U.S. Environmental Protection Agency 8/18/2010

Nonylphenol (NP) and Nonylphenol Ethoxylates (NPEs)

Action Plan [RIN 2070-ZA09]

I. Overview

Nonylphenol (NP) and nonylphenol ethoxylates (NPEs) are produced in large volumes, with uses that lead to widespread release to the aqua tic environment. NP is persistent in the aquatic environment, moderately bioaccumulative, and extremel y toxic to aquatic organisms. NP’s main use is

in the manufacture of NPEs. NPEs are nonionic surfactants that are used in a wide variety of industrial applications and consumer products. NPEs, though less to xic than NP, are also highly toxic to aquatic organisms, and in the environment degrade to more environmentally persistent NP. NP has also been detected in human breast milk, blood, and urin e and is associated with reproductive and developmental effects in rodents.

NPEs were once commonly used in household laundry detergents. EPA and the detergent manufacturers have cooperated to eliminate this use. However, NPEs are still widely used in large quantities in industrial laundr y detergents and have some additional uses that lead to releases to water. Therefore, EPA intends to initiate action to addre ss its concerns about poten tial ecological effects due to the manufacturing, processing, distribution in co mmerce, and uses of NP and NPEs. Additionally, EPA continues to have some concern about potential risk to human health. EPA anticipates that the actions put forward in this Action Plan will further reduce human exposure thereby reducing concerns

associated with NP and NPEs.

As part of the Agency's efforts to address NP and NPEs, EPA also in tends to evaluate the potential for disproportionate impact on children and other sub-populations.

II. Introduction

As part of EPA’s efforts to enhance th e existing chemicals program under the Toxic Substances Control Act (TSCA; 15 U.S.C. §2601 et seq. ), the Agency intends to identify chemicals for Action Plan development based on their presence in humans; persistent, bioaccumulative, and toxic (PBT) characteristics; use in consumer products; produc tion volume; or other similar factors. NP and certain oligomeric NPEs are highly toxic to aqua tic organisms, are moderately bioaccumulative in mollusks, are persistent in the aquatic environm ent, and accumulate in soils and sediments (EPA, 2005). This Action Plan is based on EPA’s initial review of readily available use, exposure, and hazard information on NP and NPEs. In developing the Action Plan, EPA considered which of the various authorities provided under TSCA and other stat utes might be appropriate to address potential concerns regarding NP and NPEs. The Action Plan is intended to describe th e courses of action the Agency is considering pursuing in the near term to address its concerns. It does not constitute a final Agency determination or other final Agency act ion. Regulatory proceeding s indicated by the Action Plan will include appropriate opportunities for pub lic and stakeholder inpu t, including through noticeand-comment rulemaking processes.

III. Scope of Review

This Action Plan addresses us es of nonylphenols and nonylphenol et hoxylates that fall into the general chemical categories of alkylphenols and alkylphenol ethoxylates (APEs), respectively.Chemical Abstract Service registry names and numbers (CASRNs) routinely used to refer to nonylphenols or nonylphenol ethoxylates may not accurately reflect the identity of those substances. The nine carbon nonyl group may be branched or linear and bind at various locations around the phenol ring (“ortho”, “meta” or “para”). Many manufact urers incorrectly use th e linear identity when referring to the branched nonyl phenol. CASRN 84852-15-3 corresponds to the most widely produced nonylphenol, branched 4-nonylphenol (referre d to herein as NP). Note that NP is not a single chemical structure. It is a complex mixt ure of highly branched nonylphenols, largely mono-substituted in the

para - position, but with small amounts of ortho - and di-substituted nonylphenols. In addition it

includes small amounts of branched C 8 and C 10 alkyl groups (Seidel 2004a). Much of the literature refers to the linear (or normal-) nonylphenol (CASRN 25152- 52-3), often the specific para regioisomer (i.e. 4-n-nonylphenol, CASRN 104-40-5). Many, but not all, references are inaccurate about the identity of the substances listed as nonylphenol. This is likely due to inaccura te identities in the source material. A supplier of nonylphe nol may use CASRN 104-40-5, signifying 4-nnonylphenol, while actually supplying br anched 4-nonylphenol (CASRN 84852-15-3).

