Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 7455 

1Appendix B to PBGC’s regulation on Allocation 

of Assets in Single-Employer Plans (29 CFR part 

4044) prescribes interest assumptions for valuing 

benefits under terminating covered single-employer 

plans for purposes of allocation of assets under 

ERISA section 4044. Those assumptions are 

updated quarterly. 

The interest assumptions are intended 

to reflect current conditions in the 

financial and annuity markets. 

Assumptions under the benefit 

payments regulation are updated 

monthly. This final rule updates the 

benefit payments interest assumptions 

for March 2016.1

The March 2016 interest assumptions 

under the benefit payments regulation 

will be 1.25 percent for the period 

during which a benefit is in pay status 

and 4.00 percent during any years 

preceding the benefit’s placement in pay 

status. In comparison with the interest 

assumptions in effect for February 2016, 

these interest assumptions are 

unchanged. 

PBGC has determined that notice and 

public comment on this amendment are 

impracticable and contrary to the public 

interest. This finding is based on the 

need to determine and issue new 

interest assumptions promptly so that 

the assumptions can reflect current 

market conditions as accurately as 

possible. 

Because of the need to provide 

immediate guidance for the payment of 

benefits under plans with valuation 

dates during March 2016, PBGC finds 

that good cause exists for making the 

assumptions set forth in this 

amendment effective less than 30 days 

after publication. 

PBGC has determined that this action 

is not a ‘‘significant regulatory action’’ 

under the criteria set forth in Executive 

Order 12866. 

Because no general notice of proposed 

rulemaking is required for this 

amendment, the Regulatory Flexibility 

Act of 1980 does not apply. See 5 U.S.C. 

601(2). 

List of Subjects in 29 CFR Part 4022 

Employee benefit plans, Pension 

insurance, Pensions, Reporting and 

recordkeeping requirements. 

In consideration of the foregoing, 29 

CFR part 4022 is amended as follows: 

PART 4022—BENEFITS PAYABLE IN 

TERMINATED SINGLE-EMPLOYER 

PLANS 

■ 1. The authority citation for part 4022 

continues to read as follows: 

Authority: 29 U.S.C. 1302, 1322, 1322b, 

1341(c)(3)(D), and 1344. 

■ 2. In appendix B to part 4022, add 

Rate Set 269 to the table to read as 

follows: 

Appendix B to Part 4022—Lump Sum 

Interest Rates For PBGC Payments 

* * * * * 

Rate set 

For plans with a valuation date Immediate 

annuity rate 

(percent) 

Deferred annuities 

(percent) 

On or after Before i1 i2 i3 n1 n2

*******

269 ........................ 3–1–16 4–1–16 1.25 4.00 4.00 4.00 7 8 

■ 3. In appendix C to part 4022, add 

Rate Set 269 to the table to read as 

follows: 

Appendix C to Part 4022—Lump Sum 

Interest Rates For Private-Sector 

Payments 

* * * * * 

Rate set 

For plans with a valuation date Immediate 

annuity rate 

(percent) 

Deferred annuities 

(percent) 

On or after Before i1 i2 i3 n1 n2

*******

269 ........................ 3–1–16 4–1–16 1.25 4.00 4.00 4.00 7 8 

Issued in Washington, DC, on this 4th day 

of February 2016. 

Judith Starr, 

General Counsel, Pension Benefit Guaranty 

Corporation. 

[FR Doc. 2016–02810 Filed 2–11–16; 8:45 am] 

BILLING CODE 7709–02–P 

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. 

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. 


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7456 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 

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 § 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 § 721.160(c)(3)(i). EPA 

received notices of intent to submit 

adverse comments on these SNURs. 

Therefore, as required by 

§ 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 § 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 § 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, 


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Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 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 § 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/tscainventory/about-tsca-chemicalsubstance-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 halflives comparable to, or greater than 

MCCPs. Therefore, MCCPs and LCCPs 

are expected to be very persistent; (b) 


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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 alphaolefin 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. 


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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 readacross 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 (mg)/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 readacross 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 readacross 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. 


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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 ≤ 20 

manufacturing restriction, those releases 

may pose an unreasonable risk to the 

environment. Further, apart from any 

risk resulting from releases assessed for 

the PMN chemical substance, 

chlorinated paraffins with alkyl chain 

lengths ≤ 20 are very persistent and very 

bioaccumulative toxic chemical 

substances. Thus a SNUR is important 

because it gives EPA an opportunity to 

review and evaluate data on the 

significant new use before it 

commences. These significant new use 

may have release and exposure profiles 

that are different from that considered 

in the PMN. 

To the extent that the commenter is 

suggesting that the predicted releases to 

surface water do not present a risk and 

thus do not support a significant new 

determination, EPA notes that a 

significant new use determination is not 

based on risk. 

VI. Applicability of the Significant New 

Use Designation 

If uses begun after the proposed rule 

was published were considered ongoing 

rather than new, any person could 

defeat the SNUR by initiating the 

significant new use before the final rule 

was issued. Therefore EPA has 

designated the date of publication of the 

proposed rule as the cutoff date for 

determining whether the new use is 

ongoing. Consult the Federal Register 

notice of April 24, 1990 (55 FR 17376, 

FRL 3658–5) for a more detailed 

discussion of the cutoff date for ongoing 

uses. 

Any person who began commercial 

manufacture or processing of the 

chemical substances identified in this 

rule for any of the significant new uses 

designated in the proposed SNUR after 

the date of publication of the proposed 

SNUR, must stop that activity before the 

effective date of the final rule. Persons 

who ceased those activities will have to 

first comply with all applicable SNUR 

notification requirements and wait until 

the notice review period, including any 

extensions, expires, before engaging in 

any activities designated as significant 

new uses. If a person were to meet the 

conditions of advance compliance 

under 40 CFR 721.45(h), the person 

would be considered to have met the 


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requirements of the final SNUR for 

those activities. 

