prop. 65: revised warnings one year later and...
TRANSCRIPT
Prop. 65: Revised Warnings One Year Later and
Developments in PFOA/S, Glyphosate and
Soluble NickelCompliance Challenges for Manufacturers, Distributors, Retailers and Others in the Chain of Business
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THURSDAY, JULY 11, 2019
Presenting a live 90-minute webinar with interactive Q&A
Michael D. Easter, J.D., CHMM, Principal, California EnSIGHT, Fairfield
Christopher (Smitty) Smith, Counsel, Pillsbury Winthrop Shaw Pittman, Los Angeles
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Prop. 65: Revised Warnings One Year Later and Developments in PFOA/S, Acrylamide, Glyphosate, and Soluble Nickel Christopher W. Smith, Esq., Counsel at Pillsbury Winthrop Shaw Pittman LLP
Mike K. Easter, J.D., CHMM, Principal at California EnSIGHT, Inc.
Presenter
Christopher W. Smith• Environmental Counsel at Pillsbury Winthrop Shaw Pittman LLP
• National environmental and products liability practice focusing on complex litigation, regulatory compliance, administrative proceedings, and business transactions
• Represents clients in negotiations with California regulators and the Office of the Attorney General in obtaining Prop. 65 compliance opinions
• Defends clients in Prop. 65 litigation involving food products, consumer products, and pharmaceuticals
6 | Prop 65: Revised Warnings One Year Later
Presenter
Michael D. Easter• Principal at EnSIGHT providing toxicology and risk assessment
support
• Involved in Proposition 65 since its inception and assists clients with litigation defense and compliance
• Represented clients who have successfully obtained Safe Use Determinations (SUDs) for crystalline silica in pet litter, DINP in vinyl flooring products, PVC and modular vinyl flooring carpet tiles
7 | Prop 65: Revised Warnings One Year Later
Overview
• General Background on Prop. 65
• Revised Warning Regulations One Year Later
• Prop. 65 Chemical Developmentso PFOA/S
o Acrylamide
o Glyphosate
o Soluble Nickel
8 | Prop 65: Revised Warnings One Year Later
Legal Framework
• Implementing Regulationso California Code of Regulations,
Title 27, Division 4, Sections 25102 through 27001
• Regulator: California Office of Environmental Health Hazard Assessment (OEHHA)
• Enforcement Statuteso California Health & Safety Code
sections 25249.5 through 25249.13
• Enforcer: California Office of the Attorney General (AG) and Private Citizen-Plaintiff
9 | Prop 65: Revised Warnings One Year Later
Prohibitions
• Discharge of a listed chemical into sources of drinking water (HSC § 25249.5)
• Exposure to a listed chemical (HSC § 25249.6)o No person in the course of doing business (10 or
more employees)o Shall knowingly and intentionally expose any
individualo Without first giving a clear and reasonable warning
• 900+ listed chemicalso Carcinogenso Reproductive/developmental toxicants
10 | Prop 65: Revised Warnings One Year Later
Enforcement
• Enforcer: AG or Private Citizen-Plaintiff
• Low evidentiary burden (exposure to a listed chemical)
• Evidentiary burden shifts to demonstrate warning provided or risk is not “significant”
o Exposure assessment
• Complex science
• Judges often do not have a science background
o Significant risk
• Carcinogens: one excess case of cancer in an exposed population of 100K assuming lifetime exposure at the level in question
• Reproductive/developmental toxicants: 1/1000th
of the No Observable Effect Level (NOEL)
11 | Prop 65: Revised Warnings One Year Later
Liabilities Litigation
• Civil penalties ($2,500/day/violation)o 25% to enforcer
o Each unwarned exposure = one violation
• Attorneys’ fees
• Injunctive reliefo Add warning
o Reformulation
o Oversight
• 60-day noticeo Enforcer identificationo Certificate of merit
• Venueo California state court (typically)
o California federal court
• Claimso HSC § 25249.6
• Available to AG and private citizen-plaintiff
o BPC § 17200• Available only to AG
• Potentially extends penalties period
12 | Prop 65: Revised Warnings One Year Later
Revised Warning Regulations