The mono- and di-ethoxy NPEs (NP1EO, NP2E O) do not appear on the TSCA inventory, but are among the degradation products of the polymeric NPEs and may be present with NP in the environment in appreciable concentrations.

Production

Nonylphenol

U.S. demand for NP (which includes both produ ction and imports less ex ports) is estimated to be 380 million pounds in 2010 (ICIS, 2007). This is well within the range for the reported production volume (manufactured volume plus imports) report ed under the TSCA Inventory Update Rule (IUR) in 2006, which ranged from approximately 100 to 500 million pounds, based on reporting for the most widely produced branched and linear nonylpheno l substances (i.e., CASRN 84852-15-3 and CASRN 25154-52-3, respectively).

Nonylphenol ethoxylates

NPEs are surface active agents (s urfactants) that are part of th e broader category of surfactants known as alkyphenol ethoxylates (APEs). NPEs repres ent approximately 80% to 85% of the volume

of APEs.

U.S. demand for all surfactants in 2007 wa s 7.5 billion pounds (Rust and Wildes, 2008). U.S. and Canadian consumption of NPE surfactants has been estimated between 300 and 400 million pounds per year (EPA, 2008). In a study by ToxEco logy in 2002, NPE surfactant consumption in Canada was estimated at approximately 29 million pounds . It is not clear if this estimate includes soap, so it may be an underestimate of total surf actant consumption by Canada. However, if Canadian consumption of NPEs is approximately 29 million pounds, then U.S. consumption of NPEs would range from approximately 270 to 370 million pounds.

IV. Uses and Substitutes Summary

Page 2 of 13The primary use of NP is as an intermediate in the manufacture of NPEs. NPEs are manufactured by reacting NP with ethylene oxi de (EO) under basic conditions. The degree of ethoxylation depends on the molar ratio of NP to EO. All degrees of ethoxylation may be manufactured under the CASRN for the poly-et hoxylates (formally poly(oxy-1,2-ethanediyl),  -(4- nonylphenyl)-  -hydroxy-, branched, CASRN 127087-87-0), as long as th ey are synthesized via polymerization reaction between NP and EO.

NP may also be reacted to form tris(4- nonyl-phenyl) phosphite (T NPP, CASRN 26523-78-4) an antioxidant used to protect polymers such as rubber, vinyl, polyolefins, and polystyrenics (Seidel 2004a). TNPP is also used as a stabilizer in plas tic food packaging. Although it does contain residual NP, TNPP has been approved for this use by the Food and Drug Administrati on (FDA). FDA also lists NP as an indirect food contact substance (Vazquez- Duhalt, et al., 2005). Barium and calcium salts of

NP are used as heat stabilizers for poly vinyl chloride (PVC) (Seide l 2004a). NP is also used as a catalytic diluent in epox y resins (Seidel 2004a).

Surfactants are generally categorized based upon th eir electric charge in water. Categories of surfactants include anionic (negative), nonionic (no charge), cationic (positive), and amphoteric (positive and negative). NPEs are part of the nonionic category. N on-ionic surfactants, including NPEs, are used in a wide variety of applications including detergents, cl eaners, degreasers, dry cleaning aids, petroleum dispersants, emulsifiers, wetting agents, adhesives, agrochemicals, including indoor pesticides, cosmetics, paper and textile processing formulations, prewash spotters, metalworking fluids, oilfield chemicals, paints and coatings, and dust c ontrol agents. NPEs are hydrophilic (“water-attracting”) at on e end of the molecule and hydr ophobic (“water-avoiding”) at the opposite end. The hydrophilic “head” at tracts water and the hydrophobic “tail” attracts poorly soluble substances, such as oils and greases. This abi lity to simultaneously attract water and hydrophobic

substances makes NPEs useful in the surfactant applications listed above, accounting for nearly 80% of consumption. Additional uses include: 1) phospha te antioxidants for rubber and plastics; and 2) miscellaneous uses, including lube oil additives. Th ese uses each account for another 10% of total consumption (ICIS, 2007).

