Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 4295 

Polymer CAS No. 

* * * * * * * 

[FR Doc. 2010–1578 Filed 1–26–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 723 

[EPA–HQ–OPPT–2002–0051; FRL–8805–5] 

RIN 2070–AD58 

Premanufacture Notification 

Exemption for Polymers; Amendment 

of Polymer Exemption Rule to Exclude 

Certain Perfluorinated Polymers 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is amending the polymer 

exemption rule, which provides an 

exemption from the premanufacture 

notification (PMN) requirements of the 

Toxic Substances Control Act (TSCA), 

to exclude from eligibility polymers 

containing as an integral part of their 

composition, except as impurities, 

certain perfluoroalkyl moieties 

consisting of a CF3- or longer chain 

length. This exclusion includes 

polymers that contain any one or more 

of the following: Perfluoroalkyl 

sulfonates (PFAS), perfluoroalkyl 

carboxylates (PFAC), fluorotelomers, or 

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 (affected polymers). In 

general, any person who intends to 

manufacture (which is defined by TSCA 

to include import into the customs 

territory of the United States) any of 

these polymers not already on the TSCA 

Inventory (Inventory) must complete the 

TSCA PMN review process prior to 

commencing the manufacture or import 

of such polymers. Alternatively, 

manufacturers or importers may submit 

a request for a different exemption, such 

as the Low Volume Exemption (LVE) or 

Low Release and Exposure Exemption 

(LoREX), for affected polymers that they 

reasonably believe may qualify for such 

exemptions. Those 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 

January 27, 2012. After that date, 

manufacture of these polymers will no 

longer be authorized under the polymer 

exemption rule, and continued 

manufacture or import must be 

authorized under a different TSCA 

section 5(h)(4) exemption or under a 

different TSCA section 5 authority, such 

as TSCA section 5(a)(1) or section 5(e). 

This change is necessary because, based 

on current information, EPA can no 

longer conclude that these polymers 

‘‘will not present an unreasonable risk to 

human health or the environment’’ 

under the terms of the polymer 

exemption rule, which is the 

determination necessary to support an 

exemption under TSCA section 5(h)(4). 

DATES: This final rule is effective 

February 26, 2010. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPPT–2002–0051. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

the EPA Docket Center (EPA/DC) at Rm. 

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

general information contact: Colby 

Lintner, Regulatory Coordinator, 

Environmental Assistance Division 

(7408M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 554–1404; e-mail address: 

TSCA-Hotline@epa.gov. 

For technical information contact: 

Geraldine Hilton, Chemical Control 

Division (7405M), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (202) 564– 

8986; e-mail address: 

hilton.geraldine@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you manufacture or import 

polymers that contain as an integral part 

of their composition, except as 

impurities, certain perfluoroalkyl 

moieties consisting of a CF3- or longer 

chain length (affected polymers). As 

specified in the regulatory text of this 

final rule (40 CFR 723.250(d)(6)), these 

perfluoroalkyl moieties include any one 

or more of the following: PFAS, PFAC, 

fluorotelomers, or 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. Persons who 

import or intend to import polymers 

that are covered by this final rule would 

be subject to TSCA section 13 (15 U.S.C. 

2612) import certification requirements, 

and to the regulations codified at 19 

CFR 12.118 through 12.127 and 127.28. 

Those persons must certify that they are 

in compliance with the PMN 

requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. Importers 

of formulated products that contain a 

polymer that is subject to this final rule 

as a component (for example, for use as 

a water-proof coating for textiles or as a 

top anti-reflective coating (TARC) used 

to manufacture integrated circuits) may 

also be potentially affected. A list of 

potential monomers and reactants that 

could be used to manufacture polymers 

that would be affected by this final rule 

may be found in the public docket (Ref. 

7). Potentially affected entities may 

include, but are not limited to: Chemical 

manufacturers or importers (NAICS 

code 325), e.g., persons who 

manufacture (defined by statute to 

include import) one or more of the 

subject chemical substances. 


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4296 Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

40 CFR 723.250. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the technical person listed under FOR

FURTHER INFORMATION CONTACT. 

II. Background 

A. What Action is the Agency Taking? 

In the Federal Register issue of March 

7, 2006 (Ref. 26), the Agency proposed 

to exclude from the polymer exemption 

rule (40 CFR 723.250), which exempts 

certain chemical substances from TSCA 

section 5 PMN requirements, polymers 

containing as an integral part of their 

composition, except as impurities, 

certain perfluoroalkyl moieties 

consisting of a CF3- or longer chain 

length. The proposed exclusion 

included polymers that contain any one 

or more of the following: PFAS, PFAC, 

fluorotelomers, or 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. EPA is 

finalizing the rule as proposed, with two 

changes related to the implementation 

of the final rule. The first applies to the 

effective date of the final rule, which 

will be 30 days after date of publication 

in the Federal Register instead of 12 

months, as was proposed. The second 

will allow 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, 

24 months to complete the TSCA 

section 5 review process instead of 12 

months, as was proposed. EPA is also 

clarifying that manufacturers and 

importers of affected polymers may 

submit a request for a different TSCA 

section 5(h)(4) exemption, such as a 

LVE or LoREX request, in lieu of a PMN, 

if they reasonably believe that the 

subject polymers may qualify for those 

exemptions. See Unit III.E. for 

additional information on 

implementation of the final rule. 

Non-confidential information related 

to this final rule may be found in 

administrative record number (AR) AR– 

226, which is the public administrative 

record that the Agency has established 

for perfluorinated chemical substances 

generally. Interested parties should 

consult AR–226 for additional 

information on PFAS, PFAC, 

fluorotelomers, or other perfluoroalkyl 

moieties. To receive an index of AR– 

226, contact the EPA/DC by telephone: 

(202) 566–1744 or e-mail: docketcustomerservice@epa.gov. 

Additional information may be found 

in docket ID number EPA–HQ–OPPT– 

2003–0012 which covers the Agency’s 

enforceable consent agreement (ECA) 

process for certain of these chemical 

substances. See ADDRESSES for 

instructions on accessing a public 

docket. 

B. What is the Agency’s Authority for 

Taking this Action? 

Section 5(a)(1)(A) of TSCA requires 

persons to notify EPA at least 90 days 

before they manufacture or import a 

new chemical substance for commercial 

purposes. Section 3(9) of TSCA defines 

a ‘‘new chemical substance’’ as any 

chemical substance that is not on the 

Inventory compiled by EPA under 

TSCA section 8(b). Section 5(h)(4) of 

TSCA authorizes EPA, upon application 

and by rule, to exempt the manufacturer 

or importer of any new chemical 

substance from part or all of the 

provisions of TSCA section 5 if the 

Agency determines that the 

manufacture, processing, distribution in 

commerce, use, or disposal of such 

chemical substance, or any combination 

of such activities will not present an 

unreasonable risk of injury to human 

health or the environment. Section 

5(h)(4) of TSCA also authorizes EPA to 

amend or repeal such rules. EPA has 

acted under these authorities to amend 

the polymer exemption rule at 40 CFR 

723.250. 

C. Why is the Agency Taking this 

Action? 

1. Polymers containing PFAS or 

PFAC. EPA is amending the polymer 

exemption rule, last amended in 1995, 

to exclude polymers containing PFAS or 

PFAC, because the Agency has received 

information which suggests that 

polymers containing PFAS or PFAC 

may degrade and release fluorochemical 

residual compounds into the 

environment. Once released, PFAS or 

PFAC are expected to persist in the 

environment, may bioaccumulate, and 

may be highly toxic. Accordingly, EPA 

can no longer make the determination 

that the manufacturing, processing, 

distribution in commerce, use, or 

disposal of polymers containing PFAS 

or PFAC ‘‘will not present an 

unreasonable risk to human health or 

the environment’’ under the terms of the 

polymer exemption rule, as required 

under TSCA section 5(h)(4). 

2. Polymers containing fluorotelomers 

or other perfluoroalkyl moieties. EPA is 

also excluding polymers that contain 

fluorotelomers, or that contain 

perfluoroalkyl moieties consisting of a 

CF3- or longer chain length 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. Initial studies have 

demonstrated toxic effects of certain 

compounds containing fluorotelomers 

(derived from the 8–2 alcohol, Chemical 

Abstracts Service Registry Number (CAS 

No.) 678–39–7). Preliminary 

investigations have found that 

fluorotelomer alcohols were present in 

the air above several cities, indicating 

that these chemical substances may be 

widely distributed and that air may be 

a route of exposure. Based on the 

available data, EPA expects that 

polymers containing fluorotelomers or 

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 may degrade in the 

environment thereby releasing 

fluorotelomer alcohols or other 

perfluoroalkyl–containing chemical 

substances. It is possible that, once 

released, such moieties may potentially 

degrade to form PFAS or PFAC. 

