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Page 1 of 14 Toluene Diisocyanate (TDI)

And Related Compounds

Action Plan

I. Overview

This Action Plan addresses the use of toluen e diisocyanate (TDI) and related compounds in products that may result in consumer and ge neral population exposures, particularly in or around buildings, including homes and schools. Diisocyanates are well known dermal and inhalation sensitizers in the workplace and have been documented to cause asthma, lung damage, and in severe cases, fatal reacti ons. This Action Plan focuses on the potential health effects that may result from exposures to the consumer or self-employed worker while using products containing diisocyanates (e.g., spray applied sealants and coatings) or incidental exposures to the general population while such products are used in or around buildings, including homes or schools. In conducting this review of TDI co mpounds, EPA considered a number of potential actions, including regulatory ac tions under TSCA sections 4, 5, 6, and 8; cooperative actions with other federal agencies ; and voluntary actions.

II. Introduction

As part of EPA's efforts to enhance th e existing chemicals program under the Toxic Substances Control Act (TSCA) 1 , the Agency identified an ini tial list of widely recognized chemicals, including TDI, for action plan deve lopment based on their presence in human blood; persistent, bioaccumulative, and toxic (PBT) 2 characteristics; use in consumer products; production volume; and other similar factors. This Action Plan is based on EPA’s initial review of readily available use, exposure, and hazard information 3 on TDI. EPA considered which of the various authorities provided under TSCA and othe r statutes might be a ppropriate to address potential concerns with TDI 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 and does not constitute a final Agency determin ation or other final Ag ency action. Regulatory proceedings indicated by the Action Plan will in clude appropriate opportunities for public and stakeholder input, including thr ough notice and comment rulemaking pr ocesses. In a concurrent action, a separate Action Plan is under deve lopment for Methylene Diphenyl Diisocyanate (MDI), a substance chemically related to TDI with similar hazard and exposure concerns.

III. Scope of Review

Diisocyanates (also commonly known as isocya nates) are highly re active and versatile chemicals with widespread commercial and cons umer use. Over 90% of the diisocyanates’

1 15 U.S.C §2601 et seq.

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

. 3 Information sources customarily employed include Inventory Update Report (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.*** Interagency Review DRAFT Deliberative – Do No t Cite, Quote or Release During the Review ***
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Page 2 of 14 market is dominated by two diisocyanates and their related polyisocyanates: MDI and TDI (Allport et al. , 2003). They have unique properties and functional versatility, and contain free isocyanate functional groups (-N=C =O). When isocyanates are combined with other compounds that contain free hydroxyl functiona l groups (i.e. –OH) they react and begin to form polyurethane polymers. This chemical reaction is completed when all of the initially free –N=C=O groups are bound within the polymer network. This process is commonly referred to as “curing.” Products that contain free –N=C=O groups are intended to react and undergo “curing” in the process of use. An example would be an adhesive, which is sold to be initially applied in an uncured form and as it cures (hardens), bonds two pieces of w ood together. Other polyurethane products, such as mattresses, pillows, and bowling balls, are cons idered completely cured products before they

are sold.

Because of their reactivity and the diversity of uses, TDI and its related polyisocyanates are generally supplied by their manufacturers as raw materials to formulators who take advantage of the diisocyanates’ chemistry to combine them with other chemicals to create different polyurethanes with a wide diversity of applications. This diversity of applications also means that exposures to diisocyanates can occur in a broad range of production facilities from small workshops to automated production lines. Diisocyanates are potent dermal and lung sensitizers and a major cause of work-related as thma worldwide (NIOSH, 2006). Diisocyanates are also commonly available in unreacted forms as part of product mixtures widely used in construction, automotive, and other similar applica tions that require an en d-use reaction as part of the functional performance of these products. Such appl ications occurring beyond the confines of a controlled producti on facility could result in ex posures unless there is careful observance of best practices and controls to prevent exposures, in cluding the use of protective equipment, containment, ventilation, proper clean-up practices, and me dical surveillance of anyone who may be exposed.

In the past, consumer exposures have not been a focus of con cern with respect to diisocyanates, because it has been assumed that consumers were generally exposed to products containing cured polyurethanes, which have been generally considered to be inert and non-toxic (Krone & Klinger, 2005). However, an increase in the consumer availability of or exposure to polyurethane products intended to further react and undergo “curing” has occurred in the marketplace. For example, consumer products, such as adhesives sealants may contain TDI compounds that are not completely reacted when applied and can provide potential exposures

both to the consumer as the direct user or as a bystander to such produc t use by others (Krone, 2004; Bello et al. , 2007). In addition, certain workers (e .g., self-employed) are not subject to the applicable OSHA exposure limits, and are not le gally required to receive health and safety training and chemical hazard information, or w ear personal protective equipment (PPE) and therefore could poten tially be overexposed to uncur ed polyurethane products.