Alternatives to NPEs

There is enormous variability in the stru cture of non-ionic surf actants. Most non-ionic surfactants rely on polyethoxylation to provide the hydrophilic moiety. Othe rs rely on glycerol (glycerin), glucosides, or other sugars, either as monosaccharides (e.g. sorbitol) or disaccharides (e.g. sucrose) (Seidel 2004c). The simplest substitution for NPEs is to use other APEs. NPEs are just one of many APEs available commerciall y, and other APEs are used for many of the same commercial purposes as emulsifiers, dispersant s, and surfactants. The main alternatives for NPEs also include alcohol ethoxylates, both linear a nd branched, and glucose-based car bohydrate derivatives such as alkylpolyglucoside, glucamides, and glucamine oxides. Some surfactants may substitute for specific applications only, for instance, si licon surfactants are us ed in production of pol yurethane foam while napthalene condensates are used in photofinishing solutions. In other cases, NPE can be replaced with

a surfactant blend of alte rnative nonionics or a blend that include anionic or amphoteric surfactants. Market acceptance of these alternatives depends on a number of factors including cost and performance in the intended use. Many of these a lternatives are less persistent and break down to chemicals which are less toxic than NP and may be deem ed safer substitutes for NPEs by EPA (EPA 2010a).

Page 3 of 13V. Hazard Identification Summary

The Office of Pollution Prevention and Toxics (OPPT) assessed the human health and environmental effects hazards of NP, specifica lly CASRN 84852-15-3, whic h is branched, parasubstituted NP (branched 4-nonylphenol), as part of its Hazard Charac terization (HC) of 18 alklyphenols ( http://www.epa.gov/chemrtk/hpvis/hazchar/C ategory_Alkylphenols_Sept2009.pdf ) (EPA, 2009c). This CASRN is one of two nonylphenol CASRNs included in this Action Plan. The other CASRN, 25154-52-3, is for straight chain nonylphenol. Since very little straight chain nonylphenol is produced, OPPT’s HC coverage of CASRN 84852-15-3 (a nd not of CASRN 25154- 52-3) is used here. OPPT has evaluated the metabo lism of NPEs in mammals and has concluded that they are metabolized to NP (EPA, 2007; EPA, 2010b).

Human Health Effects

The following discussion on human health effects is based on in formation contained in OPPT’s HC of 18 alkylphenols (EPA, 2009c). NP’s acute (ora l and dermal) toxicity is low. NP is highly irritating and corrosive to the skin and eye, but does not have signi ficant skin sensitizing potential. NOAELs (No Observed Adverse Effect Levels) a nd LOAELs (Lowest Observed Adverse Effect Levels) for systemic toxicity (based on body wei ght or body weight gain) in repeat dose rat oral toxicity studies range from 13 to 100 mg/kg-bw/d ay and from 43 to 400 mg/kg-bw/day, respectively. NOAELs and LOAELs in rat for reproductive toxici ty (based on decreases in epididymal sperm density or testicular sperm head counts, increases in estrous cycle length, and decreases in ovarian weights) range from 13 to19 mg/kg-bw/day, a nd from 43 to 64 mg/kg-bw/day, respectively. Developmental rat NOAELs and LO AELs for offspring (based on accelerated vaginal opening in pups) range approximately from 13 to 19 mg/ kg-bw/day and from 43 to 64 mg/kg-bw/day, respectively. Developmental NOAELs and LOAELs fo r rat maternal toxicity (based on decreased terminal body weights) range from 13 to 19 mg/kg-bw/day and from 43 to 64 mg/kg-bw/day, respectively. NP is not mutagenic in the Ames assay, in vitro chromosomal aberration assay, or in vivo micronucleus assay. There are no data on its carcinogenic potential.

