[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Rules and Regulations]
[Pages 62443-62451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-24651]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2012-0268; FRL-9397-1]
RIN 2070-AJ95
Perfluoroalkyl Sulfonates and Long-Chain Perfluoroalkyl
Carboxylate Chemical Substances; Final Significant New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is amending
a significant new use rule (SNUR) for perfluoroalkyl sulfonate (PFAS)
chemical substances to add PFAS chemical substances that have completed
the TSCA new chemical review process, but have not yet commenced
production or import and is designating (for all listed PFAS chemical
substances) processing as a significant new use. EPA is also finalizing
a SNUR for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical
substances that designates manufacturing (including importing) and
processing for use as part of carpets or for treating carpet (e.g., for
use in the carpet aftercare market) as a significant new use, except
for use of two chemical substances as a surfactant in carpet cleaning
products. For this SNUR, EPA is also making an exemption inapplicable
to persons who import or process the LCPAC chemical substances as part
of an article. Persons subject to these SNURs will be required to
notify EPA at least 90 days before commencing any significant new use.
The required notifications will provide EPA with the opportunity to
evaluate the intended use and, if necessary, to prohibit or limit that
activity before it occurs.
DATES: This final rule is effective December 23, 2013.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2012-0268, is available at
http://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency
[[Page 62444]]
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is (202) 566-1744, and the
telephone number for the OPPT Docket is (202) 566-0280. Please review
the visitor instructions and additional information about the docket
available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Nicholas Nairn-Birch, Chemical Control Division (7405M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-3668; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave. Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(including import) or process any of the chemical substances listed in
Table 4 of the regulatory text in this document or that meet the LCPFAC
chemical category definition as described in this rule.
Potentially affected entities may include, but are not limited to:
Manufacturers (including importers) of one or more of
subject chemical substances (North American Industrial Classification
System (NAICS) codes 325 and 324110); e.g., chemical manufacturing and
petroleum refineries.
Carpet and rug mills (NAICS code 314110).
Fiber, yarn, and thread mills (NAICS code 31311).
Home furnishing merchant wholesalers (NAICS code 423220).
Carpet and upholstery cleaning services (NAICS code
561740).
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 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
721.5, 40 CFR 721.9582, and 40 CFR 721.10536, which is in the
regulatory text of this document. 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.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import any chemical substance governed by a final SNUR are subject
to the TSCA section 13 (15 U.S.C. 2612) import certification
requirements and the corresponding regulations at 19 CFR 12.118 through
12.127; see also 19 CFR 127.28. Those persons must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA, including any SNUR requirements. The EPA policy
in support of import certification appears at 40 CFR part 707, subpart
B. In addition, any persons who export or intend to export a chemical
substance that is the subject of this rule are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), (see
40 CFR 721.20), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.
II. Background
A. What action is the agency taking?
In the Federal Register of August 15, 2012 (77 FR 48924) (FRL-9358-
7), EPA proposed to amend a SNUR at 40 CFR 721.9582 for PFAS chemical
substances to add PFAS chemical substances that have completed the TSCA
new chemical review process, but have not yet commenced production or
import, and to designate (for all listed PFAS chemical substances)
processing as a significant new use. In addition, the Agency also
proposed a new SNUR for LCPFAC chemical substances that designates
manufacturing (including importing) and processing for use as part of
carpets or for treating carpet (e.g., for use in the carpet aftercare
market) as a significant new use. On December 30, 2009, EPA issued the
``Long-Chain Perfluorinated Chemicals (PFCs) Action Plan'' (Ref. 1).
Today's action is consistent with the purpose of that action plan.
This final rule requires persons who intend to manufacture
(including import) or process one or more of the PFAS chemical
substances listed in Table 4 of the regulatory text for the uses
identified in 40 CFR 721.9582(a)(2) to submit a Significant New Use
Notice (SNUN) at least 90 days before commencing manufacture (including
import) or processing. Given the structural similarity of these
chemicals to the PFAS chemicals covered under 40 CFR 721.9582 and EPA's
health and environmental concerns associated with them, EPA has
concluded that today's action on these PFAS chemicals is warranted and
any manufacturing (including importing) or processing for any use of
these uncommenced PFAS chemicals would be a significant new use.
EPA is also finalizing a SNUR for LCPFAC chemical substances that
requires persons to notify the Agency at least 90 days before
commencing manufacture (including import) or processing for use as part
of carpets or for treating carpet (e.g., for use in the carpet
aftercare market) as a significant new use, except for use of two
LCPFAC chemical substances as surfactants in carpet cleaning products.
Comments submitted to the docket after the comment period indicated use
of two LCPFAC chemical substances as a surfactant in aftermarket carpet
cleaning products as an ongoing use. The use of these two chemical
substances is not included as a significant new use in this final rule.