• Became effective on August 30, 2018
• California Code of Regulations, Title 27, Division 4, Sections 25600 through 25607.31
• Goals of revised warnings:o Make them more meaningful and useful to public
o Reduce “over-warning”
o Clearer guidance to businesses on who and where to provide warnings
13 | Prop 65: Revised Warnings One Year Later
Revised Warning Regulations…One Year Later
• Greater awareness by regulated entitieso More warnings on products
o More warnings on websites
• Supply chain indemnificationo Prophylactic warnings
• OEHHA threatens to review basis for warningso 27 Cal. Code Reg. § 25205(b)
14 | Prop 65: Revised Warnings One Year Later
Revised Warning Regulations…One Year Later
• Plaintiffs – 1,223 NOVs as of 7/2/19o Looking for easy targets
• Phthalates – 675 NOVs – 61% NOVs
• Acrylamide – 76 NOVs – cooked/baked foods
• Alcoholic beverages – 68 NOVs by 1 Plaintiff for on-line sales
• Lead – over 100 NOVs - brass, food/supplements, decorative glasses/mugs
• Cadmium – 31 NOVs – dietary supplements/food products
• Still many chemicals without “Safe Harbor” values
• More SUD Requests under review by OEHHA
15 | Prop 65: Revised Warnings One Year Later
Recent Developments
• Listed chemicalso PFOA/S
o Acrylamide
o Glyphosate
o Soluble nickel
• Calculating exposure from food products
• Enforcement trends
• NY Consumer Right to Know Act
16 | Prop 65: Revised Warnings One Year Later
PFOA/S
• Perfluorooctanoic acid (PFOA) & Perfluorooctane sulfonate (PFOS)o Listed 11/10/17 as developmental toxicant by AB mechanism based on USEPA
o Warning applicable 11/10/18
• 2 NOVs for PFOA to date (6/25/2019)o Center for Environmental Health (CEH)
in cosmetics• Targets manufacturers and retailers
o Netflix movie “The Devil We Know” by CEH
17 | Prop 65: Revised Warnings One Year Later
PFOA/S (cont.)
• No MADLs (7/2/2019)o Estimated to be ~30 ng/day based on USEPA/Lau et al. (2006)
o OEHHA accounting for long half-life/slow elimination means MADL could be lower
o New human kinetics data & application by TERA suggests increasing MADL 10-20X
• Corresponds to estimated MADL value of ~400 ng/day or more
• Analytical informationo EPA method using methanol extraction
o PFOA reporting limit ~ 0.01 ng/sample
o PFOS reporting limit ~ 0.1 ng/sample
o Cost of analysis ~$500/sample
18 | Prop 65: Revised Warnings One Year Later
Acrylamide
• By-product of baking and present in many baked food products
• Coffee and cereal litigation involving alleged acrylamide exposureo Coffee – Council for Education and Research on Toxics v. Starbucks Corp.,
et al., Los Angeles Superior Court Case No. BC435759 and Second Appellate District Court of Appeal Case No. B292762
o Cereal – Post Foods, et al. v. Dr. Richard Sowinski, Supreme Court of California Case No. S250937
19 | Prop 65: Revised Warnings One Year Later
Proposed Regulation for Coffee
• Regulatory determination that exposures to acrylamide in coffee are not subject to enforcement under Prop. 65
• Regulatory solution to enforcement problem
20 | Prop 65: Revised Warnings One Year Later
Glyphosate
• Herbicides are most common source of glyphosate
• Omni-present in food products based on common usage of herbicides in farming operations
• National Association of Wheat Growers v. OEHHA, Eastern District of California Case No. 17-2401 (2018)
o Prop. 65 listing of glyphosate as carcinogen stayed
• New guidance from USEPA on glyphosate (4/30/2019)
• USEPA approval of glyphosate use called into question (5/15/2019)o National Family Farm Coalition v. USEPA, Ninth Circuit Court of Appeals Case
Nos. 17-70810 and 17-70817
21 | Prop 65: Revised Warnings One Year Later
Soluble Nickel
• DARTIC listed 10/11/18 meeting, effective date 10/28/18
• Nickel & nickel compounds listed carcinogen – only relevant if inhalation exposure
• What is soluble nickel?o Unclear from DARTIC meeting transcript
o 0.1 moles/L in water @ 20 oC (OEHHA 5/2/19)
• Ni atomic wt. = 58.69 g/mole; 1/10th mole = 5.689 g = 5,869 mg
• 5,869 mg Ni+/L = 5,869 ppm
22 | Prop 65: Revised Warnings One Year Later
Soluble Nickel (cont.)
