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3/7/2000 EPA/3M Meeting Objectives
1. Update EPA OPPT management on 3M FC initiative
- product understanding
- product stewardship
- communications
- product/process re-engineering
- product reinvention
- human health risk assessment
.
- environmental risk assessment
2. Define a "path forward" for future EPA/3M communications on the 3M FC initiative - feedback on EPA management's perspective - risk assessment
- new chemicals regulatory strategy
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Commercialized Uses of
POSFBasedChemistries
+ Paper and Packaging Protection Carpet Protection
+ Home Textiles Protection Apparel Protection
Fire Fighting Foams + Performance Chemical Sales
-fire fighting foams -mining and oil -metal plating and electronic etching baths -household additives -coatings and coating additives
-carpet spot cleaners -insecticides -intermediates
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POTENTIAL SOURCES OF EXPOSURE
+ Products
- Manufacturing residuals in products
- Degradation of high molecular weight FC
products
.
+ 3M Manufacturing Operations
- Minimize/eliminate waste streams and
emissions as potential exposure sources
- Industrial hygiene
+ Customer's Manufacturing Operations
- Help to identify and minimize waste streams
and emissions as potential exposure sources
- Industrial hygiene surveys
- Education & Training
- Screen new customers
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REGULATORY COMMUNICATIONS
| US.EPA
Initial meeting December 14, 1998
Maintain regular verbal dialogue with EPA counterparts on FC program
* Recent TSCA 8(e) submissions 4 submissions Perfluorooctane Sulfonate
1 submission on Perfluorooctanoate
+ White paper submissions
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1) PFOS: Current summary of Human Sera,
Health and Toxicology Data (January 21 1999)
2) The Science of Organic Fluorochemistry
(February 5, 1999)
3) Fluorochemical Use, Distribution and Release
Overview (May 26, 1999)
.
4) Sulfonated Perfluorochemicals in the
Environment: Sources, Dispersion, Fate and
Effects (March 7, 2000)
All submitted information reference directly to 8(e) file
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REGULATORY COMMUNICATIONS
US. FDA Initial meeting April 24, 1998 * Updated Safety Assessment submitted February 9,
1999 * No further information/communication desired by
FDA at this time pending completed review of
safety assessment. Third generation safety assessment involving real
food migration studies nearing completion.
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REGULATORY COMMUNICATIONS
Europe
BgVV - Initial visit June 25, 1998 on Scotchban products
Updated data package sent September, 1999
Expert toxicology committee review November, 1999
Canada
;
Health Canada - Initial meeting September 23, 1998
Followed up with updated FDA safety
assessment
Environment Canada - Initial meeting November, 1998
MHW-Initial meeting February, 1999 Recent meeting October 19, 1999
MITI - Initial meeting February, 1999 Recent meeting October 19, 1999
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CUSTOMER COMMUNICATIONS
* Inform them of our findings and understanding * Reinforce the appropriate use, handling, and disposal of our products * Share with them an overview of our science and stewardship programs * Provide Industrial Hygiene assessments and share experience learned from our own operations
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FLUOROCHEMICAL RE-ENGINEERING INITIATIVE
Overall Goal: Reduce Potential for Exposure
Reengineering Process Goals
Reduce Manufacturing Residuals by >90% via continuous process improvement
Past
-- Present =p Future
Average 1%
Estimate 0.5%
<0.1%
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FLUOROCHEMICAL REINVENTION INITIATIVE
Overall Goal: Reduce Potential for Exposure
Reinvention Process Goals
Identify New Product Chemistries with theFollowing Criteria for Human Health, Environment: * Very Low Toxicity
* Minimize Accumulation Properties
* Equal / Improved Product Performance * Cost Effective + Initial Screen Identified Candidates That Show Promise to Meet These Criteria. * Envision Transformation of Some Product Lines by 2001. * Will Require New PMN Filings.
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PROPOSED FUTURE MEETINGS
1. Regulatory strategy meeting with New Chemicals Notice Management Branch to discuss transition from POSB-based
chemistries to PBSF-based chemistry (within 90 days).
Suggested EPA participants:
- Flora Chow - Rebecca Cools - Vince Nabholz - Gary Thom
2. Meeting with Risk Assessment Division to begin discussing details of study plans and existing data on POSF-based chemistries (within 60 days).
Suggested EPA participants: - Oscar Hernandez
- Appropriate Scientific Staff
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