Environmental Effects

Aquatic Toxicity:

The available acute and chronic t oxicity data of NP to aquatic organisms indicates NP is highly toxic to fish, aquatic invertebra tes, and aquatic plants. The 28-da y no observed effect concentration (NOEC) of CASRN 84852- 15-3 for fish ranges from 0.05 to 0.07 mg/L and the 28-day lowest observed effect concentration (LOEC) ranges from 0.12 to 0.19 mg/L. A 33-day NOEC for fish is 0.007 mg/L and the 33-day LOEC is 0.014 mg/L. The 21-day NOEC for aquatic invertebrates ranges from 0.10 to 0.24 mg/L (EU, 2002; Canada, 2002; EPA, 2005).

For NPEs, toxicity to aquatic organisms te nds to decrease with increasing degree of ethoxylation. For example, acute toxicity to ki llifish was 1.4 mg/L, 3 mg/L, 5.4 mg/L, 12 mg/L and 110 mg/L for NP, NP1EO (i.e., NPE with one ethoxyl ate group), NP6.4EO (i.e., NPE mixture with an average of 6.4 ethoxylate groups), NP9EO and NP 16.6EO, respectively (Canada, 2002). Environment Canada, based on a comprehensive analysis of ava ilable toxicity data for NP and NPEs, developed Toxic Equivalency Factors (TEFs) for NP and NP Es, as follows: NP =1; NP1EO and NP2EO =0.5

Page 4 of 13(i.e., half as toxic as NP); NP3EO to NP8EO also = 0.5 (a conservative estimate because of inadequate data); NP9EO and greater = 0.005 (i.e., 100 tim es less toxic than NP) (Canada 2002).

Bioconcentration Factor (BCF):

The measured BCF for fish is low, rangi ng from 87 to 344. However, the BCF for mussel ranges from 14 (low) to 3,400 (moderate) (EPA, 1996).

VI. Physical-Chemical Properties a nd Fate Characteriz ation Summary

NP is a clear to pale yellow viscous liquid at room temperature with moderate water solubility and moderate vapor pressure (Ahel and Geiger, 1993; EU, 2002; Seidel, 2004b). NP has moderate volatility, and, while air c oncentrations of NP are generally exp ected to be low (EU, 2002), research has shown that in some locations there may be wate r-to-air volatilization that results in significant atmospheric concentrations of NP substances (Canada, 2002). In the atmosphere, NP will be degraded rapidly by hydroxyl radicals and is not expected to be persistent in air (EPA, 2009). NP is primarily found in the environment as a degr adation product of NPEs. NPEs are released most often to sewage treatment plants, and are degraded to shorter-c hain NPEs, including NP1EO and NP2EO in active sewage sludge; these short-chain NP Es are then further degraded to NP (EPA, 2005). NP is expected to adsorb strongly to soils and sediments. In sewage treatment plants, NP is expected to partition to sludge, and when released to the aq uatic environment, is expected to partition mainly between water and sediment (EPA, 2005; Canada, 2002). In the surf ace layer of natural waters, NP can be photolyzed with a half-life of 10-15 hours (Canada, 2002). NP a nd NPEs that are present in natural waters or landfills may also potentially leach into groundw ater (Canada, 2002). NP undergoes biodegradation, but not readily, and is considered persistent in the aquatic environment (Canada, 2002). NP also exhibits moderate bioaccumulation potential in aquatic organisms (Canada, 2002; EPA 2005).