Given the difference in potential health h azards presented by exposure to uncured vs. cured polyurethane products, the growing exposur e to these products by or around consumers as well as other unprotected building occupants, and th e lack of guidance or regulations to protect them, this action plan will focus on consum er and non-OSHA covered (e.g., self-employed) worker uses of and exposures to polyurethane products contai ning uncured TDI and its related polyisocyanates. Potential exposu res of concern include direct us e as well as incidental or bystander exposures.*** Interagency Review DRAFT Deliberative – Do No t Cite, Quote or Release During the Review ***
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Page 3 of 14 IV. Uses and Substitutes Summary

MDI and TDI are the largest vo lume aromatic diisocyanate s, are high production volume chemicals, and are predominantly used in the production of polyurethanes. In 2008, the U.S. demand for TDI was 425.2 million pounds (ACC, 2009). There are many types of polyurethane products in the marketplace, with foams repres enting the largest sector of the polyurethane industry. Non-foam polyurethane us e sectors of TDI include coati ngs, adhesives, binders, and sealants. However, these products comprise a small amount of the total production volume. Polyurethane foams take two forms: flexible a nd rigid. Flexible foam is primarily used for cushioning, while rigid foam is used mainly for insulation. TDI chemicals are primarily used in the production of flexible foams. The majority of polyurethane products undergo curing prior to reaching the consumer. However, other polyuretha ne products such as coatings, sealants and adhesives may be sold and used, most often in a mixture of formulated product, in an uncured form. Consequently, the genera l population may unknowingly be e xposed to diisocyanates in a variety of ways, such as use of consumer and bi omedical products that co ntain diisocyanates, as well as environmental release that may occur when diisocyanates are used in auto refinishing,

construction and other commercial activities. Thus there coul d be increased potential for cumulative exposures, with heightened concern for individuals who are already chemically sensitized (Bello, et al , 2007).

Because of its hazards, industry claims that uncured TDI is used in products intended for industrial use only (DOW, 2009). Generally, MD I and aliphatic diisocyanates have been replacing TDI in coating and adhesive products (Ott et al. , 2003). The 2006 Inventory Update Reporting (IUR) database indicates that TDI chemicals are used in the following consumer/commercial categories: adhesives and sealants; paints and coatings; transportation products; rubber and plastic products; wood and w ood furniture; and electrical and electronic products (EPA, 2010). The Household Products Database currently li sts one uncured TDI product, a concrete sealant for fl oors (NIH, 2010 ). That product and the deck coating used in an exposure study (Jarand et al. , 2002) are still available for purchas e and it is not clear that the products are limited to professional use only. Ba sed on online research, it appears that floor coatings and sealants are the primary types of products containing uncured TDI which might be

available to consumers.

Additionally, the synthetic recr eational surfacing industry uses a variety of polyurethane components in formulating its products for both indoor and outdoor surfaces (Advanced Polymer Technology Corporation, 2010). Pol yurethane coatings are availabl e for professional use to seal concrete, waterproof walls and refinish floors. So-called “for profe ssional use” products may also be available for purchase and use by consum ers or could be used in the presence of consumers. Polyurethane sealants have a vari ety of uses in the automotive sector, the largest being glass installation of windshields and si de windows. Consumer use of adhesives and sealants is a potential growth s ector as noted by an industry overvi ew of this sector in late 2009. This growth reflects increasing numbers of DI Y energy-conscious homeo wners doing more of their own home renovation and repair work in orde r to save money, as well as from craftsmen and consumers generally continuing to use adhesives (Pinaoforte, November 1, 2009).*** Interagency Review DRAFT Deliberative – Do No t Cite, Quote or Release During the Review ***
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Page 4 of 14 Replacement of diisocyanates in an environm entally and economically friendly manner presents a significant green-chemistry challenge . However, a new class of non-isocyanate polyurethanes that offers potentially safer altern atives to conventional polyurethanes has been reported by two research groups (Figovsky & Shapovalov, 2006; Javni et al. , 2008). Other reported technologies include an isocyanates-free expanding fo am product (Soudal, 2010) and a faster curing “isocyanates-free” flexible food packaging adhesive that reportedly prevents potential migration of isocyanate s into non-dry food. Of note, a soy-based adhesive intended to replace formaldehyde-urea adhesives received a Presidential Green Chemistry Award but more research is needed to determine if soy-based adhesives would be an ad equate substitute for polyurethane adhesives. While research and development of appropriate alternatives is underway with a goal of direct pr oduct substitutions, it is important to focus on the safe use of existing polyurethane products through hazard communication and educating product users.

V. Hazard Identification Summary

Environmental Hazard

. Because of their low ecotoxicity profiles, the hazards associated with exposures to TDI chemicals have centered on human health effects not ecological effects. Experimental ecotoxicological data for TDI and its degradation products indicate moderate to low toxicity to aquatic organisms (Curtis et al. , 1978; MITI, 1992; Tadokora et al. , 1997;

Pedersen et al. , 1998). Other toxicity data suggest low likelihood of effects to terrestrial biota such as plants, earthworms (Van der Hoeven et al. , 1992a; Van der Hoeven et al. , 1992b), and birds exposed to 2,4-TDI and 2,6-TDI (IUCLID, 2000).

