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[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Rules and Regulations]
[Pages 7455-7463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02952]

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ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2013-0399; FRL-9941-56]
RIN 2070-AB27

Significant New Use Rule on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finalizing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for three chemical substances that 
were the subject of premanufacture notices (PMNs). This action requires 
persons who intend to manufacture (including import) or process any of 
the chemical substances for an activity that is designated as a 
significant new use by this rule to notify EPA at least 90 days before 
commencing that activity. The required notification would provide EPA 
with the opportunity to evaluate the intended use and, if necessary, to 
prohibit or limit the activity before it occurs.

DATES: This final rule is effective April 12, 2016.

[[Page 7456]]

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2013-0399, is available at 
http://www.regulations.gov or at the Office of Pollution Prevention and 
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), West William Jefferson Clinton 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: Kenneth Moss, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (202) 564-9232; email 
address: moss.kenneth@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this rule. The 
following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Manufacturers (including importers) or processors of one 
or more subject chemical substances (NAICS codes 325 and 324110), e.g., 
chemical manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127 
and 19 CFR 127.28. Chemical importers must certify that the shipment of 
the chemical substance complies with all applicable rules and orders 
under TSCA. Importers of chemicals subject to these SNURs must certify 
their compliance with the 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 to a proposed or final rule are subject to the export 
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 
Sec.  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?

    EPA is finalizing SNURs, under TSCA section 5(a)(2), for three very 
long chain chlorinated paraffin (vLCCPs--alkyl chain length of 
C21 and above) chemical substances that were the subject of 
PMNs P-12-539, P-13-107, and P-13-109. This final rule requires persons 
who intend to manufacture or process any of these chemical substances 
for an activity that is designated as a significant new use to notify 
EPA at least 90 days before commencing that activity.
    In the Federal Register of August 7, 2013 (78 FR 48051) (FRL-9393-
4), EPA issued direct final SNURs on these three chemical substances in 
accordance with the procedures at Sec.  721.160(c)(3)(i). EPA received 
notices of intent to submit adverse comments on these SNURs. Therefore, 
as required by Sec.  721.160(c)(3)(ii), EPA removed the direct final 
SNURs in a separate final rule published in the Federal Register of 
November 5, 2013 (78 FR 66279) (FRL-9902-16), and issued a proposed 
rule in the Federal Register of February 10, 2014 (79 FR 7621) (FRL-
9903-43). The record for the direct final SNURs on these chemical 
substances was established as docket EPA-HQ-OPPT-2013-0399. That docket 
includes information considered by the Agency in developing the 
proposed and final rules, including comments on the proposed rule.
    EPA received several comments on the proposed rules for these three 
chemical substances, from a single commenter representing chlorinated 
paraffin (CP) manufacturers (including the submitter of the PMNs that 
are the subject of these SNURs). A full discussion of EPA's response to 
these comments is included in Unit V. of this document. After 
consideration of these comments, because the potential remains for 
increased exposure that formed the basis for the proposed SNURs, EPA is 
issuing the final rules as they were proposed for the chemical 
substances.

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 the four bulleted TSCA section 5(a)(2) 
factors, listed in Unit IV. of this rule. 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 significant new use notice 
(SNUN) to EPA at least 90 days before they manufacture or process the 
chemical substance for that use. Persons who must report are described 
in Sec.  721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the final rule to uses occurring before the effective date of the 
final rule. Provisions relating to user fees appear at 40 CFR part 700. 
According to Sec.  721.1(c), persons subject to these SNURs must comply 
with the same SNUN requirements and EPA regulatory procedures as 
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these 
requirements include the information submission 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 for 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.

III. Rationale and Objectives of the Final Rule

A. Rationale

    During review of the PMNs submitted for the three chemical 
substances that are subject to these final SNURs, EPA concluded that 
regulation was warranted under TSCA section 5(e), pending the 
development of information sufficient to make reasoned evaluations of 
the health and environmental effects of the chemical substances. The 
basis for these findings is outlined in Unit IV of the proposed rule. 
Based on these findings, a TSCA section 5(e) consent order was 
negotiated with the PMN submitter that required manufacture of the 
substances at certain cumulative,

[[Page 7457]]

aggregate volumes unless the company has submitted the results of 
certain environmental effects studies; no manufacture of the substances 
with the amount of chlorinated paraffins, with an alkyl chain less than 
or equal to 20, to exceed more than 1 percent of that PMN substance by 
weight; and risk notification. The SNUR provisions for these chemical 
substances are consistent with the provisions of the TSCA section 5(e) 
consent order. These final SNURs are issued pursuant to Sec.  721.160. 
See the docket under docket ID number EPA-HQ-OPPT-2013-0399 for the 
corresponding consent order. For additional discussion of the rationale 
for the SNURs on these chemicals, see Units II., IV, and V. of the 
proposed rule.

