## EPA Response to Public Comments Received on the Polymer Exemption Rule Amendment Docket ID #: EPA-HQ-OPPT-2002-0051

10/30/2009

[NOTE: The Comment Numbers referred to below are the Document ID numbers for the submitted comments as they appear in Docket EP AHQ-OPPT-2002-0051.]

1) Comment summary : General comments of support and opposition

EPA response : EPA appreciates the general approval and support for this amendment to the polymer exemption rule. EPA acknowledges that the rule amendment is only one tool of many for addressing concerns with perfluoroalkyl su lfonate (PFAS) and perfluoroalkyl carboxylate (PFAC) chemicals. While this rule is designed to give the Agency the op portunity to review the affected polymers under TSCA’s Section 5 PMN program (or under a different section 5(h)(4) exemption, if appropriate), the re vocation of the exempt status for these polymers is not a finding that these polymers present or may present unreas onable risks. In order to exempt a polymer from TSCA’s PMN requirements under the polymer exemption rule, EPA must determine that the polymer “will not present” an unreasonable risk to human health or the environment. Because EPA can no longer make this finding with re spect to the polymers specified in this rule, under the terms of the polymer exemption rule , the affected polymers must undergo the PMN review process or review under a di fferent section 5(h)(4) exemption.

2) Comment summary : A number of comments pertaini ng to the implementation, timing, data

collection and exclusion from other Section 5 exemptions were made:

2a ) One year is too short of a timeframe for reporting exempted polymers under the PMN program (or other TSCA Section 5 review). A number of commenters gave a variety of similar reasons why the proposed one-year tim e frame was too short to complete a PMN review of a polymer that cu rrently is manufactured in compliance with the polymer exemption rule, but would have the exempt status revoked under the new rule. See Comments #67.1, 69, 72, 74, 75, and 76.

EPA Response : Although comments on the proposed rule were not numerous, commenters expressed several reasons for poten tially needing more than a year to complete the PMN review process. Some of the reasons commenters cite d as support for additional time (i.e., longer than one year) to complete the PMN process include d the time to prepare and submit a PMN or a bonafide letter of intent and, if testing is require d, the time to secure a laboratory and conduct the testing, and the time for EPA to re view the results. EPA agrees that these activities could impact the timing of completion of the PMN review proc ess. Therefore, EPA has decided to make the

effective date of this rule 30 days after publication in the Fede ral Register. Persons who are currently manufacturing or importing affected pol ymers, or who have previously manufactured or imported them but are not doing so now, in full compliance with the 1995 polymer exemption rule, may continue manufacturing or importing them until 24 months after publication of the final rule in the Federal Register

. After that date, manufacture of these polymers will no longer be authorized under the polymer exemption rule, and continued manufacture or import must be

Page 1 of 18authorized under a different section 5(h)(4) exem ption or under a differe nt section 5 authority, such as section 5(a)(1) or section 5(e). EPA deci ded that this would be a reasonable approach to

balance the concerns of industr y and the Agency ’s objectives.

More specifically, if PMNs are submitted in a timely manner, th e 24-month period will give EPA and the submitter adequate time to negotiate consent orders, when necessary. Negotiation of consent orders generally takes 1-3 months. Over all, the most time requested by a commenter for implementation was 3 years with an option to petition for an extension; thus, the 24-month period largely accommodates those requests. Mo reover, industry has been on notice for three years since the rule was proposed in 2006 that EPA was considering this amendment, and has had that time to develop alternatives. The additional time will also help with respect to EPA’s own resources given that estimates of the number of PMNs it is likely to receive have increased since the rule was proposed. Having conc luded that EPA can no longer support the no unreasonable risk finding for these chemicals, it is appropriate to keep the implementation of this final rule moving in a timely manner.

Anyone not manufacturing or importing an affect ed polymer under the cu rrent exemption prior

to the effective date of the rule would be required, as of the effec tive date of this rule, to submit a PMN and complete the PMN review process prio r to commencing the manufacture or import of such a polymer. Alternatively, persons subject to this rule may submit a request under a section 5(h)(4) exemption other than th e polymer exemption if they r easonably believe that a polymer would qualify for such an exemption. Accordin gly, this rule would re-establish the TSCA section 5(a)(1)(A) requirement to submit a PMN for all affected polymers, unless they are already listed on the TSCA Invent ory or unless a different secti on 5(h)(4) exemption request is submitted, such as a Low Volume Exemption (LVE) or Low Release and Exposure Exemption (LOREX) request.

EPA’s policy with regard to making risk determin ations for new chemical substances, as it has always been, is to evaluate the substance based on information that is available at that time. To

ensure that there is no unreasonable risk to human health and the environment, EPA may determine during the PMN or other applicable revi ew process that regulato ry controls such as testing or controls that limit the exposure or that otherwise mitigate potential risks may be

necessary.

2b ) One commenter requested clarification that the rule does not pr eclude the option of submitting Low Volume Exemption (LVE) requests for affected polymers. The commenter asserted that the LVE process will provide EPA with th e oversight function it is looking for.

EPA Response : This rule does not preclude anyone from submitting a LVE or any other TSCA section 5(h)(4) exemptions to comply with the final rule, if the manu facturer or importer reasonably believes that the affected polymer will qualify for such an exemption (see 40 CFR 723). The “will not present an unreasonable risk to human health or the environment” criteria must be met for all section 5(h)(4) exempti ons. EPA encourages manufacturers who are currently manufacturing affected polymers in full compliance with the polymer exemption rule,

and who intend to submit a LVE or LoREX for such polymers, to do so as soon after the effective date as possible to ensure that they ha ve adequate time to submit a PMN in case the Agency denies the LVE or LoREX.

Page 2 of 182c) A commenter recommended as an alternativ e that the Agency continue to collect information on affected polymers and then us e that as the basis for a future rule.

EPA Response : EPA will continue to collect data on affected polymers and refine its position with respect to potential risks associated with su ch polymers, based on the data that is available at any given time. However, based on current data, EPA can no longer find that affected polymers will not present an unreasonable risk to human health and the environment under the terms of the polymer exemption rule and, as a result, EPA is excluding them from the polymer exemption at this time.

3) Comment summary : “Worse” chemicals may be left on the market if the exemption is

revoked. See Commenter #71.

