Consultation for European Chemicals Agency Phase 1 Restrictions on the manufacture, placing on the market and use of PFAS.

July 21, 2023

Dr. Sharon McGuinness Executive Director

European Chemicals Agency Registry of the Board of Appeal

P.O. Box 400

FI-00121 Helsinki Finland

RE: Consultation for European Chemicals Agency Phase 1 Restrictions on the manufacture, placing on the market and use of per- and polyfluoroalkyl substances (PFAS).

Dear Dr. McGuinness:

1)      Overview

The U.S. Chamber of Commerce and our coalition of companies and trade associations appreciate the opportunity to comment on the EU Universal PFAS restriction proposal published February 7, 2023 (https://echa.europa.eu/registry-of-restriction-intentions/-/dislist/details/0b0236e18663449b).

• We oppose the approach that dossier submitters are taking in proposing to ban products and broad substance categories from commerce without consideration of risk, unavoidable use, or available replacements. Instead, the dossier should focus in a more targeted way on substances used in consumer applications with high potential for exposure to actual hazardous materials.
• Any action should be based on the best available science, take a risk-based approach, and utilize a sound cost-benefit analysis.
• Any action should be balanced with other EU policy priorities that may be negatively affected by these restrictions, including the European Chips Act.
• The coalition is proposing time-unlimited exemptions for substances, products, and sectors that are already highly regulated and/or for which there is significant risks of human health exposure.
• There will be broad economic effects across many sectors that will result in costs, impacts, and unintended consequences, including banning products and chemistries for which there are no replacements for critical and valuable societal uses.
• The restrictions will create reporting burden on uses of fluoropolymers for important societal uses, such as in public and industrial safety.
• Similar to previous REACH restrictions, the Universal PFAS restriction should exempt industrial uses (e.g., in pipes, gaskets, membranes, and diaphragms) of materials meeting the broad PFAS definition envisaged in the Annex XV dossier, provided that manufacturers supply information on risk management measures and emissions controls.

This is the approach taken, for example, in the REACH restriction on intentionally added microplastics.

2)      Priorities

There are existing regulatory frameworks and industry-led standards, grounded in sound science that govern many PFAS chemistries across the broad economy— underscoring that bans are not needed:

• Existing approaches to evaluate substances (and articles) of very low regulatory concern by virtue of their lack of release to the environment already exist. The underlying science for these assessments is common to any/many applications and need not be specified in a time-limited manner.
• Reasonable proof is already available to demonstrate safe uses of fluoropolymers (e.g., PTFE, FKM, FFKM, and Viton) and low global warming potential (GWP)F-Gases (e.g., hydrofluorocarbons (HFCs) and hydrofluoroolefin (HFOs)), etc., such that the RAC should take into account the large body of evidence that negligible environmental impact comes from these substances.¹
• Common themes grounded in science across many industries’ derogation or exemption requests underscore that these PFAS are used to make products safer via longer life. Reductions to design life ratings and/or reduction in reliability/availability, an increase in occurrence of leakage, and increased maintenance/intervention frequency would be expected for all uses of PFAS-containing seals (e.g., items such as O-rings and gaskets) across all industrial sectors.

We urge time-unlimited exemptions and request better definitions on many of the proposed derogations (or exemptions) for the following applications as these applications are highly regulated and the qualification process is extensive:

• Lubricants. We note that there is already a proposed derogation for “lubricants where the use takes place under harsh conditions” or the use is needed for safe functioning and safety of equipment until 13.5 years after EIF. This time frame may not be sufficient to address these applications.
• Fluoropolymer manufacturing.
• Materials used at industrial sites. Accompanied by reporting requirements on risk management measures and emissions controls, exemptions should be similar to the approach taken in the REACH restriction on intentionally added microplastics.
• Military and defense (not covered currently).

• Petroleum (oil and gas) and mining. The Federal Energy Regulatory Commission (FERC) and the Bureau of Safety and Environmental Enforcement (BSEE) are two agencies that regulate oil and gas companies.
• Electronics and semiconductors.
• Energy applications, including batteries and hydrogen.
• Transportation (manufacturing of transportation, safety, and emissions controls technologies of vehicles).
• Aerospace. The aerospace industry should be recognized as a separate sector with a time-unlimited derogation. For space applications in particular, the National Aeronautics and Space Administration implements standards on U.S. industry.
• Aviation (individually and as part of aerospace). The European Union Aviation Safety Agency (EASA), the U.S. Department of Defense, the U.S. Federal Aviation Administration, and the U.S. Environmental Protection Agency are examples of primary agencies responsible for regulating different aspects of the aviation sector. The FAA, for example, ensures that commercial aircraft are certified to meet the safety requirements.
• Industrial applications (not covered currently)
• Chemical processing industry (not covered currently).
• Medical devices and medical products. The Food and Drug Administration (FDA) governs medical devices and medical products.
• Refrigerants, Heating, Ventilation, and Air-Conditioning and use of fluorinated gases. Having two regulatory frameworks for the same chemical substance(s) is considered at the practical level untenable.
• Water and Protection (not covered currently). 

