Document ID: EPA-HQ-OPPT-2015-0789-0001
Agency: epa
Document Type: Notice
Title: Chlorinated Paraffins: Request for Available Information on PMN Risk Assessments
Posted Date: 2015-12-23T05:00Z

[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79886-79888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32175]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2015-0789; FRL-9940-13]

Chlorinated Paraffins; Request for Available Information on PMN 
Risk Assessments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is requesting new available data on certain chlorinated 
paraffins in different industries and for different uses, to inform the 
risk assessments for chlorinated paraffins submitted as Toxic 
Substances Control Act (TSCA) Premanufacture Notices (PMNs). The risk 
assessments have been placed in a public docket. Any comments on the 
assessments or data to inform the assessments will be placed in the 
docket subject to Confidential Business Information considerations.

DATES: Available data and/or comments must be received on or before 
February 22, 2016.

ADDRESSES: Submit your data and/or comments, identified by docket 
identification (ID) number EPA-HQ-OPPT-2015-0789, by one of the 
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is 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. General Information

A. 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, processors, or users of one or more subject 
chemical substances (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries.

B. What is the agency's authority for taking this action?

    This action is issued under the authority in Section 5 of the Toxic 
Substances Control Act (TSCA), 15 U.S.C. 2604.

C. What action is the agency taking?

    EPA is requesting new available data on the chlorinated paraffins, 
referenced in Unit II., in different industries and for different uses, 
to inform the risk assessments for chlorinated paraffins submitted as 
Toxic Substances Control Act (TSCA) Premanufacture Notices (PMNs). The 
risk assessments have been placed in a public docket. Any comments on 
the assessments or data to inform the assessments will be placed in the 
docket subject to Confidential Business Information considerations.

C. Why is EPA taking this action?

    As a result of its TSCA new chemicals review, EPA preliminarily 
determined that the above mentioned chlorinated paraffin PMN substances 
may present an unreasonable risk to the environment for two independent 
reasons: (1) The PMN substances are expected to be persistent, 
bioaccumulative and toxic (PBT) chemicals; and (2) releases of the PMN 
substances may exceed concentrations of concern (COCs) to aquatic and 
sediment-dwelling

[[Page 79887]]

organisms, even without taking into consideration the expected 
persistence and bioaccumulative properties of the PMN substances. EPA's 
assessments of the PMN substances have been placed in the docket.
    1. The PMN substances are expected to be PBT chemicals based on the 
following lines of evidence:
    (a) The available data on medium-chain chlorinated paraffins 
(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 long-chain chlorinated paraffins (LCCPs), 
biodegradation data indicate increasing stability with increasing chain 
length. LCCPs are also expected to have transformation half-lives 
comparable to, or greater than, MCCPs. Therefore, the PMN substances 
are expected to be very persistent.
    (b) 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, the PMN substances are expected 
to be very bioaccumulative.
    (c) The available data on MCCPs and LCCPs indicate acute and 
chronic toxicity to aquatic organisms with effect levels below 10 
milligrams per liter (mg/L) or 0.1 mg/L, depending on the species and 
MCCP or LCCP congener evaluated. Therefore, the PMN substances 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.
    (e) EPA expects there to be releases of the PMN substances to the 
environment resulting from distribution in commerce and during 
processing and all of the substances' intended uses.
    2. Releases of the PMN substances may exceed concentrations of 
concern to aquatic and sediment-dwelling organisms, even without taking 
into consideration the expected persistence and bioaccumulation of the 
PMN substances, based on the following evidence:
    (a) Using estimated environmental concentrations, the PMN 
substances may present unreasonable acute and chronic risks to aquatic 
organisms because releases result in exceedances of COCs for aquatic 
organisms. Also, using the available measured concentrations of MCCPs 
in the environment as supporting information, the PMN substances are 
expected to partition to sediment and may partition to soil through 
land application of biosolids; and may be released to the environment 
resulting in levels at or above concentrations that are likely to 
exceed the COC. These concentrations may present acute and chronic 
risks to aquatic organisms.
    (b) EPA expects releases of the PMN substances to water during 
processing and all of the substances' intended uses to result in 
surface water concentrations that may present an unreasonable risk of 
adverse effects to aquatic and sediment-dwelling organisms. As 
described in EPA's risk assessment documents entitled ``Standard Review 
Risk Assessment on Medium-Chain Chlorinated Paraffins (PMN P-12-0282, 
P-12-0283) and Long-Chain Chlorinated Paraffins (PMN P-12-0284)'', 
``Standard Review Risk Assessment on Medium-Chain Chlorinated Paraffins 
(PMN P-12-0453) and Long-Chain Chlorinated Paraffins (PMN P-12-0433)'', 
and '' Standard Review Risk Assessment: Medium Chain Chlorinated 
Paraffins (PMNs P-14-0683/P-14-0684)'', EPA reviewed a variety of 
sources to inform its assessment on the PMN substances, including: 
Information provided in the PMNs, information on the environmental fate 
of MCCPs and LCCPs in different environmental compartments, the 
properties that control transport, and assessments performed by Canada 
and the European Union.
    Given EPA's preliminary risk determinations, under section 5(e) of 
TSCA, EPA has informed the PMN submitters that it does not believe that 
manufacture of these PMN substances should commence (Qualice, LLC,) or 
continue (Dover Chemical and INOVYN Americas, Inc.) absent the 
development of sufficient information to permit a reasoned evaluation 
of the environmental effects of the substances, as described in a 
testing strategy shared with the PMN submitters. This testing strategy 
and the risk assessments for these three groups of PMNs are available 
in the public docket (EPA-HQ-OPPT-2015-0789).
    While EPA used information provided by the submitters of the PMNs, 
EPA realizes that its assessment of some uses may be improved by more 
specific information on the chlorinated paraffins identified above. 
With this notice, EPA is requesting new, available information on 
chlorinated paraffins in different industries and for different uses to 
reduce the uncertainties in the risk assessments for the three groups 
of PMNs, submitted under TSCA by three companies. Such information may 
include whether there are uses for the PMN chlorinated paraffin 
substances that do not present the potential for direct or indirect 
release to water. In developing the risk assessments for these PMN 
substances, EPA used the information provided by the submitters of the 
PMNs and standard PMN models and scenarios. Processors and users of the 
PMN substances may have specific available data on such issues as 
treatment methods, environmental releases and other waste management 
practices, particularly for non-water based applications. EPA has 
received some information from the Independent Lubricant Manufacturers 
Association and would like to augment this information with specific 
data from other user sectors, particularly those sectors that formulate 
and use chlorinated paraffins as plasticizers and flame retardants in 
adhesives, sealants and coatings.