EPA Response : Revocation of the exemption for affect ed polymers does not mean that they must be withdrawn from the market, only that they will be subject to TSCA Section 5 PMN review, or review under a differe nt section 5(h)(4) exemption, if appropriate. Even if the chemicals were withdrawn from the market, there is no reason to believe that the alternatives for any particular use would present a risk to hum an health or the environment that would be “worse” than that presented by the current produ ct. No specific examples were provided by the

commenter.

4) Comment summary : Importers and manufacturers who have already submitted PMNs for affected polymers in accordance with section 5(a )(1) of TSCA have an economic advantage. See

Commenters #71 and 77.

EPA Response : The initial advantage, to the extent there is one, be longed to the companies that manufactured polymers that met the exemption cr iteria because they were not required to undergo the PMN review process under TSCA sect ion 5. Companies that chose to submit PMNs anyway are not at an advantage now. These companies followed the PMN process even when they were not required to and the only thing th is rule does is require manufacturers of exempt polymers to comply with the same process. Over the years, EPA has obtained more data and has learned more about these polymers and, conseq uently, EPA might place more restrictions on these polymers now than in the past, but these restrictions, if necessary, would be based on the new or current data and the speci fic characteristics of each polymer being evaluated. However, the same is true for any category of chemicals that comes under increasing scrutiny over time. The impact on marketing, if ther e is one, would occur if a comp any elects to not comply with this rule and manufacturing must cease or if, through the PMN or other applicable review process, EPA determines that restrictions on ma nufacturing are appropriate to address risks with certain affected polymers.

5) Comment summary : Revocation of the exempt status for polymers is a reversal of EPA policy which is relied upon by industry. See Commenters #71, 74, 75 and 77.

EPA Response : Affected polymers are currently ex empt from PMN reporting requirements; however, TSCA Section 5(h)(4) states, “The Administrator may upon application and by rule, exempt the manufacturer of any new chemical subs tance from all or part of the requirements of

this section if the Administrator determines that the manufact ure, processing, distribution in

Page 3 of 18commerce, use , or disposal of such chemical s ubstance, or that of any combination of such activities will not present an unreaso nable risk of injury to health or the environment. A rule promulgated under this paragraph (and any substantive amendment to, or repeal of such a rule ) shall be promulgated in accordance with paragra phs (2) and (3) of section 6(c).” (Emphasis supplied). In addition, EPA specified in the 1995 fi nal rule for polymer exemptions that it could be amended in the future through rulemaking, includi ng to exclude polymers, if necessary. See 60 FR 16326. As stated in the preamble to that final rule, exempt polymers would remain new chemicals and would not be included on the Inventory.

As the data continues to become available, EP A is reviewing the extensive database on PFOS and PFOA, and the preliminary data being deve loped on the lower chain length PFAS and PFAC chemicals. At this time, however, the available da ta are insufficient to enable EPA to conclude that affected polymers as a group wi ll not present an unreasonable risk of injury to health or the environment under the terms of the polymer exemption rule.

This narrowing of the exemption is similar to the narrowing in 1995, which eliminated the polymer exemption for all polymers made using feedstocks that were not listed on the TSCA Inventory. This rule is consistent with the st atutory requirement to allow the polymer exemption only for those polymers that will not present an unreasonable risk of injury to human health or

the environment.

6) Comment Summary : Revocation of the current polymer exemption rule will make companies less inclined to participate in th e other voluntary Agency programs. See Comment

#76.

EPA response : EPA does not tie together regulatory a nd voluntary approaches to protecting the environment. Every company is encouraged to part icipate in voluntary programs as it sees fit. EPA has no reason to believe that compliance with the new rule will interfere with a company’s participation in other, non-regulatory programs. TSCA section 5(h)(4) exemptions are only for chemicals for which EPA can make a “will not present an unreasonable risk of injury” finding. The evidence on affected polymers no longer supports that finding unde r the terms of the polymer exemption rule, so affected polymers are being excluded from the polymer exemption

rule.

7) Comment Summary : One commenter suggests an altern ative to this rule would be to

coordinate with the PF OA Stewardship Program.

EPA response : Under the PFOA Stewardship Progr am, participating companies have committed to work towards reducing the use and release of PFOA and PFOA precursors by 2010, and eliminating PFOA from commerce by 2015. While the use of voluntary programs such as this has its place, it does not replace the necessity for regulation in the protection of human health and the environment. It is important to note that the reason for this rule is that, in light of the available data, EPA can no longer fi nd that affected polymers will not present an

unreasonable risk under the terms of the polymer exemption rule. Without that finding, chemicals may not be exempted under this ex emption. The goals of the Stewardship Program will be supported by the revocation of the polymer exemption for polymers that could ultimately

lead to PFOA releases.

Page 4 of 188) Comment Summary : There would be no TSCA restri ctions placed on imported finished goods that are treated outside the U.S. with perfluorinated polyme rs. Importation of products as articles would not require TSCA Certification and there might be an increase in PFOS- and PFOA-containing finished goods entering the co untry without control. See Comment #71.

EPA response : 40 CFR section 720.3 defines the term “article” as “a manufactured item (1) which is formed to a specific shape or de sign during manufacture, (2) which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical compositi on during its end use or only those changes of composition which have no commercial purpose sepa rate from that of the article and that may occur as described in section 720.36(g)(5), except that fluids and partic les are not considered articles regardless of shape or design. A pe rson cannot domestically manufacture an article and then treat it with a substance not on the TSCA inventory; however, it is speculative that imported products treated outside the United States with pe rfluorinated polymers c ould have an advantage over domestic products, as this commenter asserte d, because this rule does not prohibit domestic manufacturers from treating ar ticles with affected polymers. For the same reason, it is speculative that there might be an increase in PFOS- and PFOA-containing finished goods entering the country as a result of this rule. In addition, the impact of the definition of an article on fluoropolymers is not unique to this rule, but would cover any chemical substance regulated domestically, and is therefore be yond the scope of this rulemaking.

9) Comment Summary : A commenter asserted that EPA lacks the authority to require polymers that have previously been manufactured under the polymer exemption rule to go through the PMN review process. Such polymer s have been manufactured in reliance on EPA’s prior regulatory determination a nd, according to this commenter, statements that the Agency would not rescind the ap plicability of the polymer exempti on rule to them. To do so would create an arbitrary and biased regulatory distin ction between perfluorinated chemicals that have identical risk profiles but that have been lega lly manufactured under the polymer exemption rule without having first gone through the PMN review process, and those that manufacturers have submitted for PMN review, even though they were not required to do so.