Toxicity in Humans

. Most of the data on human h ealth hazards resulting from diisocyanate exposures are base d on occupational populations. Thes e data indicate that exposure to diisocyanates can cause contact dermatitis, skin and respiratory tr act irritation, immune sensitization, and asthma (NIOSH, 2006). Both inhalation and dermal exposures to diisocyanates are thought to contri bute to the development of isoc yanate asthma (Bello et al., 2007). It is well documented that isocyanate exposure is the l eading cause of work-related asthma, and prevalence in the exposed workforce is estimated at 1-20% (Ott et al. , 2003; Bello et
al. , 2004). Once a worker is sensitized to diisocya nates, subsequent exposu res can trigger severe asthma attacks. Most workers who develop diis ocyanate asthma have experienced long periods of exposure (months). However, the minimu m exposure to isocyanates that can elicit sensitization responses or asthma is not know n. In addition, immune response and subsequent disease in humans can be quite variable (Redlich et al. , 2006). Fatalities linked to diisocyanate exposures in sensitized persons have b een reported (NIOSH , 1996; ACC, 2005).

There are very few reports of non-occupatio nal exposures to TDI available; however, there are case reports suggesting that paraoccupa tional asthma may have resulted from incidental exposure to TDI (De Zotti et al. , 2000). In addition, antibodies to TDI have been detected in some residents living near a facility that ma nufactured polyurethane foam, indicating that exposures may be occurring from environmental re leases from the plant and sensitizing some individuals (Orloff et al. , 1998; Darcey, 2002).

Toxicity in Laboratory Animals

. TDI has low acute toxicity via the oral and dermal routes, but is considered toxic via the inhala tion route in animals (Collins, 2002; ECB, 2005).*** Interagency Review DRAFT Deliberative – Do No t Cite, Quote or Release During the Review ***
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Page 5 of 14 TDI is uniformly distributed throughout the body, following inhalation exposure (Collins, 2002;

Gledhill et al. , 2005). TDI causes skin, eye, and lung irri tation, progressive impairment of lung function with long-term inhalation exposure and is a respiratory sensiti zer via both the dermal and inhalation routes of exposure in animals (Collins, 2002). Cross-sensitization has been observed between MDI, TDI, hexamethylene diisocyanate(HDI) and dicyclohexylmethane diisocyanate (HMDI) in mice, and between MDI, TDI and HDI in humans (O'Brien et al. , 1979). TDI is positive in gene mutation assays in vitro and negative in an in vivo mouse micronucleus assay (Collins, 2002). Animal data indicate that TDI may be car cinogenic; however, a consistent association has not been reported in epidem iologic studies (IARC, 1987b; IARC, 1987a; ECB, 2005).

VI. Fate Characterization Summary

Hydrolysis is the dominant process in determining the overall environmental fate, transport, and bioaccumulation potential of diisocya nates. Commercially, diisocyanates react at room temperature with other chemicals (i.e. polyols ) to form various polymers. Data shows that water from humidity in air can hydrolyze TDI th us forming the amine, toluene diamine (TDA),

which also has hazards associated with it. Al though their rapid hydrolysis in surface water will reduce persistence and bioaccumulation in the environment (Yakabe et al. , 1999), under conditions of low humidity, diisocyanates may be stable long enough to be transported some

distances and inhaled. Data fr om the Toxics Release Inventor y shows releases to all media (EPA, 2008b). Despite their apparent rapid reac tion time, there is unc ertainty regarding diisocyanate vapors and TDA in ambient air as a function of humidity (Dyson & Hermann, 1971). Air releases are of particular concer n, because the hydrolysis products formed are irritants and there is a potential for inhalation exposure.

VII. Exposure Characterization Summary

Occupational Exposure. Approximately 280,000 U.S. workers were estimated to be potentially exposed to diisoc yanates in 1996 (NIOSH, 1996) but given industry growth and new applications (Bello et al. , 2007), this estimate is expected to be higher today. OSHA regulates workplace exposures to TDI through its permissi ble exposure limits (PELs). To reduce worker exposures when exposure levels exceed its PELs , OSHA requires use of PPE when engineering controls (e.g., ventilation) or administrative c ontrols are infeasible or fail to reduce levels adequately.

There is a potential for workplace exposure to TDI in all industrial, commercial, or manufacturing settings where TDI is present (DOW, 2009). Because of the high volatility of TDI, exposure can occur in all phases of its manufacture and use (NTP, 2005). Short-term

airborne concentrations that exceed OSHA’s cei ling PEL for TDI continue to be reported in polyurethane foam produc tion facilities (Ott et al. , 2003), especially during upset conditions, within the foam line tunnel, or in close contact with fresh cut buns (Cummings & Booth, 2002). Overexposures to TDI were documented for floor finishing in both person al and area samples in one NIOSH evaluation (NIOSH, 2004) . In another NIOSH evaluati on of flexible polyurethane foam workers, although airborne exposures to TDI were below recommended exposure limits, respiratory (TDI-induced bronchitis and asthma), mucous membrane, and skin problems were*** Interagency Review DRAFT Deliberative – Do No t Cite, Quote or Release During the Review ***
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Page 6 of 14 noted for workers and these symptoms were associ ated with indicators of TDI exposure (NIOSH, 1998). Some sensitized workers susceptible to developing occupa tional asthma could react to isocyanate monomers at concen trations that are below 1% of the 8-hour threshold limit value (TLV) of 5 ppb for TDI/MDI (Gagne et al. , 2005). For TDI, NIOSH recommends exposure reduction to the lowest feasible minimum (NIO SH, 2005) and ACGIH is looking at reducing its 2011 TLVs for 2,4- and 2,6-toluene diisocyanate from current limits through a Notice of Intended Change (NIC). See A ppendix 2 for numerical values.