B. Objectives

    EPA is issuing final SNURs for three chemical substances described 
above to achieve the following objectives with regard to the 
significant new uses designated in this final rule:
     EPA will receive notice of any person's intent to 
manufacture or process a listed chemical substance for the described 
significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     EPA will be able to regulate prospective manufacturers or 
processors of a listed chemical substance before the described 
significant new use of that chemical substance occurs, provided that 
regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the Internet at 
http://www.epa.gov/tsca-inventory/about-tsca-chemical-substance-inventory.

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 authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 
chemical substances listed in this final rule, EPA considered relevant 
information about the toxicity of the chemical substances, likely human 
exposures and environmental releases associated with possible uses, and 
the four bulleted TSCA section 5(a)(2) factors listed in this unit.

V. Response to Comments on Proposed SNUR

    EPA received comments from the Chlorinated Paraffins Industry 
Association (CPIA), which represents the CP industry, including the 
submitter of the PMN substances that are the subject of these SNURs and 
other chlorinated paraffin manufacturers. CPIA's comments, and 
associated attachments, can be found in the public docket under ID EPA-
HQ-OPPT-2013-0399-0198.
    Comment 1: Based on existing data and recent reviews, CPIA believes 
long chain chlorinated paraffin (LCCP--alkyl chain length of 
C18 to C20) production and use in the U.S. 
present an extremely low risk to human health and the environment. 
Given this, CPIA questions the need for EPA to take specific action 
under TSCA Section 5(a)(2) for any substances that could be considered 
LCCP. CPIA then provides information on why they believe LCCPs and 
vLCCPs do not present a risk.
    Response: The comments primarily addressed the underlying risk 
assessments associated with the PMNs. EPA defers a discussion of the 
commenter's specific concerns as they are not relevant to the basis for 
determining that the uses specified in these SNURs constitute 
significant new uses. EPA is neither required to determine that a 
particular new use of any chemical substance presents, nor even that it 
may present, an unreasonable risk to human health or the environment. 
Rather, EPA issues a SNUR for a use of a substance if it is a 
significant new use (e.g., EPA has reason to anticipate that the use 
would raise significant questions related to potential exposure, so 
that the Agency should have an opportunity to review the use before 
such use should occur). EPA bases this judgment on a consideration of 
all relevant factors, including the specific factors identified at 
section 5(a)(2). Pursuant to TSCA section 5(a)(2), the PMN risk 
assessment does not serve as the basis for regulation of these SNURs, 
but as a valuable source of a breadth of information related to each 
substance's potential to threaten human health or the environment.
    Nonetheless, EPA does have concern for these chemical substances 
because when released to the environment, vLCCPs are expected to 
rapidly partition to particulates and sediments where they are 
anticipated to persist in the environment with half-lives of months or 
greater. If they do degrade over time, these substances are expected to 
form shorter chain chlorinated chemicals. Based on the complex starting 
mixtures, lack of data on biological and abiotic reactions, and 
potential degradation products, there is high uncertainty regarding the 
fate and transport of these substances. Nevertheless, by analogy to 
medium chain chlorinated paraffins (MCCPs--alkyl chain length of 
C14 to C17) and LCCPs, EPA expects vLCCPs and 
possible degradation products to be potentially highly persistent, 
potentially highly bioaccumulative, and potentially toxic to aquatic 
and sediment-dwelling organisms. Further, within the category of 
vLCCPs, EPA expects the shorter carbon chain range of these substances 
(C21 to C24) and lower chlorinated substances 
(degree of chlorination less than 50%) to present the greatest 
potential for risk, as they are expected to be the most 
bioaccumulative, mobile in the environment, and toxic. Transport and 
magnification across trophic levels may also result in toxicity to 
higher organisms, including fish, higher predators, and potentially 
humans. EPA has concerns about the potential for the vLCCPs to degrade 
to shorter chain chlorinated compounds, as well as concerns about 
potential impurities or small fractions of MCCPs and/or LCCPs.
    MCCPs and LCCPs are expected to be PBT chemicals based on the 
following lines of evidence: (a) The available data on MCCPs, sediment 
core studies, environmental fate studies, and associated calculations, 
indicate transformation half-lives of months to years, depending on the 
environmental media. Even though there are limited data on the LCCPs, 
biodegradation data indicated increasing stability with increasing 
chain length. LCCPs are also expected to have transformation half-lives 
comparable to, or greater than MCCPs. Therefore, MCCPs and LCCPs are 
expected to be very persistent; (b)