VII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not require the development of any 

particular test data before submission of 

a SNUN. The two exceptions are: 

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)). 

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 (see 

§ 720.50). However, upon review of 

PMNs and SNUNs, the Agency has the 

authority to require appropriate testing. 

Recommended testing that would 

address the criteria of concern of 

§ 721.170 can be found in Unit IV. of the 

proposed rule. Descriptions of tests are 

provided only for informational 

purposes. EPA strongly encourages 

persons, before performing any testing, 

to consult with the Agency pertaining to 

protocol selection. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs which provide detailed 

information on the following: 

• 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 

§ 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 §§ 721.25 and 720.40. E–PMN 

software is available electronically at 

http://www.epa.gov/reviewing-newchemicals-under-toxic-substancescontrol-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 HighResolution Gas Chromatography/

Electron Capture Negative Ion HighResolution 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 


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7462 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 

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. 

■ Therefore, 40 CFR parts 9 and 721 are 

amended as follows: 

PART 9—[AMENDED] 

■ 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. 

■ 2. In § 9.1, add the following sections 

in numerical order under the 

undesignated center heading 

‘‘Significant New Uses of Chemical 

Substances’’ to read as follows: 

§ 9.1 OMB Approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB Control 

No. 

* * * * * 

Significant New Uses of Chemical 

Substances 


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Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 7463 

40 CFR citation OMB Control 

No. 

* * * * * 

721.10673 ............................. 2070–0012 

721.10674 ............................. 2070–0012 

721.10675 ............................. 2070–0012 

* * * * * 

* * * * * 

PART 721—[AMENDED] 

■ 3. The authority citation for part 721 

continues to read as follows: 

Authority: 15 U.S.C. 2604, 2607, and 

2625(c). 

■ 4. Add § 721.10673 to subpart E to 

read as follows: 

§ 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 § 721.80 (j)(manufacture of 

the PMN substance with less than 1 

weight percent of chlorinated paraffins 

with an alkyl chain ≤ 20) and (p) 

(1,200,000 kg, 14,100,000 kg, 59,100,000 

kg, 78,400,000 kg, and 86,100,000 kg of 

the aggregate of the PMN substances P– 

12–539, P–13–107, and P–13–109, from 

the March 19, 2013 effective date of the 

TSCA section 5(e) consent order for P– 

12–539, P–13–107, and P–13–109).). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), and (i) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 5. Add § 721.10674 to subpart E to 

read as follows: 

§ 721.10674 Alkanes, C22–30–branched 

and linear, chloro. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

alkanes, C22–30–branched and linear, 

chloro (PMN P–13–107; CAS No. 

1401947–24–0) 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 § 721.80 (j)(manufacture of 

the PMN substance with less than 1 

weight percent of chlorinated paraffins 

with an alkyl chain ≤ 20) and (p) 

(1,200,000 kg, 14,100,000 kg, 59,100,000 

kg, 78,400,000 kg, and 86,100,000 kg of 

the aggregate of the PMN substances P– 

12–539, P–13–107, and P–13–109, from 

the March 19, 2013 effective date of the 

TSCA section 5(e) consent order for P– 

12–539, P–13–107, and P–13–109). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), and (i) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 6. Add § 721.10675 to subpart E to 

read as follows: 

§ 721.10675 Alkanes, C24–28, chloro. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

alkanes, C24–28, chloro (PMN P–13– 

109; CAS No. 1402738–52–6) 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 § 721.80 (j) (manufacture of 

the PMN substance with less than 1 

weight percent of chlorinated paraffins 

with an alkyl chain ≤ 20) and (p) 

(1,200,000 kg, 14,100,000 kg, 59,100,000 

kg, 78,400,000 kg, and 86,100,000 kg of 

the aggregate of the PMN substances P– 

12–539, P–13–107, and P–13–109, from 

the March 19, 2013 effective date of the 

TSCA section 5(e) consent order for P– 

12–539, P–13–107, and P–13–109). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), and (i) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2016–02952 Filed 2–11–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 70 

[EPA–R03–OAR–2015–0594; FRL–9942–12– 

Region 3] 

Clean Air Act Title V Operating Permit 

Program Revision; West Virginia 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving a revision to 

the Title V Operating Permits Program 

(found in West Virginia’s regulations at 

45CSR30) submitted by the State of 

West Virginia. The revision increases 

West Virginia’s annual emission fees for 

its Title V Operating Permit Program to 

$28 per ton of emissions of a regulated 

pollutant from an individual source 

subject to the West Virginia Title V 

Operating Permit Program. EPA is 

approving the revision to West 

Virginia’s Title V Operating Permit 

Program in accordance with the 

requirements of the Clean Air Act 

(CAA). 

DATES: This final rule is effective on 

March 14, 2016. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

Number EPA–R03–OAR–2015–0594. All 

documents in the docket are listed in 

the www.regulations.gov Web site. 

Although listed in the electronic docket, 

some information is not publicly 

available, i.e., confidential business 

information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available through www.regulations.gov 

or may be viewed during normal 

business hours at the Air Protection 

Division, U.S. Environmental Protection 

Agency, Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

Copies of the State submittal are 

available at the West Virginia 

Department of Environmental 

Protection, Division of Air Quality, 601 

57th Street SE., Charleston, West 

Virginia 25304. 


srobinson on DSK5SPTVN1PROD with RULES