NPEs are clear to light orange oily liquids or waxy solids, and ar e considered to be chemically stable and unreactive (SEPA, 2010). NPEs show a gra dual, linear increase in water solubility with greater degree of ethoxylation (for example the repor ted water solubility of NP5EO is 9.48 mg/L; of NP12EO, 42.5 mg/L) (Ahel and Gige r 1993; Brix et al. 2001). There are conflicting re ports in the literature on the biodegradability of NP and NPEs. Th ey are not readily biodegradable using standard tests, but are inherently biodegradable (Canada, 2002; EU, 2002). After a peri od of acclimation, NPEs, in sewage sludge or the natural environment, can undergo biodegradation to shorter-chain NPEs involving stepwise loss of ethoxy groups to lo wer NPE congeners (Maguire, 1999). In the environment the long-chain NPEs biodegrade relativ ely quickly to short-chain NPEs and NP, which are much more resistant to further degradation (Canada, 2002; EU, 2002). When in water, NPEs can also undergo photo-induced degradation (Canada, 2002).

VII. Exposure Characterization Summary

Releases

NPs and NPEs are not listed in the Toxic Release Inventory (TRI). No readily available, quantitative release data in the U.S. were found for NPs and NPEs. Based on information from the European Union (EU) and Canada (EU, 2002 and Environment Canada, 1999), there are

environmental releases of NPs and NPEs to wate r during their manufacture a nd uses including:

Page 5 of 13Release of NP

 during production of NPEs

 during production of nonylphenol/formaldehyde

 during production of epoxy resins

 during production of plastic Release of NP and NP

 in industrial and institu tional cleaning products

 during agricultural use Release of NPEs

 from emulsion polymerization processes

 in textiles processes in cluding wool scouring

 from paper processes

 from printed circuit boards manufacturing processes

 from metal extraction, refi ning and processing industry

 during paints, lacquers and va rnishes manufacturing processes

 from use in deicer formulations

Human Exposure

There are no U.S. Occupational Health and Safety Administrati on (OSHA) Permissible Exposure Limits (PELs) or National Institute for Occupational Safety and Health (NIOSH) Recommended Exposure Limits (RELs) for NP or NPEs. No readily available, quantitative occupational exposure monitoring data in the U.S. were found for NP and NPEs.

Based on IUR data, the total number of workers reasonably likely to be exposed to NP or NPEs during manufacturing and indust rial processing and use may be 1,000 or greater. There may be additional potentially exposed industr ial workers who are not included in this estimate. This estimate also does not include potentially exposed commercial workers, such as employees of laundries or cleaning services, since the IUR does not collect such data.

The National Occupational Exposure Survey (NOES), conducted from 1981 to 1983, estimated 306, 211 workers were potentially exposed to NPs and 1,961,225 workers were potentially exposed to NPEs. The Survey lists the linear isomer, but EPA believes the branched isomer is more accurate.

The following exposure information is based on information obtained from the EU (EU, 2002). It is not known if the processes a nd associated exposures in the U.S. would be similar to those in the European countries.

The EU Risk Assessment indicated the ma nufacturing and use of NP as a chemical

intermediate is carried out in closed systems. Occupational exposure may occur during sampling, maintenance and product filling to drums and ta nkers (EC, 2002). Occupational exposure was estimated at about 0.9 mg/m 3 (8-hour TWA) for both producti on and use of NP (EC, 2002).

During the manufacture of speci alty paints, the EU identified two activities where potential exposure to NP may occur: during loading of th e NP into the solvent, and during coupling and uncoupling of the pipe work during product loading into tins. The i nhalation exposure was estimated to be 0.091 mg/m 3 (8-hour TWA), and the dermal exposure was estimated to be from 0 to 0.1

Page 6 of 13mg/cm 2 /day. During the use of these paints, the EU identified two exposure points: mixing of the paint, and spray application. Dermal exposure du ring mixing was estimated to range from 0.01 to 0.24 mg/cm 2 /day, and inhalation exposure during sp raying was estimated to be 9.1 mg/m 3 (8-hour TWA) (EC, 2002).

No quantitative worker exposure data were found during the production of epoxy resins using NP. However, NP is blended directly into the ha rdening component of the epoxy resin and filled into tubes for use (EC, 2002), indicating potential exposures may occur from adding the NP to the mixer.