Self-employed workers and small firms may not have access to or be aware of the hazard information and appropriate precautions to ta ke when using uncured polyurethane products (Krone, 2004). Investigators observed workers applying a TDI-containing moisture cure urethane (MCU) floor finish w ithout using any respiratory prot ection in one investigation of airborne exposures during residential a pplication of the MCU product (ATSDR, 2005).

EPA is aware that there is uncertainty about curing time of various products under

different situations and that addi tional data are needed to addre ss certain concerns , such as reentry time, which are important for impr oving communication to prevent exposure. Additionally, while OSHA and NIOSH have develope d methods to estimate air concentrations within workplaces, current methods underestimate ai r concentrations and may warrant the use of a compensation factor and/or development of improved analytical methods. Methods for detection of dermal exposure are in the early stages of development. There are several data gaps associated with dermal exposure, sensitization, an d the availability of unc ured isocyanate groups (Streicher et al. , 1998; Bello et al. , 2007). In the U.S., only isocyanate monomers (e.g., TDI and MDI) are regulated, although similar polyisocyanates that are wide ly used in commercial and consumer products contain the same reactive isocya nates. EPA is concerned that there does not appear to be sufficient recognition that potential exposures of consumers and non-OSHA regulated workers to MDI, TDI and their related polyisocyanates may need to be addressed with similar recommendations for use of engineeri ng controls, PPE, and hazard communication as those required for OSHA-regul ated occupational settings.

Consumer/General Population Exposure. Potential exposure concerns for workers also may apply to consumers, bystanders, building occupants (including ch ildren), hobbyists and DIY applicators. Little information is available to document consumer use of products containing uncured TDI. It appears that over the years, MDI has been substituted for TDI in some consumer products (ACC, 2009). Although industry claims that uncured TDI products are for industrial use only, many such produc ts are available on the Internet and it is not clea r if there is any control over who purchases them. Un like workers who are protected by workplace regulations and, in most cases, have access to ha zard information and training for working with diisocyanates, it is likely that most consumers are unaware of the potential hazards of consumer products containing uncured TDI. Consequently , incorrect use because of insufficient and inadequate hazard communication may lead to incr eased consumer exposure. Even if consumers are aware of the hazards, they may not take appropriate precautions.

While there is not much information availa ble about direct consumer use, numerous bystander exposures to TDI products have been f ound in the literature, in cluding: emissions of TDI from concrete patio sealants (Kelly et al. , 1999; Jarand et al. , 2002); and detection of TDI in*** Interagency Review DRAFT Deliberative – Do No t Cite, Quote or Release During the Review ***
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Page 7 of 14 building air samples following use of urethane s containing TDI to coat wood floors (NYCDOHMH, 2010). In addition, two cases of pa raoccupational TDI asthma were documented through specific inhalation challe nges after the indivi duals were exposed to uncured TDI (De

Zotti et al. , 2000).

Children may have greater potential for exposur e to some types of polyurethane products, either as users of the products or as bysta nders. Since children spend a large amount of time indoors, the use of household chemicals in the indoor environment has been identified as a principal source of exposure. Ai r tight conditions in new homes ma y also increase the potential for exposure to children. One 2005 mail survey of California home users found that many never

use their windows for ventilation and ventilatio n rates in some new homes are lower than recommended levels (Offerman, February, 2010). Children exposed to the same airborne concentrations of TDI as adults may receive a larger dose because they breathe more per pound body weight and per unit respiratory surface area. Additionally, children may be more highly exposed to environmental toxicants through dermal routes than adults. For instance, children may crawl, roll or sit on surfaces treated with chemicals (i.e., carpe ts and floors) and play with objects such as toys where residues may settle. Children have a higher surface area relative to body weight, which would result in a greater dose re lative to body weight fo r a child than for an adult with an equal amount of skin exposure (EPA, 2008a). Children may have a greater potential for exposure if they use uncured TD I products, because they may not have fully developed judgment for following labeling instructions and safety precautions and may not cease activity even when they are experiencing symptoms of exposure. Childre n with asthma are an especially vulnerable population for exposur e, because they are more susceptible to inflammatory narrowing of the airways, which re sults in a proportionally greater obstruction for breathing (Trasande & Thurston, 2005).

In contrast to the large amount of exposure data available for professional workers who work with diisocyanates, there is limited e xposure data available ch aracterizing the use and exposure scenarios of consumer and commercial products containing uncu red TDI. Additional data characterizing the concentration of TDI in th e air is needed. It is unknown to what extent factors such as application techniques, product composition, and me thod of measurement influence the availability of uncured TDI. In addition, comparing conc entrations to existing workplace exposure limits is not appropriate because the worker PEL is not sufficiently protective for the consumer (Redlich, et al , 2006).