[[Page 7458]]

The available data on MCCPs and LCCPs indicate that these substances 
have bioconcentration factors (BCFs) and bioaccumulation factors (BAFs) 
that exceed 1,000 or 5,000 liters per kilogram wet weight of tissue (L/
kg ww). Therefore, MCCPs and LCCPs are expected to be very 
bioaccumulative; (c) The available data on MCCPs and LCCPs indicated 
acute and chronic toxicity to aquatic organism with effects levels 
below 10 milligrams per liter (mg/L) or 0.1 mg/L, depending on the 
species and MCCP and LCCP congener evaluated. Therefore, MCCPs and 
LCCPs are expected to be toxic to aquatic organisms; (d) EPA is 
concerned about PBT chemicals because even small releases may persist 
in environmental media, build up in the environment and concentrate/
accumulate in organisms over time. These properties increase the 
potential for continual exposure, and thus risk; and (e) EPA expects 
there to be releases of the PMN substances to the environment resulting 
from distribution in commerce and during processing and all the 
substances' intended uses.
    EPA notes that its risk assessments for certain MCCP and LCCP PMNs 
have recently been made available for public comment in the Federal 
Register of December 23, 2015 (80 FR 79886) (FRL-9940-13).
    Comment 2: CPIA questioned the appropriateness of treating certain 
of the substances in the proposed SNUR as chemical analogs to LCCPs or 
vLCCPs, because two of the three substances covered by this SNUR are 
described as being ``branched and linear'' chloroalkanes: Alkanes, 
C21 to C34-branched and linear, chloro, CAS 
Registry Number (CASRN) 1417900-96-9 (P-12-0539), and Alkanes, 
C22 to C30-branched and linear, chloro, CASRN 
1401974-24-0 (P-13-0107). CPIA could not find detailed compositional 
information about these substances in the rulemaking docket. 
Regardless, CPIA does not expect that anyone intending to make 
chlorinated paraffins would intentionally seek to make branched 
chloroalkanes. CP manufacturers have always used either n-paraffin or 
alpha-olefin feedstocks, both of which should be almost exclusively 
linear if they are to be used in CP manufacturing operations. To the 
extent that these hydrocarbon feedstocks contain branched or 
isoparaffin content, they are considered an impurity and something to 
be minimized and closely controlled. The Organisation for Economic 
Cooperation and Development (OECD) Screening Information Dataset (SIDS) 
dossier and SIDS Initial Assessment Report (SIAR) for LCCP discuss LCCP 
isoparaffin content in its section on impurities and states that the 
amount should not be more than 1-2%. This is consistent with CPIA's 
understanding of the feedstocks used in LCCP manufacture. Only linear 
chloroalkanes are desired in commercial CP products and any branched 
chloroalkane (i.e. chlorinated isoparaffin) content is considered an 
impurity and should be kept to a minimum.
    Response: EPA understands that some CPs may contain only linear 
chloroalkanes, but for these two ``branched and linear'' PMN 
submissions that EPA has received, the percent branching is greater 
than the 1-2% figure mentioned in the CPIA comments and the branching 
is thus part of the specific chemical name for TSCA Chemical Inventory 
purposes.
    Comment 3: EPA has designated the PMN/SNUR substances as very long 
chain chlorinated paraffin (vLCCP), with a nominal carbon chain length 
of C21 to C30. EPA has designated LCCP as 
C18 to C20 chloroalkanes, although in all other 
venues, including EPA's previous CP testing program, the OECD SIDS 
assessment, the European Union (EU) Regulation on Registration, 
Evaluation, Authorisation and Restriction of Chemicals (REACH) dossier, 
and other recent assessments, LCCP has been considered as 
C18 to C30. Most of the recent LCCP assessments 
have evaluated LCCP as a category comprised of three main 
subcategories: C18 to C20 Liquid LCCP, 
C20 to C30 Liquid LCCP, and C20 to 
C30 Solid LCCP.
    Response: EPA recognizes that CPIA does not agree with the EPA 
designations for LCCP vs. vLCCP. The designation/cut-off for LCCPs and 
vLCCPs represents the chain lengths potentially contained in the liquid 
chlorinated paraffins and waxy/solid chlorinated paraffins. These 
designations (i.e., the differentiation between C18-20 and 
C20 CPs) are consistent with those in other jurisdictions, 
e.g., Environment Canada (see Ref. 1). There are a series of 
interactions that the CP industry has had with EPA over the years, 
including TSCA section 4 test rules on specific TSCA chemicals and the 
Toxics Release Inventory (TRI). In previous actions under TSCA and TRI, 
the Agency has used a different naming convention, often based on 
public comment from industry. However, in each action the chemical 
substance that was the subject of the action has been clear because 
information such as chemical formula has been part of the 
identification. Previous attempts to divide chlorinated paraffins into 
various categories were based primarily on industrial usage patterns 
and industry comment, not on toxicological information.
    Regardless of the naming conventions raised by the commenter, in 
reviewing the studies submitted with the PMNs in this SNUR and other 
PMNs, and the scientific literature more broadly, EPA has concluded 
that that there is a continuum of effects linked to chain length and 
degree of chlorination. On the one end of the spectrum are SCCPs and 
MCCPs; more data are available on these chain lengths, and EPA has 
concluded that sufficient data exists to conclude that they may be 
PBTs. There are also some, albeit significantly less, data on the 
vLCCPs, most of which appear to point to a lack of effects, but the 
chemical composition of the test substances was poorly characterized. 
Ultimately, EPA is interested in specific fate and toxicity tests on 
vLCCPs that elucidate the relationship between degree of chlorination 
and alkyl chain length. The testing schema is designed to minimize the 
burden of testing of complex mixtures with numerous congeners.
    Comment 4: According to the commenter, in the United States, 
commercial LCCP products have generally been in either the 
C20 to C30 liquid or C20 to 
C30 solid subcategories, with C18 to 
C20 liquid LCCP products found mostly in the European 
market. Given the lack of C18 to C20 liquid LCCP 
products in the U.S. market, CPIA does not necessarily object to EPA's 
division of the existing category into LCCP and vLCCP. However, CPIA, 
believes that drawing a ``bright line'' at a carbon length of 
C20 is questionable based on the toxicology and 
environmental fate data available. CPIA cites as support the conclusion 
of the OECD SIDS Initial Assessment Profile (SIAP) of LCCP, that ``C20-
30 liquid and solid LCCPs are of low concern for the environment based 
on their low hazard profiles. . . . Adequate screening-level data are 
available to characterize the environmental hazard for the purposes of 
the OECD HPV (High Production Volume) Chemicals Programme.''
    Response: EPA recognizes that CPIA does not agree with the EPA 
designations for LCCP vs. vLCCP. EPA disagrees with CPIA that linear 
C18 to C20 CPs are not available within the 
United States, as EPA has received one or more PMN submissions for 
these types of CPs and therefore they may be commercially available. 
Further, these designations are consistent with those in other 
jurisdictions, e.g., Environment Canada (Ref. 1). Please refer to the 
response to Comment 1 for the issue of hazard and PBT discussions 
pertaining to chain length.