II. What chemicals are subjects of this notice?

    This notice covers seven medium- and long-chain chlorinated 
paraffins (MCCPs and LCCPs). EPA is reviewing five PMNs as a result of 
settlements resolving violations of the TSCA premanufacture notice 
obligations for production and import of various chlorinated paraffins. 
As part of consent decrees between the Department of Justice (DOJ) and 
EPA and Dover Chemical (February 7, 2012) and separately between DOJ 
and EPA and INEOS Chlor Americas (now INOVYN Americas, Inc) (August 21, 
2012) these companies were required to submit premanufacture notices 
under TSCA section 5 for all chlorinated paraffins domestically 
produced or imported. Also as part of the settlement, the companies 
were required to cease domestic manufacture and import of the closely-
related short-chain chlorinated paraffins, which have persistent, 
bioaccumulative and toxic (PBT) characteristics.
    On March 30, 2012, EPA received three PMNs: P-12-282 for the new 
chemical substance identified as Alkanes C14-16, chloro (no Chemical 
Abstract Service Registry Number (CASRN) assigned yet), P-12-283 for 
Tetradecane, chloro derivs. (no CASRN assigned yet), and Octadecane, 
chloro derivs. (no CASRN assigned yet). On October 28, 2015, the 
submitter, Dover Chemical Corporation, removed all prior assertions of 
CBI claims covering any or

[[Page 79888]]

all of the information associated with these PMNs.
    On June 27, 2012, EPA received PMN P-12-0433 for the new chemical 
substance identified as Alkanes, C18-20, chloro (CASRN 106232-85-3). On 
July 9, 2012, EPA received PMN P-12-0453 for the new chemical substance 
identified as Alkanes, C14-17, chloro (CASRN 85535-85-9). On August 13, 
2012, EPA received PMN P-12-0453 for the new chemical substance 
identified as Alkanes, C22-30, chloro (CASRN 288260-42-4). The 
submitter, INEOS Chlor Americas (now INOVYN Americas Inc.), claimed 
only production volume as CBI in these three PMN submissions.
    On July 10, 2014, EPA received PMN P-14-0683 for the new chemical 
substance identified as Tetradecane, chloro derivs. (CASRN 198840-65-2) 
and P-14-0684 for the new chemical substance identified as Alkanes, 
C14-C16, chloro (CASRN 1372804-76-6). The submitter, Qualice, LLC, made 
no CBI claims in their PMN submissions.
    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 in the Federal Register of November 4, 1999 (64 FR 
60194) (FRL-6097-7).

    Authority: 15 U.S.C. 2601 et seq.

    Dated: December 15, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
[FR Doc. 2015-32175 Filed 12-22-15; 8:45 am]
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