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 EPAHQ-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 sulfonate (PFAS) and perfluoroalkyl carboxylate 

(PFAC) chemicals. While this rule is designed to give the Agency the opportunity to review the 

affected polymers under TSCA’s Section 5 PMN program (or under a different section 5(h)(4) 

exemption, if appropriate), the revocation of the exempt status for these polymers is not a finding 

that these polymers present or may present unreasonable 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 respect 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 different section 5(h)(4) exemption. 

2) Comment summary: A number of comments pertaining 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 time frame was too short to complete a PMN 

review of a polymer that currently 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 potentially needing more than a year to complete the PMN review 

process. Some of the reasons commenters cited as support for additional time (i.e., longer than 

one year) to complete the PMN process included the time to prepare and submit a PMN or a 

bonafide letter of intent and, if testing is required, the time to secure a laboratory and conduct the 

testing, and the time for EPA to review the results. EPA agrees that these activities could impact 

the timing of completion of the PMN review process. Therefore, EPA has decided to make the 

effective date of this rule 30 days after publication in the Federal Register. Persons who are 

currently manufacturing or importing affected polymers, 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 

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authorized under a different section 5(h)(4) exemption or under a different section 5 authority, 

such as section 5(a)(1) or section 5(e). EPA decided that this would be a reasonable approach to 

balance the concerns of industry and the Agency’s objectives. 

More specifically, if PMNs are submitted in a timely manner, the 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. Overall, 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. Moreover, 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 concluded 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 affected polymer under the current exemption prior 

to the effective date of the rule would be required, as of the effective date of this rule, to submit a 

PMN and complete the PMN review process prior 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 the polymer exemption if they reasonably believe that a polymer 

would qualify for such an exemption. Accordingly, 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 Inventory or unless a different section 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 determinations 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 review process that regulatory 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 preclude the option of 

submitting Low Volume Exemption (LVE) requests for affected polymers. The 

commenter asserted that the LVE process will provide EPA with the 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 manufacturer 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) exemptions. 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 have adequate time to submit a PMN in case the 

Agency denies the LVE or LoREX. 

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2c) A commenter recommended as an alternative that the Agency continue to collect 

information on affected polymers and then use 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 such 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 affected 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 different 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 human health or the environment that would be 

“worse” than that presented by the current product. 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, belonged to the companies that 

manufactured polymers that met the exemption criteria because they were not required to 

undergo the PMN review process under TSCA section 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 this 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, consequently, 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 specific 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 there is one, would occur if a company 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 manufacturing 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 exempt 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 substance from all or part of the requirements of 

this section if the Administrator determines that the manufacture, processing, distribution in 

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commerce, use , or disposal of such chemical substance, or that of any combination of such 

activities will not present an unreasonable 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 paragraphs (2) and (3) of section 6(c).” (Emphasis 

supplied). In addition, EPA specified in the 1995 final rule for polymer exemptions that it could 

be amended in the future through rulemaking, including 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, EPA is reviewing the extensive database on PFOS 

and PFOA, and the preliminary data being developed on the lower chain length PFAS and PFAC 

chemicals. At this time, however, the available data are insufficient to enable EPA to conclude 

that affected 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. 

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 statutory 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 the other voluntary Agency programs. See Comment 

#76. 

EPA response: EPA does not tie together regulatory and voluntary approaches to protecting the 

environment. Every company is encouraged to participate 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 under 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 alternative to this rule would be to 

coordinate with the PFOA Stewardship Program. 

EPA response: Under the PFOA Stewardship Program, 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 find 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 exemption. 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. 