For this SNUR, EPA is also making the article exemption at 40 CFR
721.45(f) inapplicable to persons who import LCPFAC chemical substances
as part of carpets. The article exemption at 40 CFR 721.45(f) is based
on an assumption that people and the environment will generally not be
exposed to chemical substances in articles (see 49 FR 35014; September
5, 1984). However, as stated in Unit IV. of the proposed rule (77 FR
48928; August 15, 2012), exposure to LCPFAC chemical substances may
occur both during the carpet manufacture process and during the
lifetime of the finished carpet. Therefore, exposure would increase if
in the future LCPFAC chemical substances are incorporated in carpets
and then imported. The article exemption at 40 CFR 721.45(f) remains in
effect, however, for persons who import LCPFAC chemical substances as
part of other types of articles. The article exemption at 40 CFR
721.45(f) also remains in effect for processing of LCPFAC chemical
substances as part of an article (i.e., carpet) since EPA is aware that
this is an ongoing use. This final action does not affect the exemption
at 40 CFR 721.45(f) for PFAS chemical substances, which remains in
effect for persons who import or process these chemical substances.
The term PFAS refers to a general category of perfluorinated
sulfonate chemical substances of any chain
[[Page 62445]]
length. The PFAS chemical substances for which EPA is modifying an
existing SNUR are currently listed in 40 CFR 721.9582 in paragraph
(a)(1). The PFAS chemical substances that EPA is adding to an existing
SNUR are being inserted into this list. All of these chemical
substances are collectively referred to in this rule as perfluoroalkyl
sulfonates, or PFAS chemical substances.
The term LCPFAC refers to the long-chain category of perfluorinated
carboxylate chemical substances with perfluorinated carbon chain
lengths equal to or greater than seven carbons and less than or equal
to 20 carbons. Based on comments filed on the proposed SNUR and all
information available to EPA, the category definition of LCPFAC
chemical substances differs in this final rule from the definition
described in the proposed SNUR. The upper limit of the perfluorinated
carbon chain length is now 20 carbons. In the proposed SNUR, there was
no upper limit. Also, the LCPFAC chemical subgroup described in 40 CFR
721.10536(b)(1)(vi) of the proposed rule is removed from the definition
in this final SNUR.
LCPFAC chemical substances are synthetic chemicals that do not
occur naturally in the environment. The LCPFAC chemical substances
subject to this SNUR are identified as follows, where 5 < n < 21 or 6 <
m < 21:
a. CF3(CF2)n-COO-M
where M = H\+\ or any other group where a formal dissociation can be
made;
b. CF3(CF2)n-CH=CH2;
c. CF3(CF2)n-C(=O)-X where X is
any chemical moiety;
d. CF3(CF2)m-CH2-X
where X is any chemical moiety, and
e. CF3(CF2)m-Y-X where Y = non-S,
non-N heteroatom and where X is any chemical moiety.
The category of LCPFAC chemical substances, based on the chemical
structures delineated in 40 CFR 721.10536 (b)(1)(i) through (b)(1)(v)
of this final rule, also includes the salts and precursors of these
perfluorinated carboxylates. LCPFAC precursors may be simple
derivatives of perfluorooctanoic acid (PFOA) and higher homologues or
certain polymers that may degrade to PFOA or higher homologues. These
precursors include all fluorotelomers.
It is important to note that any LCPFAC chemical substance
identified by paragraphs (b)(1)(i) through (b)(1)(v) of this final rule
that is intentionally used during fluoropolymer formulation, such as an
emulsion stabilizer in aqueous dispersions, is subject to reporting for
the significant new uses described in 40 CFR 721.10536(b)(2). For
example, ammonium perfluorooctanoate (APFO)--when used as an aqueous
dispersion agent in fluoropolymer production--is subject to this SNUR
if the final fluoropolymer product is used as part of carpets or to
treat carpets.
B. What is the agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in TSCA section 5(a)(2). Once
EPA determines that a use of a chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires persons to submit a SNUN to EPA
at least 90 days before they manufacture (including import) or process
the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)). As
described in Unit II.C., the general SNUR provisions are found at 40
CFR part 721, subpart A.
C. Applicability of General Provisions
General provisions for SNURs appear under 40 CFR part 721, subpart
A. These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the final
rule. However, EPA is making the exemption at 40 CFR 721.45(f)
inapplicable to persons who import LCPFAC chemical substances as part
of carpets under this SNUR. As a result, persons subject to the
provisions of this rule would not be exempt from significant new use
reporting if they import LCPFAC chemical substances as part of carpets.
However, the articles exemption will remain in effect for persons who
process chemical substances as part of an article because existing
stocks of carpets may still contain LCPFAC substances.
Provisions relating to user fees appear at 40 CFR part 700.
According to 40 CFR 721.1(c), persons subject to SNURs must comply with
the same notice requirements and EPA regulatory procedures as
submitters of premanufacture notices (PMNs) under TSCA section
5(a)(1)(A). In particular, these requirements include the information
submissions requirements of TSCA section 5(b) and 5(d)(1), the
exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6
or 7 to control the activities on which it has received the SNUN. If
EPA does not take action, EPA is required under TSCA section 5(g) to
explain in the Federal Register its reasons for not taking action.
Persons who export or intend to export a chemical substance
identified in a proposed or final SNUR are subject to the export
notification provisions of TSCA section 12(b). The regulations that
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D.
Persons who import a chemical substance identified in a final SNUR are
subject to the TSCA section 13 import certification requirements,
codified at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Such
persons must certify that the shipment of the chemical substance
complies with all applicable rules and orders under TSCA, including any
SNUR requirements. The EPA policy in support of import certification
appears at 40 CFR part 707, subpart B.
