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Emerging Chemical Regulations:
California’s Green Chemistry
Initiative & Other Adventures
Presented at: Pacific Industrial & Business Association Conference
January 19, 2011
Maureen F. Gorsen, Esq.
Marisa E. Blackshire, Esq.
Alston + Bird, LLP
The New Frontier: (Everywhere)
REACH
European Community Regulation on Chemicals and their Safer Use (Registration, Evaluation, Authorisation and Restriction of Chemical Substances)
Effective June 1, 2007
Primarily about providing better and earlier information on the intrinsic properties of chemicals
Also calls for progressive substitution of the most dangerous chemicals when suitable alternatives are identified
Example: December 2011 will ban cadmium in jewelry, plastics and brazing sticks
EU Cosmetics Directive
Revised in 2003 to ban 1,100 chemicals from cosmetics
New “EU Cosmetic Products Regulation” adopted November 2009
Replaces Cosmetics Directive
Most provisions become applicable in July 2013
Central digital platform to replace all existing national notification systems
Enhanced coordination of market surveillance activities
Clearer provisions for the content and format of product safety assessments and product information files (PIF)
Responsibilities of the actors in the supply chain will be clearly defined and assigned to the responsible person
TSCA
Federal Toxic Substances Control Act (1976)
Often described as “toothless,” “meaningless,” “outdated”
TSCA Reform? Likely going nowhere in the short term
“TSCA reform is probably not going to be going anywhere,” said James Aidala, former Environmental Protection Agency official, who is now a research associate at the Washington law firm of Bergeson & Campbell P.C. “There are not going to be any amendments at all, let alone major amendments” of the 35-year-old Toxic Substance Control Act, Aidala said at the Global Chem conference in Baltimore.
“This is going to be a tough Congress to pass TSCA legislation,” agreed Mark Duvall, head of the TSCA practice at Beveridge & Diamond P.C. “But incremental progress is possible.”
Result: Regulation at the state and local level
Maine, Washington, California
California’s
“Safer Consumer Products” Regulations
1. What is California's Green Chemistry program?
2. Why should you be concerned about it?
3. What should you be doing about it now?
What is California’s Green Chemistry Program?
See also: http://www.dtsc.ca.gov/SCPRegulations.cfm
CaliforniaGreen Chemistry Initiative Final Report
CaliforniaGreen Chemistry Initiative Final Report
On DTSC website: http://www.dtsc.ca.gov/GreenChemistry
Six Recommendations
Move toward a cradle-to-cradle economy
Expand pollution prevention
Accelerate the quest for safer products
Create on-line product ingredient network
Develop a 21st century green chemistry workforce
Create an online toxics information clearinghouse
New Design Approach
Background
What forces are at work in California resulting in these regulations?
Public health - children’s biology
Marine biology
Ocean litter – plastics, Pacific Gyre
Skyrocketing costs of toxic waste sites
Childhood Toxics Exposure from
Products
Concerns about Ocean Litter
Pacific Gyre
Two Laws Passed – September 2008 SB 509 (Online Toxics Clearinghouse) and AB
1870 (Alternatives Analysis).
Identify specific data needs
Appoint Green Ribbon Science Panel to prioritize data needs
Identify and prioritize chemicals of concern
Develop science-based alternatives assessment decision-making tool
Develop criteria for regulatory responses
Health & Safety Code, Art. 14, Green Chemistry
Key Dates in Regulatory Timeline
California Green Chemistry Initiative – 2006-2008
Legislature passes two laws - AB 1879/SB 509 – September 2008
DTSC releases draft regulations
August 2009 – Straw Draft Proposal
March 2010 - Conceptual Framework Proposal
June 2010 – Workshop Draft Proposal
September 2010 – APA Draft Regulatory Text Released
November 16, 2010 – APA 15 day Revised Text Released
December 3, 2010 – End of public comment period
August 12, 2011 – Notice of Decision Not to Proceed with 2010 Text published in California Notice Register
October 31, 2011 – New Informal Draft Proposal Released
Big Picture
Is the process too complex, labor intensive, prohibitively expensive?
Are objective standards for compliance set forth in the regulations?
Are there too many listing phases?
Is listing based on hazard or risk?
Will innovation be stifled?
Will the regulations result in gridlock or litigation?
Specifically
When is a company subject to a data requests?
Who is required to do alternatives analysis?
When is it triggered?
What does it look like?
What regulatory outcomes will it produce?
How are trade secrets protected?
Does DTSC have the funding to undertake this effort effectively?
What is a “Consumer Product”
Broad
“a product or part of the product that is used, brought or leased for use by a person for any purposes.”
Better Question: What is not a “Consumer Product?”
Prescription drugs and devices (including packaging)
Dental restorative materials (including packaging)
Medical devices (including packaging)
Food
Pesticides
Will California’s New Rules Apply To Me?
(Hierarchy of Liability)
You make “consumer products” for sale in California
“Manufacturer” means any person who manufactures a product, or any person that controls the specifications and design of, or use of materials in a product that is placed into the stream of commerce in California. § 69501.2(a)(49) and (50).
You sell “consumer products” in California
“Importer” means a person who imports a consumer product into California. § 69501.2(a)(41) and (42).
“Retailer” means a person who sells, supplies, or offers for sale, directly to a consumer in California, a consumer product not produced by that person. § 69501.2(a)(69).
How Will Regulations Be Triggered?
1. List Approach
What is a chemical of concern?
Appears on a govt list
Any chemical that would be haz waste
Any potential to harm humans or environment
What is a product of concern?