[[Page 7459]]

    Comment 5: Limited information on EPA's assessment of vLCCP is 
provided in the proposed SNUR, associated Consent Order, and the 
rulemaking docket. Perhaps this limited information is due to the 
nature of this SNUR and the PMN review process.
    Response: EPA reviewed the PMNs based on the contents of the PMN 
and information available on analogs and in the literature. As with all 
PMN submissions, EPA has followed the processes, procedures and 
statutory provisions of TSCA section 5 for the chlorinated paraffin 
PMNs, including EPA's Policy Statement on PBT New Chemical Substances 
(64 FR 60194; November 4, 1999; FRL-6097-7). EPA's assessment of 
exposures and risks for these three PMN substances is provided in Unit 
IV of the Preamble to the section 5(e) Consent Order (available in the 
public docket to the proposed rule) and is also presented in the 
response to Comment 1. Note that EPA has recently made available 
assessments for certain MCCP and LCCP PMNs, in the Federal Register of 
December 23, 2015 (80 FR 79886) (FRL-9940-13).
    Comment 6: EPA indicates that it was unable to locate any chronic 
aquatic toxicity data on LCCP and as a consequence has relied solely on 
MCCP data. Further, EPA claims that based on these MCCP data there may 
be concerns regarding vLCCP's aquatic toxicity. EPA should be aware 
that there are both chronic fish and invertebrate toxicity data on 
various carbon chain length and chlorination level LCCP test materials. 
These were included in all of the recent reviews of LCCP, including the 
OECD SIDS assessment, the REACH registration dossier, and the U.K. LCCP 
Environmental Risk Assessment report.
    Response: As noted in the TSCA section 5(e) Consent Order signed 
with the PMN submitter and available in the public docket, there were 
no valid chronic aquatic toxicity data available for LCCPs or vLCCPs. 
EPA did consider the LCCP REACH Consortium aquatic toxicity database 
(see Attachment B in the CPIA comments), but the data were inadequate 
to allow EPA to identify a Concentration of Concern (COC). The studies 
tested concentrations in excess of the water solubility and did not 
analytically measure the concentrations that were in solution, which 
led to results orders of magnitude above the water solubility. Given 
the lack of reliable test data for the PMN substances listed in the 
SNUR, EPA used a read-across approach using MCCPs. The chronic aquatic 
toxicity test results and resulting COCs for MCCP data are within the 
estimated water solubilities and therefore these data are deemed 
reliable. The most reliable and acceptable studies indicate that, for 
vLCCPs, the predicted toxicity to aquatic organisms for acute endpoints 
are no effects at saturation. For the chronic toxicity endpoint, EPA 
used the aquatic invertebrate chronic value of 0.013 mg/L from the 
Thompson et al. 1997 study (Ref. 2) based on a MCCP material. This 
value was divided by an assessment factor of 10 to yield 0.0013 mg/L or 
1.3 micrograms ([mu]g)/L or 1.3 parts per billion (ppb).
    Comment 7: CPIA readily acknowledges that, as EPA notes, toxicity 
to aquatic plant life and toxicity to sediment organisms are data gaps 
for LCCP. There have been several different approaches used to fill 
these data gaps. In the case of aquatic plant life, some testing has 
been done on LCCP toxicity to aquatic plant life though the reliability 
of these data has been called into question by reviewers and the data 
were not deemed sufficiently valid to address the endpoint. Most 
assessments of LCCP have thus considered read-across data from MCCP as 
being adequate to fill this data gap. The data from MCCP indicate that 
neither MCCP, nor LCCP by analogy, are toxic to aquatic plant life. 
Given this, CPIA supports the use of MCCP data in the assessment of 