III. Rationale and Objectives for This Final Rule
A. Rationale
As discussed in Units III. and IV. of the proposed rule (77 FR
48924; August 15, 2012), PFAS and LCPFAC chemical substances are found
world-wide in the environment, wildlife, and humans. They are
bioaccumulative in wildlife and humans, and are persistent in the
environment. They are toxic to laboratory animals, producing
reproductive, developmental, and systemic effects in laboratory tests.
The exact sources and pathways by which these chemicals move into and
through the environment and allow humans and wildlife to become exposed
are not fully understood, but are likely to include releases from
manufacturing of the chemicals, processing of these chemicals into
products like carpets and textiles, and aging and wear of products
containing them.
Since the manufacture (including import) and processing of PFAS and
LCPFAC chemical substances for these uses have been discontinued in the
United States, EPA expects their presence in humans and the environment
to decline over time as has been observed in the past when production
and use of other persistent chemicals has ceased. EPA is concerned that
the manufacturing (including import) or processing of these chemical
substances, as well as importing these chemicals as part of articles,
for the new uses identified in this rule could be reinitiated in the
future. If reinitiated, EPA believes that such use would increase the
magnitude and duration of human and environmental exposure to
[[Page 62446]]
these chemical substances, constituting a significant new use.
EPA is adding processing of PFAS chemical substances (for any use
in the United States, other than the uses listed under 40 CFR 721.9582
(a)(3), (a)(4), and (a)(5)) to the significant new uses of those
chemical substances. EPA is concerned about the potential for PFAS
chemical substances manufactured (including imported) for an ongoing
use to be redirected to other uses without prior notice to the Agency.
For example, a chemical substance could be initially manufactured for
uses listed under 40 CFR 721.9582 (a)(3), (a)(4), or (a)(5), and then
redirected for another use after its initial manufacture or import. For
similar reasons, EPA is designating processing of LCPFAC chemical
substances or use as part of carpets or to treat carpet as a
significant new use, except for one specifically identified ongoing use
of two LCPFAC chemical substances as a surfactant in aftermarket carpet
cleaning products. As such, persons who process PFAS or LCPFAC chemical
substances for a significant new use will be required to first notify
EPA, even if they are not themselves manufacturers of the chemical
substance. Note, the exemption at 40 CFR 721.45(f) is not applicable
for persons who import these LCPFAC chemical substances as part of an
article, but is applicable for persons who process these LCPFAC
chemicals substances as part of an article. Pursuant to 40 CFR
721.45(f), processing of PFAS and LCPFAC chemical substances as part of
articles remains exempt from notice requirements.
Accordingly, EPA will have the opportunity to evaluate and control,
where appropriate, activities associated with those uses, if such
manufacturing (including importing) or processing were to start or
resume. The required notification provided by a SNUN will provide EPA
with the opportunity to evaluate activities associated with a
significant new use and an opportunity to protect against unreasonable
risks, if any, from exposure to PFAS and LCPFAC chemical substances.
Consistent with EPA's past practice for issuing SNURs under TSCA
section 5(a)(2), EPA's decision to promulgate a SNUR for a particular
chemical use need not be based on an extensive evaluation of the
hazard, exposure, or potential risk associated with that use. Rather,
the Agency's action is based on EPA's determination that if the use
begins or resumes, it may present a risk that EPA should evaluate under
TSCA before the manufacturing or processing for that use begins. Since
the new use does not currently exist, deferring a detailed
consideration of potential risks or hazards related to that use is an
effective use of resources. If a person decides to begin manufacturing
or processing the chemical for the use, the notice to EPA allows the
Agency to evaluate the use according to the specific parameters and
circumstances surrounding that intended use.
With this action, the Agency is designating as significant new uses
of LCPFAC chemical substances use as part of carpet or to treat carpet.
The Agency believes the 2010/2015 PFOA Stewardship Program, in which
companies committed to work toward eliminating facility emissions and
product content of PFOA--a LCPFAC chemical substance--by 2015, will
eliminate many other ongoing uses of LCPFAC chemical substances. As
those uses are phased out in the United States, EPA anticipates taking
additional regulatory actions to prevent resumption of the uses without
prior notice to EPA.
B. Objectives
Based on the considerations in Unit III.A. of this rule, EPA will
achieve the following objectives with regard to the significant new
use(s) that are designated in this rule:
1. EPA will receive notice of any person's intent to manufacture
(including import) or process PFAS or LCPFAC chemical substances for
the described significant new use before that activity begins.
2. EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing
(including importing) or processing PFAS or LCPFAC chemical substances
for the described significant new use.
3. EPA will be able to regulate prospective manufacturers
(including importers) or processors of PFAS or LCPFAC chemical
substances before the described significant new use of the chemical
substance occurs, provided that regulation is warranted pursuant to
TSCA sections 5(e), 5(f), 6 or 7.
IV. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
To determine what would constitute a significant new use of the
PFAS and LCPFAC chemical substances subject to this rule, as discussed
herein, EPA considered relevant information about the toxicity of these
substances, likely human exposures and environmental releases
associated with possible uses, and the four factors listed in TSCA
section 5(a)(2).
