California Proposes Amendments to Air Cleaner Regulation
On June 3, 2019, the California Air Resources Board (CARB) held a public workshop in preparation for its plans to initiate rulemaking later this year to amend its regulation on indoor air cleaning devices. In advance of official rulemaking, CARB has released a draft of the proposed amendments designed to strengthen the effectiveness of the regulation, streamline the certification process, and provide additional clarifications on key requirements. Notably, the proposed amendments would eliminate the exemption for in-duct air cleaning devices that has been in place since the regulations were initially adopted in 2007. CARB is continuing to accept public input on this draft (see workshop announcement).
Background
In 2007, CARB adopted the indoor air cleaner regulation pursuant to California Assembly Bill 2276 in response to emerging concerns about indoor ozone emissions. While several states and the U.S. Environmental Protection Agency warn against using ozone generators in occupied indoor spaces, and the Food and Drug Administration limits ozone emissions from medical air cleaner devices, California’s program is unique in its breadth and coverage.
The regulation generally imposes certification, ozone testing, electrical safety testing, labeling, notification, and recordkeeping requirements on covered devices intended for use in occupied spaces in California. The ozone emissions concentration limit is 0.050 parts per million (ppm). Personal air cleaners, air cleaners used in motor vehicles, stand-alone air cleaners, and products with a primary purpose other than air cleaning but that include an air cleaner are all examples of covered devices.
Certain exemptions are provided in the current regulation for industrial-use devices. In addition, due to the lack of available test methods and sales data at the time of adoption, the regulation exempts “in-duct” air cleaners that are physically integrated into HVAC systems.
In the years since the regulation was finalized, CARB has observed a significant increase in the use of air cleaners in the state, including in-duct air cleaners, in response to recent large fires, floods, and indoor marijuana use. CARB believes that this market data along with other new sources of information, including revisions to test methods and the availability of a test method for in-duct devices, warrant regulatory changes.
Summary of Key Changes
Required Certification for In-Duct Air Cleaners
The proposed amendments would no longer exempt electrical in-duct air cleaners. CARB has identified an ozone test method for in-duct air cleaners and has determined these cleaners are being sold and used in California, necessitating regulation along with the other covered devices. Purely mechanical in-duct air cleaners would still be exempt, subject to certain CARB documentation and approval requirements.
Expanded Definition of Covered Devices
The definition of indoor air cleaning devices covered by the regulation would be amended to include electric units that pull air in from outside and are not purely mechanical, such as window units that use an ionizer. Additionally, the definition would make it clear (consistent with CARB’s longstanding position) that personal devices and dual-function devices must also comply.
Refined Industrial Use Exemptions
The proposed amendments would enhance requirements for devices that meet one of the industrial use exemptions from certification. These include adjustments to the required label advisory and statements in accompanying product literature indicating that the device is intended for use in unoccupied spaces and a requirement that devices are manufactured, marketed, advertised, and labeled consistent with the exempt industrial use. Industrial use exemptions unrelated to air cleaning (e.g., water purification, mold remediation, pulp, and paper processing) would be eliminated, as these industrial uses are regulated elsewhere.
Streamlined Certification Process
The proposed amendments would streamline some aspects of the certification process and would clarify when recertification is needed. Specifically, certain portable devices using ultraviolet light within a certain wavelength would no longer need to be certified for ozone. Additionally, the proposed amendments would expressly state CARB’s current practice of requiring manufacturers of devices that make medical claims to submit proof of application for FDA approval. The recertification requirements would also be updated to require recertification only when a device is altered or rebranded.
Clarified Online Advisory Requirements
Online retailers and sellers of indoor air cleaning devices for non-industrial use that are not certified in California (for example, indoor devices not manufactured, sold or supplied in California but advertised online or in a catalog) are currently required to include an advisory on the product web or catalog page that warns potential California consumers that the device “Does not meet California requirements [and] cannot be shipped to California.”
The proposed amendment would require online retailers and sellers to specifically display the advisory before consumers enter their purchase information.
Shifted Reporting and Recordkeeping Responsibilities
CARB seeks to reduce reporting requirements by increasing recordkeeping requirements; manufacturers would need to maintain updated notice records currently required to be submitted to CARB for at least 5 years and to maintain additional device records for as long as the device is sold or in commerce under the proposed amendments.
Additional Updates
CARB proposes updates to the legal references, test standards, qualified testing labs, and required labeling language on both medical and non-medical devices to bring the regulation current.
Next Steps
Manufacturers, retailers, and sellers of air cleaners, and especially manufacturers of in-duct air cleaners or air cleaners that may require re-certification, as well as online retailers of these devices, should make note of the proposed amendments. CARB is accepting questions and comments on the draft proposed amendments now. The official public comment period on proposed amendments is expected to begin in October and the next CARB hearing on the amendments is scheduled for December 12-13, 2019. For more information from CARB, click here.
Beveridge & Diamond's Consumer Products industry group works with U.S. and multinational companies that make, distribute, transport, or sell consumer products in a hyper-competitive and evolving consumer goods market. We help them identify, understand, and comply with complex regulatory requirements throughout the product lifecycle. For more information, please contact the authors.
