U.S. Environmental Protection Agency Draft, 12/ 9 29 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

1 Short-Chain Chlorinated Paraffins (SCCPs) and Other Chlorinated Paraffins

I. Overview

To support its initial decision to proceed to commence action under TSCA, EPA
considered SCCPs toxicity, persistence, ability to bioaccumulate, widespread exposure, are found world-wide in the environment, wildlife and their demonstrated ability to b e humans. They are
bioaccumulative in wildlife and humans, are persistent and transported globally

. in the environment, and toxic to aquatic organisms at low concentrations. Based on th o e se factors, as well as the availability of viable substitutes for certain uses of SCCPs, EPA intends to initiate
action to address the manufactur ing, processing, distribution in commerce, and use of SCCPs.

EPA intends to further evaluate whether the manufacturing, processing, distribution in
commerce and/or use of medium chained chlo rinated paraffins (MCCPs) and long-chained chlorinated paraffins (LCCPs) should also be addressed.

As part of the Agency's efforts to addre ss SCCPs, EPA also intends to evaluate the potential for disproportionate impact on children and other sub-populations.

II. Introduction

As part of EPA ' ’ s efforts to enhance the existing chemicals program under the Toxic Substances Control Act (TSCA) 1 , the Agency identified an ini tial list of widely recognized chemicals, including SCCPs, for action plan development based on their presence in human
blood humans ; persistent, bioaccumulative, and toxic (PBT) 2 characteristics; use in consumer products; production volume; and or other similar factors. This Action Plan is based on EPA’s initial review of readily available use, exposure, and hazard information 3 on SCCPs. EPA
considered which of the various authorities provided under TSCA and other statutes might be appropriate to address potential concerns with SCCPs in developing the Action Plan. The Action
Plan is intended to describe the courses of action the Agency plans to pursue in the near term to address its concerns. The Action Plan does not constitute a final Agency determination or other final Agency action. Regulatory proceedings indicated by the Action Plan will include appropriate opportunities for public and stak eholder input, incl uding through notice and comment rulemaking processes.

III. Scope of Review

Chemical Identity

1 15 U.S.C. §2601 et seq.

2 Information on PBT chemicals can be found on the EPA website at http://www.epa.gov/pbt/

. 3 Information sources customarily employed include Inventory Update Reporting (IUR) submissions; Toxic Release Inventory (TRI) reporting; data submitted to the HPV Challenge Program; existing hazard and risk assessments performed by domestic and international authorities includi ng but not limited to U.S. Federal government agencies, the Organization for Economic Cooperation and Development, the Stockholm Convention on Persistent Organic Pollutants, Health and Environment Canada, the European Union; and others. Action plans will reference specific
sources used.U.S. Environmental Protection Agency Draft, 12/ 9 29 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

2 For the purposes of this action plan, SCCPs in clude the chlorinated paraffins that meet the following definition:

C

x H

(2x-y+2) Cl y where x = 10-13; y = 3-12; and the average chlorine content ranges from a pproximately 40 to 70 percent with the limiting
molecular formulas set at C 10 H 19 Cl 3 and C 13 H l6 Cl 12 . Any individual chemical meeting this
definition is considered an SCCP and is covere d by this action plan. Furthermore, this action plan covers any chemical substan ce or mixture that contains a ch emical that meets the definition. For example, CAS registry number (CASRN) 63449-39-8 (Paraffin waxes and hydrocarbon waxes, chlorinated) denotes chlorinated paraffi n waxes of unspecified carbon chain length and unspecified degree of chlorinati on. If a portion of that chemical substance falls within the
definition of SCCPs then the entire substance wo uld be subject to this action plan. Likewise, CAS registry number CASRN 71011-12-6 named (Alkanes, C 12-13 , chloro) would only contain chemicals that meet the alkyl range described in the definition and would be subject to the action plan if any of the chlorine content were consistent with the 40

- to 70 % percent criteria.

Medium chained chlorinated paraffins (MCCP; C 14-17 alkyl chain) and long-chained chlorinated paraffins (LCCP; generally C 18 - 28 ) are also discussed in this action plan.

Physical

- Chemical Properties

EPA has gathered information on the water solubility

, v apor pressure, Henry’s Law
constant, and partition coefficient (log K
ow ) data for several different SCCP m olecular formulae
to characterize the SCCP s category

.