LCCP/vLCCP.
    Response: EPA agrees that toxicity to aquatic plant life is a data 
gap for LCCP/vLCCP and that MCCP serves as an appropriate analog in a 
read-across approach.
    Comment 8: For LCCP sediment toxicity and risk, previous 
assessments by the U.K. Environment Agency and the REACH registration 
dossier have extrapolated from LCCP aquatic toxicity data to sediment 
toxicity using the equilibrium partitioning method. This approach is 
detailed in Attachment C of CPIA's comments, which is a direct excerpt 
from the U.K. Environment Agency's (EA) LCCP assessment. Given the very 
low water solubility of LCCP and the very high predicted Kow, this 
method estimates rather high predicted no effect concentrations (PNECs) 
for LCCP. A PNEC is functionally similar to EPA's concentration of 
concern (CoC) in that both are points of departure for environmental 
risk assessment. The comparison between the sediment PNECs derived by 
the EA using the equilibrium partitioning method and the sediment CoC 
derived by EPA using an MCCP sediment toxicity study are orders of 
magnitude apart. Given this large difference and the fact that both 
methods have limitations, CPIA thinks that this may be a data gap to 
consider for additional testing of vLCCP assuming chemical analysis 
concerns can be addressed and only if exposure/release information 
actually dictate a need for this testing.
    Response: EPA agrees that sediment toxicity is a data gap for 
vLCCPs. The most reliable and acceptable value for the toxicity to 
sediment invertebrate organisms is based on the MCCP material from the 
Thompson et al. 2002 study (Ref. 3). For vLCCPs, EPA used the 28-day 
sediment invertebrate Geometric Mean Acceptable Toxicant Concentration 
(GMATC) value of 187 mg/kg dry weight sediment as an analog approach to 
assess hazard. To calculate an acute concern concentration, this value 
is first multiplied by an acute to chronic ratio for invertebrates of 
10 to yield 1,870 mg/kg dry weight sediment, and then this value is 
divided by an assessment factor of 5 to yield 374 mg/kg dry weight 
sediment. For the chronic toxicity endpoint, EPA used the 28-day 
sediment invertebrate GMATC of 187 mg/kg dry weight sediment also from 
the Thompson et al. 2002 study. This value is divided by an assessment 
factor of 10 to yield 18.7 mg/kg dry weight sediment.
    Comment 9: EPA states that vLCCP by analogy to MCCP may be 
``potentially highly persistent, potentially bioaccumulative and 
potentially toxic.'' EPA further indicates that, ``[t]ransport and 
magnification across trophic levels may also result in toxicity to 
higher organisms, including fish, higher predators, and potentially 
humans,'' though it is not clear whether this statement is directed at 
vLCCP or MCCP as an analog. Regardless, EPA should be aware there has 
been considerable research done in recent years on the environmental 
fate of MCCP, including new research on biodegradation and the 
potential for bioaccumulation, including trophic magnification 
potential.
    Response: EPA has reviewed all the information cited by CPIA, 
including the specific biodegradation studies described in the comments 
and biodegradation studies on LCCPs. No persistence or bioaccumulation 
data were available or submitted to EPA for the commercial Unknown or 
Variable composition, Complex reaction products and Biological 
materials (UVCB) multicomponent substances described in the PMNs. In 
the absence of data on the commercial UVCB substances, EPA used data on 
their components, analogs and used a read-across approach. EPA notes 
that close analogs of MCCPs are the short chain chlorinated paraffins 
(SCCPs) which have been proposed for addition to the Stockholm 
Convention on Persistent Organic Pollutants.

