California’s Draft Green Chemistry Regulations Presentation Transcript
California Dreaming or Reality?
California’s New Paradigm in Chemicals and Products Management Could
Be Coming to a Store Near You.
A Legal Perspective
Webinar of the
American Bar Association
Section of Environment, Energy & Resources
November 15, 2010
Philip A. Moffat
Overview of Presentation
• Scope of Regulation
– What’s covered
– Who’s covered
• Regulatory Process
– Public & regulated community participation
• Dispute Resolution
• Protection of Confidential Information
• Practical Considerations & Concluding Thoughts
• Regulation focuses on consumer products with the goal
of encouraging the use of safer alternatives to Chemicals
• It applies to:
– “[A]ll consumer products placed into the stream of
commerce in California,” and
– “all chemicals that exhibit a hazard trait and are
reasonably expected to be contained in products
placed into the stream of commerce in California.”
§§ 69301(b)(1) and 69302.1(a).
What’s a Consumer Product?
• Broad definition: “a product or part of the product that is
used, brought, or leased for use by a person for any
purposes.” Health & Safety Code § 25251.
– Individual chemicals packaged as such and placed into the stream
of California commerce are included
– Components also included
• Easier to identify what’s not encompassed:
– Prescription drugs and devices (and packaging)
– Dental restorative materials (and packaging)
– Medical devices (and packaging)
– Mercury-containing light bulbs (until 12/31/2011)
• Products placed into the stream of California
commerce solely for manufacturing those products
that are excluded from the definition of consumer
• Products manufactured in, stored in, or transported
through California for use solely outside California.
• Unintentionally-added chemicals not known to
be present (with due diligence).
Who Has Obligations?
– The producer of a consumer product
– Owner or licensee of the brand name or trademark
• Responsible Entities (RE)
– Owner or licensee of the brand name or trademark
– California importer
– California distributor
– Any party to a contract with a California importer, distributor, or
retailer concerning a consumer product, unless contract specifically
prohibits placing into stream of California commerce
• Remove Product from CA Commerce:
– Individual RE that is not a manufacturer notifies DTSC. § 69301.4(e)(1)
• Need contract w/ supplier ensuring supplier will comply w/ regs
• Others may be continuing to place product on market
– Manufacturer submits a Product Removal Notification or, if
manufacture is also an RE, may provide other substantiation of
removal. Compare § 69301.4(e)(2) w/ § 69301.4(f)(4).
• Manufacturer Removes All Chemicals of Concern from
Product & Files Chemical Removal Notification.
– No chemical replacement or addition may occur. §§ 69301.2(15),
69301.4(f)(4), 69302.5(a) and others.
• DTSC develops two lists of chemicals:
– Chemicals Under Consideration
– Priority Chemicals
• DTSC develops two lists of products:
– Products Under Consideration
– Priority Products
• DTSC evaluates available information, and may issue
data and information call-ins to manufacturers and
responsible entities. §§ 69301.6, 69302 and 69303.
• Any person may petition to add to lists, but not delete.
§ 69304. No clearly established process for industry to
comment during DTSC review of petition.
– Federal and/or other California programs address
same public health and environmental threats
throughout the product life cycle – requires “clear &
convincing evidence” from claimant
– No exposure pathway by which chemical might
threaten health or the environment in California –
same burden of proof §§ 69302.1 and 69303.1.
• Public comments prior to finalizing chemical lists.
§§ 69302.2(b) and 69303.2(d).
• After a Priority Chemicals List is finalized, DTSC can begin
posting on its website the description and identity of
products determined to contain a Priority Chemical. § 69302.2(b).
• Compressed Timeline for Initial Prioritization:
– Initial proposed list of Chemicals Under Consideration due by
June 1, 2011
– Final initial list of Priority Products due by December 1, 2013
• Summary of Obligations of Responsible Entities (REs):
– Respond to data call-ins. § 69301.6.
– After a product is listed as a Priority Product, must file a Priority
Product Notification with DTSC. § 69303.5.
Alternatives Assessment – Tier I
• Applies after a chemical has been added to the final
Chemicals Under Consideration or Priority Chemicals List.
• Responsible entities must notify DTSC prior to placing into CA
commerce any voluntary product reformulations, redesigns, or
replacements that had chemical removed or reduced.
• Tier I AA Report must accompany notice and include:
– Rationale for reformulation
– Reductions in adverse health or environmental impacts
– Hazard traits of any substitute chemicals
• May avoid “regrettable substitutions,” but is it an impediment
Alternatives Assessment – Tier II
• Lead Assessor Prepares AA - either a Qualified Third-Party Assessment
Entity or Qualified In-House Assessment Entity.
– However, all AAs must be prepared or verified by a third party.
• AA Work Plan:
– Submitted 180 days after posting of final Priority Product list
– Scope of work must include evaluation of same “methodologies and system
boundaries” for both the Priority Product and potential alternatives
– Required elements are extensive
• AA Reports:
– DTSC specifies completion date
– Explain omission of any life cycle segments
– Include rationale for alternative selection or retention of Priority Product
– May propose regulatory response based on the selected alternative
– DTSC determines what, if any, regulatory response is required and sets an
• De minimis exemption may be available. §§ 69305.2 – 69305.10
• DTSC has a range of options and will request public comment on
– No response
– Product information to consumers
– End-of-life management
– Use restrictions
– Exposure limits
– R&D challenge §§ 69306 – 69306.8.
• REs required to notify retailers about required response, and
DTSC upon completion of response. § 69306.9.
• Exemptions available for certain responses that also conflict
or duplicate CA or federal law or int’l trade agreements ratified by
Senate – require “clear & convincing evidence” from claimant. §
• Two dispute resolution processes established:
formal and informal. § 69307 – 69307.7.
– Formal applies to challenges of certain regulatory
response actions (e.g., sales prohibitions), as well as
requests for exemptions from many of the potential
– Informal applies to all other matters (e.g., listings), and
includes opportunity to appeal to DTSC Director.
• Exhaustion of administrative remedies typically
required before seeking judicial review.
• REs are jointly & severally liable for noncompliance.
• Many options available to DTSC:
– Notice of Noncompliance to all REs w/ a cc to all other
known entities in supply chain. Id.
– Added to Failure to Comply List if not remedied or
exempted after receiving notice. Id.
– Additional fines, penalties, and other enforcement per
Article 8, Chpt. 6.5, Div. 20 Health & Safety Code. § 69301.4(g).
– Manufacturers that fail to respond to information request
may be added to Failure to Respond List. § 69301.6(d)(3).
Protection of Confidential Information
• Complicated process for protecting confidential information,
including trade secrets – six pages of regulations, expanding
the process set out in the enabling statute.
• Requires detailed legal analysis of the regulation, Health &
Safety Code section 25257, any other applicable California
statute, and the California Public Records Act as applicable.
• Thirty (30) days to seek judicial review of DTSC determination
of inadequate substantiation/justification of trade secret claim.
• Thirty days to seek judicial review after notice from DTSC that
information is subject to disclosure in response to a Public
Records Act request.
§§ 69310 – 69310.6.
Practical Considerations and