Accordingly, EPA can no longer 

conclude that polymers containing 

fluorotelomers and these other 

perfluoroalkyl moieties ‘‘will not present 

an unreasonable risk of injury to health 

or the environment’’ under the terms of 

the polymer exemption rule, as required 

for an exemption under TSCA section 

5(h)(4). Therefore, EPA is excluding 

such polymers from the polymer 

exemption at 40 CFR 723.250. 

III. Final Rule 

A. History Subsequent to the 1995 

Amendment to the Polymer Exemption 

Rule 

The 1995 amendments to the polymer 

exemption rule published in the Federal 

Register issue of March 29, 1995 (Ref. 

28) expanded the polymer exemption to 

include polymers made from reactants 

that contain certain halogen atoms, 

including fluorine. The best available 

information in 1995 indicated that most 

halogen containing compounds, 

including unreactive polymers 

containing PFAS and PFAC chemical 

substances, were chemically and 

environmentally stable and would not 


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present an unreasonable risk to human 

health and the environment. In 1999, 

however, the 3M Company (3M) 

provided the Agency with preliminary 

reports that indicated widespread 

distribution of perfluorooctane sulfonate 

(PFOS) in humans, the environment and 

wildlife (Refs. 8–10). In addition, on 

May 16, 2000, 3M announced that it 

would phase out perfluorooctanyl 

chemistry in light of the persistence of 

certain fluorochemicals and their 

detection at extremely low levels in the 

blood of the general population and 

wildlife. 3M indicated that production 

of these chemical substances would be 

substantially discontinued by the end of 

2000 (Ref. 11). Based on this 

information from 3M, EPA began to 

investigate potential risks from PFOS 

and other perfluorinated chemical 

substances, as well as polymers 

containing these chemical substances. It 

is possible that polymers containing 

PFAS or PFAC chemical substances may 

degrade, releasing these chemical 

substances into the environment where 

they are expected to persist. The 

number of carbon atoms on the PFAS or 

PFAC molecule, whether as a single 

compound, or as a component of a 

polymer, may influence 

bioaccumulation potential and toxicity. 

Based on the available data, EPA 

expects that polymers containing 

fluorotelomers or 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 may degrade, 

releasing these chemical substances into 

the environment where they may further 

degrade into PFAS or PFAC. 

B. EPA’s Responses to Comments 

Received on the Proposed Rule 

EPA specifically requested comments 

on the following issues in the proposed 

rule: 

• Whether exemption is appropriate 

under the polymer exemption rule for 

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 and where the 

perfluoralkyl moiety consists of a CF3- 

or longer chain length. 

• Alternatives for implementing the 

final rule that would achieve the 

purposes of TSCA section 5 without 

disrupting ongoing manufacture or 

import of currently exempt polymers. 

The Agency received comments on 

these and other aspects of the proposed 

rule. Comments were submitted by the 

Society of the Plastics Industry, E.I. 

DuPont de Nemours and Company, 3M 

Company, the People’s Republic of 

China, International Imaging Industry 

Association, Peach State Labs, Inc., 

Dainippon Ink & Chemicals, Inc., and 

Clariant Corporation. Summaries of 

significant comments and EPA’s 

responses to them are included in a 

separate document entitled ‘‘Response to 

Comments on the Polymer Exemption 

Rule Amendment’’ (Ref. 2). This 

document is available in the public 

docket established for this final rule. 

C. Defining Polymers that are Subject to 

this Final Rule 

1. Polymers containing PFAS or 

PFAC. This final rule applies to a large 

group of polymers containing one or 

more fully fluorinated alkyl sulfonate or 

carboxylate groups. None of these 

polymers occur naturally. Such 

polymers are considered ‘‘new chemical 

substances’’ under TSCA if they have 

not been included in the Inventory 

compiled and published under TSCA 

section 8(b) (15 U.S.C. 2607(b)). For a 

list of examples of the Ninth Collective 

Index of Chemical Abstracts of chemical 

names and CAS numbers of chemical 

substances used to make polymers that 

are subject to this final rule, see Ref. 7. 

EPA has concerns for the perfluorinated 

carbon atoms in the Rf 

(Rf=Perfluoroalkyl CF3- or greater) 

substituent, in this unit, when that Rf 

unit is associated with the polymer 

through the carbonyl (PFAC) or sulfonyl 

(PFAS) group. How these materials are 

incorporated into the polymer is 

immaterial (they may be counter ions, 

terminal/end capping agents, or part of 

the polymer backbone). 

PFAC 

O 

Õ 

Rf—C—Hetero atom (typically N or O)-Polymer 

Rf=Perfluoroalkyl CF3- or greater 

PFAS 

O 

Õ 

Rf—S—Hetero atom (typically N or O)-Polymer 

Õ 

O 

This final rule specifically excludes 

from the polymer exemption at 40 CFR 

723.250 polymers that contain any 

PFAS or PFAC group consisting of a 

CF3- or longer chain length. EPA has 

increasing concerns as the number of 

carbon atoms that are perfluorinated in 

any individual Rf substituent increases. 

PFOA (perfluorooctanoate) is a PFAC 

(see top structure) which has 7 carbon 

atoms in the Rf moiety (CAS 

nomenclature rules count the carbonyl 

carbon atom as the eighth carbon for 

naming purposes, hence the octanoate 

terminology). PFOS is a PFAS (see 

bottom structure) which has 8 carbon 

atoms in the Rf moiety. Generally, the 

longer the chain of perfluorinated C 

atoms, the greater the persistence and 

retention time in the body; furthermore, 

the C8 chain length has been associated 

with adverse health effects in laboratory 

animals. 

Most of the toxicity data currently 

available on PFAS and PFAC chemical 

substances pertain to the PFOS 

potassium salt (PFOSK) and the PFOA 

ammonium salt (APFO). There is some 

evidence that PFAS/PFAC moieties with 

longer carbon chains may present 

greater concerns than PFAS/PFAC 

moieties with shorter-carbon chains 

(Refs. 3, 12–14). However, EPA has 

insufficient information at this time to 

determine a limit for which shorter 

chain lengths ‘‘will not present an 

unreasonable risk to human health or 

the environment’’ under the terms of the 

polymer exemption rule. 


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2. Polymers containing fluorotelomers 

or other perfluoroalkyl moieties. EPA is 

also excluding from the polymer 

exemption at 40 CFR 723.250 polymers 

that contain fluorotelomers, or that 

contain perfluoroalkyl moieties of a 

CF3- or longer chain length 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. 

i. Fluorotelomers. One method that is 

commonly used to incorporate 

perfluorinated compounds into 

polymers is to use fluorotelomers, such 

as perfluoroalkyl ethanol or its 

derivatives. Telomerization is the 

reaction of a telogen with a 

polymerizable ethylenic compound to 

form low molecular weight polymeric 

compounds, commonly referred to as a 

telomer. For example, the reaction of 

pentafluoroethyl iodide (a telogen) with 

tetrafluoroethylene forms a 

fluorotelomer iodide intermediate 

which is then reacted with ethylene and 

converted into perfluoroalkyl ethanol. 

This chemical substance can be further 

reacted to form a variety of useful 

intermediates which may subsequently 

be incorporated into the polymer (Ref. 

15). The fluorochemical group formed 

by the telomerization process is 

predominantly straight chain, and 

depending on the telogen used produces 

a product having an even number of 

carbon atoms. However, the chain 

length of the fluorotelomer varies 

widely. A representative structure for 

these compounds is: 

F–(CF2–CF2)x–Anything (often CH2– 

CH2–O–Polymer) x ≥ 1 

ii. Other perfluoroalkyl moieties. 

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 can be attached to the 

polymers using conventional chemical 

reactions. A representative structure for 

these compounds is: 

F–(CF2)x–(C,S)–Polymer x ≥ 1 

D. Concerns with Respect to Polymers 

Containing PFAS, PFAC, 

Fluorotelomers, or Other Perfluoroalkyl 

Moieties 

1. Polymers containing PFAS or 

PFAC. EPA has received and reviewed 

data on the PFAS and PFAC chemical 

substances PFOS and PFOA, 

respectively, and on other 

perfluoroalkyl acids. PFAS and PFAC 

are used in a variety of polymeric 

chemical substances to impart oil and 

water resistance, stain and soil 

protection, and reduced flammability. 

