understands that it will be difficult for some businesses to know the exact number of products sold or offered for sale in Oregon by January 1, 2020, due to the delay in data for the end of 2019.

Manufacturers should work with distributors of your products (or retailers if you sell directly to them). Ask them how many bricks they have sold or offered for sale in their Oregon locations in 2018 through 2019. (Remember, you have a choice which one to report.)

Because they need this information for revenue, tax and other financial reasons, they will be able to provide a response to you for one of the two choices. Other manufacturers have done this with their retailers and distributors. Remember, the fee associated with the notice requirement is per chemical, and not based on the number of products sold or offered for sale.

When you state the "number of Bricks sold or offered for sale..." are you referring to "styles" or "SKU" or the actual quantity of each style or SKU that were sold or offered for sale in Oregon?

No, this does not refer to SKU, UPC, model or style of a particular children's product. A "brick" is a category of similar products and is the building block of the GS1 Global Product Classification standard.

For example: for fresh milk the Brick Code is “10000025” and the Brick Description is “milk and milk substitutes (perishable).

"Brick" is the unit of measure was chosen by both Oregon and Washington lawmakers for manufacturer reporting for their states’ programs.

For reporting for Oregon, using the HPCDS, reporters should provide the quantity or volume of units sold (or offered for sale) in Oregon - per brick reported in the HPCS -  during the Biennial Notice Period. This means the cumulative total of the SKU, UPC, model or styles that make up the particular brick being reported.

For reporting to Oregon, what exactly is meant by "number" of bricks?

The number quantity of units or items for each of the GS1 'bricks' specified in the HPCDS that were sold or offered for sale during the Biennial Notice Period. Reporters have a choice of providing numbers for either Number Sold or Number of Bricks Offered for Sale). Manufacturers are not required to report both. [Reporting should be on the number of 'units' of the product brick as it is typically made available for sale to consumers.]

What does Oregon require as far as the Manufacturing Control Program is concerned?

Requirements for a Manufacturing Control Program (MCP) can be found in OAR 333-016-2070(4) through (7). Guidance for writing an MCP and the process for submitting it can be found under Requirements for Manufacturers, under “Exemption Requests.”

Did I understand correctly that Oregon will require an Exception Request / Manufacturing Control Program (MCP) for a HPCCCH found as a contaminant in the final product?

Correct. Oregon’s Toxic-Free Kids Act under ORS 431A.258(5)(a) states: “The authority shall grant an exemption to a manufacturer of children’s product that applies for an exemption from the notice requirements of this section if the application demonstrates that:

(A)The high priority chemical of concern for children’s health used in children’s products is present in the children’s product otherwise subject to the notice requirements of this section only as a contaminant;

(B) The manufacturer conducts a manufacturing control program for the contaminant; and

(C) The manufacturing control program meets minimum standards for a manufacturing control program as set forth by the authority by rule. This means that a manufacturer (or a trade association representing the manufacturer) may request an exemption from the Biennial Notice requirements only for HPCCCPH found in final products as contaminants at or above the de minimus of 100 ppm.

You can find information on seeking an exemption request from the Biennial Notice requirement in the OAR 333-016-2070. Guidance for writing an MCP and the process for submitting it can be found under Requirements for Manufacturers (see "Exemption Requests”).

Are Exception Requests / MCP’s available for HPCCCH that are intentionally added during the manufacturing process?

No, they are not. Intentionally added HPCCCH found in the final product above the practical quantification limit (PQL) for a specific HPCCCH as indicated in Oregon Administrative Rules OAR 333-016-2035 Exhibit A must be reported using the HPCDS.

Yes, they are. ORS 431A.253 states that "children’s product" does not include:

(Q) Food and beverages and food and beverage packaging regulated by the United States Food and Drug Administration or the United States Department of Agriculture.

Therefore, these items are exempt from reporting requirements under the law.

How do I know if my payment of my Biennial Notice fee has been made successfully?

As discussed in the HPCDS User Guide, once a reporter has completed Step 2. Review Report for Oregon, they should continue to Step 3. Payment. 

There are two options: Pay Using a Credit Card or Submit Payment by Check:

1. 'Pay Using a Credit Card' takes the reporter to a secure third-party payment website required of all online transactions made to Oregon agencies by the State of Oregon. [There is no additional service fee to the reporter for use of this payment website.] Once Submit Payment is clicked a Payment Receipt Confirmation message will appear. It will also be emailed to the address entered by the reporter.
   
   Reporters should keep this Payment Receipt Confirmation as proof of payment.
   
   
2. 'Submit Payment by Check' allows the reporter to pay the fee with a check drawn on a U.S. bank. After following the directions and clicking the ‘Submit’ button, an HPCDS Submission Confirmation message will appear. It will also be emailed to the address entered by the reporter. It should be kept as proof of submission.
   
   Reporters should be sure to mail that check or have it expressed delivered to one of the two addresses on the screen at their earliest convenience. OHA staff will be matching received checks to the submissions made.

How can I stay informed of important announcements and changes to the Toxic-Free Kids program?

Email your name, company, and phone number to toxicfreekids.program@dhsoha.state.or.us.

Are HPCCCH and products containing them supposed to be reported annually? Does that mean that fees for Oregon are paid annually?

Under Oregon’s Toxic-Free Kids Act (ORS 431A.250), HPCCCH and the products containing them are to be reported by January 1 of even-numbered years (1/1/2018, 1/1/2020, 1/1/2022 and so on).

The second Biennial Notification (as defined by the Act) for children’s products with HPCCCH above de minimis levels is January 1, 2020. As part of that notification, a fee of $250 per HPCCCH is required. Fees per HPCCCH will be required again in 2020 and 2022.

