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PFOAS. Brief review of 10 comments submitted to US EPA in response to its March 11, 2002 proposed Significant New Use Rule. Docket control number OPPTS-50639C

The proposal the comments were addressing:

Federal Register. March 11, 2002.

PFAS: Perfluoroalkyl Sulfonates; Proposed Significant New Use Rule. EPA is proposing a supplemental significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the following 75 substances: Perfluorooctanesulfonic acid (PFOSH) and certain of its salts (PFOSS), perfluorooctanesulfonyl fluoride (POSF), certain higher and lower homologues of PFOSH and POSF, and certain other chemical substances, including polymers, that are derived from PFOSH and its homologues. These chemicals are collectively referred to as perfluoroalkyl sulfonates, or PFAS. This proposed rule would require manufacturers and importers to notify EPA at least 90 days before commencing the manufacture or import of these chemical substances for the significant new uses described in this document. EPA believes that this action is necessary because the PFAS component of these chemical substances may be hazardous to human health and the environment.

-- In the original proposed SNUR (65 FR 62319, October 18, 2000), these chemicals had been referred to collectively as perfluorooctylsulfonates, or PFOS, but commenters noted that this generic usage of PFOS was inconsistent with 3M's use of PFOS to refer only to chemicals with an eight-carbon, or C8, chain length. Many of the chemicals in the proposed SNUR included a range of carbon chain lengths, although they all did include C8 within the range. Accordingly, EPA will use the generic term PFAS to refer to any chain length, including higher and lower homologues as well as C8, and the term PFOS to represent only those chemicals which are predominantly C8.

Comments to US EPA received from:
Air Products Electronic Chemicals Kodak on behalf of the International Imaging Industry Association: Agfa, Eastman Kodak Company, Fuji Photo Film, Konica, and Kodak Polychrome Graphics
American Chemistry Council 3M
ATOFINA Chemicals, Inc. Semiconductor Industry Association
The Boeing Company Solutia Inc.
ExxonMobil Oil Corporation Ellen Connett, editor of Waste Not and Director of FAN's Pesticide Project, on the use of PFOS/PFOAS as "inerts" in pesticide.

Brief review:

Semiconductor Industry Association (SIA) March 27, 2002 - 2 pages

On behalf of the Semiconductor Industry Association (SIA) and the Semiconductor
Equipment and Materials International (SEMI)... While SINSEMI supports the proposed rule as a general matter, we have identified two issues that warrant further clarification.

First, the proposed $72 1.9582(a)(3)(ii) excludes from the SNUR certain materials “used in a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices.” As we indicated in our submissions to the Agency, the photomicrolithography processes used in our industry, and for which we have provided data to EPA, are used to produce semiconductors and electronic components of disk drives, electronics packaging, micromachines and optoelectronic devices and circuits. We read the proposed exclusion to apply to such production activities and ask EPA to confirm that understanding in the preamble to the final rule.

Second, the preamble to the proposed rule includes a broad “boilerplate" statement that exports of chemicals subject to a final SNUR are required to meet the export certification requirements under TSCA. ‘ In this particular SNUR, however, EPA is proposing specific exclusions from the SNUR in the rule itself. SIA/SEMI sees no compelling rationale for providing export notification for a use that does not warrant EPA’s attention under the SNUR. We have assumed that a person who exports one of the chemicals covered by the SNUR for an excluded use would not need to meet export notification requirements for such exports. We ask EPA to clarify this point in the preamble to the final rule...

Very truly yours,
StephenHarper
Co-Chair, SIA/SEMI PFOS Committee
and
Greg Dripps
Co-Chair, SIA/SEMI PFOS Committee

Solutia Inc. April 3, 2002 - 1 page

Solutia Inc. is a manufacturer and marketer of fire resistant airline hydraulic fluids that
contain small quantities of substances identified in the subject proposed Significant New
Use Rule (S N U R ). We have previously provided EPA with pertinent information as to
the low volume, critical use of these substances in our hydraulic fluids. We support the
Agency's language as proposed in the S N U R that will permit continued use of certain
SNUR chemicals as an anti-erosion additive, or as an intermediate to manufacture such
additives, for use in fire-resistant phosphate ester aviation hydraulic fluids...
Sincerely,
James E. Downes
Product Stewardship
Indusutrial Products
Solutia Inc.
PO Box 66760
St. Louis, MO 63166-6760

