Regulatory Reference Guide

State of Wisconsin 1 DEPARTMENT OF NATURAL RESOURCES

WISCONSIN DEPT. OF NATURAL RESOURCES

South Central Region Headquarters Jim Doyle, Governor 3911 Fish Hatchery Road Scott Hassett, Secretary Fitchburg, Wisconsin 53711-5397 Ruthe E. Badger, Regional Director Telephone 608-275-3266 FAX 608-275-3338 TTY 608-275-3231

June 24, 2003 File Ref: FID #113281520 Dane Co. HW/CMEL

Mr. John Whitley Best Cleaners of Madison 5704 Raymond Rd. Madison, WI 53711 SUBJECT: Hazardous Waste Inspection and Change of Status Dear Mr . Whitley:

On June 16, 2003 I inspected Best Cleaners of Madison located at 5704 Raymond Rd. in Madison. The purpose of my inspection was to evaluate compliance with Wisconsin's hazardous waste regulations, as specified in chs. NR 600 - 690, Wis. Adm. Code. Your facility was classified as a "small quantity generator"; however, in July of 2002 Best Cleaners replaced the perchloroethylene dry cleaning unit with a "GreenEarth" dry cleaning unit.

Based on the inspection, the manufacturer's literature, the material safety data sheets and your laboratory test data, the Department is changing your facility status to a "non-generator" of hazardous waste. As we discussed, your still bottoms can be sent to a licensed solid waste landfill. You should check with your solid waste service to see if the liquid content of the still bottoms is a problem (landfills are prohibited from disposing of free liquids). If the liquid content is too high, you may be able to add absorbent material, such as lint, to reduce the liquid content, or, the solid waste handler could use a licensed "solidification process" to allow for proper disposal.

I want to take this opportunity to commend Best Cleaners of Madison for choosing to change your dry cleaning process to a new system that does not generate hazardous waste.

If you have any questions on this letter or the attached information please contact me at (608) 275-3324 or Mark. Harder( adnr. state.wi.us.

Sincerely,

Mark Harder, P.E. Waste Management Engineer South Central Region enc.

cc: Aggie Cook - WA/3

www.dnr.state.wi.us

Quality Natural Resources Management

www.wisconsin.gov

Through Excellent Customer Service

Printed on Rec ded Peoer

707 North Robinson, P.O. Box 1677, Oklahoma City, Oklahoma 73101-1677

News Release

For Immediate Release: August 11, 2006 Contact: Monty Elder, (405)702-1017

DEQ Honors Excellence in Pollution Prevention The Oklahoma Department of Environmental Quality (DEQ) is recognizing five Oklahoma businesses for their achievements in pollution prevention. DEQ’s Oklahoma Star Incentive program recognizes businesses for their efforts to reduce waste and go beyond compliance to create a “greener” work environment.

This year, the Oklahoma Star program is honoring Tinker Air Force Base, Vireo Enterprises (Dry Cleaning Station), Flex -n-Gate Plastics, Bridgestone Firestone NA, and Webco Industries. These five businesses are participants in the voluntary program and each has significantly improved their environmental performance.

Dianne Wilkins, Pollution Prevention Program Manager for DEQ, said, “I have seen great improvements for all of these businesses, and I am proud to have been a part of their ambitious and successful environmental goals. These facilities are dedicated to creating a cleaner Oklahoma, and I hope to see more business owners following their lead.”

To be recognized by Oklahoma Star, a business must maintain compliance with environmental regulations and go beyond these regulatory requirements to improve worker safety and protect the environment. The program has three recognition levels: Silver, Gold, and Platinum. Each designation comes with its own rewards including being highlighted in local media and serving as a mentor to other interested business owners.

The five businesses being honored are all Gold minimum facilities. Bridgestone Firestone North American Tire (BFNT) is a Platinum level facility.

Tinker Air Force Base is a leader in waste reduction and pollution prevention. Tinker is also a partner in EPA's National Partnership for Environmental Priorities. Their goal is to reduce the quantity of several chemicals including mercury and cadmium currently found in products, processes, or releases using techniques such as source reduction, recycling, and materials management practices. Ongoing efforts will result in the elimination of 1800 pounds of five priority chemicals by December 2007.

The Dry Cleaning Station, owned by Tom Keenze and operated under the parent company Vireo Enterprises, is being recognized for its proactive pollution prevention policies. Located in Owasso, the Dry Cleaning Station is one of very few dry cleaners currently using the cleaning compound GreenEarth速. Approximately 80% of all dry cleaning businesses in the United States use perchloroethylene (Perc) which results in a hazardous waste when emitted into the air, water, and soil. GreenEarth速 has no emissions and generates no hazardous waste. By choosing to use GreenEarth速, The Dry Cleaning Station has positioned itself as a leader among Oklahoma businesses in pollution prevention.

Flex-n-Gate Plastics, located in Ada, manufactures plastic exterior parts for General Motors and Ford. The facility was bought by new owners in 2003 and underwent a $10 million renovation. Since 2003, Flex-n-Gate has reduced their hazardous liquid waste by 87%, hazardous solid waste by 73% and air emissions by 77%. The company is actively involved in the recycling and reuse of its byproducts. Flex-n-Gate is an active partner with the Ada Recycling Coalition and serves as a resource for the Environmental Health Science Department at East Central University.

BFNT-OKC is a charter member of EPA Performance Track and has been an active participant in that program. The facility maintains a wildlife habitat that used to be a RCRA permitted facility that was cleaned and made habitable. The habitat is certified by Wildlife Habitat Council (WHC). The facility has developed a certified Corporate Lands for Learning Program (CLL) under the certification of the WHC. BFNT-OKC has been an active member of the Oklahoma County Local Emergency Planning Committee and members of the facility have been speakers advocating environmental excellence at local, national, and WHC Conferences. The company worked closely with local Boy Scout troops and Western Heights School District to provide a natural area for projects, and nature training. The facility also has enjoyed a working partnership with the Greater Oklahoma City Food Bank to provide food grown on facility lands to the Food Bank to help feed needy persons in the community.

