80 FR 79886 - Chlorinated Paraffins; Request for Available Information on PMN Risk Assessments
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 246 (December 23, 2015)
Federal Register Volume 80, Issue 246 (December 23, 2015)
| Page Range | 79886-79888 | |
| FR Document | 2015-32175 |
[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)] [Notices] [Pages 79886-79888] From the Federal Register Online [www.thefederalregister.org] [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: 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] BILLING CODE 6560-50-P
![79886 Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Notices
Pennsylvania Ave. NW., Washington, results in an increase in the labor hours Division (7405M), Office of Pollution
DC 20460; telephone number: (202) and cost. Prevention and Toxics, Environmental
564–2970; fax number: (202) 564–0050; Protection Agency, 1200 Pennsylvania
Courtney Kerwin,
email address: yellin.patrick@epa.gov. Ave. NW., Washington, DC 20460–0001;
Acting Director, Collection Strategies
telephone number: (202) 564–9232;
SUPPLEMENTARY INFORMATION: Division.
email address: moss.kenneth@epa.gov.
Supporting documents which explain in [FR Doc. 2015–32179 Filed 12–22–15; 8:45 am]
For general information contact: The
detail the information that the EPA will BILLING CODE 6560–50–P
TSCA-Hotline, ABVI-Goodwill, 422
be collecting are available in the public South Clinton Ave., Rochester, NY
docket for this ICR. The docket can be 14620; telephone number: (202) 554–
viewed online at www.regulations.gov ENVIRONMENTAL PROTECTION
1404; email address: TSCA-Hotline@
or in person at the EPA Docket Center, AGENCY
epa.gov.
WJC West, Room 3334, 1301 [EPA–HQ–OPPT–2015–0789; FRL–9940–13]
SUPPLEMENTARY INFORMATION:
Constitution Ave. NW., Washington,
DC. The telephone number for the Chlorinated Paraffins; Request for I. General Information
Docket Center is 202–566–1744. For Available Information on PMN Risk
Assessments A. Does this action apply to me?
additional information about EPA’s
You may be potentially affected by
public docket, visit: http:// AGENCY: Environmental Protection
this action if you manufacture, process,
www.epa.gov/dockets. Agency (EPA).
or use the chemical substances
Abstract: Owners and operators of ACTION: Notice. contained in this rule. The following list
affected facilities are required to comply SUMMARY: EPA is requesting new of North American Industrial
with both reporting and record-keeping available data on certain chlorinated Classification System (NAICS) codes is
requirements for the general provisions paraffins in different industries and for not intended to be exhaustive, but rather
(40 CFR part 61, subpart A), as well as different uses, to inform the risk provides a guide to help readers
for the requirements in 40 CFR part 61, assessments for chlorinated paraffins determine whether this document
subpart E. This includes submitting submitted as Toxic Substances Control applies to them. Potentially affected
initial notification reports, performance Act (TSCA) Premanufacture Notices entities may include:
tests and periodic reports and results, (PMNs). The risk assessments have been • Manufacturers, processors, or users
and maintaining records of the placed in a public docket. Any of one or more subject chemical
occurrence and duration of any startup, comments on the assessments or data to substances (NAICS codes 325 and
shutdown, or malfunction in the inform the assessments will be placed in 324110), e.g., chemical manufacturing
operation of an affected facility, or any the docket subject to Confidential and petroleum refineries.
period during which the monitoring Business Information considerations. B. What is the agency’s authority for
system is inoperative. These reports are DATES: Available data and/or comments taking this action?
used by EPA to determine compliance must be received on or before February This action is issued under the
with the standards. 22, 2016. authority in Section 5 of the Toxic
Form Numbers: None. ADDRESSES: Submit your data and/or Substances Control Act (TSCA), 15
comments, identified by docket U.S.C. 2604.
