Formaldehyde Emissions and CA Prop 65 Information and Resources
CA Prop 65
In 1986, California voters approved Proposition 65, an initiative to address their growing concerns about exposure to toxic chemicals. The law requires California to publish a list of chemicals known to cause cancer or reproductive toxicity, and for businesses with 10 or more employees to provide warnings when they knowingly and intentionally cause significant exposures to listed chemicals. Penalties for violating Proposition 65 by failing to provide warnings can be as high as $2,500 per violation per day. Prop 65 also provides for enforcement "in the public interest" by private attorneys, who typically send a required 60-day notice to prospective violators and then seek to reach settlement agreements which usually include a monetary payment (shared by the lawyers and the state) and a correction of alleged labeling violations.
In 2013, the Environmental Protection Agency (EPA) issued a proposed rule that would regulate the amount of formaldehyde emissions from composite wood, such as hardwood plywood, medium-density fiberboard, and particleboard. Additionally, the proposed rule would regulate laminated wood products, impose more precise labeling on covered products and require compliance information to be passed down from manufacturer/importer through the distribution chain.
On December 12, 2016, EPA published a final rule to reduce exposure to formaldehyde emissions from certain wood products produced domestically or imported into the United States. The rule regulates laminated wood products, imposes more precise labeling on covered products and requires compliance information to be passed down from manufacturer/importer through the distribution chain. Any musical instrument made of composite or laminate wood is impacted by the new regulations. In July of 2018, the EPA suppressed a draft health assessment on formaldehyde, suggesting that current regulations protecting the public from overexposure to formaldehyde might not be stringent enough to prevent increased risks of developing leukemia, nose and throat cancer, and other illnesses. NAMM will continue to monitor developments.
CARB2 - California Air Resources Board’s (CARB) Phase 2. CARB2 stands for the California Air Resources Board’s (CARB) Phase 2, a stringent standard for formaldehyde emissions from composite wood products, including hardwood plywood (HWPW), particleboard (PB), and medium density fiberboard (MDF). Composite wood products are panels made from pieces, chips, particles, or fibers of wood bonded together with a resin. In the production of laminate flooring, the core board is made up of medium to high-density fiberboard. This is where the emissions concerns come from.
Note: The formaldehyde emission standards for composite wood products under the EPA final rule, and set by Congress, are identical to the California “Phase 2” formaldehyde emission standards (CARB2). EPA worked to align the other requirements of the federal rule with the California requirements. However, there are a few differences. Unlike the California requirements, among other things, the EPA rule:
- Requires records be kept for 3 years versus 2 years;
- Requires importers to provide import certification under TSCA beginning March 22, 2019;
- Requires manufacturers to disclose upon request formaldehyde testing results to their direct purchasers; and
- Requires laminated products not exempted from the definition of hardwood plywood to meet the hardwood plywood formaldehyde emissions standard beginning March 22, 2024.
Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Regulations. Manufacturers exporting musical instruments to the European Union (EU), or operating within the EU, should be aware of the REACH regulation. Effective June 1, 2007, the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) reg (EC1907/2006) is regarded as the strictest in the world pertaining to chemicals (e.g., glues, resins, etc.) used in the manufacture of a wide variety of products. Further information on REACH can be found here
- Update, 8/26/19: ECHA Requests Public Comment Regarding Use of Lead
Update, 8/26/19: ECHA Requests Public Comment Regarding Use of Lead
The European Chemicals Agency has requested public comment on the consequences of a restriction on the use of lead in a variety of products, including musical instruments. Lead is currently used in mouthpieces made of brass and silver. Specifically, the ECHA would benefit from comments from manufacturers indicating the impact on cost increases, sales, etc., if lead were restricted or banned.
Comments may be submitted until September 7, 2019 at https://echa.europa.eu/calls-for-comments-and-evidence/-/substance-rev/2....
The Confederation of European Music Industries would appreciate copies of any comments submitted. Send to email@example.com.
The issue of lead used in musical instrument mouthpieces has sparked several lawsuits in California under that jurisdiction's Prop 65 requirement to properly label products containing cancer-causing chemicals and other substances.
- Update, 12/12/18: U.S. Customs and Border Protection Requirements for Importing Regulated Composite Wood Products
12/12/18: U.S. Customs and Border Protection Requirements for Importing Regulated Composite Wood Products
The U.S. Environmental Protection Agency (EPA) published the Formaldehyde Emission Standards for Composite Wood Products final rule on December 12, 2016. This final rule established national formaldehyde emission standards and a third-party certification system for regulated composite wood products (i.e., panels) including hardwood plywood, particleboard, and medium-density fiberboard to ensure those panels are compliant in panel form before being sold to end users or fabricated into component parts or finished goods (e.g., furniture, cabinets, picture frames, toys, and many other goods). These requirements apply to regulated products imported into the United States.
