[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: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. 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
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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
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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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