Respondents/affected entities: identification (ID) number EPA–HQ–
Mercury ore processing facilities, OPPT–2015–0789, by one of the C. What action is the agency taking?
mercury cell chlor-alkali plants, sludge following methods: EPA is requesting new available data
incineration plants, and sludge drying • Federal eRulemaking Portal: http:// on the chlorinated paraffins, referenced
plants. www.regulations.gov. Follow the online in Unit II., in different industries and for
Respondent’s obligation to respond: instructions for submitting comments. different uses, to inform the risk
Mandatory (40 CFR part 61, subpart E). Do not submit electronically any assessments for chlorinated paraffins
information you consider to be submitted as Toxic Substances Control
Estimated number of respondents:
Confidential Business Information (CBI) Act (TSCA) Premanufacture Notices
107 (total).
or other information whose disclosure is (PMNs). The risk assessments have been
Frequency of response: Initially, restricted by statute. placed in a public docket. Any
occasionally, semiannually and • Mail: Document Control Office comments on the assessments or data to
annually. (7407M), Office of Pollution Prevention inform the assessments will be placed in
Total estimated burden: 20,600 hours and Toxics (OPPT), Environmental the docket subject to Confidential
(per year). Burden is defined at 5 CFR Protection Agency, 1200 Pennsylvania Business Information considerations.
1320.3(b). Ave. NW., Washington, DC 20460–0001.
• Hand Delivery: To make special C. Why is EPA taking this action?
Total estimated cost: $2,070,000 (per arrangements for hand delivery or As a result of its TSCA new chemicals
year). There are no annualized capital/ delivery of boxed information, please review, EPA preliminarily determined
startup and operation & maintenance follow the instructions at http:// that the above mentioned chlorinated
costs. www.epa.gov/dockets/contacts.html. paraffin PMN substances may present
Changes in the Estimates: There is a Additional instructions on commenting an unreasonable risk to the environment
or visiting the docket, along with more
tkelley on DSK3SPTVN1PROD with NOTICES
small increase in the respondent burden for two independent reasons: (1) The
due to an adjustment. In this ICR, we information about dockets generally, is PMN substances are expected to be
assume all existing sources will take available at http://www.epa.gov/ persistent, bioaccumulative and toxic
some time each year to re-familiarize dockets. (PBT) chemicals; and (2) releases of the
themselves with the regulatory FOR FURTHER INFORMATION CONTACT: PMN substances may exceed
requirements. This new assumption For technical information contact: concentrations of concern (COCs) to
Kenneth Moss, Chemical Control aquatic and sediment-dwelling
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![79888 Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Notices
all of the information associated with ENVIRONMENTAL PROTECTION DATES: Comments, identified by docket
these PMNs. AGENCY identification (ID) numbers identified in
On June 27, 2012, EPA received PMN Table 1 must be received on or before
P–12–0433 for the new chemical [EPA–HQ–OPP–2015–0386; FRL–9940–09] February 23, 2016.
substance identified as Alkanes, C18–
20, chloro (CASRN 106232–85–3). On ADDRESSES: Follow the detailed
Pesticide Registration Review; Draft
July 9, 2012, EPA received PMN P–12– instructions provided under ADDRESSES
Human Health and Ecological Risk
0453 for the new chemical substance Assessments for Certain in the Federal Register document of
identified as Alkanes, C14–17, chloro Organophosphates; Extension of September 25, 2015 (80 FR 57812)
(CASRN 85535–85–9). On August 13, Comment Period (FRL–9933–68).
2012, EPA received PMN P–12–0453 for
FOR FURTHER INFORMATION CONTACT:
the new chemical substance identified AGENCY: Environmental Protection Persons listed with individual
as Alkanes, C22–30, chloro (CASRN Agency (EPA).
288260–42–4). The submitter, INEOS chemicals in Table 1.
Chlor Americas (now INOVYN ACTION: Notice; extension of comment
SUPPLEMENTARY INFORMATION:
Americas Inc.), claimed only production period.
This document extends the public
volume as CBI in these three PMN
SUMMARY: EPA issued a notice in the comment period for certain chemicals
submissions.