IX. Risk Management Considerations

Similar types of uncured products are availa ble for purchase by either professionals or

consumers. Numerous authors ha ve noted the versatility of polyur ethane as well as its increasing uses. EPA is concerned that the potential exis ts for similar exposures in non-OSHA-regulated situations. Both primary users and bystanders should be made aware of the potential risks and appropriate precautions to take when uncured TDI is being used. It is unclear how many products containing uncured TDI are available fo r consumer purchase. However, even if uncured TDI products are being used by professionals , they could be used in locations, such as surfacing running tracks and gymnasium floors, where unintended exposure of bystanders, especially children, could be a concern. It is important to determine whether there are uncured*** Interagency Review DRAFT Deliberative – Do No t Cite, Quote or Release During the Review ***
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Page 8 of 14 TDI products being used in ways that could pr esent potential exposure concerns. In addition, some personal and health care products could c ontain uncured diisocyanates but are beyond the scope of this action plan. However, exposures from use of such products could contribute to cumulative diisocyanate exposures (Sommer et al. , 2000; Donnelly et al. , 2003). The factors described above suggest that a he ightened concern for potential ri sks of diisocyanate exposure to children should be addressed during actio ns taken to manage these chemicals.

Current and Ongoing Regulatory and Related Activities

TDI and its related polyisocyanates are the su bjects of a variety of regulatory and related activities, some of which are summarized below. Additional details, incl uding numerical values, are provided in Appendix 2.

EPA Regulatory Activities . TDI is regulated under the Clean Air Act as a hazardous air pollutant and under RCRA and CERCLA as a hazardous waste. Diisocyanate s as a category and TDI individually are subject to Toxics Release Inventory re porting. Under TSCA, EPA has previously used its authority under TSCA secti ons 8(a) and 8(d) to request information from industry (see 40 CFR parts 712 and 716). EPA has also received submissions regarding diisocyanates under TSCA section 8(c) and TSCA section 8(e). Diisocyanates are a TSCA New Chemicals Program Chemical Category and any ne w chemical substance falling in that category may be further regulated after a TSCA sec tion 5 premanufacture notice has been submitted (EPA, 2002).

Spray Polyurethane Foam (SPF) Federal Partnership Promoting Stewardship &

Research . In 2009, EPA convened a multi-agency partnership with OSHA, NIOSH, and the Consumer Product Safety Commission (CPSC) to ev aluate and address potential exposures to isocyanates and other chemicals during installation of spray polyur ethane foam (SPF) insulation

and air sealants in homes and schools. Commer cial and DIY applicators, as well as building occupants are often unaware of inhalation and dermal hazards. Applicators and others at the work site may not wear adequate PPE. Buildi ng occupants, who remain on the premises during the operations or re-enter the site before the pr oduct is fully cured may be at risk. The federal agencies are working with the polyurethan es industry to ensure accessible hazard communication, applicator trai ning, and best workplace practic es to prevent exposure to isocyanates and other SPF chemicals. In addi tion, the federal group has identified critical research needs to assess and measure exposures to total reactive isocyanate groups (TRIG) during use and curing of SPF products. EPA will con tinue to work with its federal partners, the polyurethanes industry, and others to ensure improved labeling a nd product safety information for polyurethane products containing unreacted is ocyanates, especially products targeted to consumers. EPA is also considering a green ch emistry challenge to encourage the development

of safer alternative chemicals.

Canada . On May 12, 2010, Canada added TDI to its List of Toxic Substances following

an assessment which determined that TDI is car cinogenic and affects the respiratory system. Environment Canada published a proposed P2 Pollution Prevention Planning Notice for the polyurethane and other foam sector. A propos ed action to investigate non-foam consumer*** Interagency Review DRAFT Deliberative – Do No t Cite, Quote or Release During the Review ***
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Page 9 of 14 products containing TDIs under the Hazard Prod ucts Act is in development (Environment Canada, 2010).

IARC . The International Agency for Research on Cancer (IARC) has classified TDI as possibly carcinogenic to humans (IARC, 1987b).

X. Next Steps

In conducting this review, EPA considered a number of potentia l actions, including regulatory actions under TSCA sections 4, 5, 6, and 8; cooperative actions with other federal agencies; and voluntary actions as described above. Based on EP A’s screening level review of TDI and its related polyisocyanates (Appendix 1), EPA intends to:

1. Initiate rulemaking under TSCA section 5(a)(2) for a Significant New Use Rule (SNUR) designating the new use as use of uncured TDI and its related polyisocyanates in a consumer product.

If it is determined that there are existi ng consumer uses of uncured TDI products, work with industry to develop a voluntary phase-out and follow it with a proposed SNUR. Propose a TSCA section 4 test rule to require exposure monitoring studies on TDI and its related polyisocyanates in cons umer products if the voluntary phase-out is not complete in one year from the date of a phase-out agreement with industry.

2. Issue a data call-in under TSCA section 8(c) to determin e if there are allegations of significant adverse effects and initiate a TSCA s ection 8(d) rule for relevant unpublished health and safety studies.