ExxonMobil Oil Corporation (ExxonMobil). April 18, 2002 - 1 page

We support the Agency’s language in the March 11, 2002 proposed SNUR that will exempt from
the SNUR PFOS chemicals when they are manufactured or imported for use as an anti-erosion
additive, or as an intermediate to manufacture such additives, in fire-resistant phosphate ester
aviation hydraulic fluids.
Sincerely,
R. T. Plutnick

The Boeing Company - April 10, 2002 - 2 pages

...Boeing manufactures commercial and military aircraft, helicopters, missiles, rockets,
spacecraft and related components and equipment. Our company currently
employs approximately 180,000 workers at 70 facilities in 27 states.

We are writing in support of EPA's proposal to exclude from the definition of
significant new use (1) the manufacture or import of certain PFAS chemicals for
use as an anti-erosion additive (Le., FC-95 and FC-98) in fire-resistant phosphate
ester aviation hydraulic fluids; and (2) the use of these PFAS chemicals as
intermediates to produce other chemicals used solely for the excluded aviation
hydraulic uses.

The use of these PFAS chemicals is critical to the aviation industry. Boeing
appreciates EPAs willingness to address our concerns, given the vital anti-
erosive properties of the PFAS chemicals, the small quantities used to
manufacture and deliver Boeing aircraft, the absence of any alternative materials,
and the minimal risk of exposure to humans and the environment.

Sincerely,

Matthew Frank
Director, Federal Safety, Health
and Environmental Affairs

Air Products Electronic Chemicals (APEC) June 5, 2002 - 2 pages

... (APEC) is a supplier of materials to the semiconductor industry. One of the many materials APEC supplies is developer. Developer is an ancillary product utilized in the photolithography process to produce semiconductors. Specifically, we are seeking clarification of an exemption to the proposed SNUR. The exemption, as published on page 2 of a March 1 1,2002 letter from Charles M. Auer, Director, Chemical Control Division of the EPA reads:

“As a component of a photoresist substance, including a photo acid generator or surfactant, or as a component of an anti-reflective coating used in a photomicrolithography process to produce
semiconductors or similar components of electronic or other miniaturized devices.

It is unclear to us if developer, including any PFAS surfactant components of developer, is included in
this exemption...

Signed

Randy Skow

Kodak on behalf of the International Imaging Industry Association - July 1, 2002 - 83 pages

Note: This submission reviews the potential exposure scenarios to PFOAS in the imaging industry

Member companies (Agfa, Eastman Kodak Company, Fuji Photo Film, Konica, and Kodak Polychrome Graphics) of the International Imaging Industry Association or 13A (formerly the Photographic & Imaging Manufacturers Association) appreciate the opportunity to provide comments on the Proposed Significant New Use Rule (SNUR) for Perfluoroalkyl Sulfonates (PFAS) published March 11,2002 (67 FR 11014).

These comments are intended to update the Agency on progress made by company efforts to reduce or eliminate uses of the PFAS substances that are the subject of the proposed SNUR.

• 1.0 Background Information on the Use of PFAS in Imaging Materials
The companies making this request have actively participated in the process that resulted in the publication of the proposed SNUR. In December of 2000, the companies submitted comments on the original proposed rule for perfluorooctyl sulfonates (PFOS) and made a public presentation in April 2001 requesting an exemption for use of PFAS chemicals covered by the proposed SNUR in the areas of digital or semiconductor-based and analog-based imaging and outlining company commitments to developing a voluntary phase-out of PFAS chemicals where feasible...

As indicated in our prior communications with the Agency, small amounts of PFAS-related materials have critical uses in several different types of products and throughout the chain of activities involved in manufacturing and using imaging products. The PFAS materials not only provide performance features necessary for the manufacture and use of imaging products, they also provide
important safety features by controlling the build-up and discharge of static electricity. The antistatic properties of these materials are important for preventing employee injury, operating equipment and product damage, and fire and explosion hazards.