Beginning June 1, 2018, regulated composite wood products and component parts or finished goods containing such panels that are manufactured (in the United States) or imported (into the United States) must be certified as compliant with either the Toxic Substances Control Act (TSCA) Title VI or the California Air Resources Board (CARB) Airborne Toxic Control Measures (ATCM) Phase II emission standards, by a Third-Party Certifier (TPC) approved by CARB and recognized by EPA. This TSCA Title VI third-party certification is different than the import certification under Section 13 of TSCA. Additionally, beginning June 1, 2018 and until March 22, 2019, regulated products certified as compliant with the emission standards must be labeled as compliant with either the TSCA Title VI or the CARB ATCM Phase II emission standards.
After March 22, 2019, regulated composite products and finished goods manufactured in or imported into the United States must be certified as TSCA Title VI compliant by an EPA TSCA Title VI TPC and labeled as such; in other words, after March 22, 2019, a CARB ATCM Phase II-only label is not sufficient.
Importer Specific Requirements: Upon request from EPA, importers must make available to EPA within 30 calendar days certain records that document compliance, as outlined in 40 CFR section 770.30(b). Note that U.S. Customs and Border Protection (CBP) requires a five-year record retention cycle for importers (see 19 C.F.R. § 163.4(a)), while the TSCA Title VI regulation requires a three-year retention cycle.
Also, beginning March 22, 2019, importers are responsible for providing a TSCA Section 13 import certification for articles containing regulated composite wood products, component parts, or finished goods imported into the U.S. customs territory in accordance with 40 CFR section 770.30(d). Although June 1, 2018 is the emission standard compliance date, as noted above, importers are not required to complete import certification under TSCA Section 13 until March 22, 2019.
Background on the EPA TSCA Title VI regulation, including webinars, compliance guides, and frequently asked questions can be accessed on the EPA formaldehyde webpage here: https://www.epa.gov/formaldehyde . If you have any questions related to the EPA’s TSCA Title VI program, contact Todd Coleman at 202-564-1208 or firstname.lastname@example.org .
- Update, 7/13/18: California’s Office of Environmental Health Hazard Assessment (OEHHA) Offers Resources
Update, July 13, 2018
California’s Office of Environmental Health Hazard Assessment (OEHHA) offers the following resources for businesses who have questions about the new Proposition 65 warning regulations that will become fully effective on August 30. 2018. (NOTE: These new regulations do not determine when a warning is required, they provide guidance for businesses once they have decided to provide a warning for a given exposure to a listed chemical. Other regulations can help businesses determine when a warning may be required. See Articles 2, 7 and 8 of the Proposition 65 regulations available at this link: California Code of Regulations)
- Questions & Answers for Businesses about the new warning regulations
- Q&A on Internet and Catalog warnings
- A side-by-side comparison of the old and new regulations
- Sample warnings (including translations into other languages)
- Warning symbols in various sizes are available here
California Chamber of Commerce Proposition 65 Coalition
A coalition of more than 200 industry groups and individual businesses is working together to ensure that Proposition 65 is not misused by individual attorneys who use the law solely for personal financial gain. The coalition reviews, comments, and testifies on regulatory and legislative developments related to Proposition 65 warning requirements, chemical listings, compliance issues, and litigation reform. To join the coalition contact: Deanna Tibbett at (916) 444-6670.
- Update, 4/10/18: American National Standards Institute Proposal
April 10, 2018. NAMM Statement in response to the American National Standards Institute Proposal. View here.
- Update, 4/4/18: Federal Register Notice
On April 4. 2018, the Environmental Protection Agency issued a Federal Register notice with updated compliance dates for the agency’s Formaldehyde Emissions Standards for Composite Wood Products Final Rule. This change is the result of a lawsuit filed by the Sierra Club which had challenged the agency’s extension of the compliance date to December 12, 2018 from December 12, 2017. The result of the Court’s decision is the following:
- By June 1, 2018, regulated composite wood panels and finished products containing such composite wood panels that are manufactured (in the United States) or imported (into the United States) must be certified as compliant with either the TSCA Title VI or the California Air Resources Board (CARB) Airborne Toxic Control Measures (ATCM) Phase II emission standards, which are set at identical levels, by a third-party certifier (TPC) approved by CARB and recognized by EPA. Previously, these products were required to be TSCA Title VI compliant by December 12, 2018.