The commenter further stated that the proposed transition period is legally unsound because it will end with a regulatory hammer. Manufacturer s would need to comply with any terms EPA imposes as a condition of continued production af ter the transition peri od or the manufacturer must cease manufacturing, processi ng and distributing the subject chemical. In imposing such conditions, EPA would not need to make any regulatory fi ndings, follow any type of administrative procedures, or otherwise be subject to any limitations. EPA has other authorities to regulate perfluorinated chemicals that are already on the market. EPA cannot circumvent the statutory scheme to modify previously issued PMN rules. The rule fails to satisfy legal requirements under TSCA and the APA for imposi ng and revoking regulato ry requirements, and is contrary to EPA’s statements in 1995 that it would not pursue revocation of the PER in the

future. See Comment #76

EPA response : EPA disagrees with the commenter th at it lacks the authority to require chemicals that have previously been manufactured under the polymer exemption rule to go through the PMN review process. EPA also disagrees that it provid ed assurances that it would not rescind the applicability of the polymer exemption rule to subject polymers. It is true that in 1993, EPA proposed procedures for revoking exemptions for polymers. It is also true that EPA

Page 5 of 18declined to finalize such procedures in the 1995 amendments to the polymer exemption rule, and that EPA’s decision not to do so was based, in part, on adverse comments. However, EPA did not, as the commenter contends, rule out future amendments to the polymer exemption rule, including exclusions of chemicals from its applicab ility. On the contrary, EPA clearly stated that it had alternative regulator y options for making such amendments, if necessary:

Should evidence be received by the Agency that casts reasonable doubt on the appropriateness of a criterion or set of criteria [that would allow for an exemption], the Agency has other regulatory options availa ble, such as publication of a proposed amendment to the polymer exemption rule to either refine the criteria or impose new restrictions, similar to EPA’s treatment of water-absorbing high [molecular weight (MW)] polymers in this rulemaking. Specifically, EPA proposed an amendment to the 1984 exemption that would exclud e this category of polymers from eligibility for the exemption based on the Agency’s evaluation of certain section 8(e) data. . . After publishing its 1993 proposal and providing an opportunity for public comment, the Agency amended the 1984 exemption in th is rulemaking to exclude high MW waterabsorbing polymers from eligibility. Simila rly, any future proposed revisions would also be subject to notice in the Federal Regi ster and comment in accordance with the

Administrative Procedure Act.

60 FR 16326. Thus, not only did EPA clearly stat e that it could amend the polymer exemption rule in the future to exclude polymers, but it also has followed notice and comment procedures for doing so, as it indicated it would do in 1995.

Further, industry was put on notice in 1995 that exempt polymers would not be included on the TSCA inventory, and that in orde r to be listed on the inventory, such polymers would need to go through the PMN process. As EPA explained:

Polymers manufactured under the amended exemption will not be included on the Inventory. . . Under the final rule, an ex empted polymer remains a new chemical substance (although legitimately manufactur ed under the terms of the exemption) until a PMN has been submitted for the substance and has completed the PMN review period, followed by manufacture fo r non-exempt commercial purpose and subsequent [notice of commencement].

Id . Without the exemption, affected polymers are like any other new chemical substance; they

cannot be manufactured under TSCA unless they go through the PMN or other applicable review process. Thus, in excluding affected polymers from the polymer exemption, EPA is not, as the commenter argues, creating an ar bitrary and biased regulatory di stinction between perfluorinated chemicals that have been legally manufactured under the polymer exemp tion rule without having first gone through the PMN review process, and those that manufacturers have submitted for PMN review, even though they were not required to do so. Rather, it is merely requiring manufacturers that have not voluntarily submitte d affected polymers for PMN review to do so now, or to submit a request for a different s ection 5(h)(4) exemption. Thus, all affected polymers that would have been eligible for the exemption will have gone through the same regulatory approval process.

Page 6 of 18This final rule requires manufact urers of affected polymers to submit PMNs or a different section 5(h)(4) exemption request for those polymers. Once PMNs or different section 5(h)(4) exemption requests are submitted, EPA will act on th em independently, according to their merits. It may be that action under authorities such as section 5(e) will be appropriate with respect to some of the PMNs submitted. However, contrary to the commenter’s assertions, any such action must be supported by specific findings and implemented in accordance with the administrative procedures required under such au thorities. Lastly, the process EPA has followed to amend the polymer exemption rule is in full compliance with the rulemaking requirem ents of TSCA and the APA. Section 5(h)(4) exemptions, such as the polymer exemption rule, and any substantive amendments to, or repeal of, such exemptions must be promulgated in accordance with the rulemaking requirements found in section 6(c)(2) and (3) of TSCA. 15 U.S.C. 2604(h)(4). EPA has complied in all respects with these procedural requirements, includi ng section 553 of the

APA.

10) Comment Summary : EPA underestimates the number of affected exempt polymers in the Economic Analysis. See Comment #71.

EPA Response : Under the current polymer exempti on, EPA does not require participating companies to report chemical identity. As a result, EPA has had no wa y of knowing whether the required exemption reports (required to be submitted by January 31 of the year subsequent to initial manufacture) for chemical s reported under the current polym er exemption rule were for

PFAS/PFAC-related or other fluorin e-containing polymers that woul d be subject to this rule. Prior to the 1995 rule amendments, EPA had speci fically excluded from the polymer exemption rule all halogen-containing polymers. EPA reasonably believes that the number of fluorinecontaining polymers as a percentage of all polymer s reported prior to the effective date of the 1995 amendments would be a fair representation of the fluorine-containing polymers in the exempted polymers reported. In addition, EPA re gularly tracks polymers that would have qualified for the polymer exemption, but that are s till submitted for TSCA section 5 review (for one reason or another). EPA also has a variety of CBI data files that support the Agency’s method for estimating the number of affected polymers. The overa ll percentage of fluorinated products runs consistently at a maximum of six percent regardless of which set of data (i.e., pre1995 PMN submissions for polymers, post-1995 submi ssions for polymers, and CBI data files)

is used to estimate the number of fluorine-contai ning polymers that might be subject to this rule

. The Economic Analysis for the final rule has been revised to increase the number of polymers that are expected to be affected by the rule fr om 12 per year, to 18 per year. This is because EPA is using a revised average number of 292 pol ymers reported annually during the period the polymer exemption has been in effect, rather than the 200 figure used in the proposed rule. EPA increased the annual number of polymers expected to be affected by th is rule because the number of polymer notices has increased over th e past two years. Applying the same six percent that was used in the Economic Analysis to the average annual estimate of 292 polymers results in an estimate of 18 polymers per year th at will no longer be eligible for the polymer exemption.