2.0 Volumes and Uses of PFAS for Imaging Purposes as Identified to the Agency in Prior Comments
Precise historical information about the use of PFAS materials for imaging purposes is difficult to develop; however, trends can be described. Prior to 3M's development of this class of chemicals, PFAS chemicals were not used for imaging purposes. However, with the development of materials that were more sensitive to light (i.e., faster film speeds, more sensitive diagnostic X-ray products), the control of static became more difficult and required the use of
perfluorinated coating aids. The current trend in imaging uses has been toward the development of digital products that are processed dry. The trend toward dry processing has increased demands for static control and tended to increase the use of PFAS materials. Thus until the mid-l990's, historic use of PFAS materials was one-half to one-third of the level used in 2000 when 3M announced its
voluntary PFAS phase-out.

In previous submissions to the Agency, we provided estimates of year 2000 use levels (i.e., prior to the phase-out announced by 3M). These estimates were developed based on purchase and market share information for major US-based operations. In calculating the estimates, an assumption was made that all
manufacturers, even those not members of I3A, were using PFAS materials supplied by 3M. Thus, the estimated worldwide use of the PFAS-related chemicals listed in the proposed S N U R for imaging purposes (36,000 kg/yr) is expected to be a high estimate of the actual use level. Of this amount 30,600 kg/yr is estimated to be used in medical applications for disease diagnosis and
5,400 kg/yr is estimated to be used in consumer and industrial applications. The use of these materials in the USA at this same time point was approximately one-half of the total worldwide use or 18,000 kg/yr. We are concerned that the wording in the proposed SNUR used to describe these volumes is ambiguous and suggests that the volume of material used in the USA and subject to the proposed SNUR is 36,000 kg/yr rather than the actual volume of 18,000 kg/yr. We request that the Agency either cite only the volume subject to use in the USA or provide wording that makes a distinction between worldwide and USA-only use in the final SNUR.

In previous comments provided to the Agency, the uses of the PFAS chemicals that were identified by imaging companies included:

1) Surfactants for mixtures used in coatings applied to films, papers, and printing plates,

2) Electrostatic charge control agents for mixtures used in coatings applied to films, papers, and printing plates,

3) Friction control agents for mixtures used in coatings applied to films, papers, and printing plates,

4) Dirt repellant agents for mixtures used in coatings applied to films, papers, and printing plates,

5) Adhesion control agents for mixtures used in coatings applied to films, papers, and printing plates,

6) Surfactants in photographic processing solutions used in the processing of films and papers,

7) Defoamer used in the production of processing chemicals for films, papers, and printing plates,

8) Photoacid generators in photolithographic processing solutions used in the manufacture of integrated circuits and printing plates,

9) Surfactants in photolithographic processing solutions used in the manufacture of integrated circuits and printing plates, and

10) Surfactants in top and bottom antireflective coatings used in the manufacture of integrated circuits.

... As a consequence of the progress made to date, the following uses can be
eliminated from the imaging industry’s request for exemption:
7) Defoamer used in the production of processing chemicals for films, papers,
and printing plates,
8) Photoacid generators in photolithographic processing solutions used in the
manufacture of printing plates, and
9) Surfactants in photolithographic processing solutions used in the
manufacture of printing plates.

... The remaining uses (Uses 1-5 and 6 with modification) remain critical
applications for PFAS coating aids used to manufacture film, paper, and printing
plates. While these uses may be considered two uses (i.e., coating aid and
surfactant), the effects they are intended to impart to a product could be one or all
of the properties described in Uses 1-6. While an exemption is being requested
for Uses 1-6, the imaging industry’s voluntary withdrawal efforts have made
significant reductions in these uses as well.

As a result of these voluntary efforts, the demand for PFAS chemicals included inthe proposed SNUR for imaging uses is expected to be 3,000 kgyr in the USA by yearend 2002. Of this amount less than 50 kg/yr are used for paper products and less than 300 kg/yr are used for printing plates with the remainder being used for various film products in the USA. Of the remaining 2650 kg/yr that is used for film, 30 kg/yr is used as a surfactant in processing solutions and 2620 kg/yr is used in film coatings.