Webco Industries in Sand Springs manufactures and supplies specialty tubing and pressure tubing products. During the process of creating tubing, hazardous waste is produced. In 2005, the owners of Webco decided to purchase an acid recovery system to reduce the amount of hazardous waste that was being created. From 2002 to 2004, before the system was in place, Webco generated more than four million pounds of hazardous waste. The associated annual waste disposal costs were $200,000. The installation of the new system has eliminated hazardous waste from this section of the manufacturing process.

DEQ is proud to recognize these five outstanding Oklahoma businesses for their achievements through the Oklahoma Star Program. A ceremony will be held to honor these businesses during Pollution Prevention Week in September.

SACRAMENTO METROPOLITAN NORMAN D . COVELL Air Pollution Control Officer

AIR QUALITY MANAGEMENT DISTRICT

April 7, 1999

Mr. Jim Douglas President Prestige Cleaners 4333 Winters St. Sacramento, CA 95838 RE: Exempt from District Permitting Requirements Dear Mr. Douglas: The District received your application for Authority to Construct and Permit to Operate two dry cleaning equipment that will use a new proprietary dry cleaning solvent, PPP SB32.

The ingredient in the proposed solvent is on the list of compounds that are excluded from the definition of volatile organic compound (VOC) pursuant to the Code of Federal Regulations (40 CFR 5 1.100) and the SMAQMD Rule 101. This compound is not listed as a hazardous air pollutant (HAP) as well.

In this regard, Prestige Cleaners' dry cleaning operations at 4333 Winters St., Sacramento is exempt from the District's permitting requirements provided the dry cleaning solvent used is an exempt compound and is not listed as HAP (Reference: SMAQMD Rule 201).

We are also returning a check you issued for the permit renewal fees for Tripplett Cleaners in the amount of $515.00 because Prestige Cleaners did not operate a perchloroethylene dry cleaning equipment from the time it took over that facility.

If we can be of further assistance to you, please do not hesitate to call at 386-6638.

Encl: Check No. 01061

916-386-6650 • FAX 916-386-6674 • SMAQMD • 8411 Jackson Rd. • Sacramento CA 95826

Department of

Environmental Protection leb Governor

Twin Towers Office Building 2600 Blair Stone Road DavW & Santo Tallahassee. Honda 32399-2400 Seery

February 21, 200

Mr. Carlos Ramirez Operations Manager OXXO Care Cleaners 1974 N Ciicie Hollywood, Florida 33020 Dear Mr. Ramirez Thank you for your February 13 correspondence in which you provided the Division of Air Resource Management information on the dry cleaning product and technology used at OXXO Care Cleaners and a request for confirmation that facilities not using the solvent perchloroethylene are exempt from permitting.

The department has established a Title V air general permit under We 62-213300(1)(a), Florida Administrative Code (F.A.C.), for peril loroethylene dry cleaning facilities only. The Title V air general permit program is administered through the Division of Air Resource Management Dry cleaning establis hments not using perchloroethylene are exempt from the Title V air general permit program at this time,

If-you have additional questions concerning the Title V air general permit program, please contact inc at 850/921-9583.

Sincerely,

Sandra Bowman Bureau of Air Monitoring and Mobile Sources.

SB/

"More Protection, Less Process"

Assessment of the Human Health Risk and the Environmental Fate and Effects of GreenEarth速 (Decamethylcyclopentasiloxane (D5)) Used in Dry Cleaning

Prepared for the Drycleaner Environmental Response Trust Fund of Illinois (DERTFI)

By GreenEarth速 Cleaning

May 1, 2006

Working Draft: April 7, 2006

Executive Summary The purpose of this document is to provide an assessment of Decamethylcyclopentasiloxane (D5), the low molecular weight siloxane fluid used in the GreenEarth® system, in order to understand and evaluate the fate, transport, and the potential ecological and human health risks of this novel dry cleaning solution in relation to commercial dry cleaning systems.

D5 is used as a dry cleaning solvent in the GreenEarth® system to carry detergent to clothes and rinse away suspended dirt and oils trapped by the detergent. GreenEarth® does not interact with textiles and therefore helps maintain the quality and color of clothes that are dry cleaned while minimizing residual on the clothing. Consequently, persons who may be exposed to D5 as a result of GreenEarth® use in dry cleaning include workers in dry cleaning establishments that use GreenEarth® as a replacement for other cleaning solvents; consumers who wear clothing dry cleaned using GreenEarth®; and the general public living in the vicinity of a dry-cleaning facility using GreenEarth®.

Workers, consumers, and the general public were assessed for dermal and inhalation exposure to D5. D5 is manufactured in closed systems and is transported in closed containers (e.g., pails, drums or tankers) to limit loss and/or contamination of the product and eliminate or reduce exposure to workers or the public. The results of air sampling (both personal and area sampling) in dry cleaning establishments using D5, demonstrated that the average employee exposure was less than 0.22 ppm in an 8-hour time weighted average (TWA). In addition to workers, consumers and the general public were assessed for dermal and inhalation exposure to D5. When exposures for each of the three populations were compared with No Observed Effect Levels (NOEL) it was clear that typical exposure to D5 whether to workers, consumers, or the general public would not result in a significant health hazard. Margins of Safety (MOS) ranged from 3.8 X107 to 9.8 X 103, far greater than the MOS of 100 that is considered to be protective of human health. Under the exposure scenarios defined in this assessment, typical exposure to D5, whether occupationally, to consumers, or to the general public, from use in GreenEarth® systems, would not result in a significant human health risk.