In addition, EPA has met with the individual member companie s of the Telomer Research Program (TRP) and Fluoropolymer Manufacturi ng Group (FMG) who have disclosed, as confidential business information (CBI), al l of the fluorotelomer-based products and fluoropolymers manufactured usi ng ammonium perfluorooctanoate (APFO), including polymers manufactured under the polymer exemption. All of these numbers support the estimates in the

Page 7 of 18Economic Analysis. Of course, EPA also recognizes that when the rule is finalized, the Agency may have underestimated or overestimated the total number of polymers affected, but EPA’s data suggests that 18 polymers annually would be consistent with curr ent trends. Moreover, none of the comments provided any eviden ce that contradicts EPA’s estimates.

11) Comment Summary : General comments that the propos ed rule grossly underestimated the true cost of the proposed rule for the regulat ed community and the EPA. See Comment #76.

11a) The Economic Analysis did not use current wages.

EPA Response : EPA updated the wage rates used in th e economic analysis for the final rule

. The wage series used in the Economic Analysis for the proposed rule, wh ich was considered to accurately reflect the types of labor used by PMN submitters and has been used in numerous EPA economic analyses, was discontinued by the Bureau of Labor Statistics (BLS) after 2003. The economic analysis for the final rule used a sl ightly different BLS wage series that has been updated through 2007.

11b) The Agency’s estimate of the time necessary to prepare and submit a PMN significantly underestimat ed the level of work for preparing PMNs for chemicals covered

under this rule.

EPA Response : In the absence of any new data submitted by commenters on the level of work required for preparing PMNs under this rule, EPA believes that the estimates it is using are the most accurate available. The Agency will contin ue to rely on the hour estimates in the Economic Analysis for the proposed rule in the absence of new information.

11c) EPA miscalculates the cost of filing a PMN under this rule by only applying an estimate of the commercialization delay co st of traditional new chemicals. The

commenter asserts that EPA has stated that it routinely issues TSCA Section 5(e) Consent Orders for testing of perfluor inated substances in the PMN Program and that the Agency is likely to do so with respect to polymers th at are subject to this rule. According to the commenter, that process is likely to take mo re than one year, which could delay by more than one year the commercialization of tr uly “new” polymers (i.e., those which are not currently being manufactured or imported under the polymer exemption rule), and “could be expected to significantly inhibit or completely stop commercial sales for currently exempt polymers.” The commenter asserts that these costs “must be recognized, acknowledged and considered in EPA’s economic analysis.

EPA Response : The Economic Analysis for the final rule differentiates between the actual cost of this rule (i.e., the cost to submit and revi ew a PMN or alternate se ction 5(h)(4) exemption request) and the potential “downstream” costs (i.e ., the cost of any testing or other 5(e) requirements). EPA’s estimates of the costs of submitting and reviewing a PMN for a chemical that is not currently or previously manufactur ed or imported, in full compliance with the 1995 polymer exemption rule, include commercializati on delay costs. These costs assume that a product is ready for sale on the market and th e PMN review process caused the company to forego production and profits for the duration of the PMN review period. The commenter is essentially asserting that poten tial “downstream” costs, whether they result from additional

Page 8 of 18commercialization delays beyond the normal PMN review period or from substantive 5(e) consent order requirements such as testing, should be considered as costs of this final rule. However, these “downstream” costs, to the extent they are incurred, result from separate regulatory actions. As explained at length in the Economic Analysis , they are dis tinct from the costs of submitting and reviewing PMN (or alternate section 5(h)(4) exemption request), which is what this rule requires.

The commenter’s concerns that PMN reviews for polymers currently being manufactured under the polymer exemption rule might not be completed within a year have also been addressed. See EPA response to Comment 2.

11d) EPA has had six years of experience in reviewing PMNs for fluorochemicals and should be able to provide an “average cost” or “reasonably antici pated” cost of PMN regulatory actions and Consent Or ders in the economic analysis.

EPA Response : In the Economic Analysis for the pr oposed rule, EPA acknowledged that there could be potential follow-on costs that companie s may experience in connection with testing requested under a TSCA section 5(e) consent orde r. As noted in the response to Comment 11c above, the Economic Analysis for the final rule di fferentiates between actual costs of this rule (i.e., the cost to submit and review a PMN) as opposed to these “downstream” costs (i.e., the cost of any potential testing or other 5(e) requirements). The Economic Analysis provides examples of previous tests requested for polymer exemp tion chemicals in the past. However, each chemical submission is reviewed on a case-by-case basis, and the Agency cannot predict future follow-on regulatory actions for individual fluorinat ed chemicals, especially in light of the Agency’s evolving understanding of these chemicals. Therefore, EPA is unable to provide any further degree of certainty in the Economic Analysis for the final rule about an “average” cost of regulatory actions following the subm ission of a PMN under the final rule.

12) Comment Summary : C8 data cannot be used for analogs. One comment is that EPA “comes to a result that polymers containing PFOA and PFOS present certain toxicities to the environment and human health” based on exposur e data from PFOA and PFOS. The commenter goes on to say that EPA cannot conclude that all affected polymers “may present an unreasonable risk of injury to human health or the environment” ba sed on the PFOS and PFOA data. See Comments #68, 71, and 79.

EPA’s Response : As noted in EPA’s response to Comment 1, this action does not constitute a finding that affected polymers present or may pres ent an unreasonable risk of injury to human health or the environment. Furthermore, EPA is not asserting that all PFAS and PFAC chemicals do, in fact, demonstrate persistence, bioaccumulative and toxicity characteristics similar to PFOS and PFOA. EPA has only stated that it is possible th at other PFAS and PFAC chemicals may share similar toxicity, persistenc e and bioaccumulation char acteristics with PFOS

and PFOA.

