By Lynn L. Bergeson and Carla N. Hutton
On July 31, 2020, the plaintiffs and EPA filed a joint case management statement in the U.S. District Court for the Northern District of California case seeking a rulemaking under Section 6 of the Toxic Substances Control Act (TSCA) to prohibit the addition of fluoridation chemicals to drinking water supplies. Food & Water Watch, Inc. v. EPA, Case No. 3:17-cv-02162-EMC. As reported in our June 12 and June 22, 2020, blog items, the court held a bench trial that concluded on June 17, 2020. After hearing closing arguments, Judge Chen asked plaintiffs and EPA to consider how to reach an agreement. According to the joint case management statement, the parties have met and conferred to discuss the potential of EPA considering a new or amended petition so that EPA, inter alia, “could consider the new science that has been published subsequent to the initial petition.” Plaintiffs offered to submit a new petition to EPA that contains all of the evidence presented at trial, including the expert declarations, expert testimony, and exhibits. EPA contends that plaintiffs’ proposal to “package” the evidence presented at trial as a new petition under Section 21 of the Toxic Substances Control Act (TSCA) “would be insufficient to reach a finding of unreasonable risk.” EPA maintains that “meaningful review of a new petition based on the specific evidence-base available for evaluating potential neurotoxic effects from exposure to fluoride from community water fluoridation programs” should include: (1) a systematic review; (2) raw data for the key studies upon which plaintiffs rely; and (3) the data underlying plaintiffs’ risk calculations, including their benchmark dose (BMD) analysis. Plaintiffs are willing to provide the data underlying Dr. Grandjean’s risk calculations, but “cannot agree to the other two requirements.” The joint statement states that first, plaintiffs maintain that they have already presented sufficient evidence to demonstrate an unreasonable risk under TSCA and are unwilling to do a new systematic review above and beyond what their experts have already done. Second, plaintiffs maintain that they do not have the ability to provide the “raw data” for the key studies upon which they rely because the data are not theirs, and that EPA is thus asking for something that plaintiffs cannot provide. Finally, plaintiffs do not believe that the raw data are necessary for EPA to evaluate the published peer-reviewed studies, and, indeed, requiring these data is “contrary to the health protective goals of TSCA.”
On August 3, 2020, plaintiffs filed a further statement on EPA’s position regarding a new petition. Plaintiffs state that they “feel compelled to bring to the Court’s attention the broader policy shift that EPA’s raw data demand represents, and the overwhelming criticism this policy has received from virtually all sectors of the public health and scientific communities.” According to the plaintiffs, EPA articulated this policy shift in its March 18, 2020, supplemental notice of proposed rulemaking (SNPRM) regarding “Strengthening Transparency in Regulatory Science” in which “EPA proposed limiting, or excluding altogether, its reliance on any peer reviewed study -- no matter how relevant or well regarded -- if the underlying raw data [are] not made publicly available.” Plaintiffs cite a “detailed analysis signed by dozens of Harvard scientists,” which states that “EPA’s new policy ‘is based on a profoundly misguided view of how the scientific process works’ and ‘unnecessarily impedes EPA’s ability to base its internal analyses and regulatory decisions on the best available science.’ Further, the rule ‘adopts a partial and biased approach to transparency that systematically favors industry science over academic science.’”
EPA filed a response on August 4, 2020, describing plaintiffs’ further statement as “procedurally inappropriate and substantively untrue.” According to EPA, by releasing the raw data and a detailed explanation of their statistical methods, the authors of the studies “could satisfy incongruities and ensure the scientific record is clear.” EPA states that it “takes the position that a meaningful substantive review, as contemplated by the Court, of the evolving scientific evidence published since Plaintiffs submitted their 2016 petition should include raw data for the key studies upon which Plaintiffs rely and, according to Dr. Grandjean’s trial testimony, is forthcoming.” EPA reiterates that its position “is based on the specific evidence-base available for evaluating potential neurotoxic effects from exposure to fluoride from community water fluoridation programs as necessary to support a potential TSCA section 6(a) rulemaking” and not, as alleged by plaintiffs, “a broader policy shift.”
The court held a status conference on August 6, 2020, via Zoom. The judge suggested that plaintiffs file a new petition and that he is holding the case open to allow them to do so. The next status hearing will be held November 5, 2020.
By Lynn L. Bergeson and Carla N. Hutton
On June 6, 2018, the New York State Department of Environmental Conservation (NYSDEC) released its final policy and form for manufacturer disclosures under the Household Cleansing Product Information Disclosure Program. The Disclosure Program is similar to the recently enacted California Cleaning Product Right to Know Act of 2017 which requires the disclosure of cleaning product ingredients by way of website or product label. The Household Cleansing Product Information Disclosure Program requires manufacturers of cleaning products sold in New York to disclose chemical ingredients and identify any ingredients that appear on authoritative lists of chemicals of concern on their websites. New York states that it “will be the first state in the nation to require such disclosure and the State’s program goes beyond initiatives in other states by requiring the robust disclosure of byproducts and contaminants, as well as chemicals with the potential to trigger asthma in adults and children.” NYSDEC has posted the Household Cleansing Product Information Disclosure Program Certification Form and Program Policy and a response to comments.
Our recent memorandum provides an in-depth review of important information from the Disclosure Program Certification Form and Program Policy, including covered products and definitions, information to be disclosed, the lists of chemicals of concern covered by the Program, and the effective dates. With the first disclosures due July 1, 2019, manufacturers need to review the Program Policy and begin compiling information concerning the ingredients of their products.
By Lynn L. Bergeson and Margaret R. Graham
On October 15, 2017, California Governor Jerry Brown signed California Senate Bill (S.B.) 258, the Cleaning Product Right to Know Act of 2017, which will require manufacturers of cleaning products to disclose certain chemical ingredients on the product label and on the manufacturer’s website. More information on S.B. 258 is available in our memorandum “California Bill Would Require Disclosure of Cleaning Product Ingredients” and on our blog under key word cleaning products.
Bergeson & Campbell, P.C. (B&C®) will soon be releasing a detailed memorandum S.B. 258 to be available on our regulatory developments webpage.
By Lynn L. Bergeson and Margaret R. Graham
It is widely reported that California Governor Jerry Brown imminently will sign California Senate Bill (S.B.) 258, the Cleaning Product Right to Know Act of 2017, which would require manufacturers of cleaning products to disclose certain chemical ingredients on the product label and on the manufacturer’s website. The final version of S.B. 258 was passed by the California Senate on September 13, 2017, by a vote of 27 to 13. The California Assembly passed the bill by a vote of 55 to 15, with nine votes not recorded, on September 12, 2017. Brown has until October 15, 2017, to sign the bill. The online disclosure requirements would apply to a designated product sold in California on or after January 1, 2020, and the product label disclosure requirements would apply to a designated product sold in California on or after January 1, 2021. More information on S.B. 258 is available in our memorandum “California Bill Would Require Disclosure of Cleaning Product Ingredients.”
It is also being reported that the State of New York’s Department of Environmental Conservation’s (DEC) Division of Materials Management will soon release formally a similar initiative, the Household Cleaning Product Information Disclosure Program. This program will require manufacturers of domestic and commercial cleaning products distributed, sold, or offered for sale in New York State to furnish information regarding such products in a certification form prescribed by the Commissioner, and is expected to require disclosure of many more chemicals than S.B. 258. The period for comments on the draft certification form and guidance document related to the program ended on July 14, 2017.
Bergeson & Campbell, P.C. (B&C®) will soon be releasing a detailed memorandum on both developments to be available on our regulatory developments webpage.
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).