The same features that make the 

polymeric coatings containing PFAS or 

PFAC useful, allow the polymeric 

compound to be stable to the natural 

environmental conditions that produce 

degradation. However, it has been 

demonstrated in certain circumstances 

that PFAS and PFAC–containing 

compounds will undergo degradation 

(chemical, microbial, or photolytic) of 

the non–fluorinated portion of the 

molecule leaving the remaining 

perfluorinated acid untouched (Ref. 22). 

Further degradation of the 

perfluoroalkyl residual compounds is 

extremely difficult. In particular, EPA 

has evidence that polymers containing 

PFAS or PFAC may degrade, possibly by 

incomplete incineration, and that these 

perfluorinated chemical substances may 

be released into the environment (Ref. 

16). Under routine conditions of 

municipal waste incinerators (MWIs), 

incinerated chemical substances are 

exposed to 1,000°C temperature for long 

retention times. Those conditions are 

sufficient to cleave the normally stable 

C–F bonds. However, when MWIs do 

not maintain sufficiently high 

temperatures or sufficiently long 

retention times to cleave the stable C– 

F bond, it is possible that the PFAS and 

PFAC produced by oxidative thermal 

decomposition of the polymers will 

remain intact and can be released into 

the environment (Ref. 16). 

PFOS and PFOA have been found in 

the blood of workers exposed to the 

chemical substances and in the general 

populations of the United States and 

other countries (Refs. 3, 17, and 18). 

They have also been found in many 

terrestrial and aquatic animal species 

worldwide (Refs. 3, 17, and 18). As 

discussed in this unit, PFAS and PFAC 

chemical substances used in the 

production of polymers may be released 

into the environment by degradation. It 

is possible, therefore, that the 

widespread presence of PFOS and 

PFOA in the environment may be due, 

in part, to the degradation of such 

polymers and the subsequent release of 

the PFAS and PFAC components into 

the environment. However, the method 

of degradation and global distribution is 

uncertain. The widespread distribution 

of the chemical substances also 

suggests, and biomonitoring studies 

confirm, that human exposure to PFOS 

and PFOA may be widespread. In 

particular, in a 2007 National Health 

and Nutrition Examination Survey 

(NHANES) report, PFOS, PFOA, 

perfluorohexane sulfonic acid (PFHxS) 

and perfluorononanoic acid (PFNA) 

were detected in > 98% of the serum 

samples from a representative sample of 

the general U.S. population ≥ 12 years 

of age (Ref. 21 and see also the Response 

to Comments Document (Ref. 2)). 

PFOS and PFOA have shown liver, 

developmental, and reproductive 

toxicity in animal studies (Ref. 3). 

Animal test data indicate that PFOS and 

PFOA may cause cancer (Ref. 3). An 

occupational study reported an excess 

of bladder cancer in a small number of 

workers at a plant that manufactured 

perfluorinated chemical substances; 

however, follow up studies have not 

confirmed an increase in bladder cancer 

incidence in workers (Ref. 3). EPA 

included a comprehensive discussion of 

use and production volume data, 

exposure data, and environmental fate 

and health effects data for PFOS and 

PFOA and other PFAS and PFAC 

chemical substances in the proposed 

rule (Ref. 26, pp. 11489–11497). That 

comprehensive discussion is 

incorporated here as modified by EPA’s 

responses to public comments received 

by the Agency on aspects of that 

discussion (Ref. 2). Although the 

Agency has far more data on PFOS and 

PFOA than on other PFAS and PFAC 

chemical substances, EPA expects that, 

based on available data, other PFAS and 

PFAC chemical substances of CF3- or 

longer chain length may share similar 

toxicity, persistence, and 

bioaccumulation characteristics that 

need to be evaluated. 

Some commenters objected to EPA’s 

statement in the proposed rule that it 

believes other PFAS and PFAC chemical 

substances of CF3- or longer chain 

length may share similar toxicity, 

persistence, and bioaccumulation 

characteristics that need to be evaluated 

and what they asserted were other 

‘‘generalized’’ statements in the 

proposed rule, noting that each PFAS 

and PFAC chemical substance should be 

examined on its own merits with 

respect to toxicity, bioaccumulation, 

and persistence. EPA agrees that 

individual PFAS and PFAC chemical 

substances, like the polymers that 

contain them, should be evaluated 

based on their own merits. That is 

precisely why it has excluded affected 

polymers from the polymer exemption 

rule. This action will allow EPA to 

evaluate affected polymers individually, 

based on their own merits, through the 

PMN process or under other appropriate 

exemption criteria. EPA also 

emphasizes that it has not stated in the 

preambles to the proposed rule or this 

final rule that other PFAS or PFAC 

chemical substances categorically share 

similar toxicity, bioaccumulation, and 

persistence characteristics with PFOS 

and PFOA. EPA has only stated that it 

believes that they may, or are expected 

to, share similar characteristics, based 


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on available information and its 

professional judgment and experience. 

Consideration of available 

information on specific chemical 

substances in light of EPA’s professional 

judgment and expertise, in order to 

draw reasonable conclusions about the 

potential risks of similar chemical 

substances, has long been an integral 

component of EPA’s implementation of 

the polymer exemption rule. This has 

been the case whether EPA is expanding 

the scope of the exemption (see, for 

example, Ref. 27, pp. 7679, 7682–7683, 

in which EPA explained the basis for 

expanding the scope of the exemption to 

include polymers that contain halogen 

groups, based on analysis of health and 

ecotoxicity data for specific polymers 

that previously had been evaluated 

under the PMN program) or narrowing 

it (see, for example, Ref. 28, pp. 16316, 

16319–16320, in which EPA excluded a 

category of water–absorbing polymers 

from the exemption, based on a single 

toxicity study submitted under TSCA 

section 8(e)). 

In this instance, EPA stated in the 

proposed rule that, based on currently 

available information, EPA believed 

that, while all PFAS and PFAC chemical 

substances are expected to persist, the 

length of the perfluorinated chain may 

have an effect on the other areas of 

concern for these chemical substances, 

such as bioaccumulation and toxicity. 

EPA also stated that there was evidence 

that PFAS/PFAC moieties with longer 

carbon chains may present greater 

concerns for bioaccumulation potential 

and toxicity than PFAS/PFAC moieties 

with shorter-carbon chains. However, 

carbon chain length may only be one 

factor in determining retention time. As 

discussed in the Response to Comments 

document (Ref. 2), data received since 

the proposed rule was published 

generally supports these statements. 

The Agency continues to investigate 

the physicochemical properties, the 

environmental fate and distribution, and 

the toxicity of PFAS and PFAC chemical 

substances, including polymers already 

in production. A recent journal article 

provides an overview of the monitoring 

data available for the environment, 

wildlife, and humans, as well as recent 

advances in the toxicology and mode of 

action for this class of compounds (Ref. 

3). These data help the Agency to 

evaluate these polymers to ascertain any 

potential risks on a case–by–case basis. 

However, available data are still 

insufficient to determine the carbon 

number below which PFAS and PFAC 

chemical substances ‘‘will not present 

an unreasonable risk.’’ At this time, 

therefore, EPA can no longer conclude 

that polymers containing PFAS or PFAC 

will not present an unreasonable risk to 

human health or the environment under 

the terms of the polymer exemption 

rule. Therefore, this final rule excludes 

polymers containing PFAS or PFAC 

from eligibility for exemption from 

TSCA section 5(a)(1)(A) reporting 

requirements for new chemical 

substances under the polymer 

exemption rule. 

2. Polymers containing fluorotelomers 

or other perfluoroalkyl moieties. EPA 

has received data on various 

perfluorinated chemical substances that 

indicate that the Agency should 

evaluate polymers that contain these 

perfluoroalkyl moieties through the 

PMN process. As discussed in the 

proposed rule (Ref. 26, p. 11497), there 

is a growing body of data demonstrating 

that fluorotelomer alcohols metabolize 

or degrade to generate PFOA. For 

example, the fluorotelomer alcohol [CA 

Index Name: 

3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10– 

Heptadecafluorodecan–1–ol; CAS No. 

678–39–7], also known as 8–2 alcohol, 

has been shown to degrade to form 

PFOA when exposed to activated sludge 

during accelerated biodegradation 

studies (Refs. 3, 19, and 20). 

Initial test data from a study in rats 

dosed with fluorotelomer alcohol and 

other preliminary animal studies on 

various telomeric products containing 

fluorocarbons structurally similar to 

PFAC or PFAS have demonstrated a 

variety of adverse effects including 

liver, kidney and thyroid effects (Refs. 3 

and 5). 