The environmental fate and effects of D5 have also been investigated. A fugacity modeling assessment was made of potential concentrations of D5 in the environment resulting from its use as a dry cleaning solvent in order to determine potential risk for the general public as well as aquatic species. The fate and distribution of D5 between environmental compartments (air, water, soil, and sediment) was evaluated using the Equilibrium Criterion (EQC) multimedia fugacity model (Mackay et al. 1996).

Simulation of the emission of D5 directly to air resulted in >99.9% of the total chemical mass residing in the air compartment. Intermedia exchange of D5 from air into other environmental compartments (water, soil, or sediment) was insignificant. About 22% of D5 was removed from the model environment by degradation in air, and 78% was removed by advective transport in air. Total residence time of D5 in the model environment was about 3.2 days. D5 will not partition to soil or water in remote regions because it does not have the potential for deposition in the biosphere after transport.

While D5 is not soluble in water and tends to evaporate (Henry’s Law Constant = 0.318 atm m3 mol-1), chronic and acute aquatic toxicity tests were conducted under very stringent laboratory conditions. In most cases, the No Effect Concentrations (NOECs) were determined to be equal to or greater than the limit of water solubility.

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The environmental modeling and testing clearly indicate that there are no significant environmental hazards from the use of D5 in dry cleaning. Based on the extensive data available for D5, the safety of the GreenEarth速 system is supported. It can also be concluded that, under the exposure scenarios defined in this assessment, typical exposure to D5, whether occupationally, to consumers, or to the general public, from use of D5 in commercial dry cleaning systems, would not result in a significant human health risk.

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I. Introduction The purpose of this document is to provide a human health and ecological assessment to understand and evaluate the fate, transport, and the potential ecological and human health risks of D5 in the GreenEarth® drycleaning system. D5 is used as a dry cleaning solvent in the GreenEarth® system to carry detergent to clothes and rinse away suspended dirt and oils trapped by the detergent. GreenEarth® does not interact with textiles and therefore helps maintain the quality and color of clothes that are dry cleaned while minimizing residual on the clothing. Consequently, persons who may be exposed to D5 from dry cleaning include workers in dry cleaning establishments that use GreenEarth® as a replacement for other cleaning solvents; consumers who wear clothing dry cleaned using the GreenEarth® solvent; and the general public living in the vicinity of a dry-cleaning facility using GreenEarth®. Because of the potential for human exposure, the toxicity of D5 in laboratory animals and the kinetics of D5 in laboratory animals and humans, as well as ecologically relevant organisms by relevant routes of exposure have been assessed.

II. Regulatory Status for Air Emission D5 was exempted from regulation as a volatile organic compound (VOC) by U.S. EPA in a direct final rulemaking (59 Federal Register No. 192, October 5, 1994, pp. 50693-50696), as well as by the State of California. D5 does not impact ozone, it is not a greenhouse gas, and it does not interact with greenhouse gasses.

III. Chemical Background Information A. Chemical Description Chemical Name: Chemical Structure:

Decamethylcyclopentasiloxane (D5)

Si

O

O

Si

Si

O Si

O Si

CAS No.: EINECS No.: Molecular Formula: Molecular wt.:

O

541-02-6 208-764-9 C10H30O5Si5 370

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IV. Human Health Risk Assessment of D5 in the GreenEarth® System A. Introduction As a result of the use of GreenEarth® in dry cleaning, persons who may be exposed to D5 include workers in dry cleaning establishments; consumers who wear dry cleaned clothing; and the general public living in the vicinity of a dry-cleaning facility. Because of the potential for human exposure, the potential hazard of D5 in laboratory animals and the kinetics of D5 in both laboratory animals and humans by relevant routes of exposure have been used to assess the safety of D5 in dry cleaning.

The purpose of this investigation was to conduct a safety assessment to evaluate the potential hazard to these populations by defining a level at which no effects would be expected and then comparing that to the level of D5 to which workers, consumers or the general public may be exposed. The technical approach to this assessment for D5 was consistent with approaches used by the U.S. EPA and other regulatory agencies, and included a hazard assessment, dose-response assessment, exposure assessment, and risk characterization.

B. Hazard Assessment The extensive experimental hazard database for D5 was reviewed. The main focus of that review was a 2-year oncogenicity bioassay of D5 in male and female Fisher 344 (F344) rats (Dow Corning Corporation 2005a). Other studies provided insights into the potential for toxicity of D5 including toxicokinetic data, mutagenicity and genotoxicity, reproductive/developmental toxicity, immunotoxicity studies, and studies designed to elucidate the mode of action for observed effects in laboratory animals and the relevance of those observations to human health outcomes. The major findings of this review were: •

D5 was absorbed by the oral, dermal, and inhalation routes of exposure, and was rapidly distributed and excreted without bioaccumulation. Dermal absorption, which is most relevant for the use of consumer products, was small (approximately 0.05% of the applied amount). The majority of the dermally- absorbed D5 (90%) was rapidly eliminated through exhalation. A PBPK model was used to estimate the internal dose in the animal bioassays and the internal dose corresponding to each of the identified exposure scenarios. (Battelle Northwest Toxicology 2001, Plotzke et al 2002, Dow Corning Corporation 1999, 2003a, 2003b, 2003d, 2005b, Utell 2004, Anderson et al 2005, Reddy et al 2005a, 2005b)

•

In subacute and subchronic repeated exposure studies by the oral (at doses up to 1600 mg/kg/day) and inhalation (at levels up to the highest concentration that remains a vapor, 160 ppm) routes of exposure, the only effects observed in rodents were adaptive, non-adverse, transient phenobarbital-like changes in liver weight, and, by the inhalation route, irritation in the nose and lungs consistent with adaptive responses to mild, non-specific irritants. (Dow Corning 1990a, 1990b, Jager and Hartmann 1991, RCC 1995a, 1995b, Experimental Pathology Laboratories 1996a, 1996b, Burns-Naas et al. 1998, Dow Corning Corporation 2000)

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•

D5 was not mutagenic or genotoxic in a variety of in vitro assays in bacterial or mammalian cells or in vivo in a variety of genotoxicity tests both with and without metabolic activation.