Except for the ongoing uses specified in 40 CFR 721.9582 (a)(3)
through (a)(5), the Agency believes the manufacture (including import)
and processing of any of the PFAS chemical substances subject to this
rule has been discontinued. Any new use of these chemicals, including
processing, could change the type and form of exposure and/or the
magnitude and duration of exposure to humans and the environment
relative to what currently exists. Based on these considerations of the
statutory factors discussed in this unit, EPA has determined that the
manufacture (including import) or processing of any of the PFAS
chemical substances subject to this rule, for any use except ongoing
uses specified in 40 CFR 721.9582 (a)(3) through (a)(5), is a
significant new use.
Exposure to LCPFAC chemical substances may occur both during the
carpet manufacture process and during the lifetime of the finished
carpet via inhalation and ingestion of dust generated from the abrasion
of carpets. This is of particular concern for children since they
engage in a variety of activities on carpets for longer periods of time
and have a greater degree of hand-to-mouth activity in their earliest
years. This will change both the magnitude of exposure and the duration
of exposure. Except for one ongoing use specified in 40 CFR
721.10536(b)(3), the Agency believes the manufacture (including import)
and processing of LCPFAC chemical substances as part of carpet or to
treat carpet has been discontinued. EPA also believes LCPFAC chemicals
substances are no longer imported as part of carpet. If reinitiated,
EPA believes these uses of LCPFAC chemical substances would
significantly increase the magnitude and duration of exposure to humans
and the
[[Page 62447]]
environment relative to what currently exists. Based on these
considerations of the statutory factors discussed in this unit, EPA has
determined that the manufacture (including import) or processing of any
of the LCPFAC chemical substances subject to this rule for use as part
of carpet or to treat carpets, except ongoing uses specified in 40 CFR
721.10536(b)(3), is a significant new use. EPA has further determined
that importing any of the LCPFAC chemical substances subject to this
rule as part of carpet constitutes a significant new use and warrants
making inapplicable the article exemption at 40 CFR 721.45(f).
V. Applicability of Rule to Uses Occurring Before Effective Date of the
Final Rule
As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is
best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. If uses begun after publication of
the proposed rule were considered ongoing rather than new, it would be
difficult for EPA to establish SNUR notice requirements, because a
person could defeat the SNUR by initiating the proposed significant new
use before the rule became final, and then argue that the use was
ongoing as of the effective date of the final rule. Thus, persons who
may have begun commercial manufacture (including import) or processing
of the chemical substance(s) subject to this rule for a significant new
use after the proposal was published on August 15, 2012 (77 FR 48924),
must cease such activity before the effective date of this final rule.
To resume their activities, these persons will have to comply with all
applicable SNUR notice requirements and wait until the notice review
period, including all extensions, expires. Uses arising after the
publication of the proposed rule are distinguished from uses that exist
at publication of the proposed rule. The former would be new uses, the
latter ongoing uses. To the extent that additional ongoing uses were
found in the course of rulemaking, EPA has excluded these uses from the
final SNUR. EPA promulgated provisions to allow persons to comply with
this SNUR before the effective date. If a person were to meet the
conditions of advance compliance under 40 CFR 721.45(h), that person
would be considered to have met the requirements of the final SNUR for
those activities.
VI. Test Data and Other Information
EPA recognizes that TSCA section 5 does not usually require
developing any particular test data before submission of a SNUN. There
are two exceptions: (1) Development of test data is required where the
chemical substance subject to the SNUR is also subject to a test rule
under TSCA section 4 (see TSCA section 5(b)(1)); and (2) development of
test data may be necessary where the chemical substance has been listed
under TSCA section 5(b)(4) (see TSCA section 5(b)(2)). In the absence
of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing
covering the chemical substance, persons are required only to submit
test data in their possession or control and to describe any other data
known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR
721.25; and 40 CFR 720.50). However, as a general matter, EPA
recommends that SNUN submitters include data that would permit a
reasoned evaluation of risks posed by the chemical substance during its
manufacture (including import), processing, use, distribution in
commerce, or disposal. EPA encourages persons to consult with the
Agency before submitting a SNUN. As part of this optional pre-notice
consultation, EPA would discuss specific data it believes may be useful
in evaluating a significant new use. SNUNs submitted for significant
new uses without any test data may increase the likelihood that EPA
will take action under TSCA section 5(e) to prohibit or limit
activities associated with this chemical.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information on:
1. Human exposure and environmental releases that may result from
the significant new uses of the chemical substance.
2. Potential benefits of the chemical substance.
3. Information on risks posed by the chemical substances compared
to risks posed by potential substitutes.
VII. SNUN Submissions
EPA recommends that submitters consult with the Agency prior to
submitting a SNUN to discuss what data may be useful in evaluating a
significant new use. Discussions with the Agency prior to submission
can afford ample time to conduct any tests that might be helpful in
evaluating risks posed by the substance. According to 40 CFR 721.1(c),
persons submitting a SNUN must comply with the same notice requirements
and EPA regulatory procedures as persons submitting a PMN, including
submission of test data on health and environmental effects as
described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No.
7710-25, generated using e-PMN software, and submitted to the Agency in
accordance with the procedures set forth in 40 CFR 721.25 and 40 CFR
720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.