Table 2
GLOBAL/DOMESTIC SOURCING AND USE OF PFAS MATERIALS
PFAS Use PFAS
Volume
(kg/yr)		 PFAS
Sourced
in USA
(% of volume)

Imported
PFAS
(% of volume)

Exported and Re-exported PFAS
(% of volume)

Polymeric
or
non-polymeric
Film Coating Aid 2620 50%-- raw material 35%-- raw material
15%-- finished article		 25% Majority is polymeric; some non-polymeric
Printing Plate Coating Aid 300 30%-- raw material 65%-- raw material
5%-- finished article		 20% Polymeric
Paper Coating Aid 50 0 100%-- finished article -0- Non-Polymeric
Film Processing Surfactant 30 0 100%-- finished product -0- Non-Polymeric

7.0 Information About Alternative Fluorinated Chemistries that have been
Used as Replacements Particularly with Regard to the Extent to which PFAS
Reductions Rely on Some of the Other Chemicals Currently Under
Investigation

As stated at the April 2001 public meeting on the proposed SNUR, the imaging
companies have made a voluntary commitment to withdraw from use of the PFAS
materials; therefore, it would be inconsistent for the companies to substitute the
materials that are being withdrawn by 3M with the same or similar materials
provided by other vendors. Specifically, C6-C8 PFAS materials that are not the
subject of the proposed S N U R have not been used to accomplish withdrawal
goals.

PFOA, chemicals related to PFOA, or chemical mixtures containing PFOA have
not been used as replacements.

Telomers are under review as replacements. The materials that are being
considered have predominantly ≤C6 or ≥C l 0 perfluoroalkyl chains (90-99%). In
a limited number of small volume applications, water insoluble, high molecular
weight polymers with primarily C8 perfluoroalkyl chains are being considered.

3M July 2, 2002 - 13 pages

... 3M would like to address two issues: (i) chemical
nomenclature and SNUR scope and (ii) health and environmental effects information.

1. CHEMICAL NOMENCLATURE AND SNUR SCOPE
The Original SNUR Proposal identified the regulated chemical category as “perfluorooctyl sulfonates” and used the chemical nomenclature “PFOS” to refer to compounds within this category. With the Supplemental SNUR Proposal, EPA has broadened the regulated chemical category to “perfluoroalkyl sulfonates” and has coined the chemical nomenclature “PFAS” for the stated reason that: 3M “refer[s] only to chemicals with an eight-carbon, or C8
chain length, [as PFOS]. Many of the chemicals in the proposed SNUR include a range of carbon chain lengths, although they all include C8 within the range. Accordingly, EPA will use the generic term PFAS to refer to any carbon chain length, including higher and lower homologues as well as C8, and the term PFOS to represent only those chemicals substances which are predominately C8.” 67 Fed. Reg.
11019.

In our comments on the Original SNUR Proposal, 3M raised the concern that the “defining PFOS” section IV of the Preamble implied the term PFOS includes substances without eight perfluorinated carbons. 3M appreciates the Agency’s efforts, as reflected in the paragraph from the Supplemental Proposal quoted above, to respond to our comments on the Original SNUR Proposal by clarifying that the term PFOS refers to species containing primarily C-8 materials and excludes those chemical species without eight perfluorinated carbons among the alkyl ranges. The concern expressed in our comments on the Original SNUR Proposal, however, did not relate only to technical chemical nomenclature. Rather, as we noted then and emphasize again here, the SNUR regulations have been grounded on 3M’s voluntary decision to discontinue its perfluorooctanyl (i.e., C8) chemistry. The great bulk of the 3M perfluorooctanyl chemistry products are derived from perfluorooctanesulfonyl fluoride (POSF) and may degrade or metabolize under some conditions to PFOS. POSF and its derivative substances, including PFOS, comprise the chemicals subject to both the Original and Supplemental SNUR Proposals
as well as the Final S N U R Rule. Under the circumstances, it seems inappropriate to extend the SNUR beyond the background and context of the 3M phase-out by using the broader chemical
category “perfluoroalkyl sulfonates” and the broader “PFAS” chemical nomenclature.