Limited toxicity data on perfl uoroalkyl moieties of various ca rbon chain lengths, including C4 and C6 sulfonates and carboxylates, have been submitted to or obtained by EPA since the proposed rule was published. In general, it appear s that the toxicity does decrease with shorter chain length in rodents (Ref. 3 in the final rule). Available information on the half-lives of the

C4 and C6 sulfonates indicate half-lives of 1 month and 8.5 years in humans, respectively. In

Page 9 of 18monkeys, the half-lives of the C4 and C6 su lfonates are much less th an those reported for humans, on the order of 4 days and 87-141 days, re spectively. Information on the half-lives of the C4 and C6 carboxylates in human s is not available. In monkeys, the half-lives of the C4 and C6 carboxylates are 1.7 and 0.8-1.5 days, respectivel y. Significant species differences in the

elimination of PFOA and PFOS betw een humans and monkeys have also been reported, with the elimination half-lives in monkeys (30 to 150 days ) being significantly sh orter than in humans (3.8 to 5.4 years) (Ref. 3 in the fi nal rule). The available toxic ity data indicate that the lower carbon chains are potentially less toxic than PFOS and PFOA; however, because the available

animal and human half-life data indicate that some could bioaccumulate in humans, the lower chain lengths are still of potential concern.

13) Comment Summary : There are insufficient data to su pport the rule. EPA should wait until all data are available on polymer degradation and toxicity before revoking the exempt status of these polymers. Commenters generally said th e EPA provided data only for conversion of C8 precursors into PFOA and showed no evidence fo r polymer degradation to produce either PFOA or precursors. On commenter (#71) specifically explained: “Our fluorinated polymers are designed to be both stable a nd durable and have shown no signs of degradation after performance testing under very rigorous conditions. It is thus apparent that the Agency’s assumption that degradation of existing fluropolym ers will result in the re lease of PFAC is not appropriate for fluropolymers made by Peach State Labs.” See Comments #68, 71 and 76.

EPA Response : As noted in the proposed rule (71 FR 1148 6) and in this final rule (see response to comment 15b), EPA has evidence demonstrati ng that polymers containing perfluoroalkyl moieties may break down in the environment thereby releasing the pe rfluroalkyl moiety. Commenters offered no evidence to the contrary, i. e., that this is NOT a potential pathway to

release of PFAS/PFAC into the environment. Moreover, EPA specifically requested comment on the appropriateness of exempting polymers containing perfluoroalkyl moieties that are covalently bound to either a carbon or sulfur atom where the car bon or sulfur atom is an integral part of the polymer molecule. In response, one commenter asserted that its fluorinated polymers showed no signs of degradation after performanc e testing under very ri gorous conditions. However, the “performance testing data” referred to is only an efficacy test for the coated product and not a study of the degr adation products one might find fr om the appropriate tests that actually measure degradation: OECD 302A, 303A , 307, 308 direct and indirect photolysis or hydrolysis testing. EPA must therefore conclude that in light of wh at it does know about potential degradation of polymers containing PFAS/PFAC precursors, and polymers containing fluorotelomers, it is reasonable to expect that polymers containi ng other perfluoroalkyl moieties may also degrade in the envir onment to produce PFAS or PFAC.

Extensive literature has been developed for both PFOA and PFOS on mode of action, toxicity, and pharmacokinetics, which EPA c ontinues to monitor and review as it becomes available. The Agency is in the process of receiving additiona l data on the toxicokinetics and environmental persistence, as well as toxicity data of th e lower chain acids and sulfonates. Given the persistence, possible bioaccumulation, and toxi city of the degradation products in the environment, EPA thinks it is prudent to go fort h with this rule until there are data showing otherwise. Although these new data have helped to inform the Agency about various aspects of perfluorinated chemicals, they have not change d EPA’s position since the ru le was proposed. In light of the available data, in cluding recent data, EPA can no l onger conclude that affected polymers as a group will not presen t an unreasonable risk of injury to health or the environment

Page 10 of 18under the terms of the polymer exemption rule. In addition, EPA believes th at the testing on new products that may result from the PMN review of polymers that would have qualified for the polymer exemption as currently written, will fu rther allow EPA to expand its understanding of the fate and toxic effects these products may ha ve on human health and the environment.

14) Comment summary : EPA is forcing companies to refo rmulate their products. This rule

will not allow use of APFO in the formulati on of polymeric products. See Comments #71, 74

and 75.

EPA response : The amended polymer exemption rule does not address the formulation of any commercial product at all; only th e composition of the specific polymer will determine whether or not the polymer meets the criteria for exempt status under the amended rule. Furthermore, EPA is not forcing companies to reformulate pro ducts; the rule only addr esses the need for PMN or other appropriate section 5 revi ew of affected polymers. Use of APFO as a processing aid and

APFO content in the formulation will not nece ssarily make the polymer ineligible for the amended polymer exemption rule. Only when (if this were to happen intentionally or unintentionally) the APFO is incorpor ated into the polymer structure (for example: as any part of the polymer backbone, as a substituent to the polym er backbone, or as a c ounter ion) would that polymer no longer be exempt from reporting under TSCA section 5. The only components of any formulation that would be s ubject to the rule are the polymers in the formulation. Products that contain polymers that are subj ect to this final rule can be reformulated to eliminate those affected polymers, or the products ca n continue to be manufactured until 24 months from publication of this rule if th ey are currently be ing manufactured, or already have been manufactured in full compliance with the existing polymer exemption rule, prior to the effective

date of this rule. After th e expiration of the exemption a llowing the manufacture of these polymers, these chemicals may no longer be manuf actured under the polymer exemption rule. Therefore, if PMNs for these polymers have not been reviewed by the Agency and the polymers have not been listed on the TSCA Inventory or, in the case of exemption requests, EPA has not granted the exemption request by 24 months after publication of this ru le, such manufacture or import must cease. (see EPA Response # 2 above)

15) Comment summary : A number of comments asserting e rrors and misrepresentations in the proposed rule were made by different commenters:

15a) The bioaccumulation claim for PFOA needs to be supported. The commenter stated that PFOA is not bioaccumulative, PFOA doe s not biomagnify through food chains, and various categorization schemes around th e world would not classify PFOA as

bioaccumulative. See Comment #78.

EPA Response : Overall, bioaccumulation of perfluorochemicals appears to be more pronounced in humans than in other species as evid enced by the half-life va lues for elimination.

PFOS and PFOA are known to bioaccumulate in humans with half-life values for elimination in the order of years. Other PFC A and PFCS show elimination half -life values in humans between one month and several year s respectively (Ref. 3).