2. Petition
Currently no role for industry in the petition process (scary)
3. Biomonitoring
Initial Lists of Chemicals
Exhibits a hazard trait or an environmental toxicological endpoint as identified in OEHHA regulations*, and:
Is on one of the 22 lists contained at § 69502.2(a); or
Is identified by the Department based upon the factors contained at § 69502.2(b)
At least 3,000 chemicals
All hazard traits and environmental toxicological endpoints treated the same
* (Almost any chemical might be described as exhibiting a hazard trait or an environmental toxicological endpoint under draft OEHHA regulations: http://www.oehha.ca.gov/multimedia/green/index.html)
Initial Set of Product Types
December 2010 draft
Children's Products
Personal Care Products
Household Cleaning Products
October 2011 draft
Does not limit the initial set of product types
However, DTSC indicates an intent to include 2-5 products on the initial list of Priority Products
Selection of Priority Product
Initial Criteria
Potential Adverse Impacts and Exposures
Availability of Information
Other Regulatory Programs
Safer Alternatives
Key Prioritization Criteria
COCs have significant potential to cause adverse public health and environmental impacts
Widely distributed in commerce/widely used by consumers
Significant potential for public and environmental exposures to COCs in quantities that raise health or environmental impact concerns
Likely to be exposures through inhalation or dermal contact
What Will I Be Required To Do?
Process
Examine safer ways to make your product – by conducting a lifecycle based alternatives analysis
Provide toxicity data on ingredients (and their potential alternatives) in your product
Submit your product design process to a public review process
Possible Regulatory Outcomes
Substitute ingredient, label, end-of-life stewardship program, fund R&D
Failure to Comply?
Fines, penalty and other enforcement per Article 8, Ch. 6.5, Div. 20 of the H&S Code
What Does The Alternatives Analysis Look
Like?
Hazard or risk based?
Human risk vs. environmental risk?
What contributes to risk in either category?
How are these risks best measured?
*Good news is, this draft provides flexibility but still some outstanding questions.
Risk Assessment v. Comparative Chemical
Hazard Assessment
Risk assessment addresses probability and helps to answer,
“Is it safe enough?”
Comparative chemical hazard assessment helps to answer,
“Which is safer?”
Green Screen -
A Tool for Comparing Hazard Traits
Green? Says who?
Know Your Product’s Footprint
Environmental Footprint for a Timberland Shoe
Sample Environmental Footprint
Certified Assessors/Accreditation Bodies
After January 1, 2015, AAs required to be completed under the charge of a Certified Assessor. §§ 65505.1(d) and 66508.
Can have existing employees certified, but certification must be obtained from an independent Accreditation Body. § 69508.1.
Who might become accredited? Teaching tools? “Economic Interest?”
1. LCA
2. iSustain
3. TPI Calculator
4. USEPA DfE
1. Safer Products
2. Chem Alts Assessment
5. CleanGredients
6. C2C Product Certification
7. Ecolabels
Potential Regulatory Outcomes
No Further Action
More Data
Product Labeling
Product Restrictions
Product Bans
Product Recall
Management Controls (BMPs)
End of Life Management (including Financial Guarantee)
Research and Development and Challenge Grant Funding
Prop 65 vs. Green Chemistry
Two hazard traits - carcinogens and reproductive toxins
One regulatory response – warning
Citizen suits in court to enforce
49+ hazard traits – incl. aquatic toxicity, mutagenicity, endocrine disruption
Multiple regulatory responses – ban, substitute, extended producer responsibility, fund R&D, label
Citizen petitions to require regulatory response to DTSC (not courts)
EU REACH vs. Green Chemistry
KEY DIFFERENCES
Focus - Chemicals
Toxicity and hazard traits of chemicals and ingredients
Focus - Product Design
Lifecycle impacts on environment from manufacture, transport, use and disposal of product
What’s Next?
December 30, 2011 – Public comment period on Informal Draft closed
Next steps? (Proposed)
February 2012 – New APA Draft Regulatory Text released
Fall 2012 - Adoption
*Largely depends on input received, scope of future revisions
Opportunity to Influence Content?
Your expertise is critical
AIHA Position Statement Adopted November 6, 2011
“Regulatory policy reform should be developed in a way that promotes informed decision making in the production and uses of existing and new chemicals while not stifling innovation.”
Are the proposed regulations practical, meaningful, legally defensible?
Your practical, science-based experience should inform the development of key regulatory components
“Reliable Information”
Identification of Chemicals of Concern
Hazard Traits/Environmental and Toxicological Endpoints
De Minimis Level - .01% for 9 specific hazard traits (e.g. carcinogens)
Alternatives Assessment
What You Should Be Doing To Prepare?
Review the Initial List of Chemicals
Do I use any of them?
Do I have any toxicity data on them?
Are there safer substitutes?
Being Selected as a Priority Product
How might one of my products be selected?
What steps can I take to avoid being placed on the list?
How do my supply chain contracts protect me?
Is my trade secret information adequately protected?
Do I have any practical, science-based reasons why certain provisions require revision in light of the above?
Ex: Trade secret protections great enough? Too burdensome?
More Specifically…
Identify the potentially vulnerable components of your products
Determine the ingredient composition of your products and review against chemicals of concern list
Identify potential alternatives to achieve same function
Implement new supply chain contracts
Protect right to cancel
Protect your options for reformulation
Revise compliance with all laws and regulations sections
Allocate risks along supply chain
Consider the need for additional customer communication and what will be needed when candidate lists are published
Plan for media inquiries
Plan for regulatory inquiries
Review intellectual property to ensure you can maintain trade secret information during public review process of product design
QUESTIONS?
For more information, contact:
Marisa E. Blackshire
Alston + Bird, LLP
213-576-1008
