DTSC Releases Draft “Green Chemistry” Regulations on June 23, 2010

On June 23, 2010, DTSC released its anxiously anticipated draft regulations implementing AB 1879, the 2008 Green Chemistry Initiative law intended to “accelerate the quest for safer products.” California Health & Safety Code section 25252 (AB 1879) requires DTSC to promulgate regulations: (1) identifying and prioritizing “chemicals of concern” in consumer products; (2) establishing methods for analyzing whether safer alternatives may exist to “chemicals of concern” currently used in consumer products; and (3) developing appropriate regulatory responses based on the results of the safer alternatives analyses. The regulations are currently set to take effect Jan. 1, 2011, after being finalized. The draft regulations are 61 pages long, include numerous definitions and cross-references to other existing regulatory programs, and are generally very complex. Determining the potential application of these draft regulations to a specific product, and the obligations of any particular commercial entity engaged in the purchase or sale of any such product, requires a detailed review of the regulations. Nonetheless, we summarize a few of the key provisions below.

The draft regulations apply to all “consumer products” made available for use in California and creates a systematic, science-based process to evaluate “chemicals of concern” in such products. “Consumer products” include a product, or any part of a product, that is used, [bought], or leased for use by a person for any purpose. However, the regulations do not apply to any products excluded from the definition of “consumer products” set forth in CA Health & Safety Code section 25251. Important categories of products excluded as a result include: 1) any “dangerous drug or device” as defined in CA Business & Professions Code § 4022 (i.e. prescription drugs and medical devices); any “food” as defined in CA Health & Safety Code § 109935, which includes any food or drink intended for use by humans or animals; and 3) any pesticide subject to regulation under either the federal FIFRA or CA Food and Agricultural Code § 12753. Over-the-counter medications and herbicides are not excluded. Moreover, the draft regulations are inapplicable to any consumer products manufactured in California, but intended solely for shipment and use outside of California.

The draft regulations require DTSC to create a list of “chemicals of concern” which would include carcinogens, mutagens, neurotoxins and compounds that disrupt hormones, persist in the environment, or accumulate in human bodies. DTSC is also required to identify “priority products,” which are consumer products heavily used by children, pregnant women, the elderly and other sensitive populations, and require manufacturers of those products to seek safer alternatives to any “chemicals of concern” used in their products. Manufacturers of “priority products” will have to submit work plans for the safer alternative assessments of their products that meet a long list of specified regulatory criteria, which will be posted on DTSC’s website. Once DTSC determines that the manufacturer’s work plan complies with those criteria, it will assign a deadline for the completion of the assessments. These safer alternatives assessments may be undertaken by third-party consultants or by manufacturers who have been certified by DTSC.

Moreover, manufacturers of any products that contain “chemicals of concern” could be required to: 1) carry warning labels; 2) have their products recalled; or 3) be asked by DTSC to replace “chemicals of concern” with safer alternatives.

The primary obligations of the draft regulations are applicable to the “manufacturer” of any consumer product subject to the regulations. A ‘manufacturer,” however, can include a number of classes of entities, including both 1) the person who produces the consumer product, and 2) the first person who makes that consumer product available for use in California, which could include the producer of the product (again), the private label manufacturer of the product, the importer of the product, or even the distributor of the product, if it does not maintain such control over the product upon its entry into California to prevent its use by a California consumer. The producer, private label manufacturer, and importer of a consumer product, who may not be one and the same entity, are jointly and severally responsible for complying with the requirements of these regulations applicable to the “manufacturer” of the product.

The draft regulations provide for tough governmental enforcement if a manufacturer fails to timely comply. For example, DTSC could prohibit any person (i.e. a distributor or retailer) from selling or offering for sale a covered consumer product unless that person has a certificate of compliance from the manufacturer/supplier. The certificate would have to state that the product complies with AB 1879 and identify any regulatory response imposed by DTSC. Also, if a “priority product” manufacturer is deemed in non-compliance by DTSC, the manufacturer must notify retailers that its “priority product” cannot be sold in California and must recall the “priority product” and provide and fund a take-back mechanism for retailers. Any person who fails to comply with the regulations is subject to enforcement actions, fines and penalties under Article 8 of Chapter 6.5 of Division 20 of the California Health and 3 Safety Code.

The draft regulations can be found here.