- Until March 22, 2019, regulated products certified as compliant with the CARB ATCM Phase II emission standards must be labeled as compliant with either the TSCA Title VI or the CARB ATCM Phase II emission standards. Regulated products manufactured in or imported into the United States after March 22, 2019 may not rely on the CARB reciprocity of 40 CFR 770.15(e) and must be certified and labeled as TSCA Title VI compliant by an EPA TSCA Title VI TPC with all of the required accreditations.
- After March 22, 2019, CARB-approved TPCs must comply with additional accreditation requirements in order to remain recognized as an EPA TSCA Title VI TPC and to continue certifying products as TSCA Title VI compliant.
The information is available under the “Compliance Date Amendment” portion of the Formaldehyde Emission Standards for Composite Wood Products website.
- Update, 12/12/16: EPA Issues Final Formaldehyde Rule
Note: Any musical instrument made of composite or laminate wood is impacted by the new regulations.
On December 12, 2016, the Environmental Protection Agency has issued its long-overdue final rule setting formaldehyde emission standards for composite wood products such as plywood, particleboard, etc. The standards, mandated by a federal law, track closely to a California state standard established several years ago.
The rule's emissions levels go into effect December 12, 2017 for all panel manufacturers. On the same date, product manufacturers and laminators will be required to use compliant core material in their products. Composite wood subject to the rule is used in such products as instrument cases and electronic keyboards.
In addition to the standards, EPA has established a new certification requirement for imports of composite wood panels or products made with composite wood. The certification requirement is effective December 12, 2018.
Text of EPA's final formaldehyde rule can be found here.
To learn more about formaldehyde and how proposed regulations can impact composite wood products, please visit the EPA for more information.
- CA Prop 65: Industry-Relevant FAQs
- What Are the Most Significant Changes to the Proposition 65 Warnings For Consumer Products?
Since the original warning requirements took effect in 1988, most Proposition 65 warnings simply state that a chemical is present that causes cancer or reproductive harm, but they do not identify the chemical or provide specific information about how a person may be exposed or ways to reduce or eliminate exposure to it. New OEHHA regulations, adopted in August 2016 and that took effect on August 30th, 2018, change the safe harbor warnings which are deemed to comply with the law in several important ways. For example, the new warnings for consumer products will say the product “can expose you to” a Proposition 65 chemical rather than saying the product “contains” the chemical. They will also include:
- The name of at least one listed chemical that prompted the warning
- The Internet address for OEHHA’s new Proposition 65 warnings website, www.P65Warnings.ca.gov, which includes additional information on the health effects of listed chemicals and ways to reduce or eliminate exposure to them
- A triangular yellow warning symbol on most warnings
- How Do the New Warnings Compare to the Current Warnings?
A typical current Proposition 65 warning states, “WARNING: This product contains a chemical known to the State of California to cause cancer.” A sample new warning might look like this:
"WARNING This product can expose you to chemicals including arsenic, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov."
- Will Businesses Be Required to Provide the New Warnings?
No. The regulation states that a business is not required to use the new safe harbor warning system to comply with the law. However, using the safe harbor warnings is an effective way for businesses to protect themselves against Proposition 65 enforcement actions. Businesses that use the safe harbor warnings are deemed compliant with the law’s requirement for clear and reasonable warnings. Businesses have the option to provide different warnings if they believe they comply with the law. Additionally, small businesses with fewer than 10 employees are exempt from Proposition 65’s warning requirements.
- Will Products Manufactured Before August 2018 Need to Use the New Warnings?
No. Products manufactured before August 30, 2018 will not need new warnings if they meet the requirements that were in effect at the time of their production.
- CA Prop 65: More Information on Warning Requirements
More Information on Proposition 65 Warning Requirements:
For direct assistance, please contact the Proposition 65 Implementation Program office directly at (916) 445-6900 or email P65.Questions@oehha.ca.gov
Formaldehyde Update: The current prop 65 list currently includes more than 850 chemicals, including formaldehyde, potentially impacting any musical instrument made of composite or laminate wood.
Styrene Update: While Styrene, an ingredient of acrylonitrile butadiene styrene (ABS, a plastic widely used in our industry), was listed as known to cause cancer under Proposition 65 in April of 2016, as of May 2017, the CA Code of Regulations has been amended to downgrade the risk, listing Styrene at a “No Significant Risk Level”.