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8) Comment Summary: There would be no TSCA restrictions placed on imported finished 

goods that are treated outside the U.S. with perfluorinated polymers. 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 country 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 design 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 composition during its end use or only those changes of 

composition which have no commercial purpose separate from that of the article and that may 

occur as described in section 720.36(g)(5), except that fluids and particles are not considered 

articles regardless of shape or design. A person 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 perfluorinated polymers could have an advantage 

over domestic products, as this commenter asserted, because this rule does not prohibit domestic 

manufacturers from treating articles 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 beyond 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 polymers have been manufactured in reliance on EPA’s 

prior regulatory determination and, according to this commenter, statements that the Agency 

would not rescind the applicability of the polymer exemption rule to them. To do so would 

create an arbitrary and biased regulatory distinction between perfluorinated chemicals that have 

identical risk profiles but that have been legally 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. Manufacturers would need to comply with any terms EPA 

imposes as a condition of continued production after the transition period or the manufacturer 

must cease manufacturing, processing and distributing the subject chemical. In imposing such 

conditions, EPA would not need to make any regulatory findings, 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 imposing and revoking regulatory 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 that 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 provided 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 

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declined 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 applicability. On the contrary, EPA clearly stated that 

it had alternative regulatory 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 available, 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 exclude 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 this rulemaking to exclude high MW waterabsorbing polymers from eligibility. Similarly, any future proposed revisions would also 

be subject to notice in the Federal Register and comment in accordance with the 

Administrative Procedure Act. 

60 FR 16326. Thus, not only did EPA clearly state 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 order 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 exempted polymer remains a new chemical 

substance (although legitimately manufactured 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 for 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 arbitrary and biased regulatory distinction between perfluorinated 

chemicals that have been legally 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. Rather, it is merely requiring 

manufacturers that have not voluntarily submitted affected polymers for PMN review to do so 

now, or to submit a request for a different section 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. 

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This final rule requires manufacturers 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 them 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 authorities. Lastly, the process EPA has followed to amend the 

polymer exemption rule is in full compliance with the rulemaking requirements 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, including 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 exemption, EPA does not require participating 

companies to report chemical identity. As a result, EPA has had no way of knowing whether the 

required exemption reports (required to be submitted by January 31 of the year subsequent to 

initial manufacture) for chemicals reported under the current polymer exemption rule were for 

PFAS/PFAC-related or other fluorine-containing polymers that would be subject to this rule. 

Prior to the 1995 rule amendments, EPA had specifically excluded from the polymer exemption 

rule all halogen-containing polymers. EPA reasonably believes that the number of fluorinecontaining polymers as a percentage of all polymers 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 regularly tracks polymers that would have 

qualified for the polymer exemption, but that are still 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 overall 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 submissions for polymers, and CBI data files) 

is used to estimate the number of fluorine-containing 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 from 12 per year, to 18 per year. This is because 

EPA is using a revised average number of 292 polymers 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 this rule because the 

number of polymer notices has increased over the 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 that will no longer be eligible for the polymer 

exemption.

In addition, EPA has met with the individual member companies of the Telomer Research 

Program (TRP) and Fluoropolymer Manufacturing Group (FMG) who have disclosed, as 

confidential business information (CBI), all of the fluorotelomer-based products and 

fluoropolymers manufactured using ammonium perfluorooctanoate (APFO), including polymers 

manufactured under the polymer exemption. All of these numbers support the estimates in the 

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Economic 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 current trends. Moreover, 

none of the comments provided any evidence that contradicts EPA’s estimates. 

11) Comment Summary: General comments that the proposed rule grossly underestimated the 

true cost of the proposed rule for the regulated 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 the economic analysis for the final rule. 

The wage series used in the Economic Analysis for the proposed rule, which 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 slightly 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 underestimated 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 continue 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 cost of traditional new chemicals. The 

commenter asserts that EPA has stated that it routinely issues TSCA Section 5(e) Consent 

Orders for testing of perfluorinated substances in the PMN Program and that the Agency 

is likely to do so with respect to polymers that are subject to this rule. According to the 

commenter, that process is likely to take more than one year, which could delay by more 

than one year the commercialization of truly “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 review a PMN or alternate section 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 manufactured or imported, in full compliance with the 1995 

polymer exemption rule, include commercialization delay costs. These costs assume that a 

product is ready for sale on the market and the 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 potential “downstream” costs, whether they result from additional 

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commercialization 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 distinct 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 anticipated” cost of PMN 

regulatory actions and Consent Orders in the economic analysis. 