In general, water solubility decreases and Henry’s Law Constant and log K
ow of SCCPs increase with increasing carbon chain length and increasing chlorine content. Short

- and
medium

- chain length chlorinated pa raffins are liquids while l onger chain, higher chlorinated paraffins are solids

. The SCCPs are viscous liquids at r oom temperature and normal pressure

. Vapor pressure of chlorinated paraffins generally decreases with increasing MW (a function of
number of chlorine atoms)

. All chlorinated paraffins have low to negligible water solubility but
the low er molecular weight chlorinated paraffins can be emulsified by adding an organic co

solvent

. The octanol

- water partition coefficients ( log K
ow ) of chlori nated paraffins range from

4. 5 to 12, with SCCPs log K
ow s ranging from approximately 4.5

– 7. 4

. The log K
ow s are generally above 5, the criteria used by many national and in ternational authorities to indicate potential for bioaccumulation because it can be readily measured and calculated on the basis of

structure.

TSCA Inventory

Only four chlorinated fractions are on the TSCA Inventory [Alkanes, C 6-18 , chloro (CASRN 68920-70-7); Alkanes, C 12-13 , chloro (CASRN 71011-12-6); Alkanes, chloro (CASRN: 61788-76-9); Paraffin waxes and Hydrocar bon waxes, chloro (CASRN 63449-39-8 )]

. )] (EPA, 2006). Other CASRNs associated with SCCPs ar e not on the TSCA Inventory. The CASRNs
associated with certain MCCPs and LCCP s are also not on th e TSCA Inventory.U.S. Environmental Protection Agency Draft, 12/ 9 29 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

3 IV. Uses and Substitutes Summary

Production Volume

The current use of chlorinated paraffins (S CCP, MCCP, and LCCP) in the United States is on the order of 150 million pounds per year. Pr oduction of short-chain and medium-chained chlorinated paraffins (C 9 to C 17 ) was 100 million pounds in 2007. A very small fraction of that number is attributable to import / / export business. According to the Chlorinated Paraffins Industry Association, MCCPs repres ent the largest production and use of chlorinated paraffins in North America while SCCPs is only half that vo lume (CPIA, 2009). Marke ting and use of SCCP has been restricted in the European Union

. (ECHA 2008a). In Canada, SCCPs are not currently manufactured and use was approximately 3000 me tric tons in 2000 and 2001, the latest figures reported (Environment Canada, 2008 b ). In the U.S., United States, Dover Chemical Corp. is the sole manufacturer of chlorinated paraffi ns and several companies import SCCPs

. (EPA, 2006).

Uses

The largest use of SCCPs in the United Stat es is as a component of lubricants and coolants in metal cutting and metal forming ope rations. The second-largest use is as both a secondary plasticizer and a flame retardant in plastics, especially PVC. Other minor domestic SCCP uses are as a plasticizer and a flame-reta rdant additive to a variet y of products including: rubber formulations, paints and other coatings, and adhesives and sealants

. (CPIA, 2009). For safety reasons, other countries (those in the European Union and Canada) have allowed SCCPs to be used as a flame retardant in undergr ound mining conveyor belts (rubber formulations) and
fire retardants in dam sealants

. (ECHA 2008a).

Alternatives

MCCPs are alternatives to SCCPs for ma ny applications. Based on their physicalchemical properties, MCCPs are also expected to be persistent in the environment and several field surveys have shown they ar e present in sediments and biota, demonstrating their release to and persistence in the environment. Field-meas ured bioaccumulation fact ors (BAFs) that are greater than 5000 and biomagnificat ion factors (BMF) greater than 1 indicate that MCCPs are bioaccumulative in biota and can biomagnify in food chains

. (UNEP, 2009). MCCPs have toxicity to sensitive aquatic organisms that is similar to SCCPs. Canada has concluded that MCCPs are “toxic” as defined by the Cana dian Environmental Protection Act (CEPA )

. ) (Government of Canada 2008). The European Union s ’s 2005 Risk Assessment Report and 2007 draft update conclude that there is a need for limiting the risks posed by certain uses of MCCPs in the production of PVC and metal cutting

. (EC, 2005, 2007).