Preliminary investigations have 

demonstrated the presence of 

fluorotelomer alcohols in the air in six 

different cities (Ref. 6). This finding is 

significant because it is indicative of not 

only widespread fluorotelomer alcohol 

distribution, but also it further indicates 

that air may be a route of direct or 

indirect exposure to these chemical 

substances, which can be degraded or 

metabolized to form PFOA. 

Fluorotelomer alcohols are generally 

incorporated into the polymers via 

covalent ester linkages, and it is 

possible that degradation of the 

polymers may result in release of the 

fluorotelomer alcohols to the 

environment. 

Based on the presence of 

fluorotelomer alcohols in the air, the 

growing data demonstrating that 

fluorotelomer alcohols metabolize or 

degrade to generate PFOA, the 

preliminary toxicity data on certain 

compounds containing fluorotelomers 

(such as the 8–2 alcohol), and the 

possibility that polymers containing 

fluorotelomers as an integral part of the 

polymer composition may degrade in 

the environment thereby releasing 

fluorotelomer alcohols or other 

perfluoroalkyl-containing chemical 

substances, EPA can no longer conclude 

that polymers containing fluorotelomers 

as an integral part of the polymer 

composition ‘‘will not present an 

unreasonable risk of injury to health or 

the environment’’ under the terms of the 

polymer exemption rule as required for 

an exemption under TSCA section 

5(h)(4). 

Although EPA does not have specific 

data demonstrating that polymers 

containing perfluoroalkyl moieties other 

than PFAS, PFAC, or fluorotelomers 

present the same concerns as those 

containing PFAS, PFAC, or 

fluorotelomers, EPA is nevertheless 

excluding polymers containing 

perfluoroalkyl groups, consisting of a 

CF3- or longer chain length, 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 from the polymer exemption. 

Based on available data which indicate 

that compounds containing PFAS or 

PFAC may degrade in the environment 

thereby releasing the PFAS or PFAC 

moiety, and that fluorotelomers may 

degrade in the environment to form 

PFAC, it is possible that polymers 

containing these other types of 

perfluoroalkyl moieties may also 

degrade over time in the environment 

thereby releasing the perfluoroalkyl 

moiety. Based on available data, EPA 

expects that once released, such 

moieties may potentially degrade to 

form PFAS or PFAC. EPA therefore 

cannot continue to make the ‘‘will not 

present an unreasonable risk of injury to 

health or the environment’’ finding 

under the terms of the polymer 

exemption rule for such polymers. 

E. Implementation 

The proposed rule would have 

established an effective date for the final 

rule that was 1 year after the date of 

publication of the final rule. This would 

have allowed manufacturers or 

importers of affected polymers who 

were already manufacturing or 

importing such polymers in full 

compliance with the terms of the 

polymer exemption rule, to continue 

manufacture or import for a period of 1 

year after the date of publication of the 

final rule. However, in order to continue 

manufacturing or importing affected 

polymers after the 1–year period, 

manufacturers or importers would have 

had to complete the PMN review 

process within the 1–year period before 

the final rule became effective. 

As an alternative to the 1 year 

effective date, EPA also specifically 


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sought comment on an implementation 

approach that would have established 

an effective date 30 days after 

publication of the final rule, but provide 

an extended compliance date for those 

who, prior to the effective date, had 

already initiated the manufacture or 

import of affected polymers (see Ref. 26, 

pp. 11484, 11488). Under the alternative 

approach, the TSCA section 5(a)(1)(A) 

requirement to submit a PMN for a new 

chemical substance would have been reestablished with respect to affected 

polymers beginning 30 days after 

publication of the final rule. However, 

those who were manufacturing or 

importing affected polymers in full 

compliance with the existing exemption 

would have had 1 year from the 

effective date to complete the PMN 

process. EPA specifically requested 

comment on these or other 

implementation approaches. 

Commenters generally asserted that 1 

year was not enough time to develop a 

PMN and to complete the PMN review 

process. Several commenters suggested 

as an alternative that EPA require 

submission of a PMN within a year or 

that it extend the 1–year ‘‘grace period’’ 

to 3 years. One commenter also 

requested clarification regarding 

whether a LVE request could be 

submitted in lieu of a PMN in order to 

comply with this final rule. Upon 

review of these comments and proposed 

alternatives, EPA agrees that 1 year 

would likely not provide sufficient time 

to complete the PMN review process for 

all affected polymers currently being 

manufactured or imported under the 

polymer exemption rule. The Agency 

has therefore changed the proposed 

approach, and is also clarifying that 

requests for different TSCA section 

5(h)(4) exemptions, such as a LVE or 

LoREX request, may be submitted to 

comply with the final rule, if 

manufacturers or importers reasonably 

believe affected polymers may qualify 

for such exemptions. 

The effective date of this final rule 

will be 30 days after its publication in 

the Federal Register, which is the 

minimum required by section 553(c) of 

the Administrative Procedure Act. 

Accordingly, the TSCA section 

5(a)(1)(A) requirement to submit a PMN 

(or alternate exemption request, if 

appropriate) for a new chemical 

substance applies to all affected 

polymers beginning 30 days after 

publication of the final rule in the 

Federal Register. However, EPA is 

providing an extended compliance date 

for those who, prior to the effective date 

of the final rule, had already initiated 

the manufacture or import of affected 

polymers in full compliance with the 

1995 polymer exemption rule. 

Specifically, this final rule allows 

manufacturers or importers of affected 

polymers, who are in full compliance 

with the terms of the 1995 polymer 

exemption rule, to continue 

manufacture or import of such polymers 

under the polymer exemption rule until 

January 27, 2012. 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 

January 27, 2012, such manufacture or 

import must cease. With respect to PMN 

submissions, the company must submit 

a notice of commencement (NOC) 

within 30 days of commencing nonexempt manufacturing (see 40 CFR 

720.102), so that the polymer can be 

placed on the TSCA Inventory where 

appropriate, after the review of the PMN 

submission. The NOC must be filed as 

a condition of continued manufacture or 

import. A company may at any time 

during the review process elect to 

withdraw its PMN or exemption 

request. If a manufacturer or importer 

elects to withdraw its PMN or 

exemption request, all manufacturing or 

importing activity must cease as of 

January 27, 2012. 

EPA will strive to complete the 

review of the PMN (or alternate 

exemption request) submitted in 

response to this final rule promptly. For 

those PMNs for which EPA determines 

that action under TSCA section 5(e) may 

be necessary, the 90–day review period 

is generally suspended by the reviewer 

as the consent order is developed/ 

negotiated. In addition, at any time in 

the review period, EPA may determine 

that good cause exists to extend the 

PMN notice review period for a total 

period of extension not to exceed 90 

days (see 40 CFR 720.75). However, for 

polymers currently being manufactured 

under the terms of the existing polymer 

exemption rule, the TSCA section 5 

review process must be completed by 

January 27, 2012. Therefore, the Agency 

recommends that manufacturers 

currently manufacturing affected 

polymers under the polymer exemption 

rule submit their PMNs early in the 24 

months following the publication of this 

final rule. In particular, manufacturers 

intending to submit an LVE or LoREX 

should 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. In 

addition to reviewing the applicable 

regulations pertaining to submission of 

PMNs and alternate TSCA section 

5(h)(4) exemption requests, 

manufacturers may consult with the 

OPPT New Chemicals Management 

Branch ((202) 564–9373) in the TSCA 

New Chemicals Program to determine 

what information will enable timely 

review. 

EPA decided on this approach 

because the proposed rule would have 

inadvertently allowed polymers not 

already being manufactured under the 

polymer exemption rule to be 

manufactured or imported for a year 

without going through the PMN or other 

TSCA section 5 review process. As 

noted in the proposed rule, the delayed 

effective date was intended to provide 

current manufacturers or importers of 

affected polymers who are in full 

compliance with the terms of the 

existing polymer exemption rule 

additional time to come into compliance 

with the final rule, without disrupting 

their ability to manufacture or import 

those polymers. (Ref. 26, p. 11487). 

Those who are not currently 

manufacturing or importing affected 

polymers would not experience such 

disruptions. Accordingly, EPA believes 

it is reasonable to make the effective 

date of the final rule 30 days after 

publication in the Federal Register, but 

provide additional time to complete the 

TSCA section 5 review process for 

manufacturers or importers who began 

manufacturing or importing affected 

polymers in full compliance with the 

terms of the existing polymer exemption 

rule prior to the effective date of the 

final rule. 

