Chlorinated Paraffins; Request for Available Information on PMN Risk Assessments, 79886-79888 [2015-32175]
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79886
Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Notices
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Pennsylvania Ave. NW., Washington,
DC 20460; telephone number: (202)
564–2970; fax number: (202) 564–0050;
email address: yellin.patrick@epa.gov.
SUPPLEMENTARY INFORMATION:
Supporting documents which explain in
detail the information that the EPA will
be collecting are available in the public
docket for this ICR. The docket can be
viewed online at www.regulations.gov
or in person at the EPA Docket Center,
WJC West, Room 3334, 1301
Constitution Ave. NW., Washington,
DC. The telephone number for the
Docket Center is 202–566–1744. For
additional information about EPA’s
public docket, visit: https://
www.epa.gov/dockets.
Abstract: Owners and operators of
affected facilities are required to comply
with both reporting and record-keeping
requirements for the general provisions
(40 CFR part 61, subpart A), as well as
for the requirements in 40 CFR part 61,
subpart E. This includes submitting
initial notification reports, performance
tests and periodic reports and results,
and maintaining records of the
occurrence and duration of any startup,
shutdown, or malfunction in the
operation of an affected facility, or any
period during which the monitoring
system is inoperative. These reports are
used by EPA to determine compliance
with the standards.
Form Numbers: None.
Respondents/affected entities:
Mercury ore processing facilities,
mercury cell chlor-alkali plants, sludge
incineration plants, and sludge drying
plants.
Respondent’s obligation to respond:
Mandatory (40 CFR part 61, subpart E).
Estimated number of respondents:
107 (total).
Frequency of response: Initially,
occasionally, semiannually and
annually.
Total estimated burden: 20,600 hours
(per year). Burden is defined at 5 CFR
1320.3(b).
Total estimated cost: $2,070,000 (per
year). There are no annualized capital/
startup and operation & maintenance
costs.
Changes in the Estimates: There is a
small increase in the respondent burden
due to an adjustment. In this ICR, we
assume all existing sources will take
some time each year to re-familiarize
themselves with the regulatory
requirements. This new assumption
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results in an increase in the labor hours
and cost.
Courtney Kerwin,
Acting Director, Collection Strategies
Division.
[FR Doc. 2015–32179 Filed 12–22–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
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.
[EPA–HQ–OPPT–2015–0789; FRL–9940–13]
SUPPLEMENTARY INFORMATION:
Chlorinated Paraffins; Request for
Available Information on PMN Risk
Assessments
I. General Information
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
Kenneth Moss, Chemical Control
SUMMARY:
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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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Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Notices
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 mediumchain 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,
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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 sedimentdwelling 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
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79887
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 mediumand 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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Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Notices
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]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2015–0386; FRL–9940–09]
Pesticide Registration Review; Draft
Human Health and Ecological Risk
Assessments for Certain
Organophosphates; Extension of
Comment Period
Environmental Protection
Agency (EPA).
AGENCY:
ACTION:
Notice; extension of comment
period.
EPA issued a notice in the
Federal Register of September 25, 2015,
opening a comment period on draft
human health and ecological risk
assessments for certain
organophosphate pesticides listed in
Table 1, along with additional
chemicals. Following this, EPA issued a
notice in the Federal Register of
November 20, 2015, extending the
comment period for an additional 45
days, until January 8, 2016. This
document extends the close of the
comment period for an additional 45
days for only the chemicals listed in
Table 1, from January 8, 2016 to
February 23, 2016. This comment
period is being extended in response to
comments received by the Agency. The
Agency is also taking comments on the
document entitled, ‘‘Literature Review
on Neurodevelopment Effects & FQPA
Safety Factor Determination for the
Organophosphate Pesticides’’ in
conjunction with this comment period
and not through a separate comment
period.
SUMMARY:
Comments, identified by docket
identification (ID) numbers identified in
Table 1 must be received on or before
February 23, 2016.
DATES:
Follow the detailed
instructions provided under ADDRESSES
in the Federal Register document of
September 25, 2015 (80 FR 57812)
(FRL–9933–68).
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Persons listed with individual
chemicals in Table 1.
SUPPLEMENTARY INFORMATION:
This document extends the public
comment period for certain chemicals
established in the Federal Register
document of September 25, 2015 (80 FR
57812) (FRL–9933–68). In that
document, a public comment period
opened on EPA’s draft human health
and ecological risk assessments for the
registration review of certain members
of a group of pesticides known
collectively as organophosphates (found
in Table 1) and the document entitled,
‘‘Literature Review on
Neurodevelopment effects; FQPA Safety
Factor Determination for the
Organophosphate Pesticides,’’ and a
number of other chemicals. Following
this, EPA issued a Notice in the Federal
Register of November 20, 2015 (80 FR
72717) (FRL–9936–94), extending the
comment period for an additional 45
days, until January 8, 2016. EPA is
hereby further extending the comment
period for only the chemicals, and their
associated support documents, found in
Table 1, which was set to end on
January 8, 2016, to February 23, 2016.
TABLE 1—CHEMICALS WITH EXTENDED COMMENT PERIODS
Docket ID No.
Chemical review manager and contact
information
Chlorpyrifos-methyl 8011 ...................................
EPA–HQ–OPP–2010–0119 .............................
Dicrotophos Case 0145 .....................................
EPA–HQ–OPP–2008–0440 .............................
Dimethoate 0088 ...............................................
EPA–HQ–OPP–2009–0059 .............................
Ethoprop 0106 ...................................................
EPA–HQ–OPP–2008–0560 .............................
Profenofos 2540 ................................................
EPA–HQ–OPP–2008–0345 .............................
Terbufos 0109 ...................................................
EPA–HQ–OPP–2008–0119 .............................
Tribufos 2145 .....................................................
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Registration review case name and No.
EPA–HQ–OPP–2008–0883 .............................
Dana L. Friedman, friedman.dana@epa.gov,
(703) 347–8827.
Khue Nguyen, Nguyen.khue@epa.gov, (703)
347–0248.
Kelly Ballard, ballard.kelly@epa.gov, (703)
305–8126.
Tracy Perry, perry.tracy@epa.gov, (703) 308–
0128.
Christina Scheltema, scheltema.christina@
epa.gov, (703) 308–2201.
Matthew Manupella, manupella.matthew@
epa.gov, (703) 347–0411.
Marianne Mannix, mannix.marianne@epa.gov,
(703) 347–0275.
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://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]
BILLING CODE 6560-50-P