VIII. Discussion of the Final Significant New Use Rule and Response to
Comments
This action finalizes the SNUR proposed in the Federal Register on
August 15, 2012 (77 FR 48924). This final rule requires persons who
intend to manufacture (including import) or process one or more of the
chemical substances listed in Table 4 of the regulatory text for the
uses identified in 40 CFR 721.9582(a)(2) to submit a SNUN at least 90
days before commencing manufacture (including import) or processing.
This rule also requires persons who intend to manufacture (including
import) or process one or more LCPFAC chemical substances, as defined
in 40 CFR 721.10536(b)(1), for use as part of carpets or for treating
carpets (except for one specifically identified ongoing use of two
LCPFAC chemical substances as a surfactant in aftermarket carpet
cleaning products) to submit a SNUN at least 90 days before commencing
manufacture (including import) or processing.
It should be noted that the LCPFAC chemical substances category
definition now delineates a perfluorinated carbon chain length upper
limit of 20 carbons. The definition in the proposed rule contained no
upper limit. Also, the LCPFAC chemical subgroup that was described in
40 CFR 721.10536(b)(1)(vi) of the proposal is removed from the
definition in this final SNUR. The rationale for these changes is
explained in greater detail in the response to comments below.
The Agency reviewed and considered all comments received related to
the proposed rule. Copies of all non-CBI comments are available at
http://www.regulations.gov in the public docket for this action, EPA-
OPPT-2012-0268. A discussion of the comments germane to the rulemaking
and the Agency's responses follow.
1. Comment summary. In defining the chemicals subject to this SNUR
in the proposed rule, no upper limit was given for carbon chain length.
Submitters suggested an upper limit of 20 carbons, which would exclude
from the LCPFAC
[[Page 62448]]
category definition polymers weighing greater than 1,000 daltons.
Response. EPA agrees with commenters that there should be an upper
limit to the chain length in the definition. PFAC chemicals with
greater than 20 perfluorinated carbons can be considered polymers
within the polymer exemption under 40 CFR 723.250 (e.g., exceed a
molecular weight of 1,000 daltons and contain at least three monomer
units). As it is not the Agency's intent to regulate fluoropolymers in
this rule, the LCPFAC category definition in this final rule includes a
perfluorinated carbon chain length upper limit of 20.
2. Comment summary. Commenters requested clarification as to
whether or not fluoropolymers are included in the LCPFAC definition.
Commenters also requested a definition of fluoropolymers that clearly
distinguished them from fluorotelomer-based chemicals.
Response. It is not the Agency's intent to regulate fluoropolymers.
The category definition is changed in this final rule to include a
perfluorinated carbon chain length upper limit of 20. With this change,
fluoropolymers no longer meet the LCFPAC chemical substances
definition.
Since fluoropolymers are not subject to this SNUR, EPA will not
include a definition of fluoropolymers. However, the Agency notes that
it has distinguished fluoropolymer and fluorotelomer-based chemicals in
two corresponding enforceable consent agreement test rules published on
July 8, 2005 (70 FR 39630 and 70 FR 39623).
3. Comment summary. Several commenters argued that the proposed 40
CFR 721.10536(b)(1)(vi) [``structurally similar degradation products of
any of the compounds in (i) through (v) of this paragraph''] is
prohibitively broad and unnecessary and therefore unenforceable. They
argued that it should be either removed or replaced with a definition
that explicitly delineates LCPFAC precursors.
Response. The Agency agrees that the chemical subgroup definition
described in 40 CFR 721.10536(b)(1)(vi) is unnecessary and it is
removed from the LCFPAC category definition in this final rule. The
Agency believes that 40 CFR 721.10536 (b)(1)(i)-(b)(1)(v) do not
exclude any LCPFAC chemical substances defined in 40 CFR
721.10536(b)(1)(vi), and thus sufficiently define the LCPFAC category
of chemicals.
4. Comment summary. A submitter claimed that the LCPFAC chemical
category definition is not adequate to verify which chemicals are in
use by suppliers. Instead, a thorough list of CAS numbers is needed.
Response. EPA believes the most precise way to identify the
chemicals subject to this SNUR is through the chemical structure
definition. Downstream customers should have sufficient information
from suppliers (i.e., CAS number and unique chemical identity) to
generate the specific structure for any potentially reportable
substance, which they can compare to the LCPFAC category definition.
As a convenience to the regulated community, EPA has made available
in the public docket an illustrative list of chemical substances
subject to the rule. As part of that list, EPA has provided specific
examples of chemicals that meet the various components of the LCPFAC
category definition.
5. Comment summary. A submitter suggested that 40 CFR
721.10536(b)(1)(ii) of the regulatory text should state
``CF3(CF2)mCH=CH2, where m > 6''
rather than
``CF3(CF2)nCH=CH2, where n
> 5'' to be consistent with PFOA precursors identified in the PFOA
Stewardship Program.
Response. EPA disagrees with this comment. The specific structural
formula was chosen to accommodate the possibility of oxidation cleavage
of the olefin to produce PFOA directly. Applied to the representative
structure suggested by the submitter, this mechanism would produce
perfluorononanoic acid (PFNA), which is one carbon longer than PFOA,
the smallest of the LCPFAC chemical substances.
6. Comments summary. A commenter expressed concern that the article
exemption was not made inapplicable to PFAS as part of carpets.