(Litton Bionetics Inc 1978, Wilcox et al 1990, Dow Corning Corporation 2003c, Dow Corning Corporation 2004b, Dow Corning Corporation 2004f)

•

D5 was not immunotoxic when administered by inhalation for 28 days at concentrations up to 160 ppm. (Burns-Naas et al. 1998)

•

No parental toxicity or reproductive toxicity was noted in adult male or female rats, nor was there neonatal toxicity or developmental neurotoxicity in their offspring in a two-generation reproductive toxicity test at inhalation concentrations up to 160 ppm. (WIL 1996, WIL 1999)

•

D5 did not demonstrate estrogenic or anti-estrogenic activity in several assays designed to assess estrogen agonist potential. D5 did demonstrate dopamine agonist activity. (Dixon and Brown 1979, Dow Corning Corporation 2004a, 2004c, 2004d, 2004e)

•

There were no treatment-related, adverse non-neoplastic effects seen in the 2-year bioassay in male and female F344 rats at doses up to 160 ppm (Dow Corning Corporation 2005a).

The only neoplastic lesion noted was an increase in uterine endometrial adenocarcinomas in the high exposure group females, found primarily on terminal sacrifice. Because there was a positive finding in this bioassay, a weight-of-evidence assessment was conducted to include consideration of the mode of action of the only carcinogenic response observed in animals following chronic exposure to D5. The relevance of these tumors for human health safety assessment was considered using a framework proposed by the U.S. EPA (2005) and others (Meek et al 2003). The evidence in the scientific literature indicates that the tumorigenic effect of D5 in female rats exposed by inhalation to very high concentrations (160 ppm) for two years is related to a rodent-specific imbalance in the normal hormonal milieu that occurs in aging female F344 rats. These changes are common in rodents and are not relevant to humans because the hormonal control mechanisms are different in aging rodents and in aging humans.

C. Dose-Response Assessment As noted above, the mode of action for the development of tumors in female rats is not relevant in humans. Administration of D5 did not produce significant, treatment-related noncarcinogenic effects relevant to human health outcomes in either the 2-year bioassay or in the reproductive or immunotoxicity studies, nor were there precursor lesions, such as an increase in uterine hyperplasia, found in the 2-year bioassay. Consequently, there were no relevant chronic effects that would provide data for modeling a potential effect level. Therefore, 160 ppm, the highest concentration tested in the 2-year bioassay, represented the No Observed Adverse Effect Level (NOAEL).

While not considered relevant to human health, dose-response modeling using the tumor data was conducted only as a point of comparison to the experimentally-derived NOAEL and to provide a conservative evaluation of hazard. Typically, when deriving a no effect level for humans, an experimentally-derived NOAEL is adjusted for inherent uncertainties by dividing by

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uncertainty factors to account for species extrapolation, human variability, and confidence in the data base.

In this assessment, a comparison of the internal dose associated with the NOAEL to the internal dose estimated for each human exposure scenario was conducted to derive the exposure-specific margins of safety (MOS).

D. Exposure Assessment The exposure scenarios considered were designed to represent the exposure from the use of D5 in dry cleaning and attempted to characterize the populations who may be exposed; the pathways or routes by which that exposure could occur; and the frequency, duration, and intensity (amount) of that exposure. The populations considered were: • Occupational - workers in the dry cleaning industry using D5; • Consumers – individuals who wear clothing cleaned with D5-containing solvent; • General Public – individuals living in the vicinity of a dry cleaning establishment who may be exposed to ambient levels of D5 released to the environment.

The PBPK model was used to determine the internal doses that were specific to the population and exposure scenario. Air sampling was conducted to measure actual exposure levels.

Occupational Dermal Exposure to D5 Workers in a dry cleaning establishment could be exposed to D5 via dermal contact, e.g., in the event of a spill or leakage from a container during transfer of the solvent to the dry-cleaning machines. Other than for periodic maintenance work on the machines, dermal exposure to D5 during dry-cleaning operations at times other than solvent-loading of the machines is not expected for workers in the dry cleaning industry because D5 is used in closed systems with little or no opportunity for dermal contact with D5. In estimating dermal exposure of workers, it was assumed that transferring D5 into the machines, with subsequent dermal exposure of workers’ hands occurred once per week. Calculations for dermal surface area, number of hours worked, and employment duration were based on U.S. EPA’s standard exposure factors.

Occupational Inhalation Exposure to D5 An industrial hygiene (IH) survey was sponsored by GreenEarth® Cleaning® utilizing an independent third party Certified Industrial Hygienist (CIH Services, Inc.). The survey consisted of both personal and area monitoring, and measured employee exposures as both an 8-hour time weighted average (TWA) as well as for Short term Exposure Limits (STELs) for particular tasks within the dry cleaning process. These survey results presented here reflect only the “dry to dry” process, as this represents over 99% of the machines using D5 as a solvent and the practice of “wet transfer” is not supported. These locations included various types of dry cleaning equipment “retrofitted” to utilize the D5-based dry cleaning process.

Eleven different sites using the D5-based solvent were examined, most of them on multiple days, simulating different weather conditions (several open doors and windows representing summer and no doors or windows open simulating winter). The kinds of personal tasks monitored were those typical to nearly all dry cleaning facilities, for example, loading and unloading machines, spotting, pressing, hanging, etc. The area monitoring included nearly every point in the cleaning

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process from very close to the cleaning machines, to the garment processing areas, to the area where garments were hung awaiting customer pickup.