EPA Response: In the Economic Analysis for the proposed rule, EPA acknowledged that there 

could be potential follow-on costs that companies may experience in connection with testing 

requested under a TSCA section 5(e) consent order. As noted in the response to Comment 11c 

above, the Economic Analysis for the final rule differentiates 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 exemption 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 fluorinated 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 submission 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 exposure 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” based 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 present 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 that other PFAS and PFAC 

chemicals may share similar toxicity, persistence and bioaccumulation characteristics with PFOS 

and PFOA. 

Limited toxicity data on perfluoroalkyl moieties of various carbon 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 appears 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 

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monkeys, the half-lives of the C4 and C6 sulfonates are much less than those reported for 

humans, on the order of 4 days and 87-141 days, respectively. Information on the half-lives of 

the C4 and C6 carboxylates in humans is not available. In monkeys, the half-lives of the C4 and 

C6 carboxylates are 1.7 and 0.8-1.5 days, respectively. Significant species differences in the 

elimination of PFOA and PFOS between humans and monkeys have also been reported, with the 

elimination half-lives in monkeys (30 to 150 days) being significantly shorter than in humans 

(3.8 to 5.4 years) (Ref. 3 in the final rule). The available toxicity 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 support 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 the EPA provided data only for conversion of C8 

precursors into PFOA and showed no evidence for polymer degradation to produce either PFOA 

or precursors. On commenter (#71) specifically explained: “Our fluorinated polymers are 

designed to be both stable and 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 fluropolymers will result in the release 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 11486) and in this final rule (see response 

to comment 15b), EPA has evidence demonstrating that polymers containing perfluoroalkyl 

moieties may break down in the environment thereby releasing the perfluroalkyl 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 carbon 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 performance testing under very rigorous conditions. 

However, the “performance testing data” referred to is only an efficacy test for the coated 

product and not a study of the degradation products one might find from 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 what it does know about 

potential degradation of polymers containing PFAS/PFAC precursors, and polymers containing 

fluorotelomers, it is reasonable to expect that polymers containing other perfluoroalkyl moieties 

may also degrade in the environment to produce PFAS or PFAC. 

Extensive literature has been developed for both PFOA and PFOS on mode of action, toxicity, 

and pharmacokinetics, which EPA continues to monitor and review as it becomes available. The 

Agency is in the process of receiving additional data on the toxicokinetics and environmental 

persistence, as well as toxicity data of the lower chain acids and sulfonates. Given the 

persistence, possible bioaccumulation, and toxicity of the degradation products in the 

environment, EPA thinks it is prudent to go forth 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 changed EPA’s position since the rule was proposed. In 

light of the available data, including recent data, EPA can no longer conclude that affected 

polymers as a group will not present an unreasonable risk of injury to health or the environment 

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under the terms of the polymer exemption rule. In addition, EPA believes that 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 further allow EPA to expand its understanding of 

the fate and toxic effects these products may have on human health and the environment. 

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

will not allow use of APFO in the formulation 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 the 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 products; the rule only addresses the need for PMN 

or other appropriate section 5 review of affected polymers. Use of APFO as a processing aid and 

APFO content in the formulation will not necessarily make the polymer ineligible for the 

amended polymer exemption rule. Only when (if this were to happen intentionally or 

unintentionally) the APFO is incorporated into the polymer structure (for example: as any part of 

the polymer backbone, as a substituent to the polymer backbone, or as a counter ion) would that 

polymer no longer be exempt from reporting under TSCA section 5. The only components of 

any formulation that would be subject to the rule are the polymers in the formulation. Products 

that contain polymers that are subject to this final rule can be reformulated to eliminate those 

affected polymers, or the products can continue to be manufactured until 24 months from 

publication of this rule if they are currently being manufactured, or already have been 

manufactured in full compliance with the existing polymer exemption rule, prior to the effective 

date of this rule. After the expiration of the exemption allowing the manufacture of these 

polymers, these chemicals may no longer be manufactured 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 rule, such manufacture or 

import must cease. (see EPA Response # 2 above) 

15) Comment summary: A number of comments asserting errors 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 does not biomagnify through food chains, and 

various categorization schemes around the 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 evidenced by the half-life values for elimination. 

PFOS and PFOA are known to bioaccumulate in humans with half-life values for elimination in 

the order of years. Other PFCA and PFCS show elimination half-life values in humans between 

one month and several years respectively (Ref. 3). 

