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Copyright © 2017 | www.khlaw.com Keller and Heckman LLP 1Copyright © 2017 | www.khlaw.com 1Keller and Heckman LLPCopyright © 2019 | www.khlaw.com 1Keller and Heckman LLP
Perfluorinated Coatings for Paper -- Regulatory ChallengesInternational Molded Fiber Association Seminar
National Harbor, Maryland -- March 8, 2019
George G. Misko Holly H. Foley
[email protected] [email protected]
202-434-4170 202-434-4146
Keller and Heckman, LLPWashington, D.C.
202-434-4100
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Perfluorinated Paper Additives
Facing enhanced scrutiny
• Federal agencies
• State legislatures
• NGOs
Complicated by terminology
• Perfluorinated Compounds (PFC)
• Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
• Others: C8, PFOA, PFOS, GenX, ADONA, FTOH . . .
• These terms cover a variety of different chemicals with differing toxicity profiles
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PFAS Uses and Functions
Fluoropolymer production• PFOA (aka APFO) used as surfactant during polymerization
Aqueous film-forming foams (AFFF) for fire fighting
Surface treatments for soil/stain/grease/water resistance• Textiles and paper, including paper food packaging
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What are PFAS?
Broad category of substances
No widely accepted definition!
Long chain PFAS (C8 and
above), including
PFOA, PFOS, etc.
Other substances containing carbon and
fluorine atoms
Short chain PFAS (C6
and below)
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C8 Chemistries – PFCs with 8-carbon chain length
Perfluorooctanoic acid (PFOA)
Perfluorooctane sulfonate (PFOS)
Fluorotelomer alcohol (e.g., 8:2 FTOH)
Fluorinated polymers with C8 telomer acrylates/methacrylates
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C8 Chemistries – Safety Considerations
Strength of C-F bond• Stable to metabolic, environmental degradation
Biopersistence*• Preferential deposition of substance in tissues• Resistance to removal by natural clearance mechanisms• Persistence and accumulation in tissue
Human internal exposure relative to dose > animals?
FDA:* Data on PFOA, PFOS, 8:2 alcohol relevant to all C8 PFCs
*FDA: 81 Fed. Reg. 5 (Jan. 4, 2016).
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C8 Chemistries – Safety Considerations
Carcinogenicity• Liver, testicular, pancreatic tumors• Mechanism – peroxisome proliferation?• Relevance to humans?
Developmental/Reproductive toxicity• Pup survival, growth, development• Skeletal development
Target organ effects• Liver, kidney
Immunotoxicity
ATSDR. Toxicological Profile for Perfluoroalkyls. Draft for Public Comment. 2018.
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C8 Chemistries – Regulatory History
Beginning in 2006, C8 production voluntarily phased out in the U.S.
• EPA PFOA Stewardship Program
In 2011, industry voluntarily ceased producing C8 perfluorinatedpaper food packaging treatments previously cleared by FDA through the Food Contact Notification (FCN) process
• FCNs not revoked; FDA Inventory includes statement of unavailability
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C8 Chemistries – Regulatory History
In 2016, FDA amended 21 C.F.R. 176.170 to revoke clearance for five C8 fluorinated additives for food-contact paper applications
• 3 removed in response to NGO petition (safety basis)• 2 removed in response to industry petition (no production)
** Substances had been long abandoned by industry **
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C6 Chemistries
C8 chemistries replaced by shorter chain PFCs (C6 and below) based on lower biopersistence and toxicity potential
FDA has cleared many new ≤ C6 chemistries for use in food-contact paper
New data have raised questions on potential biopersistence of C6 PFCs . . .
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C6 Compounds – Ongoing FDA Safety Assessment C6 PFCs “do not appear to possess the biopersistence and potent systemic and reproductive
toxicity that are characteristic of C8 PFCs”
C6 PFCs “are rapidly and completely excreted and do not appear to accumulate in biological fluids”
BUT . . .
• “Significant data gaps remain in the toxicological profile of 6:2 FTOH”
‒ Pharmacological profile in humans and rodents
‒ Data on chronic, reproductive, developmental toxicity
‒ No data in mice > more sensitive than rats to PFCs
‒ 5:3 Acid = metabolite with highest internal exposure and slowest clearance rate
potential for biopersistence and systemic toxicity?