[[Page 7460]]

    Comment 10: Given the available data, CPIA believes that any 
analogy to MCCP for vLCCP must consider that while lower chlorinated CP 
substances may have somewhat greater capacity to bioaccumulate--though 
bioaccumulation will also decrease significantly with increasing carbon 
chain length--these same lower chlorinated CPs show a greater potential 
to biodegrade. In fact, MCCP constituents up to 50% chlorination have 
been found to be readily biodegradable and therefore are not 
persistent, bioaccumulative, and toxic chemicals (PBTs). Higher 
chlorinated MCCP constituents also showed significant potential to 
biodegrade though the results did not reach the ``ready'' criteria. 
Perhaps even more telling is the fact that field studies have not shown 
MCCP to biomagnify across trophic levels (Ref. 4). CPIA believes that 
vLCCP, which is less soluble in water and less bioavailable than MCCP, 
will have even less potential to move up through the troposphere and 
biomagnify. This conclusion was similarly reached by the U.K. 
Environment Agency (Ref. 5), the OECD (Ref. 6), and the European 
Chemical Bureau (ECB) PBT Working Group (Ref. 7).
    Response: EPA has reviewed all the information cited by CPIA 
including the specific bioaccumulation/biomagnification studies 
described in the comments. No persistence or bioaccumulation data were 
submitted for the commercial UVCB multicomponent substances described 
in the PMNs. In the absence of data on the commercial UVCB 
multicomponent substance, EPA used data on components of that 
substance, structural analogs and a read-across approach. Although 
bioaccumulation data are lacking with vLCCPs, there is still concern 
for the presence of lower chain length and moderately chlorinated 
components in the vLCCP commercial UVCB multicomponent substance that 
have the potential to be both persistent and bioaccumulative. EPA 
considered more recent reviews of the bioaccumulation potential of 
MCCPs by Thompson and Vaughn (Ref. 4) and Arnot (Ref. 8) in making the 
determination that MCCPs may be very bioaccumulative. The framework for 
assessing bioaccumulation outlined by Gobas et al. (Ref. 9) describes a 
preferred data hierarchy that places field Trophic Magnification Factor 
(TMF) studies at the top. EPA recognizes that there are significant 
uncertainties associated with the available TMF data for MCCPs. In the 
absence of such data, the framework outlines the use of 
bioconcentration factors (BCFs), bioaccumulation factors (BAFs), and 
biomagnification factors (BMFs) to be considered with caution. EPA 
believes that its review of available data on the bioaccumulation 
potential of MCCPs is consistent with the approach described by Gobas 
et al. (Ref. 9) and that the data support its finding that MCCPs may be 
very bioaccumulative and by analogy so may vLCCPs.
    Comment 11: CPIA is concerned that EPA's proposed testing approach 
for vLCCP in the proposed SNUR (Attachment A of CPIA's comments) fails 
to consider the highly complex nature of the LCCP/vLCCP UVCB substances 
and the analytical limitations inherent to this complex composition. 
For example, even a single carbon-chain length straight-chain 
chloroalkane, will have tens of thousands or more possible isomers. 
Tomy et al. (Ref. 10) calculated that for a C13 chloroalkane 
at 60% chlorination by weight, the total number of possible isomers is 
3,549, even assuming no more than one chlorine atom bound to an 
individual carbon atom. This number of theoretical isomers more than 
doubles with each added carbon number, suggesting that by 
C21, the lowest carbon chain length that EPA has proposed 
testing, this test material could have hundreds of thousands of 
possible isomers.
    Response: EPA understands the complexity of vLCCPs and therefore 
stipulates under the consent order for the PMN substances the testing 
of three specific chain lengths and chlorination levels. EPA expects 
that a single chain length at a specific chlorination level can be 
produced. The purpose of the sequence of testing, i.e., biodegradation 
testing and identification of degradation products followed by 
bioaccumulation testing and benthic toxicity testing, is to use the 
results of the biodegradation tests to identify biodegradation 
products. The selection of three less complex congener PMN surrogates 
for testing reduces the analytical complexities associated with 
characterization of the test substance and identification of products 
formed during biodegradation testing.
    Comment 12. Current guidance from manufacturers indicates that 
vLCCP substances should not be released to surface water and/or poured 
down the drain. When this guidance is applied to exposure models, the 
predicted releases levels to surface water and corresponding 
concentrations in sediment are below the levels of concern.
    Response: While the SNUR is not based on EPA's risk assessment, EPA 
notes that information regarding releases of vLCCPs was submitted to 
EPA by the PMN submitter of these three SNUR substances and is used in 
the risk assessment. EPA's risk assessment for the PMN substances 
indicated that releases of the substances may occur and that without 
the less than 1 weight percent of chlorinated paraffins with an alkyl 
chain  Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    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 Sec.  720.50. SNUNs must be 
on EPA Form No. 7710-25, generated using e-PMN software, and submitted 
to the Agency in accordance with the procedures set forth in Sec. Sec.  
721.25 and 720.40. E-PMN software is available electronically at http://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/how-submit-e-pmn.