3. Initiate a TSCA section 4 test rule to require general population exposure monitoring studies in representative locati ons where commercial products w ith uncured TDI would be used.

4. Consider initiating rulemaking under TSCA section 6 to regulate commercial uses of uncured TDI products in locations where the general population could be exposed.

5. Identify additional diisocyanates and pol yisocyanates that may be present in an uncured form in consumer products that should be evaluated for regulatory and/or voluntary

action.

XI. References

ACC (2005). American Chemistry Council. TSCA 8(e) Notice of Substantial Risk 8EHQ-0905- 16225 Fatalities linked to diisocyanates. EPA. ACC (2009). American Chemistry Council. 2008 E nd Use Market Survey on the Polyurethanes Industry in the US, Canada, and Me xico. (A. IAL Consultants, Ed.). Advanced Polymer Technology Corporation (2010). Advanced Polymer Technology Corporation July 6, 2010. h ttp://www.advpolytech.com/index.htm

. Allport, D., Gilbert, D., and Outterside, S. (2003). MDI and TDI: Safety, Health and the

Environment . John Wiley & Sons, Ltd, West Sussex, England.*** Interagency Review DRAFT Deliberative – Do No t Cite, Quote or Release During the Review ***
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Page 10 of 14 ATSDR (2005). Agency for Toxic Disease Registry . Airborne Exposures to Moisture Cure Urethane (MCU) in Multi-Family Residential Buildings. In New York Health Consultation: Exposure Investigation Report U.S. Department of Health and Human Services Public Health Service Agency fo r Toxic Substances and Disease Registry

Division of Health Assessment and Consultation. Bello, D., Herrick, C. A., Smith, T. J., Woskie, S. R., Streicher, R. P., Cullen, M. R., Liu, Y., and Redlich, C. A. (2007). Skin Exposure to Isocyanates: Reasons for Concern. Environ Health Perspect 115

. Bello, D., Woskie, S. R., Streicher, R. P., Liu, Y ., Stowe, M. H., Eisen, E. A., Ellenbecker, M. J., Sparer, J., Youngs, F., Cullen, M. R., and Re dlich, C. A. (2004). Polyisocyanates in occupational environments: a critical re view of exposure limits and metrics. Am J Ind

Med 46 , 480-491. California EPA (2010). Office of Environmenta l Health Hazard Asse ssment (OEHHA). Air Toxics Hot Spots Program – Proposed Revise d Reference Exposure Levels For Toluene Diisocyanate And Methylene Di phenyl Diisocyanate [04/23/10]. <http://www.oehha.ca.gov/air/chronic_rels/RELS042310.html>. Collins, M. A. (2002). Toxicology of Toluene Diisocyanate. Applied Occupational and Environmental Hygiene 17 , 846-855. Cummings, B. J., and Booth, K. S. (2002). Industrial hygiene samp ling for airborne TDI in six

flexible slabstock foam manuf acturing facilities in the United States: a comparison of the short-term and long-term sampling data. Appl Occup Environ Hyg 17 , 863-871. Curtis, M. W., Copeland, T. L., and Ward, C. H. (1978). Aquatic toxicity of substances proposed for spill prevention regulation National Confer ence Control of Hazardous Material Spills pp. 99-103. Darcey, D. (2002). Clinical findi ngs for residents near a polyur ethane foam manufacturing plant Archives of Environmental Health 57 , 239-246. De Zotti, R., Muran, A., and Zambon, F. (2000). Two cases of paraoccupational asthma due to toluene diisocyanate (TDI). Occupational and Environmental Medicine 57 , 837-839. Donnelly, R., Buick, J., and Macmahon, J. (2003). Occupational asthma after exposure to plaster casts containing methylene diphenyl diisocyanate. Occupational Medicine 53 , 432-434. DOW (2009). Product Safety Assessment DOW Modi fied Toluene Diisocyanate (TDI) Products July 16, 2010. http://www.dow.com/PublishedLite rature/dh_034d/0901b8038034d515.pdf ?filepath=pro ductsafety/pdfs/noreg/233-00617.pdf&fromPage=GetDoc

. Dyson, W., and Hermann, E. (1971). Reduction of Atmosphe ric Toluene Diisocyanate American Industrial Hygiene Association Journal 741-744. ECB (2005). European Chemicals Bureau . European Union Risk Assessment Report MDI. http://ecb.jrc.ec.europa .eu/documents/ExistingChemicals/RISK_ASSESSMENT/REPORT/mdireport304.pdf

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. EPA (2002). TSCA New Chemicals Program (N CP) Chemical Categories July 16, 2010. http://www.epa.gov/oppt/newchems/pubs/cat02.pdf

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Science , pp. 1633-1652. Taylor & Francis. Gagne, S., Lesage, J., Ostiguy, C., Cloutier, Y., and Van Tra, H. (2005). Quantitative determination of hexamethylen e diisocyanate (HD I), 2,4-toluene diisoc yanate (2,4-TDI) and 2,6-toluene diisocyanate (2,6 -TDI) monomers at ppt levels in air by alkaline adduct coordination ionspray ta ndem mass spectrometry. Journal of Environmental Monitoring