3)      Impact

• Each of the applications mentioned has a beneficial societal impact. We highlight some examples of impact based on the current proposal. For instance, all commercial airplanes use PFAS materials in safety functions such as in engine fuel line sealing (prevents fuel leaking in air and fire) and in hydraulic equipment to help land safely. Water and protection applications use PFAS, such as PVDF, in water filtration membranes to provide access to clean drinking water. This use supports the UN Sustainability Goal to “ensure availability and sustainable management of water and sanitation for all” (UNSustainable Development Goal 6). In the semiconductor industry, PFAS is used in chip manufacturing and in devices such as cellphones. Another UN Sustainability goal is to “significantly increase access to information and communications technology and strive to provide universal and affordable access to the internet” (UN Sustainable DevelopmentGoal 9). A restriction on PFAS would also impact the ability to achieve the European Chips Act as manufacturing would move out of the region. PFAS are also used in membranes for dialysis equipment, as well as coatings for implants and surgical tools.These are essential uses because blood platelets and pathogens do not adhere to the surface coating, which greatly reduces the risk of blood clots and pathogen-borne infections, supporting UN Sustainable Development Goal 3.
• For instance, in the aerospace sector—

Members of the U.S. Chamber and our coalition are participating in Socio-Economic Analyses (SEAs) and utilizing research by the Fluoropolymer Product Group (FPG), the European Sealing Association (ESA), and an economic assessment with CEFIC. These documents and an executive summary will be submitted in a second submission to support derogations and exemptions for key sectors and product categories.

Sincerely,

Aerospace Industries Association

Airlines for America

The Alliance for Automotive Innovation

American Forest & Paper Association

American Fuel and Petrochemical Manufacturers

American Petroleum Institute

Fluid Sealing Association

National Association of Chemical Distributors

National Association for Surface Finishing

National Council of Textile Organizations

National Oilseed Processors Association

Plastics Industry Association

PRINTING United Alliance

U.S. Chamber of Commerce

Valve Manufacturers Association

Cc: John Thompson, Deputy Assistant Secretary, Bureau of Oceans and International Environmental and Scientific Affairs, State Department

¹ Henry, Barbara J., Joseph P. Carlin, Jon A. Hammerschmidt, Robert C. Buck, L. William Buxton, Heidelore Fiedler, Jennifer Seed, and Oscar Hernandez. "A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers." Integrated Environmental Assessment and Management 14, no. 3 (2018): 316-334. [REVIEW]

https://doi.org/10.1002/ieam.4035

Korzeniowski, Stephen H., Robert C. Buck, Robin M. Newkold, Ahmed El kassmi, Evan Laganis, Yasuhiko Matsuoka, Bertrand Dinelli et al. "A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: fluoroplastics and fluoroelastomers." Integrated Environmental Assessment and

Management 19, no. 2 (2023): 326-354. [REVIEW]

https://doi.org/10.1002/ieam.4646

² Response to the public consultation on the PFAS restriction proposal, AmCham EU, June 2023.?

^[2] See recent Mammalian toxicity of trifluoroacetate and assessment of human health risks due to environmental exposure, Dekant et al., 17 February 2023; and all relevant previous UNEP (EEAP and SAP) reports.

³ Trifluoroacetic acid, EC no: 200-929-3, CAS no: 76-05-1, Molecular formula: C2HF3O2.

⁴​ F-gases in the PFAS restriction file.

Appendix 1: One for PTFE and for each of the key PFAS that needs a broad exemption and for which derogations could be unbound by time limit.

Attached is Henry et al. (2018) Supplemental Material (58 pages) and the 2023 SOT abstract/ poster/table driving home the fact that PTFE need not be “banned” if RAC would evaluate the scientific proof.