EPA has extended by 12 months the 

time that manufacturers and importers 

who are currently manufacturing or 

importing affected polymers would have 

had under the proposed rule to 

complete the TSCA section 5 review 

process. Under the proposed rule, such 

manufacturers would have had to 

submit a PMN to EPA within 6 months 

after publication of the final rule in 

order for EPA to have had the entire 180 

day period authorized by TSCA section 

5 to complete the PMN review. This 

time frame may have been too short in 

some circumstances. For example, one 

trade group indicated that notifications 

for imported affected polymers might 

take longer than normal to prepare 

because its members would need to 

coordinate with non-domestic suppliers 

to obtain information, which may be 

proprietary, on formulations that they 

import. Another commenter observed 

that manufacturers or importers may 

need to submit bona fide letters of intent 

prior to submitting a PMN to determine 

whether affected polymers that they 

manufacture or import are already listed 

on the Inventory. 


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Under this final rule, such 

manufacturers and importers will have 

up to 18 months to submit a PMN in 

order for EPA to have the entire 180 day 

review period (90 days plus opportunity 

for up to a 90–day extension under 

TSCA section 5(c)) to complete the 

review. This approach will allow such 

manufacturers and importers additional 

time to compile the information 

necessary to prepare and submit PMNs 

or exemption requests. However, EPA 

encourages manufacturers and 

importers to submit PMNs or alternate 

exemption requests as soon as possible 

after publication of the final rule. Doing 

so will provide EPA with more time to 

complete consent orders and, if 

necessary, establish testing 

requirements for those polymers for 

which EPA may have concerns of 

potential unreasonable risk to human 

health or the environment. 

The proposed regulatory text in 40 

CFR 723.250(d)(6)(i) has therefore been 

changed from ‘‘Except ... may no longer 

be manufactured after January 27, 2011 

unless that polymer has undergone a 

premanufacture review ...’’ to: ‘‘Any 

polymer that has been manufactured 

previously in full compliance with the 

requirements of this section prior to 

February 26, 2010 may no longer be 

manufactured under this section after 

January 27, 2012.’’ 

Manufacturers or importers of affected 

polymers that are already on the 

Inventory compiled and published 

under TSCA section 8(b) (15 U.S.C. 

2607(b)) are not impacted by this final 

rule. The PMN requirements in TSCA 

section 5(a) apply only to new chemical 

substances which are those that are not 

included on the Inventory of Chemical 

Substances. 

IV. Objective and Rationale for this 

Final Rule 

The objective of this final rule is to 

amend the polymer exemption rule to 

exclude polymers containing as an 

integral part of the polymer 

composition, except as impurities, any 

one or more of certain perfluoroalkyl 

moieties consisting of a CF3- or longer 

chain length from eligibility for the 

exemption from TSCA section 5 

reporting requirements allowed under 

the 1995 amendments to the polymer 

exemption rule. In TSCA section 

5(a)(1)(A), Congress prohibited persons 

from manufacturing (including 

importing) new chemical substances 

unless such persons submitted a PMN to 

EPA at least 90 days before such 

manufacture. Pursuant to TSCA section 

5(h)(4), EPA is authorized to exempt the 

manufacturer of any new chemical 

substance from all or part of the 

requirements of TSCA section 5 if the 

Agency determines that the 

manufacture, processing, distribution in 

commerce, use, or disposal of the 

chemical substance, or any combination 

of such activities, will not present an 

unreasonable risk of injury to health or 

the environment. Section 5(h)(4) of 

TSCA also authorizes EPA to amend or 

repeal such rules. 

The polymer exemption rule is 

intended to exempt certain polymers 

from certain TSCA section 5 

requirements polymers because EPA 

believes those exempted polymers pose 

a low risk of injury to health or the 

environment. The exemption criteria are 

therefore designed to exempt polymers 

that are of low concern because of their 

stability, molecular size, and lack of 

reactivity, among other properties. EPA 

has excluded certain polymers from the 

exemption where: 

• The Agency has insufficient data 

and review experience to support a 

finding that they will not present an 

unreasonable risk; or 

• The Agency has found that under 

certain conditions, the polymers may 

present risks which require a closer 

examination of the conditions of 

manufacturing, processing, distribution, 

use, and disposal during a full 90–day 

PMN review (i.e., the Agency has 

information suggesting that the 

conditions for an exemption under 

TSCA section 5(h)(4) are not met). 

This approach allows the Agency to 

maintain full regulatory oversight over 

potentially higher risk polymers while 

streamlining the review process for lowrisk polymers. 

Based on the data currently available, 

for the reasons stated herein, EPA can 

no longer can make a generally 

applicable finding, without additional 

information, that the manufacture, 

processing, distribution in commerce, 

use, and/or disposal of affected 

polymers will not present an 

unreasonable risk of injury to health or 

the environment under the terms of the 

polymer exemption rule. 

V. Economic Considerations 

EPA has evaluated the potential costs 

of eliminating the polymer exemption 

for the chemical substances described in 

this final rule. The results of this 

evaluation are contained in a document 

entitled ‘‘Economic Analysis of the 

Amendment to the Polymer Exemption 

Rule to Exclude Certain Perfluorinated 

Polymers’’ (Ref. 1). A copy of this 

economic analysis is available in the 

public docket for this action, and is 

briefly summarized here. 

The industry costs for completing and 

submitting a PMN reporting form are 

estimated to be $8,269 per chemical 

substance. Because the final rule would 

eliminate the cost of complying with the 

recordkeeping and reporting 

requirements of the polymer exemption 

rule, the cost for completing and 

submitting a PMN as a result of this 

amendment is reduced by $372, for a 

net cost of $7,897 per chemical 

substance (Ref. 1). 

Companies that currently 

manufacture an affected polymer under 

the exemption are estimated to incur a 

total net cost of $7,897 per chemical 

substance. Companies that do not 

currently manufacture an affected 

polymer, but begin to manufacture such 

polymers in the future, may also incur 

potential net costs of $14,522 associated 

with potential delays in 

commercialization of the new chemical 

substance. These companies are 

estimated to incur a total cost of $22,419 

per chemical substance as a result of 

this final rule (Ref. 1). These net costs 

do not include the following per 

chemical substance costs that would 

have been incurred had a manufacturer 

of an affected polymer been allowed to 

continue to submit an exemption 

notification under the polymer 

exemption rule (i.e., had this 

amendment to the polymer exemption 

rule not been finalized): 

• $372 for recordkeeping and 

reporting costs. 

• $9,572 commercialization delay 

cost. 

The potential number of PMNs that 

may be submitted each year under the 

final rule was estimated using the 292 

polymer reports received by EPA 

annually between 1996 and 2006 under 

the polymer exemption rule. EPA 

estimates this final rule could affect a 

maximum of 6% of the 292 polymers 

reported annually, and, therefore, 

estimates that a maximum of 18 PMNs 

may be submitted each year under the 

final rule. Using the same estimated 

number of 18 chemical substances per 

year for the 14 years (1996 through 

2009) during which affected polymers 

were exempt from PMN requirements 

under the polymer exemption rule, 252 

previously exempt chemical substances 

(18 chemical substances x 14 years) 

could be expected to have a PMN 

submitted under the final rule. EPA 

expects to receive the majority of PMNs 

for previously exempt chemical 

substances during the second year of the 

proposed rule. However, because EPA 

has no way of predicting accurately the 

actual timing of the submissions, EPA is 

averaging the 252 PMNs over the 2–year 

period and is assuming that 126 PMNs 

for previously exempt chemical 

substances will be submitted in each of 


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the first 2 years after publication of the 

final rule. 

In addition, EPA is expecting a 

maximum of 18 PMNs to be submitted 

to the Agency each year for new 

chemical substances. Therefore, the 

Agency estimates that a maximum of 

144 PMNs (126 + 18) might be 

submitted during each of the first 2 

years after the effective date of the final 

rule, and that a maximum of 18 PMNs 

might be submitted in each subsequent 

year. 

Using the estimated per chemical 

substance costs and the estimated 

number of PMNs anticipated, EPA 

estimates the potential PMN submission 

costs to industry in each of the first 2 

years of the final rule for manufacturers 

of 144 chemical substances (126 

previously exempt new chemical 

substances and 18 new chemical 

substances) to be $1,398,564, or $1.4 

million per year, including $995,022 for 

previously exempt chemical substances 

(126 chemical substances x $7,897 per 

chemical substance) + $403,542 (18 new 

chemical substances x $22,419). This 

will decrease to an estimated annual 

cost of $403,542 in the third year and 

beyond for the maximum of 18 PMNs 

that EPA believes could be submitted 

annually by manufacturers and 

importers of new chemical substances 

that are no longer eligible for the 

exemption. 

