perfluorinated coatings for paper -- regulatory challenges

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

mailto:[email protected]

mailto:[email protected]


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

Keller and Heckman LLP 2Copyright © 2019 | www.khlaw.com


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


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)


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


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).


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.


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



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 **



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 . . .


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


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


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


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


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


CA Safe Drinking Water & Toxic Enforcement Act – Prop 65


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)


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

http://www.p65warnings.ca.gov/

http://www.p65warnings.ca.gov/product


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


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


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?


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

Copyright © 2017 | www.khlaw.com Keller and Heckman LLP 23Copyright © 2017 | www.khlaw.com 23Keller and Heckman LLPCopyright © 2019 | www.khlaw.com 23Keller and Heckman LLPKeller and Heckman LLP

Thank you

perfluorinated coatings for paper -- regulatory challenges

Documents