LCCPs appear to have been used as alte rnatives to SCCPs in some of the more demanding metal working applications ( Helsinki Commission HELCOM , 2002). LCCPs also appear to have potential as an alternative in the leather, paints and coat ings, sealants and rubber applications. LCCPs are expected to be persiste nt and bioaccumulative in the environment based on their physical-chemical properties and bio accumulation modeling, respectively. Canada hasU.S. Environmental Protection Agency Draft, 12/ 9 29 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

4 concluded that LCCPs up to C 20 are “toxic” as defined by CEPA (Government of Canada

, 2008).Canada has not made a determinati on of whether LCCPs greater that C 20 are toxic.

A number of other potentia l alternatives, e.g. nitroa lkanes, alkyl phosphate and sulfonated fatty acid esters and vegetable oil based products, are available for specific applications. It is stated that these alternativ es are considered less harmful than chlorinated paraffins (UNECE, 2006). These non -chlorinated paraffin alternativ es are often more expensive and may require special handling. A UK estimated cost for completely converting SCCPs to nonSCCPs in metal working was predicted to be £ 4 four million £ per year ( UNECE IRTA, 2004 ). An analysis of costs conducted in California f ound that overall metal working processing costs were more expensive for the SCCP alternatives but including other associated costs (clean up and waste removal) made the non-SCCP alternatives competitive (IRTA, 2004).

V. Hazard Identification Summary

Human Health Effects

Acute toxicity of SCCPs (C 10-13 ) is very low

. (EC, 1999; UNEP, 2009). SCCPs may cause skin and eye irritation upon repeated app lication, but do not appear to induce skin
sensitization

. (EC, 1999; UNEP, 2009). There was no evidence of developmental effects in prenatal developmental toxicity studies in rats and rabbits

. (EC, 1999; UNEP, 2009).

The liver, kidney and thyroid are major target organs in repeated-dose studies with rats and mice. When administered by gavage, chlorinated paraffins (C 12 , 60 % percent chlorine) are carcinogenic in rats and mice of both sexes (NTP 1986 , 1986a; 2005 ). The underlying mechanisms for the carcinogenicity of SCCP in rats and mice are not clearly known. SCCP

was SCCPs were not mutagenic to bacteria with or without metabolic activation

. (NTP 1986a, b).
There are some indications that the SCCP-induced ki dney tumors in male rats are associated with alpha 2  -globin accumulation in hyaline droplets, a mode of action unique to male rats and irrelevant to humans, but this could not be confirmed by immunocytochemical techniques. There are also data showing that the liver toxicity/car cinogenicity induced by S CCP is associated with peroxisome proliferation, whereas the thyroid e ffects are correlated to altered thyroid hormone
homeostasis. A number of scientific working groups (

, including the International Agency for Research on Cancer ( IARC ) ), have concluded that liver tumors induced by peroxisome proliferators are not relevant to humans

. (IARC, 1990; Klaunig et al., 2003). Humans are expected to be much less sensitive to thyr oid hormone perturbation than rats and mice. There is no experimental evidence usi ng human data that demonstrates the carcinogenicity of SCCPs. Chlorinated In the 11 th Report on Carcinogens, NCI lists chlorinated paraffins (C 12 , 60 % percent chlorine) are listed as reasonably anticipated to be human carcinogens based on sufficient evidence of carcinoge nicity in experimental animals ( 11 th Report on Carcinogens, NCI)

. NTP, 2005). They are classified by the International Agency for Research on Cancer ( IARC ) as Group 2B - possibly carcinogenic to humans based on sufficient evidence of carcinogenicity in experimental animals and mechanistic consid erations (IARC, 1990). The Current European Union hazard classification fo r SCCPs in regard to human health is: Carcinogen Category 3 ( substances which cause concern for man owing to possible carcinogenic effects but in respect of which the ava ilable information is not ade quate for making a satisfactoryU.S. Environmental Protection Agency Draft, 12/ 9 29 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

5 assessment) ; limited evidence of a carcinogenic effect

.

Health Canada has determined that and Environment Canada have characterized all chlorinated paraffins (SCCPs, MCCP s and LCCPs) as “toxic” under CEPA

. (Government of Canada 2008).