However, per 333-016-2060 Notification Requirements, if a manufacturer has included a children’s product in a notice required under these rules, and determines that there is no change to the information submitted to the Authority in the previous notice, the manufacturer may, in lieu of including the children’s product again in a subsequent notice, submit a written statement, or if available, an electronic notification indicating that the previous reported data is still valid for that children’s product.

Further information on how this is to be done is found here under the Did your company report for the January 1, 2018 Biennial Notice due date? heading

Oregon does not require products to be specified below their brick level, right?

Correct. Currently, Oregon & Washington do not require manufacturers to use codes or descriptions below the Brick Code level.  Vermont currently requires notification at the SKU Code level.

Is there a second phase that is being planned to "restrict" these 68 chemicals as opposed to simply "reporting"?

Yes, manufacturers will be required to remove HPCCCH from subsets of products in Phase 3 of the TFK Act’s implementation. (See Rules and Rulemaking for more information on the Act’s implementation.)

Per ORS 431A.260, starting January 1, 2022 manufacturers will be required to remove/substitute/gain a waiver for HPCCCH in specific categories of children’s products. These categories are:

• Those products that are mouthable (as defined in ORS 431A.253);
• a children’s cosmetic; or
• for children under 3 years of age.

Rule-making for this and related provisions in the Act are occuring now.

This seems to be a voluntary reporting program. Will there eventually be limits put on these substances?

Per ORS 431A.258, manufacturers must provide Biennial Notice to OHA of children's products sold or offered for sale in Oregon that are covered by the Oregon Toxic-Free Kids Act and contain High Priority Chemicals of Concern for Children's Health (HPCCCH) at or above de minimis levels in the final product.

This is not voluntary.

ORS 431A.275 provides for civil penalties for violations of ORS 431A.258 as well as other provisions of the Act. Information on "who" must report and "what" must be reported, is found at the HPCCCH Biennial Notice Reporting System page.

As addressed above, per ORS 431A.260, starting January 1, 2022 manufacturers will be required to remove/substitute/gain a waiver for HPCCCH in specific categories of children’s products. These categories are:

• Those products that are mouthable (as defined in ORS 431A.253);
• A children’s cosmetic; or
• Products made for children under 3 years of age.

Rule-making for this and related provisions in the Act is occuring now.

Reporting requirements under the TKFA seem similar to the state of Washington’s Children’s Safe Products Act. What are some important differences?

Oregon’s Toxic-Free Kids Act differs from Washington’s Children’s Safe Products Act in how we have chosen to deal with components that are not accessible to a child through normal and reasonably foreseeable use and abuse. While Washington’s law does not require reporting of these components, Oregon’s law does require that they be reported. Oregon’s law does not exempt a component based on its location in the product. If a HPCCCH is in any component or location of the final product, above the applicable de minimis, it should be reported using the HPCCCH Biennial Notice Reporting System before January 1, 2018.

Oregon charges a fee per chemical for biennial notice reporting. Oregon also has enforcement provisions and civil penalties established in rule that can be imposed in the event that a manufacturer does not comply with the requirements in ORS 431A or OAR Chapter 333, Division 016. You can find the language for fees in OAR 333-016-2080 and language pertaining to enforcement and penalties in OAR 333-016-2090.

Oregon’s Act also provides the following exemptions:

• A manufacturer of children’s products with annual worldwide gross sales of less than $5 million, as reported on the most recent tax return filed by the manufacturer before the notification required under OAR 333-016-2060, is exempt from all the requirements of these rules.
• Any HPCCCH found in a final children’s product that is present only as a contaminant at or above de minimis (100 ppm), for which a manufacturer or trade association has submitted a Manufacturing Control Program (MCP) that meets the requirements found in OAR 333-016-2070(4), and for which approval has been received by the OHA prior to the January 1, 2018 reporting deadline.

Will Oregon implement the PIN program like Washington state where a manufacturer/distributor can report on behalf of a retailer?

YES! This will be a feature of the HPCDS where an "Accountable Organization" who is obligated to report under Oregon law can designate one or more "Non-Accountable Organizations" (suppliers, vendors, etc.) to report on their behalf. Under Oregon’s Toxic-Free Kids Act, biennial notifications are to be made by manufacturers or the trade associations that represent them. Manufacturers’ are defined by ORS 431A.253 as "...any person that produces a children’s product or an importer or domestic distributor of a children’s product. For [Reporting purposes], "importer" means the owner of the children’s product." See OAR 333-016-2060(10) for more information.

What strategies could businesses use to comply with these requirements to ensure their products do not contain any of the listed chemicals, and in turn, avoiding the need to report?

Oregon’s Toxic-Free Kids Act requires manufacturers of children's products sold or offered for sale in Oregon to report products containing one or more High Priority Chemicals of Concern for Children's Health (HPCCCH) if found at or above specific (de minimis) levels in those products. Specific de minimis levels for each HPCCCH are found under Requirements for Manufacturers. The de minimis for HPCCCH found in a final product only as a contaminant is 100 ppm.

One strategy for ensuring products do not contain HPCCCH, and for complying with ORS 431A.258 is for manufacturers to test the final children’s product or require suppliers to test their products (and the raw materials that go into them) to determine if HPCCCH are present.

This should help manufacturers determine the levels (PPM-parts per million) of HPCCCH found in components in final products made available for sale in Oregon to assess whether they are at or above de minimis levels. Products containing HPCCCH above de minimis levels must be reported.

De minimis levels are as follows:

• For HPCCCH that are intentionally-added, de minimis level is the practicable quantification limit for a specific HPCCCH as indicated in OAR 333-016-2035 Exhibit A.
• For HPCCCH found as a “contaminant,” the de minimis level is 100 ppm ORS 431A.253 – Definitions.