The High Stability of Polytetrafluoroethylene (PTFE) Does Not Imply Toxicity or Bioaccumulation, Future Degradation, and Release or Transformation into a Source of Substances of Concern. Authors:B. J. Henry¹, H. S. Adragna¹, and P. D. Drumheller.²¹W. L. Gore & Associates, Elkton, MD; and ²W. L. Gore & Associates, Flagstaff, AZ.

The European Chemicals Agency considers persistence to be the key marker of high risk in the hazard assessment of all PFAS. To determine if PTFE’s high stability results in or is correlated with hazard, fine powder PTFE (meeting ASTM D4895-18, made with a non-PFOA fluorinated polymerization aid) was subjected to standard OECD eFate studies at Charles River Labs (Den Bosch, the Netherlands). Following the current risk assessment paradigm with these data, we pose questions for a new paradigm for persistent compounds differing from traditional POPs.

Studies to investigate air, water, soil partitioning, and biodegradability included melting point/range OECD 102, molecular weight (MW) and MW weight distribution OECD 118, vapor pressure OECD 104, Henry’s Law constant, thermal gravimetric analysis, octanol-air partition coefficient, thermal stability in air OECD 113, solution/extraction behavior in water OECD 120, water solubility OECD 105, partition coefficient OECD 107 and OECD 117, ready biodegradability OECD 301B, inherent biodegradability OECD 302C, biodegradability in seawater OECD 306. Vapor pressure was <1 x 10-10 mm Hg at 20°C. Thermal gravimetric analysis showed no decomposition or chemical reaction <150°C and 5% weight loss at 549°C. Fine powder PTFE was thermally stable at continuous use processing temperature of 260 °C. The melting transition temperature of ~350°C was determined using differential scanning calorimetry, with no further melting/decomposition below 400°C, showing stability at environmentally relevant temperatures. These results demonstrate low volatility or partitioning to air at <150°C. Fine powder PTFE was not sufficiently soluble to be evaluated using GPC even after sonication and stirring (19 hours) in representative solvents. Standard Specific Gravity and Melt Flow Rate are used to determine fluoropolymers MW rather than rheological and dynamic light scattering methods. By alternative methods, the molecular weight was >500,000 Da. Fine powder PTFE was not dissolvable in water (OECD 105, 120). The lack of solubility in octanol or water (OECD 107, 117) prevented determination of octanol/air or octanol/water partition coefficients. The Henry’s Law constant was not determined due to the insolubility of fine powder PTFE. Fine powder PTFE was not readily (OECD 301B) or inherently (OECD 302C) biodegradable. ISO 10993-1, Biocompatibility of Medical Devices testing (cytotoxicity, irritation, sensitization, implantation, acute and subchronic toxicity, material-mediated pyrogenicity, hemocompatibility, genotoxicity (in vitro and in vivo) on fine powder PTFE was performed in compliance with good laboratory practices. The results demonstrate the biocompatibility and low toxicity of fine powder PTFE. The data generated on fine powder PTFE, from the standard OECD eFate studies under environmentally relevant conditions, support that this PTFE does not partition to air, water, or soil. PTFE was biotically/abiotically stable and not transformed to perfluoroalkyl acids, which are substances of toxicological concern. PTFE has inherently low toxicity as demonstrated by OECD eFate studies and ISO 10993-1 testing. These studies confirm that PTFE does not degrade nor release/transform into a continuous source of PFAS substances of concern. The high stability of PTFE does not imply hazard.”

Appendix 2: Similar reporting-based exemptions could be implemented for industrial uses of PFAS: Didn’t edit this section since all quoted.

“1. [Microplastics] shall not be placed on the market as substances on their own or, where the synthetic polymer microparticles are present to confer a sought-after characteristic, in mixtures in a concentration equal to or greater than 0,01 % by weight. […]

4. Paragraph 1 shall not apply to the placing on the market of:

(a) synthetic polymer microparticles for use at industrial sites.

[…] manufacturers and industrial downstream users of synthetic polymer microparticles in the form of pellets, flakes, and powders used as feedstock in plastic manufacturing at industrial sites, and [..] other industrial downstream users using synthetic polymer microparticles at industrial sites shall submit the following information to the Agency by 31 May of each year:

(a)  a description of the uses of synthetic polymer microparticles in the previous calendar year.

(b)  for each use of synthetic polymer microparticles, generic information on the identity of the polymers used.

(c)  for each use of synthetic polymer microparticles, an estimate of the quantity of synthetic polymer microparticles released to the environment in the previous calendar year.”