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Telomer Research Program Update, April 3,2003
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T R P Telomer Research Program
ASAHI GLASS COMPANY
C la ria n t
Presentation For US Environmental Protection Agency
3 April 2003
3
D A IK IN
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Telomer Research Program
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TRP Presentation Outline
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Introductions and Agenda TRP US EPA Letter of Intent (LOI) March LOI Submissions April LOI Submissions Product & Article Analysis Rationale Preliminary Biodegradation Study Overview Conclusions, Discussion & Questions
2003-04-03 , page 2
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Telomer Research Program
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Investigate the potential formation and/or release of perfluorooctanoic acid (PFOA) from Fluorotelomer-based polymeric products and consumer articles treated with such products and from manufacturing operations making or using these products
Better understand telomer-based polymeric product
environmental fate and disposal
2003-04-03 , page 3
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Product and Article Analysis
Analysis of "Aged" Products and "In Use" Articles
Potential PFOA Release from Product Manufacture
Potential PFOA Release from Article
Manufacture
Biodegradation
and Analysis of Polymeric Products
Incineration Analysis
^Analyses on Polymeric Products for Carpet, Textile, and Paper Segments Most of these analyses will be done in parallel, not sequential
Product Stewardship: Added Programs &
Handbook
Continuation of 8-2 Telomer Alcohol Research Activities
2003-04-03 , page 5
7
Information Exchange & Document Submissions
Telomer Research Program
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Product and Article Analysis
Scope and rationale for analyzing for PFOA in telomer-based products and telomer-treated articles by 31 March 2003 (done)
Analysis for PFOA in representative telomer-based polymeric products and telomer-treated articles
Covers primary polymeric product end-use applications: carpet, textiles, paper
Information on products to be tested to be provided by TRP companies (under CBI) - by March 2003 (done); other products and applications - by May 2003 [CAS # / name / structure, 2002 use and volume ]
Method development and validation to begin in March 2003 followed by
sample analysis; results expected by June / July 2003
2003-04-03 , page 6
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Analysis of "Aged" Products and "In Use" Articles*
Develop plan for conducting PFOA "aging" and "in use" analytical studies in initial end use segments of Carpet, Textiles, and Paper by April 2003.
Define relevant "aging" and "in use" conditions for carpet, textiles, paper including light exposure, "walk off", degradation, volatilization, and leaching
Develop appropriate analytical methods and study protocols - in Qtr 2 / 2003
Conduct and complete studies by Qtr 3 / 2003
*For this analysis, "aged" means the storage and distribution of products and "in-use" means the distribution and use of the treated articles
2003-04-03 , page 7
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Telomer Research Program
and exposure (TRP member companies) - by end of May 2003
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F (C F 2C F 2) nC H 2C H 2O H
Telomer B Alcohol
Acrylate Monomer is the most common raw material used to create Finished Products F(CF2CF2)nCH2CH20 C (0 )C H = C H 2
Telomer Acrylate Monomer
2003-04-03 , page 9
Actual process and manufacturing practices vary by company
PFOA is not used or added in these processes
aFinished Products i
Generally, these processes are closed and PFOA creation and/or emissions are expected to be at very low levels
//
Characterizing Potential PFOA Release from Article Manufacture
Develop article manufacture release estimations of PFOA (carpet, textiles, paper); completion by June / July 2003
Develop and demonstrate sampling and analytical methods for PFOA determination in mill simulations - during Qtr 3 / 2003
Conduct mill simulations of potential releases of PFOA from telomertreated article manufacture - begin in Qtr 3 / 2003
2003-04-03 , page 10
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Biodegradation Analysis of Polymeric Products
Develop study approach, protocols and rationale for conducting biodegradation analyses of telomer-based polymeric products - by April 2003 to EPA for review and comment
Conduct biodegradation studies for potential generation of PFOA from polymeric products used in Product & Article Analysis - results expected beginning in July 2003
2003-04-03 , page 11
13
Analysis of Incineration
Compile information on polymeric products and uses to understand ultimate fate and disposal routes (landfill versus incineration) for telomer-treated articles in US - provide to EPA by July 2003
Review applicable incineration tests and provide summary of information to EPA by end of Qtr 2 / 2003
2003-04-03 , page 12
Iff-
Product Stewardship for Customers
TRP member companies will have additional product stewardship programs for customers / users of telomer-based products and telomer-treated articles in place by July 2003
Programs will be designed with reference to the Responsible Care guidelines outlined in SOCMA Management Practices / Product Stewardship Code
Develop TRP Safe Handling and Use Handbook for customer review by August 2003
2003-04-03 , page 13
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Continuation of 8-2 Telomer Alcohol Research Activities
Toxicology and Pharmacokinetics (pilot studies) Physical-Chemical Properties Submit 8-2 Telomer alcohol preliminary biodegradation screening
study reports to EPA by 24 March 2003 (done) Environmental Fate & Effects
Hydrolysis, atmospheric degradation, ecotoxicity, biodegradation
2003-04-03 , page 14
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Information Exchange
Final reports from TRP-sponsored studies as they become available (ongoing); report schedule for 2003 provided to EPA
Provide list and copies of documents and materials in TRP database - March / April 2003; new documents as they become available
Information from TRP companies on their own studies on telomer products sold in US market - as they become available
Periodic briefings, expected to be monthly, to summarize current results from telomer studies
2003-04-03 , page 15
/7
Develop site specific plans on its US operations to assess levels of PFOA in air and water from manufacturing operations around each site; development of plans will begin not later than 30 days after the date of this letter.