A recent compilation of toxicity data indicate s the acute toxicity of MCCPs is low and they are not genotoxic. Prenatal developmental toxicity studies in ra ts and rabbits showed reduced fetal body weight. A repr oductive toxicity study also s howed postnatal developmental toxicity as demonstrated by reduced pup body weight , as well as reduced pup survival at higher doses; there was no evidence of reproductive toxicity. Repeated- dose studies in rats and dogs showed effects on the liver (ECHA

, 2008 c a ).

Environmental Effects

SCCPs are highly toxic to aquatic in vertebrates following acute (48-hr EC 50 = 0.043 to 11 mg/L) and chronic (NOEC = 0.005 to 2 mg/L) exposures . In fish high toxicity is associated with chronic exposures, but not fo r acute exposures (96-hr LC 50 = 300 to 10,000 mg/L and NOEC = 0.0096 to 0.05 mg/L). For aquatic plan ts, there is high toxicity a ssociated with both acute and chronic exposures to SCCPs (96-hr EC 50 s range from 0.043 to 0.39 mg/L and NOEC ranges from 0.012 to 0.39 mg/L )

. ) (UNEP, 2009).

Both Health Canada and Environment Cana da have characteri zed all chlorinated paraffins (SCCPs, MCCPs and LCCPs) as “toxic” under CEPA

. (Government of Canada 2008).

VI. Physical-Chemical Properties and Fate Characterization Summary

EPA has gathered information on the water solub ility, vapor pressure, He nry’s Law constant, and partition coefficient (log K
ow ) data for several different SCCP molecular formulae to characterize the SCCPs category (Environment Cana da, 2008; HSDB, 2008; UNEP, 2009). In general, water solubility decreases and Henr y’s Law Constant and log K
ow of SCCPs increase with increasing carbon chain length and increasing chlorine c ontent. Short- and medium- chain length chlorinated paraffins are liquids while longer chain, hi gher chlorinated paraffins are solids. The SCCPs are viscous liquids at room temperat ure and normal pressure . Vapor pressure of chlorinated paraffins generally de creases with increasing MW (a function of number of chlorine atoms). All chlorinated paraffins have low to neg ligible water solubility but the lower molecular weight chlorinated paraffins can be emulsified by a dding an organic co-solvent. Persistence and
Bioa ccumulation

The octanol-water partition coefficients (log K
ow ) of chlorinated paraffins range from 4.5 to 12, with SCCPs log K
ow s ranging from approximately 4.5 to 7.4. The log K
ow s are generally above 5, the criteria used by many national and international author ities to indica te potential for bioaccumulation because it can be readily measur ed and calculated on the basis of structure (UNEP, 2009). SCCPs are persistent and bioaccumulative in the environment. The Persistence Organic Pollutant Review Committee (POPRC) of the St ockholm Convention has c oncluded that SCCPsU.S. Environmental Protection Agency Draft, 12/ 9 29 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

6 fulfill the persistence and bioaccumulation criteria put forth in Annex D of the Stockholm
Convention for Persistence and Bioaccumulation on Persistent Organic Pollutants (UNEP, 2009).
The EU has concluded that SCCPs meets its criter ia for both persistent and bioaccumulative (PB) substance and a very persistent, ve ry bioaccumulative (vPvB) substance

. (ECHA 2008b). Canada
has also concluded SCCPs are persistent and bioaccumulative

. (Environment Canada 2008).

SCCPs released to the atmosphere are expected to exist in the vapor and particulate phase in the ambient atmosphere given the range of vapor pressures reported for these substances. Vapor phase constituents are degraded in air by reaction with hydroxyl radical s with half-lives of
less than 1 one to slightly greater than 10 ten days. A half-life greater than about 2 two days in the atmosphere can be a significant f actor in facilitating l ong-range transport of pe rsistent chemicals.

SCCPs released to water are expected to ad sorb to sediment and suspended particulate matter based on log K
oc values. They are stable to hydrolys is and photolysis. Volatilization from water is expected to be mode rate based on estimated Henry’s Law constants of the individual congeners; however, adsorption to suspended so lids and sediment in the water column may
attenuate the rate of volatili zation. No degradation was observed in sediments under anaerobic
conditions. Detection of SCCPs in sediment co res dating back to the 1940s provides evidence that SCCPs are persistent (UNEP, 2009).