7 , 145-150. Gledhill, A., Wake, A., Hext, P ., Leibold, E., and Shiotsuka, R. (2005). Absorption, distribution,

metabolism and excretion of an inhala tion dose of 14 C 4,4 ' -methylenediphenyl diisocyanate in the male rat. Xenobiotica 35 , 273-292. IARC (1987a). International Agency for Research on Cancer . 4,4'-Methylenediphenyl diisocyanate and polymeric 4,4'-Methyl enediphenyl diisocyanate May 3, 2010. <http://monographs.iarc.fr/ENG/monographs/vol71/mono71-47.pdf>. IARC (1987b). International Agency for Research on Cancer . Toluene Diisocyanates May 3, 2010. <http://monographs.iarc.fr/ENG/monographs/vol71/mono71-37.pdf>. IUCLID (2000). CAS RN 26471-62-5 m-tolyiden e diisocyanate. European Commission Jan, R. L., Chen, S. H., Chang, H. Y., Yeh, H. J., Shieh, C. C., and Wang, J. Y. (2008). Asthmalike syndrome in school child ren after accidental exposure to xylene and methylene diphenyl diisocyanate. J Microbiol Immunol Infect 41 , 337-341. Jarand, C. W., Akapo, S. O., Swenson, L. J., a nd Kelman, B. J. (2002). Diisocyanate emission from a paint product: a preliminary analysis. Appl Occup Environ Hyg 17 , 491-494. Javni, I., Hong, D. P., and Petrovic, Z. S. (2008). Soy-based polyuret hanes by nonisocyanates

route Journal of Applied Polymer Science 108 , 3867-3875. Kelly, T. J., Myers, J. D., and Holdren, M. W. (1999). Testing of household products and materials for emission of toluene diisocyanate. Indoor Air 9 , 117-124. Krone, C., and Klinger, T. (2005). Isocyana tes, polyurethane and childhood asthma. Pediatric Allergy and Immunology 16 , 378-379. Krone, C. A. (2004). Diisocyanates a nd Nonoccupational Disease: A Review. Archives of

Environmental Health 59 , 306-316. MITI (1992). Ministry of International Trade & Indus try. Biodegradation and bioaccumulation: data of existing chemicals based on the CSCL. Chemical Industry Ecology-Toxicology & Information Center. , Tokyo, Japan. NIH (2010 ). National Institute of Heath . Household Products Database. June 9, 2010. <http://householdproducts.nlm.nih.gov/cgi-bin/ household/brands?tbl=chem&id=1949>

. NIOSH (1996). National Institute for Occ upational Safety and Health . Preventing asthma and death from diisocyanate exposur e: NIOSH Alert. (DHHS, Ed.). NIOSH (1998). National Institute for Occ upational Safety and Health . HETA 98-0011-2801, Woodbridge Corporation, Brodhead, Wisconsin. http://www.cdc.gov/niosh/ hhe/reports/pdfs/1998-0011-2801.pdf

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. NIOSH (2006). National Institute for Occ upational Safety and Health . Preventing Asthma and Death from MDI Exposure During Spray-on Tr uck Bed Liner and Related Applications: NIOSH Alert. <http://www.cdc.gov/ niosh/docs/2006-149/default.html>. NTP (2005). National Toxicology Program . Report on Carcinogens, Eleventh Edition; U.S. Department of Health and Human Services, Public Health Service. Substance Profile, Toluene Diisocyanates. http://ntp.nies h.nih.gov/ntp/roc/eleventh /profiles/s177tdi.pdf

. NYC-DOHMH (2010). New York City Department of Health and Mental Hygiene . Moisture Cure Urethanes (MCU)s July 16, 2010. http://www.nyc.gov/html/doh/html/epi/mcufact.shtml

. O'Brien, I. M., Harries, M. G., Burge, P. S., a nd Pepys, J. (1979). Toluene di-isocyanate-induced asthma I. Reactions to TDI, MDI, HDI and histamine. Clinical & Experimental Allergy 9

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Association. Orloff, K. G., Batts-Osborne, D., Kilgus, T., Me tcalf, S., and Cooper, M. (1998). Antibodies to toluene diisocyanate in an e nvironmentally exposed population. Environ Health Perspect

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59. Pedersen, F., Bjornestad, E., Vulpius, T., a nd Rasmussen, H. (1998). Immobilisation Test of Aniline Compounds with the Crustacean Daphnia magna Proj.No.303587, Report to the Danish EPA, Copenhagen, Denmark. Pinaoforte, K. (November 1, 2009). Adhesi ves and sealants market update. In Coatings World. Redlich, C. A., Bello, D., and Wisnewski, A. (2006) . Isocyanate exposures and health effects. In Environmental and Occupational Medicine (W. Rom, and S. Markowitz, Eds.), pp. 502- 516. Lippincott Willimas & Wilkins Philadelphia, PA. Sommer, B. G., Sherson, D. L., Kjoller, H., Ha nsen, I., Clausen, G., and Jepsen, J. R. (2000). Asthma caused by methylene-diphenyl -diisocyanate cast in a nurse. Ugeskr Laeger 162