IX. Economic Analysis

    EPA evaluated the potential costs of SNUN requirements for 
potential manufacturers and processors of the chemical substances in 
the rule. The Agency's complete Economic Analysis is available in the 
docket under docket ID number EPA-HQ-OPPT-2014-0390

X. References

    The following is a listing of those documents used to prepare the 
preamble to this final rule. Additional information for this final rule 
can be located under docket ID number EPA-HQ-OPPT-2013-0399, which is 
available for inspection as specified under ADDRESSES.

1. Environment Canada, August 2008. Canadian Environmental 
Protection Act, 1999 Follow-up Report on a PSL1 Assessment for Which 
Data Were Insufficient to Conclude Whether the Substances Were 
``Toxic'' to the Environment and to the Human Health: Chlorinated 
Paraffins.
2. Thompson, R.S., N.J. Williams, and E. Gillings. 1997. Chlorinated 
Paraffin (52% Chlorinated, C14-C17): Chronic Toxicity to Daphnia 
Magna. AstraZeneca Confidential Report, BL 5791/B.
3. Thompson, R.S., D.V. Smyth, and E. Gillings. 2002. Medium-Chain 
Chlorinated Paraffin (52% Chlorinated, C14	17): Effects in Sediment 
on the Survival, Growth and Sexual Development of the Freshwater 
Amphipod, Hyalella Azteca. AstraZeneca Confidential Report BL7469/B.
4. Thompson, Roy and Martin Vaughn. 2014. Medium-chain chlorinated 
paraffins (MCCPs): A review of bioaccumulation potential in the 
aquatic environment. Integrated Environmental Assessment and 
Management. Volume 10, Issue 1, pages 78-86, January 2014.
5. U.K. Environment Agency (EA). 2009. Environmental Risk Evaluation 
Report: Long-Chain Chlorinated Paraffins. January 2009.
6. Organisation for Economic Cooperation and Development (OECD). 
2009. SIDS Initial Assessment Report (SIAR) and SIDS Initial 
Assessment Profile (SIAP) for Long Chain Chlorinated Paraffins 
(LCCPs). Reviewed and approved at SIAM-29, October 20-23, 2009.
7. European Chemicals Bureau (ECB) PBT Working Group. 2007. Results 
of the Evaluation of the PBT/vPvB Properties of Paraffin waxes and 
Hydrocarbon waxes, chlor; EC number 264-150-0; CAS number 63449-39-
8. PBT List No. 110. September 11, 2007.
8. Arnot, Jon. 2013. Comments on Preliminary Bioaccumulation 
Assessment of Medium Chain Chlorinated Paraffins (MCCPs): Prepared 
for the MCCP REACH Consortium. April 30, 2013.
9. Gobas, Frank APC; Watze de Wolf; Lawrence P. Burkhard; Eric 
Verbruggen; Kathleen Plotzke. 2009. Revisiting Bioaccumulation 
Criteria for POPs and PBT Assessments. Integrated Environmental 
Assessment and Mangement 5(4): 624-637.
10. Tomy, Gregg T.; Gary A. Stern, Derek C.G. Muir, Aaron T. Fisk, 
Chris D. Cymbalisty, and John B. Westmore. 1997. Quantifying C10-C13 
Polychloroalkanes in Environmental Samples by High-Resolution Gas 
Chromatography/Electron Capture Negative Ion High-Resolution Mass 
Spectrometry. Analytical Chemistry 69: 2762-2771.