Response. The Agency recognizes this concern and is addressing it
in the upcoming proposed SNUR for long-chain perfluoroalkyl carboxylate
chemical substances. Doing so in the upcoming proposed SNUR will allow
EPA to solicit and respond to any public comments.
7. Comment summary. Submitters requested clarification on the
applicability of the articles exemption to export notifications.
Response. This SNUR does not require notice of export for articles
as part of the section 5 action. In accordance with 40 CFR 707.60(b),
persons who export LCFPAC chemical substances contained in articles
remain exempt from notices of export under TSCA 12(b).
8. Comment summary. One commenter asserted that the following
statement in the proposed rule's preamble is incorrect: ``These
precursors include certain fluoropolymers and all fluorotelomers.'' In
support of this assertion, the submitter notes that many new short-
chain fluorotelomer products cannot break down to PFOA.
Response. The LCPFAC category definition does not include short-
chain fluorotelomers. The quote refers only to precursors of the long-
chain perfluorinated chemicals defined in 40 CFR 721.10536(b)(1), which
excludes short-chain fluorotelomers. Fluoropolymers are also no longer
included in the LCPFAC definition.
9. Comment summary. A commenter noted that even fluoropolymers not
made with PFOA can have detectable levels of PFOA in them due to
environmental cross-contamination, which creates an enforcement and
compliance problem. The uncertainty this issue creates suggests that
fluoropolymers should be excluded from the LCPFAC definition. The
commenter also requested clarification of the term `contamination' used
in the preamble.
Response. Fluoropolymers are not subject to this SNUR. In the
preamble of the proposed rule, the Agency referred to a `contaminated'
chemical as one that does not meet the LCPFAC definition itself, but
that contains a LCPFAC chemical substance due to its intentional use
during chemical formulation. In such a case, this LCPFAC chemical
substance would be subject to this SNUR for the significant new uses
described in 40 CFR 721.10536(b)(2). For example, APFO used as an
emulsifier in the production of fluoropolymers would be subject to this
SNUR for the significant new uses described in 40 CFR 721.10536(b)(2).
IX. Economic Analysis
A. SNUNs
EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers (including
importers) and processors of the chemical substance included in this
rule (Ref. 2). In the event that a SNUN is submitted, costs are
estimated at $8,589 per SNUN submission for large business submitters
and $6,189 for small business submitters. These estimates include the
cost to prepare and submit the SNUN, and the payment of a user fee.
Businesses that submit a SNUN would be subject to either a $2,500 user
fee required by 40 CFR 700.45(b)(2)(iii), or, if they are a small
business with annual sales of less than $40 million when combined with
those of the parent company (if any), a reduced user fee of $100 (40
CFR 700.45(b)(1)). The costs of
[[Page 62449]]
submission of SNUNs will not be incurred by any company unless a
company decides to pursue a significant new use as defined in this
SNUR. EPA's complete economic analysis is available in the public
docket for this rule (Ref. 2).
The final SNUR will require importers of LCPFAC chemical substances
as part of carpets to notify EPA at least 90 days before importing any
such articles containing chemicals subject to the final rule. The final
rule may also affect firms that do not currently import carpet
containing the chemicals, but who may be interested in importing these
articles in the future. Typically, firms have an understanding of the
contents of the articles they import. However, EPA acknowledges that
importers of articles may have varying levels of knowledge about the
chemical content of the articles that they import.
While not required by the SNUR, these parties may incur costs to
take additional steps to determine whether the articles they plan to
import are covered by this SNUR. This determination may involve
gathering information from suppliers along the supply chain, and/or
testing samples of the article itself. EPA believes that the LCPFAC
chemical substances included in this final rule are no longer being
manufactured (including imported) for use as part of carpet or for
treating carpet (e.g., for use in the carpet aftercare market) in the
United States, except for use of two chemical substances in carpet
cleaning solution, and that LCPFAC chemical substances are not being
imported as part of carpets. Therefore, EPA believes that these costs
would be minimal.
B. Export Notification
Under TSCA section 12(b) and the implementing regulations at 40 CFR
part 707, subpart D, exporters must notify EPA if they export or intend
to export a chemical substance or mixture for which, among other
things, a rule has been proposed or promulgated under section 5. For
persons exporting a substance the subject of a SNUR, a one-time notice
must be provided for the first export or intended export to a
particular country. The total costs of export notification will vary by
chemical, depending on the number of required notifications (i.e., the
number of countries to which the chemical is exported). EPA is unable
to make any estimate of the likely number of export notifications for
the chemical covered in this SNUR.
X. References
As indicated under ADDRESSES, a docket has been established for
this rule under docket ID number EPA-HQ-OPPT-2012-0268. The following
is a listing of the documents cited in this document. The docket
includes information considered by EPA in developing this rule,
including the documents listed in this unit, which are physically
located in the docket. In addition, interested parties should consult
documents that are referenced in the documents that EPA has placed in
the docket, regardless of whether these referenced documents are
physically located in the docket. For assistance in locating documents
that are referenced in documents that EPA has placed in the docket, but
that are not physically located in the docket, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT. The
docket is available for review as specified under ADDRESSES.
1. USEPA. ``Long-Chain Perfluorinated Chemicals Action Plan.'' December
30, 2009.