In the proposed rule, EPA stated that PFOA and other perfluoro chemicals (PFCs) may be 

bioaccumulative. Bioaccumulation is a general term 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 18 
chemicals from water (bioconcentration) and from 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 removed at rates adequate to 

prevent their bioaccumulation in aquatic or terrestrial species including humans and other 

mammals. Unlike many persistent organic pollutants that bioaccumulate, PFCs do not partition 

into fatty tissues or lipids. Many of the various rating systems used around the world for 

bioaccumulation are based on the premise that bioaccumulative 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 and other international organizations support this 

position (OECD 2006; UNEP 2006)1

. EPA believes that, when available, human 

bioaccumulation or half-life data should be used in the assessment of whether a chemical 

bioaccumulates, particularly for PFCs. The half-life in humans for PFOA is calculated at 3.8 

years and for PFOS at 5.4 years (Ref. 3 in the final rule). Thus, PFOA and PFOS are not quickly 

cleared from the human body. In light of this information, EPA believes that it should evaluate 

affected polymers under the PMN review process or under a different section 5(h)(4) exemption, 

if the manufacturer or importer 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 biomagnify in some aquatic food webs, as noted by 

the commenter. Other studies suggest 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 wildlife is a cause for concern and that such 

presence supports its decision to no longer allow exemption for these polymers. 

 

15b) EPA indicated that polymers containing PFAS or PFAC may degrade, possibly by 

incomplete incineration, and release perfluorinated chemicals into the environment. The 

commenter requested that EPA identify the page and information in the referenced study 

that supports this statement. Also, the commenter 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 incinerators. 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 incomplete incineration, and release these 

perfluorinated chemicals into the environment is contained in Reference 3 cited in the proposed 

rule (Ref. 16 in the final rule), “Fluorochemical Use, Distribution and Release Overview,” in the 

section on exposure assessment for the paper and packaging business. Specifically, page 341 of 

Reference 3 contains a supply chain flow chart for fluorochemicals in the paper and packaging 

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

1 OECD SIDS Ammonium Perfluorooctanate & Perfluorooctanoic 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 & Perfluorooctanoic Acid, SIDS Initial Assessment Report (SIAR), 

April 2006. 

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

also shows release of fluorochemicals from the incinerator. 

Although it was not cited in the preamble to the proposed rule, EPA subsequently reviewed a 

scientific journal article, "Thermolysis 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 products 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 detected 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 may 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 contain data that show that thermolysis of 

PFOA/APFO occurs at the experimental conditions of the studies reported in these journal 

articles, resulting in degradation products that include 1-H-perfluoroheptane, Perfluoro-1-

heptene, as well as other unidentified fluorine containing high 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 directly 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-based acrylic polymer as well as 

the pure polymer under conditions of 1000C, a residence time of 2 seconds, and 85% excess air, 

which are the typical conditions for municipal waste incineration according to the article. PFOA 

was not detected in the combustion products over the temperature range of 600C to 1000C. 

However, other degradation products, comprising 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 seconds, and 85% excess air are the least stringent 

conditions of municipal waste incineration or are otherwise representative of the thermal 

degradation conditions under which articles containing the polymers 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 inconclusive as to a specific vapor pressure 

(VP) for 8-2 alcohol. Regardless of what the “correct” 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. 

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sufficient to partition to this media giving EPA concern for its widespread 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 principal use is as a fluoropolymer processing 

aid, was the most commonly used form. See Comment #78. 

EPA Response: EPA concurs with the commenter and acknowledges that the ammonium salt 

(APFO), which is used as a fluoropolymer processing aid, is the most commonly used form. 

15e) EPA attributed funding of the Mabury research 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 effects cited in the proposed rule were animal, 

not human health effects. See Comment #79. 