Conduct site-specific air dispersion modeling for applicable manufacturing operations, using the EPA approved Industrial Source Complex Short Term 3 (ISCSTS) model, as described in EPA's Guideline on Air Quality Models (40 C.F.R. Part 51, Appendix W), and assess the results using the air screening levels established in West Virginia.
Conduct ground and surface water analyses at each site, and assess the results using the water screening levels established in West Virginia.
Use the West Virginia screening levels to determine what additional actions, if any, may need to be taken, after reviewing the information with EPA.
2003-04-03 , page 16
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Telomer Research Program
Six months after this Letter is submitted, reports will be submitted for each site on progress made with respect to environmental assessments.
In addition, by April 1, 2003: provide EPA with applicable existing industrial hygiene air monitoring data for PFOA from DuPont operations at Chambers Works; and the DuPont telomers business will provide EPA with summary data on existing employee blood monitoring results from telomer manufacturing operations and PFOA recycle operations at Chambers Works. (Item completed)
2003-04-03 , page 17
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TRP Submissions to EPA - Planned for March 2003
Title / Description TRP Database List Company-specific information on products - submitted as CBI General Description of Telomer Process Biodegradation Research - Scope & Rationale Product & Article Analysis - Scope & Rationale Air monitoring data for PFOA from DuPont operations at Chambers Works Employee blood monitoring data from telomer manufacturing + PFOA recycle operations
3 April 2003
Contractor (TRP)
(TRP companies) (TRP) (TRP) (TRP)
(DuPont)
(DuPont)
2003-04-03 , page 18
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TRP Submissions to EPA - Planned for April 2003
3 April 2003
Title / Description
Contractor
Submit plan for review and comment on conducting PFOA "aging" and "in-use" analytical
studies in carpet, textile, and paper end-use segments
(TRP)
Description of specific telomer manufacturing process chemistry by member companies
and information about potential releases of PFOA and exposure routes from US
operations
(TRP Companies)
Develop study approach, protocols, and rationale for biodegradation analysis of polymeric
products used in the Product and Article Analysis and share with EPA for review and
comment
(TRP)
Provide copies of documents and other materials from the TRP database
____ (TRP)____
2003-04-03 , page 19
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Purpose
To investigate the potential formation and/or release of PFOA from telomer-based products and consumer articles treated with such products
To determine whether articles treated with representative telomer-based products contribute to significant human or environmental exposure to PFOA
2003-04-03 , page 20
Overview
Screening Study -- being conducted by independent research lab
Treated Articles 3 major end-use applications - carpets, textiles and paper Samples of telomer-treated articles under representative or actual mill conditions
- Primary Products Polymers - represent approximately 85% of telomer-based products manufactured and sold by TRP member companies - Primary product classes in commerce -12 product formulations to be tested
2003-04-03 , page 21
3
Approach & Methodology
Method Development and Validation
Develop sampling, shipment and analysis procedures (TRP experts) Prepare primary and [1,2-13C] PFOA analytical standards Identify and solicit bids from potential contract labs; select lab Develop method for quantitative determination of PFOA in various article matrices and
telomer-based products (contract lab) Validate methodology for determining PFOA in treated articles
Article Analysis
Collect and provide samples of 12 telomer-treated articles (TRP companies) - samples from pilot plant facilities or commercial manufacturing facilities
Types of samples: representative textile, carpet and paper articles (12 total) Analyze samples for PFOA using developed / validated analytical method
2003-04-03 , page 22
Approach & Methodology
Article Analysis (cont.)