o Can it be empirically tested? What are the conditions?
• pH
• Hardness
• Duration
o 2012 OEHHA REL document for Nickel & Nickel
Compounds
• Ni metal CAS# 7440-02-0 deemed “insoluble”
• Ni oxide CAS# 1313-99-1 deemed “insoluble”
• 11 other nickel compounds deemed in soluble in Table 2
23 | Prop 65: Revised Warnings One Year Later
Calculating Exposure from Food Products
• Foundational Case: Environmental Law Foundation v.
Beech-Nut Nutrition Corp. (2015) 235 Cal.App.4th 307
o Allowed for averaging over lots using a geometric versus
arithmetic mean to establish exposure to a listed chemical in a
food product
• Mateel Environmental Justice Foundation v. OEHHA (2018)
24 Cal.App.5th 220
o Failed attempt to establish arithmetic mean as default method to
calculate food product exposures
24 | Prop 65: Revised Warnings One Year Later
Calculating Exposure from Food Products (cont.)
• Proposed Amendments to Sections 25821(a) and (c) (10/5/2018)
o Regulatory action to establish arithmetic mean as default method to
calculate food product exposures
• Modification to Proposed Amendments to Sections 25821(a) and
(c) (7/5/2019)
o Withdrawal of regulatory action to establish arithmetic mean as default
o Exposure calculation will be based on chemical concentration in product
as offer for sale to end consumer, even if product contains ingredients
sourced from different manufacturers or producers
25 | Prop 65: Revised Warnings One Year Later
Enforcement Trends• Notices of Violation (NOV)
o 2015 – 1,336 NOVs
o 2016 – 1,576 NOVs
o 2017 – 2,711 NOVs
o 2018 – 2,364 NOVs
o 2019 – 1,223 NOVs as of 7/2/19
• 114 more than 2018 at same time last year
• Few cases litigatedo High cost & high uncertainty to defend
o Defendant recovery limited to expert fees
o Two key Ct of Appeals cases – Bondo & Beech-Nut
26 | Prop 65: Revised Warnings One Year Later
Enforcement Trends (cont.)
• Primary targets• Phthalates – 675 NOVs – 61% NOVs
• Acrylamide – 76 NOVs – cooked/baked foods
• Alcoholic beverages – 68 NOVs by 1 Plaintiff for on-line sales
• Lead – over 100 NOVs - brass, food/supplements, decorative glasses/mugs
• Cadmium – 31 NOVs – dietary supplements/food products
• Settlementso 2018 465 O/CSs = $9.6M; ave. = $20.7; 87% atty. fees
o 2018 367 I/C CJs = $30.6M; ave. = $83.5K; ~ 4X more;79% atty fees
27 | Prop 65: Revised Warnings One Year Later
New York Consumer Right to Know Act
• Proposed legislation modeled after Prop. 65
• Authorizes NY State Dept. of Environmental Conservation to promulgate requirements to “increase transparency” and alert consumers to presence of designated chemicals in products
• Significant differences from Prop. 65 –o NY state agencies responsible for determination of warning requirement
o NY state agencies charged with enforcement
o Other differences may emerge as details about legislation yet to be drawn up
28 | Prop 65: Revised Warnings One Year Later
Questions…Contact Us
Christopher W. Smith
P: 213.488.3619
W: pillsburylaw.com
Michael D. Easter
P: 925.585.5432
W: 707.864.3997
29 | Prop 65: Revised Warnings One Year Later