While the final rule clarifies that other 

TSCA section 5(h)(4) exemption 

requests may be submitted. EPA 

estimates that the cost of preparing an 

LVE or a LoREX is equal to the cost of 

preparing a PMN. However, LVEs and 

LoREXs are not subject to the $2,500 

user fee. Accordingly, if the Agency 

receives no LVE or LoREXs notices as a 

result of this clarification, then Agency 

estimated costs are not affected by this 

clarification. However, if the Agency 

does receive any LVE or LoREX notices, 

then estimated costs would be 

overstated because these notices would 

not be subject to the user fee. The 

Agency has never received a 

photographic film exemption request 

and does not expect to as a result of this 

final rule 

In addition, as was the case prior to 

the promulgation of the polymer 

exemption rule in 1995, the Agency 

recognizes that the submission of a PMN 

may lead to other regulatory actions 

under TSCA, for example consent 

orders issued under TSCA section 5(e). 

Any such actions are highly dependent 

on the circumstances surrounding the 

individual PMN (e.g., available 

information and scientific 

understanding about the chemical 

substance and its risks at the time the 

PMN is being reviewed). Such potential 

actions and any costs associated with 

them would not be a direct result of this 

final rule. Nevertheless, the economic 

analysis does contain a brief discussion 

of the Agency’s previous and ongoing 

regulatory activities with respect to 

potentially affected polymers. 

VI. References 

As indicated under ADDRESSES, a 

docket has been established for this 

final rule under docket ID number EPA– 

HQ–OPPT–2002–0051. The following is 

a listing of the documents that are 

specifically referenced in this final rule. 

References from the proposed rule that 

have not been referenced in the final 

rule are relevant to EPA’s decisions in 

this final rule and can also be found in 

this docket. The docket includes these 

documents and other information 

considered by EPA in developing this 

final rule, including documents that are 

referenced within the documents that 

are included in the docket, even if the 

referenced document is not physically 

located in the docket. For assistance in 

locating these other documents, please 

consult the technical person listed 

under FOR FURTHER INFORMATION

CONTACT. 

Reference documents identified with 

an ‘‘AR’’ designation are cross-indexed 

to non-regulatory, publicly accessible 

information files maintained in the 

EPA/DC. Copies of these documents can 

be obtained as described in ADDRESSES. 

1. EPA. Economic Analysis of the 

Amendment to the Polymer Exemption 

Rule To Exclude Certain Perfluorinated 

Polymers. Wendy Hoffman (EPA/OPPT/ 

Economics, Exposure and Technology 

Division (EETD)). October 19, 2009. 

2. EPA. Response to Comments on the 

Polymer Exemption Rule Amendment. 

July 14, 2009. 

3. Lau, C.; Anitole, K.; Hodes, C.; Lai, 

D.; Pfahles-Hutchens, A.; Seed, J. 

Perfluoroalkyl Acids: A Review of 

Monitoring and Toxicological Findings. 

Toxicological Sciences. Vol. 99(2), pp. 

366–394. 2007. 

4. (AR–226–1440) Hagen, D.F.; 

Belisle, J.; Johnson, J.D.; Venkateswarlu, 

P. Characterization of fluorinated 

metabolites by a gas chromatographichelium microwave plasma detector—the 

biotransformation of 1H, 1H, 2H, 2Hperfluorodecanol perfluorooctanoate. 

Analytical Biochemistry. Vol. 118(2), 

pp. 336–343. 1981. 

5. (AR–226–1147) DuPont 

presentation to the Agency at the 

meeting held on November 25, 2002. 

6. (AR–226–1281) Scott Mabury, P.I. 

Interim Annual Report of Activities for 

TRP Grant to University of Toronto; 

Project years: 1 September, 2001 to 1 

September, 2002. 

7. Memo from Dr. Gregory Fritz (EPA/ 

OPPT/EETD) to Mary Begley (EPA/ 

OPPT/Chemical Control Division (CCD)) 

re: Polymer Feedstocks Resulting in 

Excluded Polymers. April 18, 2002. 

8. (AR–226–0620) Sulfonated 

Perfluorochemicals in the Environment: 

Sources, Dispersion, Fate, and Effects. 

3M. St. Paul, MN. March 1, 2000. 

9. (AR–226–0547) The Science of 

Organic Fluorochemistry. 3M. St. Paul, 

MN. February 5, 1999. 

10. (AR–226–0548) Perfluorooctane 

Sulfonate: Current Summary of Human 

Sera, Health and Toxicology Data. 3M. 

St. Paul, MN. January 21, 1999. 

11. (AR–226–0600) Weppner, William 

A. Phase-out Plan for PFOS-Based 

Products. 3M. St. Paul, MN. July 7, 

2000. 

12. Kudo, Naomi, et al. Comparison of 

the Elimination Between Perfluorinated 

Fatty Acids with Different Carbon Chain 

Lengths in Rats. Chemico-Biological 

Interactions. Vol. 134(2), pp. 203–216. 

2001. 

13. Goeke-Flora, Carol M. and 

Nicholas, V. Reo. Influence of Carbon 

Chain Length on the Hepatic Effects of 

Perfluorinated Fatty Acids, A 19F- and 31P-NMR Investigation. Chemical 

Research in Toxicology. Vol. 9(4), pp. 

689–695. 1996. 

14. (AR–226–1030a109) 

Fluorochemical Decomposition 

Processes. 3M. St. Paul, MN. April 4, 

2001. 

15. Bultman, David and Pike, Myron. 

The Use of Fluorochemical Surfactants 

in Floor Polish. 3M. St. Paul, MN. 

16. (AR–226–0550) Fluorochemical 

Use, Distribution and Release Overview. 

3M. St. Paul, MN. May 26, 1999. 

17. (AR–226–1093) Seed, Jennifer. 

Hazard Assessment of Perfluorooctanoic 

Acid and Its Salts, Revised Draft (EPA/ 

OPPT/Risk Assessment Division (RAD)). 

Washington, DC. November 4, 2002. 

18. (AR–226–1140) Organization for 

Economic Co-operation and 

Development (OECD), Hazard 

Assessment of Perfluorooctane sulfonate 

(PFOS) and its Salts. OECD Publication 

No. ENV/JM/ RD(2002)17/FINAL. 

November 21, 2002. 

19. (AR–226–1149) Biodegradation 

screen studies for telomer type alcohols. 

3M. November 6, 2002. 

20. (AR–226–1262) DuPont Executive 

Summary—Biodegradation Screening 

Studies of 8–2 Telomer B Alcohol. 

March 20, 2003. 

21. Calafat, A.; Wong, L.; Kuklenyik, 

Z.; Reidy, J.; Needham, L. 

Polyfluoroalky Chemicals in the U.S. 

Population: Data from the National 

Health and Nutrition Examination 


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Survey (NHANES) 2003–2004 and 

Comparisons with NHANES 1999–2000. 

Environmental Health Perspectives. Vol. 

115(11), pp. 1596–1602. 2007. 

22. Remde, A. and Debus, R. 

Biodegradability of Fluorinated 

Surfactants Under Aerobic and 

Anaerobic Conditions. Chemosphere. 

Vol. 32(8), pp. 1563–1574. 1996. 

23. OECD, Screening Information Data 

Sets (SIDS). Ammonium 

Perfluorooctanate & Perfluorooctanoic 

Acid, SIDS Initial Assessment Report 

(SIAR). April 2006. 

24. United Nations Environment 

Program/Persistent Organic Pollutants/ 

Persistent Organic Pollutants Review 

Committee (UNEP/POPS/POPRC). Draft 

risk profile: Perfluorooctane sulfonate 

(PFOS). July 2006. 

25. Ellis, D.A.; Mabury, S.A.; Martin, 

J.W.; Muir, D.C.G. Thermolysis of 

fluoropolymers as a potential source of 

halogenated organic acids in the 

environment. Nature. Vol. 412, pp. 321– 

324. 2001. 

26. EPA. Premanufacture Notification 

Exemption for Polymers; Amendment of 

Polymer Exemption Rule to Exclude 

Certain Perfluorinated Polymers; 

Proposed Rule. Federal Register (71 FR 

11483, March 7, 2006) (FRL–7735–5). 

27. EPA. Premanufacture Notification 

Exemptions; Revisions of Exemptions 

for Polymers; Proposed Rule. Federal 

Register (58 FR 7679, February 8, 1993) 

(FRL–3890–1). 

28. EPA. Premanufacture Notification 

Exemptions; Revisions of Exemptions 

for Polymers; Final Rule. Federal 

Register (60 FR 16316, March 29, 1995) 

(FRL–4929–8). 