SCCPs released to soil are expected to have low mobility given their log K
oc . Volatilization from moist soil surfaces is expected to be moderate based on estimated Henry’s Law constants of the individual congeners; how ever, adsorption may a ttenuate the rate of
volatilization. Based on laboratory and field data, SCCPs degrade at negligible to slow rates and thus are persistent

.

Measured data indicate SCCPs bioaccumulate in biota. High bioconcentration factors (BCFs) have been measured, ranging from 1,000 to 50,000 for whole body and/or individual tissues in a variety of fres hwater and marine organisms

. (Environment Canada, 2008; UNEP, 2009). Field-derived bioaccumulation factors (BAFs) over 1 one million were measured for vertebrate species collected from the Gr eat Lakes and in arctic marine mammals

. (Environment Canada, 2008; UNEP, 2009).

Transport

The Henry’s Law constant values for SCCPs im ply partitioning from water to air or from moist soils to air, depending on environmental c onditions and prevailing c oncentrations in each compartment. Evidence that SCCPs undergo such tr ansport is provided by fi ndings that they are globally dispersed in the envir onment and appear in the Arctic (Hüttig, 2005). The Persistent Organic Pollutant Review Committee (POPRC) of the Stockholm Convention on Persistent Organic Pollutants (POPs) decided concluded that evidence is sufficient to conclude that SCCPs meet the screening criterion on potential fo r long-range environmental transport (UNEP

, 2009). In December 2009 the Executive Body of the Convention on Long-Range Transboundary Air Pollution will consider adding SCCPs to the POPs Protocol to the Convention

. (UNECE, 2009).U.S. Environmental Protection Agency Draft, 12/ 9 29 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

7 VII. Exposure Characterization Summary

Releases

SCCPs have the greatest potential for e nvironmental release and exposure of the chlorinated paraffins. The likely sources of releas es for SCCPs are identified as manufacturing and lubricant applications. In 2000 and 2001, nearly all usage of SCCPs wa s reported to be in metalworking applications. Losses from the use of SCCPs in paint and sealants are generally regarded as much lower than those from me talworking. Releases of SCCPs may occur during production, storage, transportati on, industrial and consumer us ag e of chlorinated paraffincontaining products, disposal and burning of wa ste, leaching, runoff or volatilization from landfills, and sewage sludge or other waste disposal sites (Tomy et al., 1998).

Major sources of releases of chlorinated pa raffins into the environment are likely the formulation and manufacturing of products containing chlorinated paraffins and use in metalworking fluids as an extreme pressure ad ditive. EPA estimated releases of SCCPs during metalworking fluid use have been estimated using generic scenario methodology. Releases to wastewater were estimated to be approximately 2,400 kg/site-yr from c ontainer cleaning, dragout (fluid that remains on the part after shaping), disposal of filter media and spent metalworking
fluid. Releases to landfill and incineration from th ese same release sources were estimated to be approximately 900 kg/site-yr using the generic s ite methodology. Incinerators would not be as significant a source.

The possible sources of releases to water from manufacturing include spills, facility wash down and drum rinsing/disposal. Ch lorinated paraffins in metalwor king/metal cutting fluids may also be released to aquatic environments from drum disposal, carry-off and spent bath. These releases often ultimately end up in the effluents of sewage treatment plants. In comparison to river and lake sediments, concentrations of SC CPs/MCCPs in sewage sludge are much higher, especially from waste water treatmen t plants serving industrial areas.

Human Exposure

The primary non-occupational routes of exposure to chlorinated paraffins SCCPs include ingestion, both directly and through contaminat ed food, and dermal contact with products. Chlorinated paraffins have been isolated from human liver, kidneys, adipose tissue and breast milk. Due to their potential for environmental transport, SCCP exposure may occur from sources far from their use and release. For example, SCCPs have been found in breast milk samples
taken from Inuit women

. (UNEP, 2009).

There is potential for inhalation exposure to SCCPs in metalworking fluids from mists generated during metal shaping operations in SCCPs use in metalworking fluids . EPA estimated
the that potential inhalation exposure range s from 1.8 to 8.3 mg/day for this scenario . There is also potential inhalation exposure to mists in uses where products containing SCCPs are spray applied such as in paints , adhesives and sealants.U.S. Environmental Protection Agency Draft, 12/ 9 29 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

8 EPA estimated the potential for o ccupational dermal exposure for the various manufacturing, formulation and use scenarios with estimates of potential dermal ex posure ranging to range up to 1800 mg/day. These exposures could be mitigated by the use of personal protection equipment, such as gloves that have b een demonstrated to be effective in preventing permeation by SCCPs and formulations containing SCCPs.