XI. Statutory and Executive Order Reviews

A. Executive Order 12866

    This final rule establishes SNURs for chemical substances that were 
the subject of PMNs. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to 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 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. EPA is amending the table in 40 CFR part 9 to list the OMB 
approval number for the information collection requirements contained 
in this final rule. This listing of the OMB control numbers and their 
subsequent codification in the CFR satisfies the display requirements 
of PRA and OMB's implementing regulations at 5 CFR part 1320. This 
Information Collection Request (ICR) was previously subject to public 
notice and comment prior to OMB approval, and given the technical 
nature of the table, EPA finds that further notice and comment to amend 
it is unnecessary. As a result, EPA finds that there is ``good cause'' 
under section 553(b)(3)(B) of the Administrative Procedure Act (5 
U.S.C. 553(b)(3)(B)) to amend this table without further notice and 
comment.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the

[[Page 7462]]

Agency, the annual burden is estimated to average between 30 and 170 
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.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) 
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a 
significant economic impact on a substantial number of small entities 
where the following are true:
    1. A significant number of SNUNs would not be submitted by small 
entities in response to the SNUR.
    2. The SNUR submitted by any small entity would not cost 
significantly more than $8,300.
    A copy of that certification is available in the docket for this 
final rule.
    This final rule is within the scope of the February 18, 2012 
certification. Based on the Economic Analysis discussed in Unit VIII. 
and EPA's experience promulgating SNURs (discussed in the 
certification), EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity 
significantly more than $8,300.
    Therefore, the promulgation of the SNUR would not have a 
significant economic impact on a substantial number of small entities.

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 reasons to believe that any 
State, local, or Tribal government will be impacted by this final rule. 
As such, EPA has determined that this action does not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

    This action will 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, entitled 
``Federalism'' (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This action does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 
final rule does not significantly nor uniquely affect the communities 
of Indian Tribal governments, nor does it involve or impose any 
requirements that affect Indian Tribes. Accordingly, the requirements 
of Executive Order 13175, entitled ``Consultation and Coordination with 
Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not 
apply to this final rule.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (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

    This action is not subject to Executive Order 13211, entitled 
``Actions Concerning Regulations That Significantly Affect Energy 
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because 
this action is not expected to affect energy supply, distribution, or 
use and because this action is not a significant regulatory action 
under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this action does not involve any technical 
standards, NTTAA 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).

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: February 5, 2016.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.

0
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 sections 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.

* * * * *

------------------------------------------------------------------------
                                                            OMB Control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 

[[Page 7463]]

 
                                * * * * *
721.10673...............................................       2070-0012
721.10674...............................................       2070-0012
721.10675...............................................       2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

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. Add Sec.  721.10673 to subpart E to read as follows:

Sec.  721.10673  Alkanes, C21-34-branched and linear, chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, C21-34-
branched and linear, chloro (PMN P-12-539; CAS No. 1417900-96-9) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (j)(manufacture of the PMN substance with 
less than 1 weight percent of chlorinated paraffins with an alkyl chain 
pre>
```