2. USEPA. ``Economic Analysis of the Significant New Use Rule for
Perfluoroalkyl Sulfonates and Long-Chain Perfluoroalkyl Carboxylate
Chemical Substances.'' Prepared by Timothy Lehman and Abt Associates
Inc. May 7, 2013.
XI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Office of Management and Budget (OMB) has determined that this SNUR is
not a ``significant regulatory action,'' because it does not meet the
criteria in section 3(f) of the executive order. Accordingly, this
action was not reviewed by OMB under Executive Orders 12866 and 13563
(76 FR 3821; January 21, 2011).
B. Paperwork Reduction Act (PRA)
According to the PRA, 44 U.S.C. 3501 et seq., an Agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under the PRA,
unless it has been approved by OMB and displays a currently valid OMB
control number. The OMB control numbers for EPA's regulations in Title
40 of the CFR, after appearing in the Federal Register, are listed in
40 CFR part 9, and included on the related collection instrument, or
form, if applicable. The information collection requirements related to
this action have already been approved by OMB pursuant to the PRA under
OMB control number 2070-0038 (EPA ICR No. 1188). This action does not
impose any burden requiring additional OMB approval. If an entity were
to submit a SNUN to the Agency, the annual burden is estimated to
average 92 hours per response. 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
SNUN.
C. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., the
Agency hereby certifies that promulgation of this SNUR would not have a
significant economic impact on a substantial number of small entities.
The rationale supporting this conclusion is as follows. A SNUR applies
to any person (including small or large entities) who intends to engage
in any activity described in the rule as a ``significant new use.'' By
definition of the word ``new'' and based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activity. Since this SNUR will require a person who
intends to engage in such activity in the future to first notify EPA by
submitting a SNUN, no economic impact will occur unless someone files a
SNUN to pursue a significant new use in the future or forgoes profits
by avoiding or delaying the significant new use. Although some small
entities may decide to conduct such activities in the future, EPA
cannot presently determine how many, if any, there may be. However,
EPA's experience to date is that, in response to the promulgation of
SNURs covering over 1,000 chemical substances, the Agency receives only
a handful of notices per year. For example, the number of SNUNs was
four in Federal fiscal year (FY) 2005, eight in FY 2006, six in FY
2007, eight in FY 2008, and seven in FY 2009. During this 5-year
period, three small entities submitted a SNUN. Therefore, EPA believes
that the potential economic impact of complying with this SNUR is not
expected to be significant or adversely impact a substantial number of
small entities. In a SNUR that published as a final rule on August 8,
1997 (62 FR 42690) (FRL-5735-4), the Agency presented its general
determination that proposed and final SNURs are not expected to have a
significant economic impact on a substantial number of small entities,
which was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
[[Page 62450]]
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reason to believe that any
State, local, or Tribal government would be impacted by this
rulemaking. As such, EPA has determined that this regulatory action
would not impose any enforceable duty, contain any unfunded mandate, or
otherwise have any effect on small governments subject to the
requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531-
1538.
E. Executive Order 13132: Federalism
This action would not have a substantial direct effect on 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 Executive Order 13132 (64 FR
43255, August 10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This rule does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This rule
does not significantly or uniquely affect the communities of Indian
Tribal governments, nor involve or impose any requirements that affect
Indian Tribes. Accordingly, the requirements of Executive Order 13175
(65 FR 67249, November 9, 2000) do not apply to this rule.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use
This rule is not subject to Executive Order 13211 (66 FR 28355, May
22, 2001), because this action is not expected to affect energy supply,
distribution, or use.
I. National Technology Transfer Advancement Act (NTTAA)
Since this action does not involve any technical standards; section
12(d) of the NTTAA, 15 U.S.C. 272 note, does not apply to this action.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).
XII. Congressional Review Act (CRA)
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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 action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: September 30, 2013.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001,
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C.
9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326,
1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3
CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f,
300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-
2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q,
7542, 9601-9657, 11023, 11048.
0
2. In Sec. 9.1, add the following section in numerical order under the
undesignated center heading ``Significant New Uses of Chemical
Substances'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
40 CFR citation OMB control No.
------------------------------------------------------------------------
* * * * *
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.10536............................................ 2070-0038
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--[AMENDED]
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. In Sec. 721.9582:
0
a. Revise paragraph (a)(1) introductory text.
0
b. Add Table 4 to paragraph (a)(1).
0
c. Revise paragraphs (a)(2) through (5).
The revisions and addition read as follows:
Sec. 721.9582 Certain perfluoroalkyl sulfonates.
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances listed in Table 1, Table 2,
Table 3, and Table 4 of this section are subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
* * * * *
Table 4--Fourth Set of PFAS Chemicals Subject to Reporting
------------------------------------------------------------------------
Premanufacture Notice Case No. Generic chemical name
------------------------------------------------------------------------
P-83-0126............................. Modified fluoroaliphatic adduct
P-90-0110............................. Fluorochemical epoxide
P-94-1508............................. Fluorinated polysiloxane
P-94-1509B............................ Fluorinated polysiloxane
P-98-0809............................. Fluorochemical esters
P-99-0296............................. Fluoroalkyl derivative
P-01-0035............................. Perfluorooctane sulfonate
------------------------------------------------------------------------
(2) The significant new uses are:
(i) Manufacturing (including importing) or processing of any
chemical substance listed in Table 1 of paragraph (a)(1) of this
section for any use.