Environmental Exposure

In 1986, EPA/OPPT conducted a monitoring st udy of Sugar Creek near the Dover Chemical manufacturing facility in Dover, Ohio

. (Murray et al., 1988). SCCP concentrations of 0.21 μg/L were detected in water at the outfall an d 0.3 μg/L in particulates in water upstream from the outfall. Monitoring of a metalworking fl uid end-user on Tinkers Creek did not detect chlorinated paraffins in either f iltered water or particulates. The report authors thought that this may be due to analytical difficulties. In 1988, a production plant in the same city reported C 10-13 , 60 % percent chlorine SCCP concentrations of <1 50-3300 ng/L in water from an impoundment drainage ditch that received effluent from chlorinated paraffins (Murray et al., 1988). SCCPs were detected in the Houston Ship Channel in 1978 at levels ranging from less than 1.0 μg/L to 1.5 μg/L. In 1977, near a Diamond Shamrock Facil ity on the Grand River in Painesville, OH, concentrations as high as 3.0 μg/L were detect ed upstream and downstrea m from the plant (EPA, 1993).

As summarized in a draft Risk Profile prep ared by the POPs Review Committee of the Stockholm Convention, SCCPs have been measur ed in a variety of environmental media including air, sediment, surface waters, and wastew ater in North America, Europe, Japan, and/or the Arctic (UNEP, 2009).

SCCPs have also been measured in a variety biota, including freshw ater aquatic species from North America, Europe and the Arctic, mari ne mammals from several locations in Canada and the Arctic, and avian and terrestrial wild life in Europe. In addition, SCCPs have been detected in samples of human breast milk from Canada and the United Kingdom, as well as in a variety of food items from Japan and va rious regions of Europe (UNEP, 2009).

VIII. Risk Management Considerations

Characteriz ation Summary

SCCPs are persistent, bioaccumulative, and toxic to aquatic organisms at low
concentrations

. They can remain in the environment fo r a significant amount of time and can bioaccumulate in animal tissues, in creasing the probability and duratio n of exposure

. SCCPs continue to be manufactured, imported, processed and used in industrial applications in the
United States. SCCPs are persistent, bioaccumulative, a nd toxic to aquatic organisms at low
concentrations. Even The persistence and bioaccumulative properties of SCCPs increase the probability and duration of exposure such that even relatively small releases of these chemicals
from individual facilities that manufacture

, import, process or use these chemi cals or
releases them or from waste management facilities have the potential to accumulate over time to higher levels and that cause significant adverse impacts on th e environment. Thus, a snapshot ofU.S. Environmental Protection Agency Draft, 12/ 9 29 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

9 industrial and other releases of SCCPs will undere stimate the environmental loadings and burden in biota, and thus potential risks. Indeed, S CCPs have been measured in biota and various environmental media, including in terrest rial as well as aquatic organisms.

Other chlorinated paraffins such as MCCPs and LCCPs can be used as substitutes for SCCPs. They are also persistent and bioaccumula tive although they have lower water solubilities than SCCPs. They have also been measured in environmental media and bi ota. The toxicity of MCCPs and LCCPs may appear to be lower based on their lower solubility and bioavailability, however, their toxicity is ge nerally not as well characterized as for the SCCPs.

There are no specific impacts on children associated with chlorinated paraffins.

IX. Next Steps

EPA is addressing the discrepancy between th e specific chlorinated paraffins companies are actually manufacturing or importing a nd those listed on the TSCA Inventory. Only a subset some of the chlorinated paraffin fractions being manufactured or imported is are on the TSCA Inventory. EPA intends to require companie s to submit Pre-Manufacture Notices for the SCCPs, MCCPs, and LCCPs fractions that are no t on the TSCA Inventory and, if appropriate,
would will initiate action under TSCA § section 5 to address the potential risks posed by such SCCPs, and potential risks associated with MCCPs and LCCPs.