EPA Response: In the proposed rule, health effects reported from exposure to perflurorinated 

chemicals were in fact effects observed in animals, 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, such 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 moieties [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 transformed into a longer chain length PFAS or 

PFAC. EPA does have evidence that chemical substances having longer Rf perfluoro chain 

moieties (where Rf = Perfluoroalky CF3- or greater) can be converted 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 where a CF3 group had been attached to a (C, 

S) atom would have to result from polymer degradation products arising from 

depolymerization. The commenter, therefore, 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 cleavage of the bonds around the Rf moiety to liberate 

PFAS/PFAC or corresponding precursor chemicals. The simple fact that fluorine-containing 

Page 14 of 18 
polymers subjected to hazardous waste incinerator conditions are destroyed is evidence that 

depolymerization can occur at high temperatures (all 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, and even internal polymer degradation that could 

lead to the formation of PFAS and PFAC are sufficient to warrant examination of these polymers 

during PMN or other applicable review and revocation of the 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. Specifically, the proposed rule indicates 

that an epidemiologic study reported an increased incidence of bladder cancer mortality 

and goes on to state that it cannot be ascertained whether fluorochemicals 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 clarifies and addresses any 

confusing or misleading statements 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 backbone, 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 force 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 (as a side chain or in the middle of a 

perfluoropolypropylene homopolymer) make that polymer 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. Hydrogen-terminated poly PTFE, 

H-[CF2CF2]x-H, would not be subject to the 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 sulfonic acid) have the 

potential to be generated. This rule does not address whether internal –[CF2]x- moieties can 

degrade to PFAC. While that may be a reasonable 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 polymer exemption at a later date. 

Testing under this ECA involves subjecting perfluoro-containing polymers to simulated 

municipal waste incineration conditions. Additional 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 bioaccumulation of PFAC or PFAS chemicals, the 

distribution and half-lives of PFOS/PFOA in the body, results of subchronic and developmental 

toxicity studies, thyroid effects and tumorigenicity of PFOS and/or PFOA. EPA’s general 

Page 15 of 18 
response is provided below followed 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-generalizing when referring to the various PFAS or 

PFAC substances. These statements have been clarified or adjusted in the final rule where 

appropriate, or in EPA’s responses to specific comments. Nonetheless, in light of the available 

data, EPA can no longer conclude that affected 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" and 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 phrase 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 review of perfluoralkyl 

acid monitoring and toxicological findings (Ref. 3 in the final rule), which addresses 

toxicological findings for both PFOS and PFOA. 

17b) Tumorigenicity: The commenter questions the accuracy of the statement in the 

proposed rule that PFOS is "carcinogenic, inducing tumors of the liver, and thyroid and 

mammary glands." The comment basically asserts that the statement should be qualified 

with respect to thyroid tumorigenicity 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), there were none in the high-dose group treated for 

two years. The commenter also states that "PFOS did not increase mammary tumors" 

because, even though the pairwise values for the 0 .5 and 2 ppin dose groups were 

statistically significantly higher 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 regarding whether PFOS induces thyroid tumors. With 

respect to benign versus malignant tumors, EPA regards both as important in assessing the 

potential carcinogenicity of a compound (see EPA'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 discussed at page 11493 of the preamble to the proposed rule 

occurred at doses that were toxic to the maternal animals. The commenter says that, 

without such context, the lay reader can easily misconstrue the significance of the effects. 

The commenter also says "As EPA and 3M researchers involved in these studies have 

Page 16 of 18 
pointed out, the teratological findings in laboratory 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 toxicity studies and did not distinguish 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 occurring at higher doses than other developmental effects, and as such 

these effects are not the main concern. It should 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 Developmental 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 asserts that the following statement on page 

11493 of the proposed rule is misleading: ". . .workers with the highest PFOS exposures 

had significantly higher serum triiodothyronine levels and significantly lower thyroid 

hormone binding ratio. . ." The commenter provides a number of reasons, supported by 

various studies, explaining why the statement 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 PFOA exposure. It also cites a follow-up study 

which purportedly "did not show an exposure-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 exposure categories were 

modified." 

17f) Pituitary Weight: The commenter states that the reduced pituitary weight discussed 

in the subject study "was not a significant biological finding. . ." 

EPA Response: EPA summarized the organ weight results on page 11496 of the proposed rule, 

but did not comment on the biological 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 "incorrect, and outdated, and should be updated in 

Page 17 of 18 
the final [FR] notice." The commenter refers 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 causes “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. 

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