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Page 13 of 14 Van der Hoeven, N., Roza, P., and Henzen, L. (1 992a). Determination of the effect of TDI, TDA, MDI, and MIDA on the emergence and growth of the plant species Avena sativa

and Lactuca sativa according to OECD Guideline No. 208. . British Library Document Supply Centre, Boston Spa, Wetherby, West Yorks. Van der Hoeven, N., Roza, P., and Henzen, L. (1 992b). Determination of the LC50 (14 days) of TDi, TDA, MDI, and MDA to the earthworm Eisenia fetida according to OECD guideline no. 207. British Library Docume nt Supply Centre, Boston Spa, Wetherby,

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Appendix 1

Tier 1: TDI monomers and related isomers and polymers

No CASRN CA Index Name Acronym Common Name

1 91-08-7 Benzene, 1,3-diisocyanato-2-methyl- 2,6-TDI 2,6-Toluene diisocyanate

2 584-84-9 Benzene, 2,4-diisocyanato-1-methyl- 2,4-TDI 2,4-Toluene diisocyanate 3 26471-62-5 Benzene, 1,3-diisocyanatomet hyl- TDI 80/20 Toluene diisocyanate

4 9017-01-0 Benzene, 1,3-diisocyanatomethyl-, homopolymer Polymeric

TDI Poly(toluene diisocyanate)

Tier 2: TDI dimers, trimers and polymers

No CASRN CA Index Name Acronym Common Name

5 26747-90-0 1,3-Diazetidine-2,4-dione, 1,3- bis(3-isocyanatomethylphenyl)- 2,4-TDI

dimer Tolylene diisocyanate

dimer

6 26603-40-7 1,3,5-Triazine-2,4,6(1H,3H,5H)- trione, 1,3,5-tris(3- isocyanatomethylphenyl)- TDI

trimer Tolylene diisocyanate

trimer

Appendix 2 – Regulatory and Exposure Limits for TDI

EPA . The EPA’s Integrated Risk Informati on System (IRIS) program has developed a

reference concentration (RfC) for TDI of 7 x 10 -5 mg/m 3 using chronic decline in lung function (FEV1) in an occupationally exposed populat ion as the critical effect (EPA, 1995).

OSHA . Diisocyanate hazards are addressed by OSHA in specific standards for the general industry, shipyard employment, and the construction industr y, including PELs for workplace exposure.

OSHA’s PEL for the TDI monomer 0.140 mg/m 3 (0.02 ppm) as a ceiling limit (29 CFR 1910.1000). OSHA also requires the use of PPE to reduce worker exposure to hazards when*** Interagency Review DRAFT Deliberative – Do No t Cite, Quote or Release During the Review ***
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Page 14 of 14 engineering and administrative controls are not f easible or effective in reducing exposure below

its PELs.

NIOSH

. In 1996 and 2006, NIOSH issued Alerts to prevent asthma and death from diisocyanate exposure to workers in certain situations (NIOSH, 1996; NIOSH, 2006).

NIOSH also considers TDI to be an o ccupational carcinogen a nd recommends exposure

reduction to the lowest feasib le minimum (NIOSH, 2005).

ACGIH . American Conference of Governmental Industrial Hygienists. Threshold Limit Values (TLVs) for TDI address respiratory sensi tivity but not dermal sensitivity. It has been suggested that there is now sufficient informati on to recommend the addition of a “skin notation” to the TLVs for TDI to bring atte ntion to the potentia l for absorption of di isocyanates through the

skin.

ACGIH has assigned TDI a TLV of 0.036 mg/m 3 (0.005 ppm) as a TWA for a normal 8- hour workday and a 40-hour workweek and a 15- minute Short Term Exposure Limit (STEL) of 0.14 mg/m 3 (0.02 ppm) (ACGIH, 2009).

As noted in its 2010 Notices of Intended Changes (NIC) for the 2011 TLVs, ACGIH is also considering reducing the TLV for 2,4 and 2,6 Toluene Diisocyanate (TDI) (CAS 584-84-9; 91-08-7) from 0.005 pp m to 0.001 ppm.

California, OEHHA . In April 2010, California’s O ffice of Environmental Health Hazard Assessment (OEHHA) released “for co mment” draft documents describing proposed Reference Exposure Levels (RELs) for TDI which ha ve been revised to in clude consideration of possible differential effects on the health of infa nts, children and other sensitive subpopulations (California EPA, 2010)

Canada . On May 12, 2010, Canada added TDI to its List of Toxic Substances following

an assessment which determined that TDI is car cinogenic and affects the respiratory system. Environment Canada published a proposed P2 Pollution Prevention Planning Notice for the polyurethane and other foam sector. A propos ed action to investigate non-foam consumer products containing TDIs under the Hazard Products Act is in development.

In 2005, Canada (Ontario Province) updated and lowered its air quality standard for TDI (http://www.ene.gov.on.ca/envision/env_reg/er/ documents/2005/airstandards/PA02E0010.pdf).

IARC . The International Agency for Research on Cancer (IARC) has classified TDI as possibly carcinogenic to humans (IARC, 1987b).