No readily available quantitative information on exposure to NP or NPEs were found for use of NP in the manufacturing of NPEs or the processing or uses of NPEs in industrial and institutional cleaning products, emulsion polymer ization, textiles, pulp and pape r, electrical and electronic products, metal extraction, refining and processing i ndustry or lacquers and varnishes industry.

General population exposure to NP (either di rectly or as a metabolite of NPE) has been confirmed by biomonitoring data from breast milk (Ademollo et al., 2008), umbilical cord blood (Chen et al., 2008) and urine (Calafet et al., 2008). The maximum level of NP found in the breast milk

was 56.3 μ g/L, leading to an estimated maximum dose for an infant of 3.9 μ g /kg/day (Ademollo et al., 2008). Exposure is a result of th e presence of NP and NPEs in detergents, cleane rs, agricultural and indoor pesticides, food packaging and cosmetic s. These are potentially products of concern for women and children. For example, small children crawling on floors would be exposed to NPEs and NP in floor and carpet cleaners.

Estimates of human exposure are available fo r several of these sources. These include exposures from: diet_0.1  g/kg/day from a reported 7.5  g/day with the conversion done for a 70 kg person (Guenther et al. 2002); hair dye_0.1  g/kg/day; food containers_2  g/kg/day; and indoor pesticides_0.35  g/kg/day (EU, 2002). The EU report al so estimates NP exposure due to

environmental sources to be 5  g/kg/day, with 70% – 80 % of this due to fish and shellfish consumption (EU 2002). A biomonitoring study of breast milk also found a positive correlation between seafood consumption and levels of NP (A demollo et al., 2008). Si gnificant exposure could

also result from hard surface cleaners and their residue. The largest estimated exposure (4.4 mg/kg/day) was due to living n ear a textile factory that used NP and NPEs (EU, 2002). The appropriate exposure factors for drin king water ingestion of water across all ages ranges from a mean of 0.926 L/day to the 95 th percentile factor of 2.544 L/day (E PA, 2009). If the measured value of

1  g/L (EPA, 2001) for alkylphenols in drinking wate r is combined with th e mean drinking water estimate of 0.926 L/day; the result is an estimated exposure of 0.01  g/kg/day. Based on this analysis, EPA believes that drinking water should not be the main source of exposure, a view shared by other sources (EU, 2002; Soares et al. 2008).

Environmental Exposure

Ecological receptors have the potential for significant exposure to NP and NPE for two reasons: 1) facilities that manu facture products containing NP or NPEs are discharging them into surface waters (Ellis et al., 1982); and 2) NP and NPEs tend to partition to sediments and accumulate (Naylor et al., 1992). Both freshwater and saltwater inve rtebrates, plants and fish are sensitive to this category of chemicals and have demonstrated toxicity to it in varying degrees. EPA’s Office of Water

has derived freshwater and saltw ater water quality criteria (WQC ) for NP. The acute and chronic

Page 7 of 13WQC for freshwater species are 28 μ g/L and 6.6 μ g/L, respectively. The acute and chronic WQC for saltwater species are 7 μ g/L and 1.7 μ g/L, respectively (USEPA, 2005). A range of surface water and

sediment levels of NP and NPEs have been meas ured in US waters. APEs are widely used as industrial laundry detergents and fre quently found in wastewater and sewage treatment plant effluents (Ying et al. 2002). Surface waters ne ar 11 different industrial discharg es ranged in concentration of

NP from 2 to 1617 μ g/L (Shackelford et al., 1983). Surface wate r and sediments measured in the Great

Lakes contained NP concentrations from 0.01 to 0.92 μ g/L for water and 37 μ g/g to 300 μ g/g for sediments (Bennett et al., 1997). Surface water samples collected along the Ohio River measured for total NPEs ranged from 0.13 to 1.0 μ g/L for water, from 250 to 1020 μ g/g for sediments, and from 32

to 920 μ g/g for carp, a bottom dwelling fish (Rice et al ., 2003). Some of the measured surface water concentrations particularly those near industrial discharg es exceed the WQC for freshwater species living in the water column. NP and NPEs in th e freshwater and saltwater ecosystems have the potential for ecological effects on all trophic levels of aquatic sp ecies exposed to them (USEPA, 2005).