The results of the IH survey are summarized as follows: 1) Personal monitoring – 8 hour TWA. One hundred twenty eight (128) samples were collected for the determination of the 8-hour time weighted exposures. The average 8-hr TWA was determined to be less than 0.22 ppm. (‘less than’ is used here since a majority of the samples were below the limit of detection, in which case the limit of detection number was used.) All of the samples were well below any industrial hygiene guidelines recommended by the industry, with the highest sample being 3.5 ppm and only 6 of the 128 data points being above 1 ppm.

2) Area Monitoring – 8 hour TWA. Three hundred and twelve (312) samples were taken to determine the 8-hr TWA in various locations of the dry cleaning workplaces. The average 8hr TWA was determined to be less than 0.19 ppm. (again, ‘less than’ is used since a majority of the samples were below the limit of detection, in which case the limit of detection number was used.). All of the samples were well below any industry-recommended IH guideline, with the highest sample being 2.2 ppm and only 17 of the 312 data points being above 1 ppm.

3) Short Term Exposure Limits (STELs). A sampling of 136 individuals was sampled for short-term tasks (as indicated above) where exposures were expected to be highest. Typical sampling times for the various tasks were in the 2-3 minute range, none of the tasks took more than 10 minutes (although the American Board of Governing Industrial Hygienists (ACGIH) allows for 15 minute STEL excursions). All of the STELs were well below the ACGIH recommendation that STELs be set 3-5 times the workplace guideline (for a guideline of 10 ppm, the STEL would be 30-50 ppm), with the highest sample being 14.9 ppm and only 2 of the 136 data points actually reaching the guideline of 10 ppm 8-hour TWA. The American Conference of Government Industrial Hygienists (ACGIH) sets industry guidelines for acceptable limits of workplace exposures as Threshold Limit Values (TLVs) and the US Occupational Safety and Health Administration (OSHA) determines government exposure limits as measured Permissible Exposure Limits (PELs). The safety limits as set by ACGIH TLV and OSHA PEL do not regulate D5 solvent and no guidelines have been set. The workplace exposure guideline recommended by the silicone industry is a voluntary guideline, and was initially set based on observed changes in liver weight in rat toxicology studies.

Subsequent research has clearly shown this to be an adaptive effect in rats, which is not relevant to humans. Consequently, the IH guideline represents an extremely conservative approach to worker protection.

Internal dose exposure was estimated for the inhalation route using varying assumptions for the duration and frequency of exposure and amount of D5 measured in air in the work environment.

The air concentrations to which workers could potentially be exposed varied depending on the job category or job description of the worker. As described above, eight-hour time-weighted

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average air concentrations were calculated at GreenEarth Cleaning速 sites. An average of TWA values (0.22 ppm) was used to represent all dry-cleaner workers.

Consumer Exposure Exposure to consumers wearing clothes cleaned with D5-based solvent is expected to be limited based on the extremely low concentration of D5 remaining on the clothes and the rapid volatilization of D5 from the clothes following removal from the dry cleaning machines.

Relative to the potential exposure to workers, exposure of consumers is negligible. If the MOS for workers indicates a lack of hazard, then consumer MOS will also be adequate.

General Public Exposures Exposure to people who may live near a dry cleaning facility using products containing D5 was considered. It was assumed that residents, both adults and children, were at their residence 24 hours per day for a lifetime. No data are currently available for ambient air levels outside of dry cleaning establishments, but the data on ambient air levels outside D5 manufacturing sites was taken as a worse-case scenario. Data were available from outdoor air samples that were collected from 70 facilities and analyzed for D5 content (Maxim et al. 1998). The average value reported in the ambient air was used to estimate the exposure for the general public.

E. Risk Characterization A Margin of Safety (MOS) of >100 is generally considered to be sufficiently protective of human health. In the Risk Characterization step, MOS were estimated. A MOS was defined as the ratio of the internal dose associated with the no adverse effect level in animals to the internal dose estimated for each relevant human exposure scenario. Further, uncertainties associated with this evaluation were considered and, where possible, the impact of the assumptions made on these MOS was considered.

Estimated Margins of Safety The MOS for workers in the dry cleaning industry were about 10,000 or greater. These MOS would indicate that D5 does not pose a significant hazard to workers in the dry cleaning industry, based on the exposure scenario defined.

As discussed earlier, D5 will rapidly evaporate from clothes dry-cleaned with D5-based solvent, virtually eliminating exposure to consumers from the dry-cleaned clothes. Since the MOS for workers is sufficiently protective, consumer exposures will be lower, and exposure to D5 will not pose a significant risk.

For the general public, exposure to D5 was assumed to be limited to inhalation of D5 in ambient air. The MOS determined for this scenario for men, women and children were all greater than 1,000,000. This indicates that residential inhalation exposure to D5 does not pose a significant risk to human health.

Consideration of Uncertainties As part of the Risk Characterization, uncertainties in the assessment were considered and were classified into two major categories, PBPK model uncertainties and uncertainties associated with

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assumptions, data, and judgments made in the exposure assessment. In balance, the data used and the assumptions made tended to overestimate rather than underestimate exposure.