Concurrently, EPA intends to initiate consider initiating action under TSCA § section 6(a) to ban or restrict the manufacture, import, pr ocessing or distribution in commerce, export, and use of SCCPs based on the persistence, bioacc umulation and toxicity of SCCPs and their presence in the environment. EPA will develop more detailed assessments to support the TSCA section 6(a) “presents or will present an unreas onable risk” findings. If these more detailed assessments indicate that a different approach to risk management is appropriate, EPA will consider additional approaches.

EPA intends to further evaluate whether the manufacturing, processing, distribution in commerce, use and/or disposal of MCCPs and LCCPs should also be addressed under TSCA § section 6(a).

As part of the Agency's efforts to address these chemicals of concern, EPA intends to evaluate the potential for disproportionate impact on children and other sub-populations.

--------------- --------------- ------------ X. References :

CPIA. 2009. Chlorinated Paraffins Industry Association (CPIA) website

. Accessed Apr il . Chlorinated Paraffins: A Status Report. http://www .regnet.com/cpia/status_ report.html (accessed Apr 1, 2009

. http://www.regnet.com/cpia/status_report.html ).

EC. 2008. European Commission. European Union Risk Assessment Report Alkanes, C 10-13 , chloro, CAS No.
85535-84-8. Volume 81. EUR 23396 EN. Office for Official Publications of the European Communities: Luxembourg, 2008.U.S. Environmental Protection Agency Draft, 12/ 9 29 /2009 U.S. Government Internal Deliberative Document, Do Not Quote, Cite, or Release

10 EC. 2007. European Commission. European Union Risk Assessment Report Alkanes, C 14-17 , chloro, (Medium-Chain Chlorinated Paraffins), CAS No. 85535-85-9. Draft Environment Addendum of August 2007. R331_0807_env.http://ecb.jrc.ec.europa.eu/DOCUMENTS/ExistingChemicals/RISK_ASSESSMENT/ADDENDUM/mccp_add_331.pdf (accessed Dec 22, 2009).

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ECHA

. 2008a. European Chemicals Agency. Data on Manufacture, Import, Export, Uses and Releases of Alkanes,

C 10-13 , C c hloro, SCCPs ...; 2008

. http://echa.europa.eu/doc/consultations/recommendations .as well as Information on
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ECHA

. 2008b. European Chemicals Agency. Agreement of the Member State Committee on Identification of Alkanes, C10-13, C c hloro (SCCP) as a Substance of Very High Concern. Adopted on 8 October 2008. http://echa.europa.eu/doc/about/organisati on/msc/agreements_svhc/msc_svhc_agreement_sc cp.pdf http://echa.europ a.eu/doc/about/organisation/msc/ag reements_svhc/msc_svhc_agreement_ sccp.pdf (accessed Dec 11, 2009). ECHA 2008c. Data on Manufacture, Import, Export, Uses and Releases of Alkanes, C10

- 13, Chloro (SCCPs) as well as Alternatives to its Use

. 2008.
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. Canada Gazette Vol. 142 No. 38 (September 20, 2008).
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- 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 Healt h

. August 2008. European Chemicals Agency (ECHA)

. Alkanes, C10

- 13, chloro (SCCPs): Jus tification for the Draft Recommendation of Inclusion in Annex XIV; 14 January 2009. http://www.echa.europa.eu/doc/consultations/r ecommendations/justifications/justif_sccps.pdf European Commission (EC), Scientific Committee on Health and Environmental Risks (SCHER)

. Scientific Opinion on the Risk Assessment Report on Alkanes, C14

- 17, chloro, MCCP; Human Health Part; 15 January 2008 http://ec.europa.eu/health/ph_risk/c ommittees/04_scher/docs/scher_o_078.pdf
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. Environment Canada. 2008. 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. August 2008. http://www.ec.gc.ca/CEPARegistry/doc uments/subs_list/ChlorinatedParaffins /CPs_followup.pdf (accessed Dec 22, 2009).

EPA. 1993. U.S. Environmental Protection Agency. RM2 Exit Briefing on Chlorinated Paraffins and Olefins; Office of Pollution Prevention and Toxics: Washington, D.C., 1993.

EPA. 2006. U.S. Environmental Protection Agency. Toxi c Substance Control Act (TSCA) Chemical Substance Inventory. 2006 Inventory Update Rule Public Database. Office of Pollution and Prevention of Toxics: Washington, D.C., 2006.

Government of Canada. 2008. Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999

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