VIII. Risk Management Considerations

General Considerations

EPA has identified a number of issues that it has taken into consideration in the development

of an Action Plan for NP and NPEs:

1) NP and the short-chain NPEs (NP1EO and NP2EO) are persistent, moderately bioaccumulative, and extremely toxic to aquatic organisms. EPA has established water quality criteria for NP of 6.6 μg/L for acute exposures and 1.7 μg/L for chronic exposures; Environment Canada has also

established a concern level for NP (and NPEs, as expressed in NP Toxic Equivalency (TEQ) units) of 0.7 μg/L for indefinitely chronic exposures (EPA, 2005, Canada, 2002). The long-chain NPEs, while less “PBT”, are also highly to xic and degrade to the more toxi c and persistent short forms of NPEs and NP in the environment. Internationally, Canada and the EU have acted to regulate NP and NPEs, and the United Nations Environment Progr amme (UNEP, 2003) has identified NP as a chemical of global concern in its Regionally-ba sed Assessment of Persistent Toxic Substances (http://www.chem.unep.ch/pts /gr/Global_Report.pdf ). 2) NPEs are generally sold as mixtures; substanc es represented by CASRNs under the IUR cover a broad spectrum of these substances. There appear to be possible reporting inaccuracies regarding what is actually manufactured. Original TSCA i nventory substances identif ied as straight-chain

substances have often been found to be branched-c hain forms. PMN submissions for straight-chain

NPEs have also been found to be branched a nd are corrected during th e PMN review process. 3) NPEs frequently contain a mixture of substances with C6 to C12 (hexyl to dodecyl) alkylphenol ethoxylates; these “APEs” could al so be sold as easily manufactured substitutes for NPEs. These substances are anticipated to have similar prope rties as NPEs. EPA notes, however, that for many uses of NPEs, safer substitutes are available and use of these substitute chemicals should be encouraged. 4) It appears that a large proportion of use and subsequent environmen tal release is associated with industrial laundries; however, mo re analysis is needed to un derstand other TSCA (and non-TSCA)

uses and releases. 5) EPA’s Office of Pesticide Programs (OPP) also conducted an assessment of NPEs (EPA, 2010b). OPPT and OPP have worked together to ensure that the toxicologica l conclusions in both

documents are consistent.

Page 8 of 13Potential Impacts on Children

There are potential ch ildren’s health concerns related to NP and NPEs. NP exposure over several generations has been observed to cause sli ght changes in the estrous cycle length, timing of vaginal opening, ovarian weight, and sperm/sperma tid count in laboratory animals (EU, 2002). NP exposure over several generations has been observed to cause sli ght but statistic ally significant changes in the estrous cycle length, timing of vagi nal opening, ovarian weight, and sperm/spermatid count in laboratory animals be ginning in 30-100 mg/kg/d dose groups (EU, 2002; Chapin et al., 1999). These findings are consistent with the observation that NP has estrogenic activity (EU, 2002), but a mode of action analysis has not been conducted. Data on childre n’s exposure are limited, though children may have greater exposure to NP and NPEs because they consume more food, drink more water, and breathe more air per pound than adults. While biomonitoring data ar e also limited, a recent Italian study found maximum exposures from human breast milk of 3.9 μ g /kg/day (Ademollo, 2008).

IX. Next Steps

In conducting this review of NP and NPEs , EPA considered a number of potential risk management actions, including regulatory actions under TSCA sections 4 and 5, requiring reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) section 313, and voluntary actions through such programs as Design for the Environment (DfE).

Based on its screening-level review of h azard and exposure information, EPA intends to initiate actions to protect the environment fr om exposure to NP and NPEs due to manufacture (including import) use, or disposal of commercial NP and NPEs. In addition, as part of the Agency’s efforts to address these chemical substances, EPA also intends to evaluate the potential for disproportionate impact of exposure to NP and NPEs on children and other sub-populations.