VII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This action is not a ‘‘significant 

regulatory action’’ under section 3(f) of 

Executive Order 12866, entitled 

Regulatory Planning and Review (58 FR 

51735, October 4, 1993), and was not 

therefore reviewed by the Office of 

Management and Budget (OMB) under 

Executive Order 12866. 

EPA has prepared an economic 

analysis of the potential impacts 

associated with this action. A copy of 

this economic analysis, ‘‘Economic 

Analysis of the Amendment to the 

Polymer Exemption Rule to Exclude 

Certain Perfluorinated Polymers’’ (Ref. 

1) is available in the public docket for 

this action and is briefly summarized in 

Unit V. 

B. Paperwork Reduction Act 

The information collection 

requirements related to the submission 

of PMNs are already approved by OMB 

under the Paperwork Reduction Act 

(PRA), 44 U.S.C. 3501 et seq. That 

Information Collection Request (ICR) 

document has been assigned EPA ICR 

number 0574 and OMB control number 

2070–0012. This final rule does not 

impose any new requirements that 

require additional OMB approval. 

Under PRA, ‘‘burden’’ means the total 

time, effort, or financial resources 

expended by persons to generate, 

maintain, retain, or disclose or provide 

information to or for a Federal agency. 

This burden estimate includes the time 

needed to review instructions, search 

existing data sources, gather and 

maintain the data needed, and 

complete, review, and submit the 

required PMN, and maintain the 

required records. 

Based on the estimated burden in the 

existing ICR, if an entity were to submit 

a PMN to the Agency, the annual 

reporting burden is estimated to average 

between 95 and 114 hours per response, 

with a midpoint respondent burden of 

107 hours. This estimate was adjusted to 

account for the elimination of the 

existing burden related to the 

recordkeeping and reporting 

requirements in the polymer exemption 

rule, which is estimated to impose a 

burden on industry of 6 hours per 

chemical substance, i.e., 2 hours for 

reporting, and 4 hours for 

recordkeeping. The net paperwork 

burden for submitting a PMN as a result 

of this final amendment is therefore 

estimated to be 101 hours per PMN 

submission. The net cost to submit a 

PMN under the final rule is estimated to 

be $5,397. In addition, PMN 

submissions must be accompanied by a 

user fee of $2,500 (set at $100 for small 

businesses with annuals sales of less 

than $40 million). These net paperwork 

hours and associated costs do not 

include the per chemical substance 6 

hour burden and $372 associated cost 

that would have been incurred had a 

manufacturer of an affected polymer 

been allowed to continue to submit an 

exemption notification under the 

polymer exemption rule (i.e., had this 

amendment to the polymer exemption 

rule not been finalized). 

The final rule clarifies that other 

TSCA section 5(h)(4) exemption 

requests may be submitted in lieu of 

PMNs. EPA estimates that the cost of 

preparing an LVE or a LoREX is equal 

to the cost of preparing a PMN. 

However, LVEs and LoREXs are not 

subject to the $2,500 user fee. 

Accordingly, if the Agency receives no 

LVE or LoREXs notices as a result of this 

clarification, then Agency estimated 

costs are not affected by this 

clarification. However, if the Agency 

does receive any LVE or LoREX notices, 

then estimated costs would be 

overstated because these notices would 

not be subject to the user fee. The 

Agency has never received a 

photographic film exemption request 

and does not expect to as a result of this 

final rule. 

For the first 2 years after publication 

of the final rule, EPA estimates that the 

one-time burden for the companies that 

submit PMNs for chemical substances 

already in production will be a 

maximum of 12,726 hours (126 

chemical substances x 101 hours per 

submission). Based on the high-end 

assumption of 18 PMNs for new 

chemical substances annually, the 

annual burden is estimated to be 1,818 

hours (18 x 101 hours). Therefore, EPA 

estimates that the burden in each of the 

first two years for the 144 PMNs will be 

14,544 hours. The burden is expected to 

decrease to 1,818 hours in the third year 

of the final rule and beyond. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to an information collection 

request subject to PRA unless it displays 

a currently valid OMB control number. 

The OMB control numbers for EPA’s 

regulations are listed in 40 CFR part 9 

and included on any related collection 

instrument (e.g., on the form or survey). 

C. Regulatory Flexibility Act 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), the Agency hereby 

certifies that this action will not have a 

significant adverse economic impact on 

a substantial number of small entities. 

The Agency’s basis is briefly 

summarized here and the analysis is 

detailed in the economic analysis (Ref. 

1). 

Small entities include small 

businesses, small organizations, and 

small governmental jurisdictions. For 

purposes of assessing the impacts of this 

final rule on small entities, small entity 

is defined as: 

1. A small business as defined by the 

Small Business Administration’s (SBA) 

regulations at 13 CFR 121.201 based on 

the applicable NAICS code for the 

business sector impacted. 

2. A small governmental jurisdiction 

that is a government of a city, county, 

town, school district or special district 

with a population of less than 50,000. 

3. A small organization that is any 

not-for-profit enterprise which is 

independently owned and operated and 

is not dominant in its field. 

The regulated community does not 

include any small governmental 

jurisdictions or small not-for-profit 


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4304 Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 

organizations. For small businesses, the 

Agency assessed the impacts on small 

chemical manufacturers in NAICS codes 

325 and 324110. The SBA size 

standards for sectors under NAICS code 

325 range from 500 to 1,000 employees 

or fewer in order to be classified as 

small. The size standard for NAICS code 

324110, petroleum refineries, is 1,500 

employees. 

As summarized in Unit V., the 

industry costs for completing and 

submitting a PMN reporting form are 

estimated to be $7,897 per chemical 

substance (Ref. 1). Small businesses 

with less than $40 million in annual 

sales are entitled to a reduced user fee 

of $100 for submitting a PMN, rather 

than the $2,500 user fee, which would 

reduce the per PMN costs for small 

businesses to $5,497 per chemical 

substance. 

Based on estimates of the number of 

PMNs expected to be submitted as a 

result of this action, it appears that 12 

or fewer businesses would be affected 

per year (Ref. 1). The five companies 

that manufacture the majority of the 

volume of chemical substances that will 

be affected by the polymer exemption 

rule belong to either or both of the 

Fluoropolymer Manufacturers Group 

and the Telomer Research Program. 

These two groups, which have no other 

members beyond the five companies, 

have negotiated TSCA section 4 ECAs 

and other voluntary testing 

arrangements with the Agency for 

testing specific chemical substances that 

would be affected by the polymer 

exemption rule. The two groups have 

told the Agency that their member 

companies manufacture the majority of 

the volume of chemical substances that 

would be affected by the final rule. 

None of these five companies meet the 

definition of small under the Small 

Business Administration employee size 

criteria. The remaining volume of 

chemical substance that could be 

affected by the final rule is low enough 

so that even if a small company were to 

be affected, a significant number of 

businesses would not be affected, nor 

would any individual small business 

experience significant impacts. 

D. Unfunded Mandates Reform Act 

This action contains no Federal 

mandates for State, local, or tribal 

governments or the private sector under 

the provisions of Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA), 2 U.S.C. 1531–1538. This 

action will not have an annual impact 

of $100 million or more on the private 

sector, nor will it impact State or tribal 

governments. Based on EPA’s 

experience with past PMNs, State, local, 

and tribal governments have not been 

affected by this reporting requirement, 

and EPA does not have any reason to 

believe that any State, local, or tribal 

government will be affected by this final 

rule. As such, EPA has determined that 

this regulatory action does not impose 

any enforceable duty, contain any 

unfunded mandate, or otherwise have 

any affect on small governments subject 

to the requirements of sections 202 or 

205 of UMRA. 

E. Executive Order 13132 

Pursuant to Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999), EPA has determined 

that this action does not have federalism 

implications because it will not have 

substantial direct effects on the States, 

on the relationship between the national 

government and the states, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in the 

Order. Thus, Executive Order 13132 

does not apply to this final rule. 

F. Executive Order 13175 

As required by Executive Order 

13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000), EPA has determined that this 

action does not have tribal implications 

because it will not have any affect on 

tribal governments, on the relationship 

between the Federal government and 

the Indian tribes, or on the distribution 

of power and responsibilities between 

the Federal government and Indian 

tribes, as specified in the Order. Thus, 

Executive Order 13175 does not apply 

to this final rule. 

G. Executive Order 13045 

EPA interprets Executive Order 

13045, entitled Protection of Children 

from Environmental Health Risks and 

Safety Risks (62 FR 19885, April 23, 

1997), as applying only to those 

regulatory actions that concern health or 

safety risks, such that the analysis 

required under section 5-501 of 

Executive Order 13045 has the potential 

to influence the regulation. This action 

is not subject to Executive Order 13045 

because it does not establish an 

environmental standard intended to 

mitigate health or safety risks. 