Rice, “C6-Perfluorinated Compounds: The New Greaseproofing Agents in Food Packaging,” Curr Envir Health Rpt 2:33-40 (2015)
Kabadi et al., “Internal exposure-based pharmacokinetic evaluation of potential for biopersistence of 6:2 fluorotelomer alcohol (FTOH) and its metabolites,” Food and Chemical Toxicology 112 (2018) 375-382
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Impact on FDA Food-Contact Clearances
FDA states that existing exposures are safe
FDA does not intend to take action on existing clearances
New FCNs will need to show substantially low exposures or provide additional toxicity data
FDA is proceeding with its own pharmacokinetics study at NCTR
• Full mass balance study to determine fate of all FTOH 6:2 metabolites
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U.S. EPA Action Plan to Address PFAS Challenges
Initiate steps to evaluate the need for a maximum contaminant level (MCL) for PFOA and PFOS;
Begin the necessary steps to propose designating PFOA and PFOS as “hazardous substances;”
Develop groundwater cleanup recommendations for PFOA and PFOS at contaminated sites;
Develop toxicity values or oral reference doses (RfDs) for GenX chemicals and PFBS
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Washington State Ban on PFAS in Food Packaging
State law (passed in 2018) bans the use of PFAS in paper food packaging effective January 2022
PFAS is broadly defined as any fluorinated organic chemical compound containing at least one fluorinated carbon atom
Food packaging is narrowly defined to only include a package or component that is--• Intended for direct food contact
• Comprised, in substantial part, of paper, paperboard, or other materials originally derived from plant fibers
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Washington State Ban on PFAS in Food Packaging
BUT, only if safer alternatives are identified prior to that date by Washington Department of Ecology
By January 1, 2020, DOE to publish findings on whether safer alternatives in specific applications
Alternative assessment must demonstrate• The alternatives are readily available in sufficient quantity and at a
comparable cost • Perform as well as or better than PFAS chemicals in specific
applications • If a chemical, previously approved for food contact use by FDA
If no alternative is found, DOE to continue the search • Assessment to include evaluation of hazards, exposure,
performance, cost, availability
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CA Safe Drinking Water & Toxic Enforcement Act – Prop 65
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California Prop 65 Requirements
No person in the course of doing business shall –• Knowingly discharge listed chemicals into sources of drinking
water without giving prior warning (effective 20 months after listing)
• Knowingly and intentionally expose any individual to listed chemicals from: (1) consumer products, (2) workplace, or (3) environment without first giving clear and reasonable warning (effective 12 months after listing)
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New Warning for Consumer Products (as of August, 2018)
WARNING: This product can expose you to chemicals including
[name of one or more chemicals], which is [are] known to the State
of California to cause [cancer/birth defects and/or other reproductive
harm]. For more information go to www.P65Warnings.ca.gov.
New “On Product” warning option:
WARNING: Cancer (and/or Reproductive Harm) -www.P65Warnings.ca.gov
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When is a Prop 65 Warning Not Required?
Carcinogens:
No Significant Risk Level (NSRL) –
• Level that would result in no more than 1 excess case of cancer in an exposed population of 100,000
• Assumes lifetime exposure (70 years)
Reproductive toxicants: Maximum Allowable
Dose Level (MADL) –
• Exposure to reproductive toxicant at <1/1000th of No Observed Effect Level (NOEL)
“Naturally occurring in food”
• Very difficult to demonstrate
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Proposition 65 – Enforcement
California Attorney General and local and city District
Attorneys are empowered to enforce Prop 65
BUT more common are private lawsuits• Bounty Hunter provision
• Permits private suits for failure to provide a warning
• Penalties can be as much as $2,500/violation/day
• Bounty is 25% of penalty amount
• Settlements are common
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Prop 65 and PFOA/PFAS
PFOA and PFOS added to the Prop 65 list of chemicals on November 10, 2017
Listed based on reproductive toxicity (developmental endpoint)
Warning required beginning November 18, 2018
No MADL established by CalEPA – What to do?
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Prop 65 and PFOA/PFAS
Create a Defense• Gather the available toxicity data • Assess the data in accordance with Prop 65 regulations
‒ Based on evidence and standards of comparable scientific validity to the evidence and standards which form the scientific basis for listing the chemical
‒ Only studies producing the reproductive effect which provides the basis for the listing shall be utilized for the determination of the NOEL
‒ Animal bioassay studies for assessment shall meet generally accepted scientific principles as to thoroughness, dosing, exposure pattern, duration, test material purity, the number and size of exposed groups, and route of exposure, and the extent of occurrence of effects
‒ The NOEL shall be based on the most sensitive study deemed to be of sufficient quality
• Demonstrate absence or sufficiently low levels of the compound as to not require a warning based on the route of exposure