In the proposed rule, EPA stated that PFOA a nd other perfluoro chemicals (PFCs) may be bioaccumulative. Bioaccumulation is a general te rm that is used to describe the process by which organisms may accumulate certain chemicals in their bodies. The term refers to uptake of

Page 11 of 18chemicals from water (bioconcentration) and fr om ingested food, sediment, soil, residues and other sources. Persistent, bioaccumulative and toxic (PBT) chemicals are therefore toxic chemicals that partition to water, sediment, dust, or soil and are not remove d at rates adequate to prevent their bioaccumulation in aquatic or te rrestrial species including humans and other mammals. Unlike many persistent organic pollut ants that bioaccumulate, PFCs do not partition into fatty tissues or lipids. Many of the va rious rating systems used around the world for bioaccumulation are based on the premise that bi oaccumulative pollutants partition into fatty tissues or lipids, or on surrogate ways of measuring or indicating this premise. In EPA’s view, this premise may not be appropriate for PFCs an d other international or ganizations support this position (OECD 2006; UNEP 2006) 1 . EPA believes that, when available, human

bioaccumulation or half-life data should be us ed in the assessment of whether a chemical bioaccumulates, particularly for PFCs. The ha lf-life in humans for PFOA is calculated at 3.8 years and for PFOS at 5.4 years (Ref. 3 in the fi nal rule). Thus, PFOA and PFOS are not quickly cleared from the human body. In lig ht of this information, EPA be lieves that it should evaluate affected polymers under the PMN review process or under a different section 5(h)(4) exemption, if the manufacturer or importe r reasonably believes such an exemption would apply.

Many studies on PFOA and bioaccumulation in the environment continue to be performed. Some were cited by this commenter. EPA acknowledges that PFOA does not appear to bioaccumulate in fish nor does it appear to biom agnify in some aquatic food webs, as noted by

the commenter. Other studies s uggest that PFOA has the potential to biomagnify in some marine and Canadian Arctic mammalian food webs. (OECD 2006) 2 EPA continues to believe that the presence of PFOA in human serum and some w ildlife is a cause for concern and that such presence supports its decision to no longe r allow exemption for these polymers.

15b) EPA indicated that polym ers containing PFAS or PFAC may degrade, possibly by incomplete incineration, and release perfluorin ated chemicals into the environment. The commenter requested that EPA identify the pa ge and information in the referenced study that supports this statement. Also, the co mmenter cites certain thermal degradation and

combustion studies that it says show PFOA and articles treated with types of fluorotelomer based polymers are destroyed in municipal incinera tors. The commenter

asks EPA to consider these studies.

EPA Response : The supporting information for EPA’ s statement that polymers containing PFAS or PFAC may degrade, possibly by in complete incineration, and release these perfluorinated chemicals into th e environment is contained in Re ference 3 cited in the proposed rule (Ref. 16 in the final rule), “Fluorochemical Use, Distributi on and Release Overview,” in the section on exposure assessment for the paper and p ackaging business. Specifically, page 341 of Reference 3 contains a supply ch ain flow chart for fluorochemical s in the paper and packaging

business. This flow chart also shows waste tr eatment methods, environmental releases, and endof-life disposal means for products from the va rious components of the supply chain. Both postconsumer paper and packaging waste and the sl udge waste from the waste water treatment

1 OECD SIDS Ammonium Perfluorooctanate & Perfluor ooctanoic Acid, SIDS Initial Assessment Report (SIAR), April 2006; and UNEP/POPS/POPRC, Draft risk profile : Perfluorooctane sulfonate (PFOS), July 2006.

2 OECD SIDS Ammonium Perfluorooctanate & Perfluor ooctanoic Acid, SIDS Initial Assessment Report (SIAR), April 2006.

Page 12 of 18process for industrial wastes are shown to be di sposed of through incineration. The flow chart

also shows release of fluoroche micals from the incinerator.

Although it was not cited in the pr eamble to the proposed rule, EPA subsequently reviewed a scientific journal article, "The rmolysis of Fluoropolymers as a Potential Source of Halogenated Organic Acid in the Environment" 3 . The article describes a study in which four different pure fluoropolymers (PTFE, CPTFE, ECTFE, and PFEPE) , which are polymers that are subject to the rule, as well as commercial produc ts containing these polymers, were heated in the presence of a continuous stream of air to 360C and 500C, and the exhaust gases were analyzed. Decomposition products were detect ed that include trifluoroacetic acid (TFA), which is a PFAC chemical, and chlorodifluoroacetic acid (CDFA) . This study shows that these fluoropolymers degrade through thermolysis under conditions that ma y be similar to those of some of the use processes for these fluoropolymers as well as open burning of domestic waste.

The journal articles cited by the commenter c ontain data that show that thermolysis of PFOA/APFO occurs at the experimental conditio ns of the studies repo rted in these journal articles, resulting in degradation products th at include 1-H-perfluoroheptane, Perfluoro-1- heptene, as well as other uni dentified fluorine containing hi gh molecular weight compounds. This information does not contradict the Agency ’s statement in the proposed rule because the thermal decomposition of PFOA/ APFO does not pertain direct ly to the fate of the polymers that are the subject of the proposed rule when they are subjected to the conditions of incomplete combustion or other thermal degradation means.

The other journal article cited by the commenter presents the results for a laboratory scale

incineration test of textiles and paper treated with fluorotelomer-b ased acrylic polymer as well as the pure polymer under conditions of 1000C, a resi dence time of 2 seconds, and 85% excess air, which are the typical conditions for municipal wa ste incineration accordi ng to the article. PFOA was not detected in the combustion products over the temperature range of 600C to 1000C. However, other degradation products, comp rising chemicals with CF3 and CF2CH=CH2 functional groups and others that were not explicitly identified but were determined to be related to telomer functionality, were detected. This information does not contradict the Agency’s justification for the proposed rule because this article does not provide supporting information for the claim that 1000C, a residence time of 2 se conds, and 85% excess air are the least stringent conditions of municipal waste in cineration or are otherwise re presentative of the thermal degradation conditions under whic h articles containing the polyme rs that are subject to the proposed rule may be disposed.

15c) The vapor pressure value used for 8-2 alcohol was only one of many values reported. A more accurate value than the one reported by EPA is available. See

Comment #78.

