# Presentation: 104103

## PFOS and PFOA Program Office Update

- Mary F. Dominiak
- U.S. Environmental Protection Agency
- Office of Pollution Prevention & Toxics

- 8/7/2003

## History: Definition and Source

- Perfluoroalkyl sulfonates (PFAS): acids, salts, halides, etc., including perfluorooctyl sulfonate (PFOS), produced in quantity before end of 2000, widely used
- Over 300 chemicals on Inventory, including polymers
- Produced since 1950’s for use in surface treatment, paper protection, and performance chemical (surfactant and insecticide) products

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**Notes:**
All of the perfluoros are manmade; they don’t occur in nature. Use began in the late 1940’s, early 1950’s with the advent of such products as Scotchgard®.

## History: Definition and Source

- Perfluorooctanoic acid (PFOA) used only as an _*essential*_ processing aid to make fluoropolymers
- Enclosed process, controllable releases
- PFOA not expected in final fluoropolymer products except as trace contaminant; testing needed
- Fluoropolymers are widely used:
- Industry uses in electrical/chemical/automotive/ aerospace/military/medical/construction
- Coatings on cookware, fabric waterproofing

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**Notes:**
Gaskets, conduit, architectural coatings, chemical-resistant tubing and pipe, medical devices, barrier garments, heck – even slick dental tape. Fluoropolymers are everywhere.

## History: Definition and Source

- “Telomers” – small polymers not made from and not containing PFOA – may be a source: PFOA may be formed in the environment via the biodegradation and metabolism of telomers
- Telomers competed with and substitute for PFOS-based products:
- Soil/stain/grease-resistant textile, carpet, paper coatings
- Surfactant in fire fighting foams, cleaners

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**Notes:**
Note here that the only telomer on which we have metabolism and biodegradation data is the 8-2 alcohol, which is the basic building block for most of the telomer products.

This is also where you can bring up the issue of the problem being that, if telomer product degradation is indeed a source of PFOA, trying to find effective ways to reduce releases and exposures will be a challenge.

Like fluoropolymers, telomers are everywhere.

## History: Initial EPA Focus

- EPA began investigating perfluorinated compounds in late 1999, based on new data on perfluorooctyl sulfonate (PFOS)
- EPA expanded investigation in 2000 to perfluorooctanoic acid (PFOA) and fluorinated telomers (small polymers)

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## History: The Changing Picture

- 3M voluntarily began PFOS phase-out in 2000, complete in 2002; sole U.S. manufacturer
- EPA published Significant New Use Rules (SNURs) in 2000 and 2002 to close out return of PFOS
- SNURs require prior notice before any new manufacture or import of 88 PFAS, including PFOS
- Exceptions only for 3 high tech, low volume, low exposure/release uses: semiconductor manufacture, aviation hydraulics, and limited imaging

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## History: The Changing Picture

- Industry began voluntary research on PFOA and telomers in 2000
- Research produced additional concerns
- EPA released draft hazard assessments on PFOA in 9/02 and 11/02
- 3/03, Industry submitted Letters of Intent outlining additional voluntary research

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## History: To The Present

- 4/03, EPA released Preliminary Draft Risk Assessment on developmental concerns, published FR notice soliciting parties for enforceable consent agreements (ECAs)
- ECA focus on understanding sources of PFOA in environment, pathways leading to human and environmental exposure
- ECA negotiations substitute for Toxic Substances Control Act (TSCA) §4 test rule: consent-based, published in FR

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**Notes:**
Can cite back here to the areas of uncertainty that Jennifer mentioned in her presentation – that source and pathway are key areas of uncertainty, and that until we understand source and pathway, we couldn’t propose means to control or reduce potential risk. 

## ECA Process

- Industry LOIs promise data:
- Market and use information, p-chem data
- Product and article contamination analysis
- Monitoring/modeling for releases
- Test chemical and product selection
- ECAs seek additional data:
- Incineration, degradation, article aging, additional chemicals, additional sampling

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**Notes:**
The market, use, and p-chem data have largely been submitted, although market and use data are substantially CBI. Some additional tox-related data were also included in the LOIs, including the pharmacokinetic studies that Jennifer will have mentioned.

May note that, in the telomer area, the industry has proposed to do testing under their LOI on 12 polymeric chemicals used in the areas of largest production volume – carpet, paper, and fabric treatment – and that EPA may propose additional chemicals for testing under ECA to ensure that the data provide a picture of the complete telomer family of chemicals, including the surfactants. (Generically speaking, in the industry’s own estimation, the low molecular weight surfactants are manufactured and used at much lower volumes, but EPA is concerned that they may be more bioavailable than the high volume polymeric materials. Can’t say more without getting into CBI concerns, but this much would be okay.) 

On the fluoropolymer side, probably fair to say that most chemicals are covered, but might have an interest in looking further at specific products.

## ECA Process

- Initial plenary public meeting 6/03: 191 attendees, 50 interested parties
- Parties include FDA, CPSC, industry, environmental groups, local and state government entities, and plaintiffs in class action suit involving PFOA contamination of local water supplies in OH and WV

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**Notes:**
This qualifies as the largest and most complex ECA negotiation in EPA history.

## ECA Process

- June Plenary formed technical workgroups to pursue possible ECAs; meetings held 6/23-24, 7/9-10/2003
- Fluoropolymer and telomer incineration
- Telomer biodegradation
- Fluoropolymer aged article analysis
- Environmental sampling and monitoring

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**Notes:**
Can note that additional potential ECA topics may be identified as process continues, particularly in the area of additional chemicals/products being suggested for testing.

Mention communications workgroup dealing with CBI issues.

## ECA Process

- Additional technical ECA meetings 8/03 and 9/03; next plenary session 10/03
- Goal: reach agreement in principle on one or more ECAs at 10/03 plenary; continue ECA negotiations to pursue additional agreements on remaining data issues
- Process expected to continue into future

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## ECA Process

- ECA negotiation is public process, open to comment and participation
- Online docket:  _[www.epa.gov/edocket/](http://www.epa.gov/edocket/)_, use “Quick Search” to locate docket OPPT-2003-0012
- Extensive data repository in file AR-226: 14 CDs, electronic index available from _[oppt.ncic@epa.gov](mailto:oppt.ncic@epa.gov)_

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## Additional Related Matters

- EPA proposed that CDC include PFOS, PFOA, and other perfluorinated chemicals in the next NHANES study; decision soon
- Provide baseline of human exposures to compare with current data and track future trends to assess release/exposure reductions
- EPA nominating class study to National Toxicology Program

- 8/7/2003

**Notes:**
On the second point – our tox data are almost all on C-8. Class study would look at homologues and assess how changes in carbon chain length affect toxicity and bioaccumulation potential.

This slide is here primarily to tie things back together with what Jennifer discussed – all these investigations interrelate, and will combine together to determine the course of action that the Agency will take.

## For Further Information ...

- Consult online docket and AR-226 data
- To be put on email notification list to receive ECA process updates, email _[dominiak.mary@epa.gov](mailto:dominiak.mary@epa.gov)_

- 8/7/2003