On the basis of existing information, the Agency believes that the following actions would be

warranted:

1. Supporting and encouraging the voluntary phase out of the use of NPEs in industrial laundry detergents.

a. In discussions with EPA, the Textile Rental Services Association of America (TRSA), whose members represent a large majority of the industrial launderers in the U.S., agreed to expedite a phase out of the use of NPEs in industrial laundry detergents. The phase out, which has already begun, would e nd the use of NPEs in industrial laundry detergents by 2013 (for liquid detergents ) and 2014 (for powder detergents).

b. The phase-out of detergents in industrial laundry detergents and other products will

also be coordinated with EPA’s DfE Safer Detergents Stewardship Initiative (SDSI) program which has had great success in obtaining public commitment by consumer product manufacturers to end the use of NP Es in household laundry detergents. EPA intends to encourage any indus trial launderers who are not members of TRSA to also join this effort.

2. Initiating rulemaking to simultaneously propose a TSCA significant new use rule (SNUR) and

a test rule for NP and NPEs.

a. The proposed SNUR would propose to design ate use of NPEs in detergents and cleaning products as a signi ficant new use, which would require submission of a

Page 9 of 13significant new use notice (SNUN) to EPA at least 90 days before beginning that use. This gives EPA the opportunity to take regul atory action if appropriate. EPA plans to publish the proposed SNUR at the end of 2011; with the effective date of the final SNUR timed to coincide with the anticipated completion of the phase-out of NPEs in

industrial laundr y detergents.

b. The proposed test rule under section 4 of TSCA would pr opose to require development of the information necessary to determine th e effects that NPEs and NP may have on

human health or the environment. EPA ha s already issued an advance notice of proposed rulemaking (ANPRM) for NPEs a nd NP (published June 17, 2009). However,EPA intends to evaluate how releases and exposures are mitigated through the phaseout action and would finalize any propos ed testing actions accordingly.

c. EPA also intends to evaluate the utility of issuing a SNUR for the straight-chain NPEs that EPA believes are no longer being manufactured. Many commercial NPEs are identified as linear nonyl isomer, but EPA believes that these may be misidentified branched forms. In part, the intent of the SNUR would be to elim inate discrepancies on the TSCA inventory and improve accur acy in reporting under the IUR.

d. In addition, EPA will consider SNURs for a dditional uses, depending on the results of an ongoing use and exposure analysis.

3. Consider initiating rule making under TSCA Section 5(b)(4) of TSCA to add NP and NPEs to the list of chemicals that present or may present an unreasonable risk of injury to health or the environment. EPA plans to publish a notice of proposed rulemaking by the end of 2011.

4. Initiating rulemaking in late 2011 to add NP and NP Es to the TRI list. At present, neither NP

nor NPEs are on this EPCRA section 313 list of toxic chemicals.

5. Supporting and encouraging the elimination of other uses of NP and NPEs, followed by regulatory actions as necessary.

a. EPA intends to encourage the manufacturer s of all NPE-containing direct-release products (e.g., firefighting gels and foams, dust-control agents and deicers) to move to NPE-free formulations. As TRSA implements its phase-out commitment through SDSI, it will provide an example for other product sectors to follow, es pecially those with

“direct releases” to the environment. Th e DfE-sponsored CleanG redients database offers a source of ready alternatives—f unctionally equivalent to NPEs based on performance characteristics and safer because they meet the DfE Criteria for Safer Surfactants. (For more information, visit http://www.epa.gov/dfe/pubs/pro jects/form ulat/sdsi.htm. )

b. EPA will develop an alternatives analysis and encourage the elimination of NPE use in other industries that discharg e NPEs to water, such as the pulp and paper processing and textile processing sectors, where safer alternatives may be available. DfE also intends to expand the scope of SDSI, a nd encourage those industries to make

commitments under SDSI.

X. References

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