EPA Response : EPA agrees that available data are inc onclusive as to a spec ific vapor pressure (VP) for 8-2 alcohol. Regardless of what the “corre ct” VP for 8-2 alcohol is, the fact is that this

chemical has been found in the air above a number of cities. Its presence there suggests its VP is

3 Ellis, DA, Mabury, SA, Martin, JW, Muir, DCG. 2001. Thermolysis of fluoropolymers as a potential source of halogenated organic acids in the environment. Nature (412): 321-324.

Page 13 of 18sufficient to partition to this me dia giving EPA concern for its wide spread presence as a potential

source of PFOA.

15d) EPA stated that PFOA’s largest use is as a chemical intermediate but did not state that the ammonium salt (APFO), whose prin cipal use is as a fl uoropolymer processing aid, was the most commonly used form. See Comment #78.

EPA Response : EPA concurs with the commenter a nd acknowledges that the ammonium salt (APFO), which is used as a fluoropolymer pro cessing aid, is the most commonly used form.

15e) EPA attributed funding of the Mabury re search to DuPont. It was the TRP that generally funded fluorotelomer research. See Comment #78.

EPA Response : EPA concurs with the commenter that in the proposed rule, EPA inadvertently attributed funding of the Mabury research to Dupont when the Telomer Research Program (TRP) generally funded fluorotelomer research.

15f) The concerns raised for the health eff ects cited in the proposed rule were animal,

not human health eff ects. See Comment #79.

EPA Response : In the proposed rule, h ealth effects reported from e xposure to perflurorinated

chemicals were in fact effects observed in animal s, not in humans. However, in recent years, monitoring studies on humans have detected widespread presence of PFOS and PFOA in both human blood and plasma. A recent journal article provides an overview of the monitoring data

available for humans and of recent advances in the toxicology and mode of action for perfluoroalkyl acids (Ref . 3 in the final rule).

15g) The commenter requested clarification “as to how a one carbon moiety such as CF3 can degrade to become a larger moiety, su ch as a C2, C3, C4, etc." See Comment #78.

EPA Response : The commenter mistakenly interpreted EPA's statement, "EPA also believes that once released, such moie ties [containing CF3 or larger perfluoroalkyl groups] may potentially degrade to form PFAS or PFAC." It is common knowledge that the length of the perfluoroalkyl group will limit the length of the PFAS or PFAC that can be formed. EPA never stated that CF3 (C1 chain length) could be tr ansformed into a longer chain length PFAS or

PFAC. EPA does have evidence that chemical substances having longer Rf perfluoro chain moieties (where Rf = Perfluoroa lky CF3- or greater) can be c onverted into PFAS / PFAC having shorter chain length Rf composition.

15h) A comment was also made that the formation of PFAC/PFAS resulting from cleavage of a polymer along the backbone wher e a CF3 group had been attached to a (C, S) atom would have to result from po lymer degradation products arising from depolymerization. The commenter, theref ore, presumed EPA intended only CF3- containing side chain polymers to be subject to this rule. See Comment #78.

EPA Response : The route for potential formation of PFAC/PFAS from polymers containing CF3 and larger perfluroalkyl moieties is cleav age of the bonds around the Rf moiety to liberate PFAS/PFAC or corresponding precursor chemicals. The simple fact th at fluorine-containing

Page 14 of 18polymers subjected to hazardous waste incinerato r conditions are destroyed is evidence that depolymerization can occur at high temperatures (a ll the way to mineralization). Since the C-F bonds require the most energy to break, evidence of fluoro-containing species from the partial degradation of polymer side chains, termini, a nd even internal polymer degradation that could

lead to the formation of PFAS and PFAC are suff icient to warrant examination of these polymers during PMN or other applicable review and revocation of th e exemption status under the polymer exemption rule.

15i) A commenter asserted that EPA made erroneous statements in the preamble concerning the potential risk of bladder cancer. Specificall y, the proposed rule indicates that an epidemiologic study reported an incr eased incidence of bladder cancer mortality and goes on to state that it ca nnot be ascertained whether fl uorochemicals are responsible for the excess of bladder cancer deaths. Based on these statements, the commenter asserted that the information is confusing (mixing incidence and mortality), misleading and incomplete. See Comment #79.

EPA Response : EPA has provided language in the preamble that cl arifies and addresses any confusing or misleading statemen ts pertaining to bladder cancer. For a further discussion see

Unit III.D.1 of the final rule.

16) Comment Summary : Commenters wanted clarity on the structures used to identify the chemicals that would be subject to the final rule. They generally believe that the CF3 must be attached only as a side chain to the polymer bac kbone, and not part of the backbone itself, for the polymer to be within the scope of the rule. There was confusion whether the CF3 termini attached to a second CF2- would effectively forc e all CF3-(CF2)x- moieties to be subject to the proposed rule because the second CF2 is a C atom. See Comments #74, 75, 76, 78 and 79.

EPA Response : The structure is accurate as drawn. All chains terminated with a CF3 moiety appearing anywhere in the molecule (a s a side chain or in the middle of a perfluoropolypropylene homopolymer) make that pol ymer subject to the rule. Trifluoromethoxy moieties (CF3 attached to “O”) would not meet the requirement, while pentafluoroethoxy (CF3 attached to a “C” atom from CF2-O) would meet the criteria. Hydroge n-terminated poly PTFE, H-[CF2CF2]x-H, would not be subject to th e rule, while hydrogen-terminated poly HFP, H- [CF(CF3)CF2]x-H would be subject to the rule. The RF position is immaterial. What matters is only that the PFAC (fluorinated carboxylic acid) or PFAS (fluorinated su lfonic acid) have the potential to be generated. Th is rule does not address whether internal –[CF2]x- moieties can degrade to PFAC. While that may be a re asonable proposition, the data currently being generated under a TSCA section 4 Enforceable Consent Agreement (ECA) should address those concerns and may warrant another set of exclusions from the polym er exemption at a later date. Testing under this ECA involves subjecting perfluoro-containing polymers to simulated municipal waste incineration conditions. Add itional information concerning this ECA is

available in EPA Docket ID No. OPPT-2003- 0012. Instructions on accessing an EPA public docket are provided at the beginning of the final rule under ADDRESSES.

17) Comment Summary : A commenter stated that EPA made several overly broad and/or unqualified statements concerning bioaccumu lation of PFAC or PFAS chemicals, the

distribution and half-lives of PFOS/PFOA in the body, results of subchronic and developmental toxicity studies, thyroid eff ects and tumorigenicity of PFOS and/or PFOA. EPA’s general

Page 15 of 18response is provided below followe d by responses to specific comments made by the commenter.