On July 10, 2014, EPA received PMN Federal Register of September 25, 2015, established in the Federal Register
P–14–0683 for the new chemical opening a comment period on draft document of September 25, 2015 (80 FR
substance identified as Tetradecane, human health and ecological risk 57812) (FRL–9933–68). In that
chloro derivs. (CASRN 198840–65–2) assessments for certain document, a public comment period
and P–14–0684 for the new chemical organophosphate pesticides listed in opened on EPA’s draft human health
substance identified as Alkanes, C14– Table 1, along with additional and ecological risk assessments for the
C16, chloro (CASRN 1372804–76–6). chemicals. Following this, EPA issued a registration review of certain members
The submitter, Qualice, LLC, made no notice in the Federal Register of of a group of pesticides known
CBI claims in their PMN submissions. November 20, 2015, extending the collectively as organophosphates (found
As with all PMN submissions, EPA comment period for an additional 45 in Table 1) and the document entitled,
has followed the processes, procedures days, until January 8, 2016. This ‘‘Literature Review on
and statutory provisions of TSCA document extends the close of the Neurodevelopment effects; FQPA Safety
section 5 for the chlorinated paraffin comment period for an additional 45
Factor Determination for the
PMNs, including EPA’s Policy days for only the chemicals listed in
Organophosphate Pesticides,’’ and a
Statement on PBT New Chemical Table 1, from January 8, 2016 to
February 23, 2016. This comment number of other chemicals. Following
Substances in the Federal Register of this, EPA issued a Notice in the Federal
November 4, 1999 (64 FR 60194) (FRL– period is being extended in response to
comments received by the Agency. The Register of November 20, 2015 (80 FR
6097–7).
Agency is also taking comments on the 72717) (FRL–9936–94), extending the
Authority: 15 U.S.C. 2601 et seq. comment period for an additional 45
document entitled, ‘‘Literature Review
Dated: December 15, 2015. on Neurodevelopment Effects & FQPA days, until January 8, 2016. EPA is
Maria J. Doa, Safety Factor Determination for the hereby further extending the comment
Director, Chemical Control Division, Office Organophosphate Pesticides’’ in period for only the chemicals, and their
of Pollution Prevention and Toxics. conjunction with this comment period associated support documents, found in
[FR Doc. 2015–32175 Filed 12–22–15; 8:45 am] and not through a separate comment Table 1, which was set to end on
BILLING CODE 6560–50–P period. January 8, 2016, to February 23, 2016.
TABLE 1—CHEMICALS WITH EXTENDED COMMENT PERIODS
Chemical review manager and contact
Registration review case name and No. Docket ID No. information
Chlorpyrifos-methyl 8011 ................................... EPA–HQ–OPP–2010–0119 ............................. Dana L. Friedman, friedman.dana@epa.gov,
(703) 347–8827.
Dicrotophos Case 0145 ..................................... EPA–HQ–OPP–2008–0440 ............................. Khue Nguyen, Nguyen.khue@epa.gov, (703)
347–0248.
Dimethoate 0088 ............................................... EPA–HQ–OPP–2009–0059 ............................. Kelly Ballard, ballard.kelly@epa.gov, (703)
305–8126.
Ethoprop 0106 ................................................... EPA–HQ–OPP–2008–0560 ............................. Tracy Perry, perry.tracy@epa.gov, (703) 308–
0128.
Profenofos 2540 ................................................ EPA–HQ–OPP–2008–0345 ............................. Christina Scheltema, scheltema.christina@
epa.gov, (703) 308–2201.
Terbufos 0109 ................................................... EPA–HQ–OPP–2008–0119 ............................. Matthew Manupella, manupella.matthew@
epa.gov, (703) 347–0411.
Tribufos 2145 ..................................................... EPA–HQ–OPP–2008–0883 ............................. Marianne Mannix, mannix.marianne@epa.gov,
(703) 347–0275.
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Document Created: 2018-03-02 09:20:47
Document Modified: 2018-03-02 09:20:47
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Available data and/or comments must be received on or before February 22, 2016. | |
| 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 | |
| FR Citation | 80 FR 79886 |
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