IV. Environmental Risk Assessment A. D5 Physical/Chemical Property Data Molecular weight (g mol-1): Melting point (ºC): Boiling point (ºC): Vapor pressure at 25ºC (Pa):

Water solubility at 25ºC (g m-3): Log KOW (no units): Henry’s constant (atm m3 mol-1): Hydrolysis rate constants at 25ºC: • kH+ (M-1 h-1) • kOH- (M-1 h-1) Hydrolysis half-life ( T0HYD .5 ; d) • at pH 7.0, 25ºC • at pH 7.8, 25ºC • at pH 7.8, 12ºC Oxidation rate constants (cm3 mol-1 sec-1) • OH radical ( R OH ) • O3 ( R O3 ) Overall Reaction Half-life Data (d): • air ( T0AIR .5 )

371 -38.0 211 33.2

Patnode and Wilcock (1946) Flaningam (1986) AIChE DIPPR (2005); interpolated value over temperature range –38.0 to 346 ºC 0.017 Varaprath et al. (1996) 5.20 Bruggeman et al. (1984) 0.318 Kochetkov et al. (2001)

740 3200 73.4 14.2 40.2

Kozerski (2006)

Calculated from measured rate constants (Kozerski 2006)

1.55×10-12 Atkinson (1991) 3.00×10-20 10.2

•

water ( T0WATER ) .5

14.2

•

soil ( T0SOIL ) .5

12.5

•

sediment ( T0SED .5 )

142

Calculated from oxidation rate constants (Atkinson 1991) and hydrolysis rate constants (Kozerski 2006) Calculated from hydrolysis rate constants (Kozerski 2006) at pH 7.8 an 25ºC Calculated from degradation rate constants in soil (Xu and Chandra 1999) Calculated as 10-times the overall half-life in water

B. Potential for D5 Emissions to Air, Water, and Soil The emission of D5 from the dry cleaning process is limited because D5 is used in a closed system, limiting exposures to workers and the environment.. Evaluations of worker exposure

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were conducted in 2000 and 2005. The results are described in the Human Health section of this multimedia assessment.

Independent testing on D5 (designated SB32 in the testing report) as used in daily operation at GreenEarth® dry cleaning sites was conducted. The study report (IFI 2002) states that D5 by itself (and also when used in conjunction with appropriate additives such as detergent, spotting chemicals, etc.) is not a hazardous waste under federal or California law. However, the residue sometimes referred to as “still bottoms”, remaining after the D5 is distilled off for recycling into the dry cleaning process, contains all of the substances cleaned off the clothes as well as any other chemicals introduced into the process, which may be a hazardous waste. Similarly, filter cartridges, designed to remove the larger particulate that may come into the process from soiled laundry, could also potentially lead to a hazardous waste, despite D5 itself being classified as non-hazardous.

C. Ecotoxicity Data Available acute, prolonged-acute, and chronic toxicity data show that D5 is essentially non-toxic to freshwater aquatic organisms exposed to concentrations up to and above the limit of water solubility of 0.017 mg/L. Two fish toxicity studies have been conducted at concentrations in excess of water solubility.

No effects to juvenile carp, Cyprinus carpio were observed in a 96-h semi-static (daily renewal of test solutions) exposure to a water-accommodated fraction prepared at a loading rate of 1 g/L (IUCLID 2005). Similarly, no effects were seen in a 14-d flow-through study with juvenile rainbow trout, Oncorhynchus mykiss (IUCLID, 2005). The flow-through test system was pulsedosed every 17 seconds with D5 in solvent at a rate designed to deliver a test concentration of 5 mg/L. No mortality or adverse effects were observed during the course of this study.

More realistic fish toxicity studies conducted up to the limit of water solubility have also found no test material related toxicity. A 14-d flow-through toxicity test was conducted with juvenile rainbow trout, Oncorhynchus mykiss at concentrations up to the limit of water solubility (Springborn 2000). D5 has a very high air/water partition coefficient (Henry’s constant), thus it is very difficult to maintain D5 in test solutions unless extraordinary measures are taken. This study was conducted as a flow-through study using completely filled, sealed containers with no headspace (i.e. no air/water interface). D5 was added in solvent via a continuously flowing serial dilutor system. Nominal concentrations of D5 were 2.2, 3.7, 6.1, 10, and 17µg/L. Measured concentrations were 2.1, 3.1, 5.0, 8.6, and 16µg/L. All guideline test conditions were normal (e.g., dissolved oxygen, temperature, photo-period, pH, etc.) during the course of the study. No dose-related adverse effects were observed during the 14-d exposure period with the results recorded as NOEC = 16 µg/L and the LC50 > 16 µg/L. Similarly, no D5-related adverse effects were noted for fathead minnows, Pimephales promelas during 35-d exposure to D5 as part of a bioconcentration study (Drottar 2005). Fish were exposed to measured D5 concentrations of 1.1 and 15µg/L throughout the 35-d uptake/exposure period. Radio-labeled D5 was administered in solvent via syringe pump into a specially designed mixing vessel prior to addition to open-top test vessels. Flow rates were adjusted (i.e., increased) to minimize the impact of test material volatilization in order to retain the test material at the

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desired concentrations in the test vessels. All guideline test conditions were normal (e.g., dissolved oxygen, temperature, photo-period, pH, etc.) during the course of the study. Toxicity results included a NOEC of 15µg/L and an LC50 > 15µg/L. A flow-through 48-h acute toxicity test with Daphnia magna was conducted at concentrations below the limit of water solubility (17µg/L) (Machado 2002). Daphnids were exposed to five concentrations of test material in closed, zero-headspace test vessels. Guideline test parameters (e.g., hardness, temperature, dissolved oxygen, photoperiod, pH, etc,) were all within normal ranges. Nominal concentrations were 2.2, 3.6, 6.1, 10 and 17µg/L. Measured concentrations were disappointingly low, and may be reflective of flaws in analytical procedures.

Corresponding measured values were 2.1, 1.6, 1.8, 2.5, and 2.9µg/L. Test results at 48-h revealed no immobilization or toxicity at the highest measured dose of 2.9µg/L, and hence the reported 48-h NOEC is 2.9 µg/L and the reported EC50 is >2.9µg/L. A 21-d chronic toxicity test was conducted with Daphnia magna (Springborn Smithers 2003a).