In particular, it is technically correct to say that the term PFAS includes sulfonated chemicals of any carbon chain length. The diversity of PFAS chemical species, however, does not allow for treatment of all PFAS chemicals as a single chemical category for
purposes of hazard as~essrnent.~ Indeed, the breakdown products and hazard profile of PFOS chemicals are distinct from lower homologue compounds. For this reason, use of the broader
chemical category and chemical nomenclature create the potential for misunderstandings regarding EPA’s hazard assessment and its basis for regulatory action, and in turn, for confixion among the public and the commercial marketplace...

II. HEALTH AND ENVIRONMENTAL EFFECTS DATA AND OTHER INFORMATION UNDERLYING THE SUPPLEMENTAL SNUR PROPOSAL
The Supplemental SNUR Proposal cites to the August 2000 EPA Hazard Assessment’ referenced in the Original SNUR Proposal and refers back to the Preamble of the Original S N U R Proposal for a more detailed discussion of PFOS hazards. In our comments on the Original SNUR Proposal, 3M raised several specific issues with this Preamble discussion and the August 2000 Hazard Assessment. Given that the Supplemental SNUR Proposal continues to rely on these same sources, we reiterate our comments on the Original SNUR Proposal, another copy of which is attached hereto.

3M also believes that the Supplemental SNUR Proposal should acknowledge more generally the additional data that have become available since the Original SNUR Proposal. These data include nearly 200 animal toxicology and environmental fate and effects
studies on both PFOS and PFOS precursors. These studies have advanced the knowledge regarding PFOS chemicals from the time of the Original SNUR Proposal and EPA’s August 2000 Hazard Assessment and provide an even more robust body of data that continues to indicate no association of adverse effects with the PFOS levels measured either in the environment or in the general population. We believe that any final S ”R should recognize this
substantial progress in understanding PFOS that has been made since the Original SNUR Proposal. In addition, 3M supports the efforts by the Organization For Economic And Community Development (OECD) to prepare a PFOS hazard assessment. We think that it is also important for any final S N U R to acknowledge the OECD hazard assessment effort, which is relevant to and complementary of any final SNUR rule.

Michael A. Santoro
Director of Environmental, Health
Safety And Regulatory Affairs
Specialty Materials Markets
Building 236-1B-10, 3M Center, St. Paul, MN 55144

5 pages

Included with 3M's letter is an 8 page December 29, 2000, submission to EPA, responding to the Oct 18, 2000, Federal Register. 3M comments on its phase out of chemicals, the terminology of PFOS, and health effects. The submission was signed by (who notes that Michael Santoro will be his successor).

William A. Weppner, Ph.D
Director Of Environmental, Health
Safety And Regulatory Affairs
Specialty Materials Markets
Building 236-1 B-IO, 3M Center, St. Paul, MN 55144

July 9, 2002

Comments submitted on Proposed Significant New Use Rule to US EPA by Ellen Connett, editor of Waste Not and Director of FAN's Pesticide Project. Docket control number OPPTS-50639C  

American Chemistry Council July 12, 2002 - 4 pages

... As already indicated, ACC supports efforts by EPA and industry to address health concerns pertaining to chemical substances on a cooperative basis. Where those efforts lead to the cessation of an existing use of a chemical substance, ACC believes it may be within EPA’s authority to promulgate a SNUR covering that discontinued use, so that EPA would be notified before that use may be started anew. However, ACC does not believe EPA has authority to promulgate a SNUR for a use that is ongoing and therefore not new. We do not believe an increase in manufacture or importation for an existing use should be considered a "new use" within the meaning of section 5(a)(2).

Larry W. Rampy I
Product Stewardship Team

ATOFINA Chemicals, Inc. July 12, 2002 - 3 pages

ATOFINA Chemicals is a member company of the Amencan Chemistry Council (ACC) and supports the
comments that ACC is submitting on the proposed SNUR on perfluoroalkyl sulfonates...
ATOFINA Chemicals does not believe EPA has authority under section 5(a)(2) io restrict existing uses of
chemical substances on the TSCA Inventory. Instead, the company believes a SWUR may be promulgated
only for a use that would be both new and significant...
ATOFINA Clemicals does not believe EPA has authority to promulgate a SNUR for a use that is ongoing
and therefore not new. We do not consider an increase in manufacture or importation for an existing use is a
“new use” within the meaning of TSCA section 5(a)(2).

Craig H. Fad, Ph.D.
Associate Director,
Product Stewardship and Toxicology