See Comment #79.

EPA Response : EPA agrees with many of the comments made concerning these specific areas. EPA agrees that one must be careful in over-gen eralizing when referring to the various PFAS or

PFAC substances. These statements have been cl arified or adjusted in the final rule where appropriate, or in EPA’s responses to specific comments. Nonethele ss, in light of the available data, EPA can no longer conclude that affect ed polymers as a group will not present an unreasonable risk of injury to health or the environment under the terms of the polymer exemption rule.

17a) Toxicity and Reproductive Toxicity: The commenter asserts that the cited EPA hazard assessment cited on page 11486 of the proposed rule does not state that PFOA is associated with "a high level of toxicity" a nd that the cited study pertains only to PFOA,

and not to PFOS.

EPA Response : EPA agrees that the cited study does not say that PFOA is associated with "a high level of toxicity." EPA revised this phras e in the final rule for both PFOS and PFOA. The

final rule states that "PFOS and PFOA have shown liver, developmental, and reproductive toxicity in animal studies." The reference for this statement is a 2007 re view of perfluoralkyl acid monitoring and toxicological findings (R ef. 3 in the final rule), which addresses toxicological findings fo r both PFOS and PFOA.

17b) Tumorigenicity: The commenter questions the accuracy of the statement in the proposed rule that PFOS is "carcinogenic, indu cing tumors of the liver, and thyroid and mammary glands." The comment basically asse rts that the statement should be qualified with respect to thyroid tumo rigenicity in that the study failed to show increases in malignant tumors and that while there were increases in adenomas in the high-dose recovery group (treated only one year), th ere were none in the high-dose group treated for two years. The commenter also states th at "PFOS did not increase mammary tumors" because, even though the pairwise values for the 0 .5 and 2 ppin dose groups were statistically significantly highe r than control, the 5 ppm, 20 ppm, and 20 ppm recovery groups were all lower than controls.

EPA Response : EPA agrees that there is no evidence that PFOS induces mammary tumors. EPA also agrees that the meaning of the thyroid tumors in the recovery animals is problematic with respect to drawing conclusions regardi ng whether PFOS induces thyroid tumors. With respect to benign versus malignant tumors, EP A regards both as important in assessing the potential carcinogenicity of a compound (see EP A's Guidelines for Carcinogen Risk Assessment

– available at: http://cfpub.epa.gov/ncea/cfm/ recordisplay.cfm?deid=116283 ).

17c) Developmental Effects: The commenter takes issue with EPA's failure to note that the teratological effects disc ussed at page 11493 of the preamble to the proposed rule

occurred at doses that were toxic to the ma ternal animals. The commenter says that, without such context, the lay r eader can easily misconstrue the significance of the effects. The commenter also says "As EPA and 3M re searchers involved in these studies have

Page 16 of 18pointed out, the teratolo gical findings in labora tory animals exposed to perfluorochemicals are "unremarkable."

EPA Response : On page 11493 of the proposed rule, EPA summarized the findings in each of the prenatal developmental toxic ity studies and did not distinguis h between effects that may be considered "teratological" versus other effects. EPA only summarized the doses that affected

maternal animals and those that affected the developing fetuses. It is apparent that the "teratological" effects are occurri ng at higher doses than other deve lopmental effects, and as such

these effects are not the main concern. It shoul d be noted that EPA does not agree that it is important to explain that certain effects occurred at doses that were toxic to maternal animals. According to EPA's Guidelines for Developmen tal Toxicity Risk Assessment (available at: http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=23162 ), developmental effects that occur at maternally toxic doses should not be discounted.

17d) Thyroid Hormones: The commenter assert s that the following statement on page 11493 of the proposed rule is misleading: ". . .workers with the highest PFOS exposures had significantly higher serum triiodothyroni ne levels and significantly lower thyroid hormone binding ratio. . ." The commente r provides a number of reasons, supported by various studies, explaining why the statemen t is supposedly misleading. The commenter

concludes that the statement in the proposed rule "appears to suggest effects on thyroid hormones are caused by PFOS, when the weight of the evidence is to the contrary."

EPA Response : EPA simply summarized the findings in this study. EPA had already discounted the findings, which is apparent in the statement on pages 11493-11494 of the proposed rule: "however, hormonal parameters were not measured longitudinally." EPA recognizes the more recent research and agrees that the weight of evidence is to the contrary.

17e) Prostrate Cancer: The commenter objects to the statement that "[a] weak association with PFOA exposure and prostate cancer was reported in one study." It says that the investigators relate the association to duration worked in a particular chemical division at one of the commenter’s facilities, not to PF OA exposure. It also cites a follow-up study which purportedly "did not show an expos ure-related association between the PFOAspecific job matrix categories and prostate cancer.”

EPA Response : EPA agrees, and on page 11494 of the proposed rule EPA states "A weak association with PFOA exposure and prostate cancer was reported in one study; however, this result was not observed in an update to the study in which the e xposure categories were

modified."

17f) Pituitary Weight: The commenter states th at the reduced pituitary weight discussed in the subject study "was not a si gnificant biological finding. . ."

EPA Response : EPA summarized the organ weight results on page 11496 of the proposed rule, but did not comment on the biologic al significance of each finding. In this particular study, there were other effects occurring at lower doses that were the basis of the LOAEL and NOAEL.

17g) Mammary Tumors: The commenter asserts that the statement on page 11497, col. 1, regarding mammary tumors in rats is "incor rect, and outdated, a nd should be updated in

Page 17 of 18the final [FR] notice." The commenter refe rs to its previous comments on mammary cancer in the "Tumorigenicity" section to support is position.

EPA Response : EPA is aware of the new report from the Pathology Working Group and is evaluating the new information. However, PFOA is associated with tumors in other organs in animal studies, and thus the final preamble states "that animal studies have shown that PFOS and PFOA may cause cancer."

18) Comment Summary : A commenter stated that, it is a fundamental misstatement of the data to suggest either PFOS or PFOA cau ses “reproductive” toxicity in laboratory animals. There is no effect on reproductive function in animals treated with PFOS or PFOA (as opposed to developmental effects).” See Comment #79.

EPA Response : EPA does not agree that reproductive effects of PFOA/PFOS in animals have

not been demonstrated. EPA considers effects on timing of puberty to be reproductive effects.

Page 18 of 18