H. Executive Order 13211 

This action is not a ‘‘significant energy 

action’’ as defined in Executive Order 

13211, entitled Actions Concerning 

Regulations that Significantly Affect 

Energy Supply, Distribution, or Use (66 

FR 28355, May 22, 2001) because it is 

not likely to have a significant adverse 

effect on the supply, distribution, or use 

of energy. 

I. National Technology Transfer 

Advancement Act 

Since this action does not involve any 

technical standards, section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (NTTAA), 

Public Law 104–113, section 12(d) (15 

U.S.C. 272 note), does not apply to this 

action. 

J. Executive Order 12898 

This action does not entail special 

considerations of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994). EPA has determined 

that this final rule will not have 

disproportionately high and adverse 

human health or environmental effects 

on minority or low-income populations 

because it increases the level of 

environmental protection for all affected 

populations without having any 

disproportionately high and adverse 

human health or environmental effects 

on any population, including any 

minority or low-income population. 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This rule is not a ‘‘major rule’’ 

as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 723 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: January 15, 2010. 

Stephen A. Owens, 

Assistant Administrator, Office of Prevention, 

Pesticides and Toxic Substances. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 723—[AMENDED] 

■ 1. The authority citation for part 723 

continues to read as follows: 

Authority: 15 U.S.C. 2604. 


hsrobinson on DSK69SOYB1PROD with RULES
Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 4305 

■ 2. Section 723.250 is amended by 

adding the definitions below in 

alphabetical order to paragraph (b) and 

by adding a new paragraph (d)(6) to read 

as follows: 

§ 723.250 Polymers. 

* * * * * 

(b) * * * 

Fluorotelomers means the products of 

telomerization, which is the reaction of 

a telogen (such as pentafluoroethyl 

iodide) with an ethylenic compound 

(such as tetrafluoroethylene) to form 

low molecular weight polymeric 

compounds, which contain an array of 

saturated carbon atoms covalently 

bonded to each other (C-C bonds) and to 

fluorine atoms (C-F bonds). This array is 

predominantly a straight chain, and 

depending on the telogen used produces 

a compound having an even number of 

carbon atoms. However, the carbon 

chain length of the fluorotelomer varies 

widely. The perfluoroalkyl groups 

formed by this process are usually, but 

do not have to be, connected to the 

polymer through a functionalized 

ethylene group as indicated by the 

following structural diagram: (RfCH2CH2-Anything). 

* * * * * 

Perfluoroalkyl carboxylate (PFAC) 

means a group of saturated carbon 

atoms covalently bonded to each other 

in a linear, branched, or cyclic array and 

covalently bonded to a carbonyl moiety 

and where all carbon-hydrogen (C-H) 

bonds have been replaced with carbonfluorine (C-F) bonds. The carbonyl 

moiety is also covalently bonded to a 

hetero atom, typically, but not 

necessarily oxygen (O) or nitrogen (N). 

Perfluoroalkyl sulfonate (PFAS) 

means a group of saturated carbon 

atoms covalently bonded to each other 

in a linear, branched, or cyclic array and 

covalently bonded to a sulfonyl moiety 

and where all carbon - hydrogen (C-H) 

bonds have been replaced with carbon 

- fluorine (C-F) bonds. The sulfonyl 

moiety is also covalently bonded to a 

hetero atom, typically, but not 

necessarily oxygen (O) or nitrogen (N). 

* * * * * 

(d) * * * 

(6) Polymers which contain certain 

perfluoroalkyl moieties consisting of a 

CF3- or longer chain length. Except as 

provided in paragraph (d)(6)(i), after 

February 26, 2010, a polymer cannot be 

manufactured under this section if the 

polymer contains as an integral part of 

its composition, except as impurities, 

one or more of the following 

perfluoroalkyl moieties consisting of a 

CF3- or longer chain length: 

Perfluoroalkyl sulfonates (PFAS), 

perfluoroalkyl carboxylates (PFAC), 

fluorotelomers, or 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. 

(i) Any polymer that has been 

manufactured previously in full 

compliance with the requirements of 

this section prior to February 26, 2010 

may no longer be manufactured under 

this section after January 27, 2012. 

(ii) [Reserved] 

* * * * * 

[FR Doc. 2010–1477 Filed 1–26–2010; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF TRANSPORTATION 

Federal Motor Carrier Safety 

Administration 

49 CFR Chapter III 

Regulatory Guidance Concerning the 

Applicability of the Federal Motor 

Carrier Safety Regulations to Texting 

by Commercial Motor Vehicle Drivers 

AGENCY: Federal Motor Carrier Safety 

Administration (FMCSA), DOT. 

ACTION: Notice of regulatory guidance. 

SUMMARY: The FMCSA announces 

regulatory guidance concerning texting 

while driving a commercial motor 

vehicle (CMV). The guidance is 

applicable to all interstate drivers of 

CMVs subject to the Federal Motor 

Carrier Safety Regulations (FMCSRs). 

DATES: Effective Date: This regulatory 

guidance is effective on January 27, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Thomas L. Yager, Chief, Driver and 

Carrier Operations Division, Office of 

Bus and Truck Standards and 

Operations, Federal Motor Carrier Safety 

Administration, 1200 New Jersey Ave., 

SE., Washington, DC 20590. 

E-mail: MCPSD@dot.gov. Phone (202) 

366–4325. 

SUPPLEMENTARY INFORMATION: 

Legal Basis 

The Motor Carrier Safety Act of 1984 

(Pub. L. 98–554, Title II, 98 Stat. 2832, 

October 30, 1984) (the 1984 Act) 

provides authority to regulate drivers, 

motor carriers, and vehicle equipment. 

It requires the Secretary of 

Transportation to prescribe regulations 

which ensure that: (1) CMVs are 

maintained, equipped, loaded, and 

operated safely; (2) the responsibilities 

imposed on operators of CMVs do not 

impair their ability to operate the 

vehicles safely; (3) the physical 

condition of operators of CMVs is 

adequate to enable them to operate the 

vehicles safely; and (4) the operation of 

CMVs does not have a deleterious effect 

on the physical condition of the 

operators. (49 U.S.C. 31136(a)). Section 

211 of the 1984 Act also grants the 

Secretary broad power in carrying out 

motor carrier safety statutes and 

regulations to ‘‘prescribe recordkeeping 

and reporting requirements’’ and to 

‘‘perform other acts the Secretary 

considers appropriate.’’ (49 U.S.C. 

31133(a)(8) and (10), respectively). 

The Administrator of FMCSA has 

been delegated authority under 49 CFR 

1.73(g) to carry out the functions vested 

in the Secretary of Transportation by 49 

U.S.C. chapter 311, subchapters I and 

III, relating to commercial motor vehicle 

programs and safety regulation. 

Background 

This document provides regulatory 

guidance concerning the applicability of 

49 CFR 390.17, ‘‘Additional equipment 

and accessories,’’ to CMV operators 

engaged in ‘‘texting’’ on an electronic 

device while driving a CMV in interstate 

commerce. 

Currently, 49 CFR 390.17 states, 

‘‘Nothing in this subchapter shall be 

construed to prohibit the use of 

additional equipment and accessories, 

not inconsistent with or prohibited by 

this subchapter, provided such 

equipment and accessories do not 

decrease the safety of operation of the 

commercial motor vehicles on which 

they are used.’’ [Emphasis added]. As 

used in § 390.17, ‘‘this subchapter’’ 

means Subchapter B [49 CFR parts 350– 

399] of Chapter III of Subtitle B of Title 

49, Code of Federal Regulations (CFRs). 

CMVs are defined in 49 CFR 390.5 as 

‘‘any self-propelled or towed motor 

vehicle used on a highway in interstate 

commerce to transport passengers or 

property when the vehicle— 

(1) Has a gross vehicle weight rating 

or gross combination weight rating, or 

gross vehicle weight or gross 

combination weight, of 4,536 kg (10,001 

pounds) or more, whichever is greater; 

or 

(2) Is designed or used to transport 

more than 8 passengers (including the 

driver) for compensation; or 

(3) Is designed or used to transport 

more than 15 passengers, including the 

driver, and is not used to transport 

passengers for compensation; or 

(4) Is used in transporting material 

found by the Secretary of Transportation 

to be hazardous under 49 U.S.C. 5103 

and transported in a quantity requiring 

placarding under regulations prescribed 


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