Nominal test concentrations of D5 were 1.1, 2.1, 4.3, 8.5 and 17µg/L. The respective measured test concentrations were 1.1, 1.7, 3.5, 7.2, and 15µg/L. Guideline test parameters (e.g., hardness, temperature, dissolved oxygen, photoperiod, pH, etc,) were all within normal ranges. Test endpoints were mortality, growth (length and weight), and reproduction (cumulative number of offspring). Results for all endpoints were 21-d NOEC = 15µg/L, and 21-d EC50 >15µg/L. The results of the longer term study suggest that the NOEC for the 48-hour acute test would have been significantly higher had the analytical determination of dose been more appropriate.

Toxicity to the sediment-dwelling invertebrate, Chironomus riparius was also investigated (Springborn Smithers 2003b). A 28-d full-life cycle study of the midge larva was conducted with spiked sediment at concentrations of 13, 30, 73, 180, and 580 mg/kg (dry weight). Test endpoints included larval survival, larval wet weight, emergence (i.e., maturation to adult fly), and rate of development. Results for larval survival provided a 10-d LC50 = 450 mg/kg and a NOEC of 180 mg/kg. Results for larval wet weight were a 10-d EC50 = 410 mg/kg and a NOEC of 73 mg/kg. Results for emergence indicated a 28-d EC50 = 420 mg/kg and a 28-d NOEC of 180 mg/kg. Development rate results included a 28-d EC50 > 580 mg/kg and a 28-d NOEC of 69 mg/kg.

The toxicity of D5 to algae was investigated using the unicellular green alga, Pseudokirchneriella subcapitata, formerly Selenastrum capricornutum (Hoberg 2001). Algae were exposed to D5 at a single nominal concentration of 20 µg/L in closed test flasks to which additional sodium bicarbonate was added as a carbon source. The measured test concentration at study initiation was 12µg/L. Results for the standard effects endpoints of cell density and growth revealed an EC50 > 12µg/L and a NOEC = 12µg/L. Thus, no effect was seen at a dose approximately equivalent to the limit of water solubility.

As reported above, a bioconcentration study with fathead minnows, Pimephales promelas was performed (Drottar 2005). Fish were exposed to measured D5 concentrations of 1.1 and 15µg/L throughout a 35-d uptake/exposure period. Radio-labeled D5 was administered in solvent via syringe pump into a specially designed mixing vessel prior to addition to open-top test vessels.

The resulting steady state bioconcentration factor (BCFss) values from this study were 7060 for

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the 1.1Âľg/L exposure concentration and 1950 for the 15Âľg/L concentration. However, in subsequent work, the steady-state, lipid normalized biomagnification factor (BMF, uptake from food) for rainbow trout (Oncorhynchus mykiss) exposed to D5 was 0.63 and the onecompartment kinetic BMF was 1.4 (Drottar 2006). Sediment bioaccumulation factors for midge larvae (Chironomous riparius) after 10-d exposure to D5 in sediment (steady-state conditions not confirmed) ranged from 0.5 to 1.2 and increased with decreasing exposure concentration (Putt 2003). Laboratory studies with fish indicate that D5 may bioaccumulate in aquatic organisms because of uptake across the gills and to a minor extent by uptake from food. However, laboratory studies only provide an assessment of the potential for bioaccumulation to occur. In the environment, the extent of bioaccumulation is determined by the portion of the material in the environment that exists in a form that can be absorbed or taken up by the organisms. D5 not lost through volatilization will adsorb to suspended solids, sediments, humic acids or other macromolecules and as a result, true environmental bioavailability is expected to be low. If a material is not environmentally bioavailable, for example because exposure concentrations are too low or the material is irreversibly bound to an environmental matrix, then bioaccumulation will be minimal or may not occur.

The other important factors that governs the potential for bioaccumulation is metabolism and elimination processes. In mammals, D5 is readily metabolized to water soluble metabolites (Varaprath 2004). Additional studies are planned to understand the extent of metabolism in aquatic species. Lastly because D5 is rapidly eliminated by pulmonary and metabolic clearance in mammals, tissue concentrations, even in fat, do not increase with repeated exposures (Andersen 2005). Therefore biomagnification up the food chain would not be likely to occur in air breathing animals.

Available ecotoxicity data indicate that D5 has low potential for harm to the environment. D5 has been found to be nontoxic to all pelagic aquatic organisms exposed to concentrations up to and above the limit of water solubility. Similarly, the NOEC values for D5 to the sediment-dwelling invertebrate midge larva are well in excess of concentrations expected in sediment.

Concentrations have been measured in sediments ranging from below detection up to 2.0 mg/kg dry weight for D5 (Nordic Council of Ministers 2005). Consequently, D5 is not expected to cause any adverse effects in the aquatic environment.

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D. Fate and Transport Assessment of environmental fate and distribution is a complex process best evaluated using multimedia or fugacity-based models. The fate and distribution of D5 between environmental compartments (air, water, soil, and sediment) was evaluated using the Equilibrium Criterion (EQC) multimedia fugacity model (Mackay et al. 1996). Level I, II, and III models for a Type-1 chemical (i.e., chemicals that partition into all environmental media) were used for the simulations. All simulations were conducted at a data temperature of 25°C using default values of the model for compartment dimensions and properties.

Level I Simulation A Level I simulation evaluates the equilibrium distribution of a fixed quantity of chemical in a closed environment, with no degradation reactions, no advective processes, and no intermedia transport process (e.g., no wet deposition or sedimentation). Output from the simulation provides a general indication of the likely media into which a chemical will tend to partition and the relative concentrations in each medium.

Results from the Level I simulation indicate that D5 will partition almost exclusively into the air compartment, which is expected to hold ≥ 99.9% of the total chemical mass. Much smaller amounts of D5 (≤ 0.1%) are expected to be found in soil and insignificant amounts (≤ 0.01%) in water, sediments, suspended sediments, and fish.

