Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham

On March 28, 2018, the Superior Court of California, Los Angeles County, issued its Statement of Decision (Phase II) (Defendants’ Alternative Significant Risk Level (ASRL) Affirmative Defense) that found that the defendants failed to meet their burden of proof on their ASRL affirmative defense.  Council for Education and Research on Toxics (CERT) v. Starbucks Corporation (Starbucks), No. BC435759 (L.A. Super. Ct., filed April 13, 2010).  CERT’s (plaintiff) complaint alleged that Starbucks, along with 18 other defendants (the total later reached 91 defendants when a second action was filed (now consolidated)), that sell ready-to-drink coffee failed to provide warnings to consumers that the coffee sold contained high levels of acrylamide, a carcinogenic chemical, in violation of Proposition 65 (Prop 65).  The defendants denied the material allegations and asserted various affirmative defenses, violation of the First Amendment, and federal preemption.  According to the order, the parties did not dispute that acrylamide, listed as a carcinogen by the International Agency for Research on Cancer (IARC), and under Prop 65 since 1990, is listed by the State of California as a chemical believed to cause cancer; or that they failed to provide warnings to consumers that the ready to drink coffee they sold contained high levels of acrylamide.  

In Phase I of the trial, the court came to a similar conclusion, that defendants failed to meet their burden of proof by preponderance of evidence on their affirmative defenses of “no significant risk level,” First Amendment, and federal preemption to avoid the requirement of cancer warning labels as to the existence of acrylamide in brewed coffee.  The trial on Phase II of the case ran from September 2017 to November 2017 and post-trial briefs were filed in December 2017 and January 2018.  The order states that to have prevailed on their ASRL defense, defendants needed prove all of the below, which they failed to do:

  1. Establish that acrylamide is created by cooking or processing necessary to render the coffee safe or palatable (defendants only argued that acrylamide levels in coffee cannot be reduced at all without negatively affecting safety and palatability);
  2. Demonstrate that “sound considerations of public health” justify applying an alternative (less strict) risk level (defendants did not counter plaintiffs evidence that consumption of coffee increases harm to the fetus, infants, children, and adults; and the court found their proffered evidence that coffee itself confers some benefit to human health to be unpersuasive); and
  3. Present persuasive evidence of what would be an appropriate alternative risk level, taking into account the identified public health considerations (defendants did not conduct a quantitative risk assessment of the risk of cancer from exposure to acrylamide in coffee, necessary to prove an alternative risk level for acrylamide in coffee).

The ASRL affirmative defense is grounded on an exemption to the cancer hazard warning requirement under Prop 65, but as the defendants were not able to prevail on this defense, they will now be required to provide the Prop 65 warning language on their ready-to-drink coffee products, but the order does not specify any details regarding this.  The decision also exposes the defendants to liability in terms of millions in fines.  The defendants have until April 10, 2018, to file objections to the decision.


 

The attorneys, scientists, policy experts, and regulatory advisors of Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) endeavor year-round to keep you informed on key developments as they happen, and prepared for looming changes and deadlines, to help you maintain compliance and competitive advantage as you market your products throughout the world. As the new year begins, we offer you this look back at the top stories of 2016 (as measured by clicks, reads, and shares by readers of our blogs and e-mails), a year that was full of surprises and dramatic shifts -- many of which will play out well into the new year.

 

June 22, 2016

TSCA Reform:  An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA

 

September 22, 2016

Proposition 65:  OEHHA Adopts Revisions to Its Proposition 65 Warning Regulations

 

August 8, 2016

TSCA Reform: Proposed Changes to SNUR Procedures Would, Perhaps Inadvertently, Result in Disclosure of CBI to Third Parties/Possible Competitors

 

June 29, 2016

TSCA Reform:  EPA Publishes First Year Implementation Plan

 

April 8, 2015

K-REACH:  List of Priority Existing Substances Submitted for Consultation

 

December 20, 2016

TSCA:  EPA Amends Procedures for TSCA Section 6 Rulemaking

 

January 6, 2016

EPA Releases Preliminary Risk Assessment for Neonicotinoid Insecticide Imidacloprid

 

January 8, 2016

EPA Sued Over Guidance Classifying Seeds Coated with Neonicotinoid Insecticides as Treated Articles Exempt from Registration under FIFRA

 

February 10, 2016

Bayer Announces That It Will Not Submit Voluntary Cancellation Requests for Flubendiamide

 

October 19, 2016

Brazil Delays Promulgation of Final Industrial Chemicals Regulation

 

October 6, 2015

EPA Announces Revisions to Its Worker Protection Standard

 

September 28, 2016

EPA Announces Regulatory Determinations on MCANs and PMNs

 

January 13, 2016

EPA Denies SDA Nomenclature Petition, But Options for Adding Biobased Sources Remain Open

 

December 1, 2016

Brexit -- An Overview of Transformative Developments and Their Potential Impact on European Chemical Laws

 

 

Top Articles Authored by B&C:

 

Kathleen M. Roberts, Richard E. Engler, Ph.D., Charles M. Auer, Lynn L. Bergeson, "An Analysis of Section 8 of the New Toxic Substances Control Act," BNA Daily Environment Report, August 9, 2016.

 

Lynn L. Bergeson, Charles M. Auer, "An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders," Industrial Biotechnology, Volume 12, Issue 4, August 2016.

 

Charles M. Auer, "Old TSCA, New TSCA, and Chemical Testing," BNA Daily Environment Report, August 16, 2016.

 

L. Bergeson, B. Auerbach, L. Campbell, T. Backstrom, S. Dolan, J. Vergnes, R. Engler, J. Bultena, K. Baron, C. Auer, "The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology?," Woodrow Wilson International Center for Scholars Synthetic Biology Project Report, October 15, 2015.

 

 

Coming first quarter 2017 from ABA Books:

 

Lynn L. Bergeson, Charles M. Auer, New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation, American Bar Association (2017).