(ii) Manufacturing (including importing) or processing of any
chemical substance listed in Table 2 of paragraph (a)(1) of this
section for any
[[Page 62451]]
use, except as noted in paragraph (a)(3) of this section.
(iii) Manufacturing (including importing) or processing of any
chemical substance listed in Table 3 of paragraph (a)(1) of this
section for any use, except as noted in paragraphs (a)(3) through (5)
of this section.
(iv) Manufacturing (including importing) or processing of any
chemical substance listed in Table 4 of paragraph (a)(1) of this
section for any use.
(3) Manufacturing (including importing) or processing of any
chemical substance listed in Table 2 and Table 3 of paragraph (a)(1) of
this section for the following specific uses shall not be considered as
a significant new use subject to reporting under this section:
(i) Use as an anti-erosion additive in fire-resistant phosphate
ester aviation hydraulic fluids.
(ii) Use as a component of a photoresist substance, including a
photo acid generator or surfactant, or as a component of an anti-
reflective coating, used in a photomicrolithography process to produce
semiconductors or similar components of electronic or other
miniaturized devices.
(iii) Use in coating for surface tension, static discharge, and
adhesion control for analog and digital imaging films, papers, and
printing plates, or as a surfactant in mixtures used to process imaging
films.
(iv) Use as an intermediate only to produce other chemical
substances to be used solely for the uses listed in paragraph
(a)(3)(i), (ii), or (iii) of this section.
(4) Manufacturing (including importing) or processing of
tetraethylammonium perfluorooctanesulfonate (CAS No. 56773-42-3) for
use as a fume/mist suppressant in metal finishing and plating baths
shall not be considered as a significant new use subject to reporting
under this section. Examples of such metal finishing and plating baths
include: Hard chrome plating; decorative chromium plating; chromic acid
anodizing; nickel, cadmium, or lead plating; metal plating on plastics;
and alkaline zinc plating.
(5) Manufacturing (including importing) or processing of: 1-
Pentanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,5-undecafluoro-, potassium
salt (CAS No. 3872-25-1); Glycine, N-ethyl-N-
[(tridecafluorohexyl)sulfonyl]-, potassium salt (CAS No. 67584-53-6);
Glycine, N-ethyl-N-[(pentadecafluoroheptyl)sulfonyl]-, potassium salt
(CAS No. 67584-62-7); 1-Heptanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro-, ammonium salt (CAS No.
68259-07-4); 1-Heptanesulfonamide, N-ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,7-pentadecafluoro- (CAS No. 68957-62-0);
Poly(oxy-1,2-ethanediyl), .alpha.-[2-
[ethyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl]-.omega.-methoxy-
(CAS No. 68958-60-1); or 1-Hexanesulfonic acid,
1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd. with 2,2'-
iminobis[ethanol] (1:1) (CAS No. 70225-16-0) for use as a component of
an etchant, including a surfactant or fume suppressant, used in the
plating process to produce electronic devices shall not be considered a
significant new use subject to reporting under this section.
* * * * *
0
5. Add Sec. 721.10536 to subpart E to read as follows:
Sec. 721.10536 Long-chain perfluoroalkyl carboxylate chemical
substances.
(a) Definitions. The definitions in Sec. 721.3 apply to this
section. In addition, the following definition applies: Carpet means a
finished fabric or similar product intended to be used as a floor
covering. This definition excludes resilient floor coverings such as
linoleum and vinyl tile.
(b) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified below, where 5 < n <
21 or 6 < m < 21, are subject to reporting under this section for the
significant new uses described in paragraph (b)(2) of this section.
(i) CF3(CF2)n-COO-M where M = H\+\
or any other group where a formal dissociation can be made;
(ii) CF3(CF2)n-CH =
CH2;
(iii) CF3(CF2)n-C(=O)-X where X is
any chemical moiety;
(iv) CF3(CF2)m-CH2-X
where X is any chemical moiety; and
(v) CF3(CF2)m-Y-X where Y = non-S,
non-N heteroatom and where X is any chemical moiety.
(2) The significant new use for chemical substances identified in
paragraph (b)(1) of this section are: Manufacture (including import) or
processing for use as part of carpets or to treat carpets (e.g., for
use in the carpet aftercare market), except as noted in paragraph
(b)(3) of this section.
(3) Manufacture (including import) or processing of the following
two long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances
for use as a surfactant in aftermarket carpet cleaning products shall
not be considered a significant new use subject to reporting under this
section:
(i) Phosphonic acid, perfluoro-C6-12-alkyl derivs. (CAS No. 68412-
68-0) and
(ii) Phosphinic acid, bis(perfluoro-C6-C12-alkyl) derivs. (CAS No.
68412-69-1).
(c) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (c).
(1) Revocation of certain notification exemptions. With respect to
imports of carpets, the provisions of Sec. 721.45(f) do not apply to
this section. A person who imports a chemical substance identified in
this section as part of a carpet is not exempt from submitting a
significant new use notice. The other provision of Sec. 721.45(f),
respecting processing a chemical substance as part of an article,
remains applicable.
(2) [Reserved]
[FR Doc. 2013-24651 Filed 10-21-13; 8:45 am]
BILLING CODE 6560-50-P