LC/MS/MS method with [1,2-13C] PFOA internal standard Lower limit of quantitation for PFOA: 1 ppb Relative standard deviation: less than 20% Extraction efficiencies goal: 70-110% for 3 matrices
- carpet (nylon), textile (polyester) and paper - PFOA fortification levels: 1 ppb, 10 ppb, 100 ppb
Samples: 162 untreated carpet (shaved), textile and paper samples
Method validation under GLP - 36 samples for each article: 6 samples each at 1 ppb, 10 ppb, 100 ppb on 2 separate days (108 total)
2003-04-03 , page 23
at
Product & Article Analysis Summary
Approach & Methodology
Article Analysis (cont.) Test Samples: 12 articles treated with single telomer-based polymeric product
(4 unique carpet/product paris, 6 textile/product pairs, 2 paper/product pairs)
- 6 sub-samples to be analyzed for each article / product pair (72 total) - samples selected by block design approach - 4 untreated samples for control and extraction efficiency verification
2003-04-03 , page 24
&6
Approach & Methodology
Product Analysis Product types: acrylate and urethane polymers (12 product formulations) LC/MS/MS method with [1,2-13C] PFOA internal standard Lower limit of quantitation for PFOA: 1 ppm Relative standard deviation: 20% Extraction efficiencies to be evaluated (prior to product analysis) on 2-3 product groups Product analysis to be conducted under GLP
2003-04-03 , page 25
<57
Schedule
January - February 2003
Develop sampling, shipment and analysis procedures (TRP experts) Prepare primary and [1,2-13C] PFOA analytical standards Identify and solicit bids from potential contract labs; select lab Prepare internal standard for use by contract lab (TRP company)
March - April 2003
Develop and validate analytical and sample methods (contract lab) Prepare and deliver samples to contract lab for analysis (TRP companies)
May - June 2003
Analyze telomer-treated articles and telomer-based polymeric products Prepare final report (expected June/July 2003)
2003-04-03 , page 26
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Telomer Research Program
2003-04-03 , page 27
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Telomer Research Program
imriinrnifim-ii
The sum of the % values = 100 The model predicts this will be the distribution of transformation products
2003-04-03 , page 28
28 Day "Ready" Biodegradation Screening Study
- Cold Test Material C8F17CH2CH2OH Test Systems
Non-acclimated municipal sludge
8-2 Telomer B Alcohol is the only carbon source Endpoints monitored : parent loss, fluoride
Began Dec. 2002
2003-04-03 , page 29
3)
m
8-2 Telomer B Alcohol (ppb)
Telomer Research Program
# Growth medium: OECD 301D mineral medium without yeast extract
Inoculum source: POTW, fresh sludge (Incubated for 0 - 2 8 days)
Conclusion: 8-2 TBA is not readily biodegradable.
2003-04-03 , page 30
Aerobic Ready Biodegradation (Modified OECD 301D Closed Bottle Test) (12/31/02 -1/28/03)
Telomer Research Program
Growth medium:
OECD 301D mineral medium without yeast extract
Aerobic Ready Biodegradation (Modified OECD 301D Closed Bottle Test) (12/31/02 -1/28/03)
Inoculum source:
POTW, fresh sludge (Incubated for 0 - 2 8 days)
Key Observation: No defluorination occurred.
2003-04-03 , page 31
Accelerated Screening Study
Cold Test Material C,,F17CH2CH2OH Test Systems
Acclimated industrial sludge
yeast extract as additional carbon for co-metabolism Endpoints monitored : parent loss, fluoride, fluorinated
acids
Began July 2002, Completed January 2003
2003-04-03 , page 32
3
Telomer Research Program
8-2 Telomer B Alcohol Biodegradation Screening Stuc
Growth Medium:
E2-BSMYE (2 g/L of yeast extract as additional carbon)
Inoculum source:
Industrial WTP (28 days; TA50-51-52; 7/19 - 8/16/02)
Starting Cone of 8-2 TBA: -800 ppb
Observation:
8-2 TBA has been rapidly biotransformed
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1200
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2003-04-03 , page 33
Accelerated Biodegradation
0 5 10 15 20 25 30
Days after the initiation
AT
Telomer Research Program
Growth Medium: E2-BSMYE (2 g/L of yeast extract as additional carbon)
Inoculum source: Industrial WTP (28 days; TA50-51-52; 7/19 - 8/16/02)
Starting Cone of 8-2 TBA: -800 ppb
Observation: A net increase of 60 ppb of fluoride over 28 days.
2003-04-03 , page 34
0 5 10 15 20 25 30
Days after the initiation
Telomer Research Program
Accelerated Screening Study : Identified Transformation Products*
F(CF2)8CH2CH2OH
~ Mass Balance** (%)
co r F(CF2)8CH2COOH
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* Only these four transformation products were monitored for. Other potential transformation products were not determined.
** Mass Balance was not a primary objective and was not achieved
2003-04-03 , page 35
Telomer Research Program
TRP is actively and aggressively conducting work and analyses on telomer-based products, treated articles and processes
Protocols and procedures are being developed
Significant analytical challenges remain
The TRP believes telomer-based products are safe for their intended uses and is committed to continued work to support this conclusion.
2003-04-03 , page 36
3*
Letter of Intent Comments 8-2 Alcohol Program Regulatory Items and Actions
2003-04-03 , page 37