Level II Simulation A Level II simulation evaluates the equilibrium distribution of a chemical that is continuously discharged to the environment at a constant rate, and achieves a steady-state condition at which the input and output rates are equal. Degradation reactions and advective processes are treated as the mechanism of loss or output. Intermedia transport processes are not quantified (e.g., no wet deposition or sedimentation). Similar to a Level I simulation, output from a Level II simulation provides an indication of the likely media into which a chemical will tend to partition and the relative concentrations in each medium. In addition, the Level II simulation also provides an indication of environmental persistence and the loss processes that are likely to be most important.

The Level I simulation indicated that air would be the primary environmental compartment in which D5 would be found. Therefore, it was assumed that degradation and transport in the atmosphere would be the dominant mechanisms for removal of D5 from the environment. The dominant degradation process for most chemicals in the atmosphere is the gas-phase reaction with hydroxyl radicals or other photochemically-produced radicals (Atkinson 1988). Cyclic siloxane materials such as D5 also undergo hydrolytic degradation upon contact with water or water vapor. Consequently, the overall rate of degradation of D5 in air (kov) was estimated by combining the degradation rate constants for hydroxyl radical oxidation (kox) and hydrolysis (khyd), as follows:

k ov = k ox C +

1 k hy 10

where:

C is the average concentration of hydroxyl radical

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Because of the decreased activity of water, the rate of hydrolysis in air was assumed to be one-tenth (1/10) of the rate in water. The rate constant for hydroxyl radical oxidation of D5 at 25ºC is 1.34×10-7 cm3·mol-1·d-1 (Atkinson 1991) and the average atmospheric concentration of hydroxyl radical based on a 24 hour day is 5.00×105 mol·cm-3 (Prinn et al. 1992). The rate constant for hydrolysis of D5 at pH 7.0 and 25 ºC is 7.43×10-3 d-1 (Kozerski 2006). Combining these rate constants using the above equation gives an overall degradation rate constant for D5 in the atmosphere of 6.77×10-3 d-1. This is equivalent to an overall half-life in air of 10.2 days.

Level II simulations were used to evaluate the effect of degradation in air on persistence of D5 in the environment. For the purpose of these simulations, the reaction half-life in air was fixed at 10.2 days, as previously described. Reaction half-lives in water, sediment, and soil were varied from 1 day to 3650 days (10 years). The simulations demonstrated that degradation and advection in air were the most important parameters determining overall persistence in the model environment. Changes in reaction half-life in water, sediment, and soil from 1 to 3650 days had essentially no effect on distribution or persistence of D5. In all simulations, ≥ 99.9% of the steady-state mass of D5 resided in the air compartment. Partitioning to soil, water, and sediment was < 0.1% and considered insignificant. About 21-22% of the D5 was removed from the local region by degradation in air and 74-78% was removed by advective transport in air. Degradation in soil accounted for the remaining 0-5% of the D5 removed from the system. Total residence time of D5 in the model environment was about 3.1 days.

Level III Simulation A Level III simulation is similar to a Level II simulation in that a) the chemical is continuously discharged to the environment at a constant rate, b) achieves a steady-state condition at which the input and output rates are equal, and c) the mechanism of loss is determined by degradation reactions and advective processes. However, unlike a Level II simulation, equilibrium between environmental compartments is not assumed and inter-compartmental transport processes are quantified (e.g., wet deposition, sedimentation, re-suspension, soil runoff, aerosols, etc. are taken into account). Output from a Level III simulation provides a more realistic description of a chemical’s fate, including the important degradation and advective losses and the intermedia transport processes. In addition, the simulation gives an indication on how source of entry of a chemical to the environment (e.g., to air, to water, and/or to soil) effects distribution and persistence.

Level III simulations were first used to evaluate the effect of source of entry on the distribution and persistence of D5. The overall reaction half-life in air was set at 10.2 days, as previously discussed. The overall reaction half-life in water was set at 17.3 days based on the hydrolysis rate at pH 7.8 and 25 ºC (Kozerski 2006). The overall reaction half-life in soil was set at 12.5 days based on soil degradation studies (Xu and Chandra 1999). Laboratory studies indicate that D5 does not readily biodegrade. Therefore, the overall reaction half-life in sediment was estimated to be 10-times the half-life in water or 173 days. Emission rates of 0 or 1000 kg/h were used for the single compartment emission rates for each simulation.

As expected on the basis of the Level II simulations, emission of D5 directly to air resulted in >99.9% of the total chemical mass residing in the air compartment. Intermedia exchange of D5 from air into other environmental compartments (water, soil, or sediment) was insignificant.

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About 22% of the D5 was removed from the model environment by degradation in air and 78% was removed by advective transport in air. Total residence time of D5 in the model environment was about 3.2 days.

Similar results were obtained when D5 was emitted directly to the soil compartment. Because of its vapor pressure, 58% of the steady-state chemical mass of D5 was found in the air and 42% in the soil. Intermedia exchange from soil to air (i.e., volatilization) accounted for 89% of the D5 removed from the soil compartment. Inter-media exchange from soil to other compartments was insignificant. About 31% of the total mass of D5 was removed from the model environment by degradation in air (20%) and soil (11%). The remaining 69% of D5 was removed from the model environment by advective transport in air. The overall persistence of D5 released to soil was 4.9 days.

In contrast to that observed for emission to the air and soil compartments, emission of D5 to the water compartment resulted in only 5.6% of the total chemical mass residing in air. When released directly to the water compartment, 32% the total chemical mass of D5 was found in the water and 63% in the sediment. About 49% of the D5 released to the water compartment was removed by inter-media exchange from water to air (41%) and from water to sediment (8%).

About 49% of the total mass of D5 was removed from the model environment by degradation in air (9.1%), water (33%), and sediment (6.6%). The remaining 51% of D5 was removed from the model environment by advective transport in air (32%), water (18%), and sediment (1%). The overall persistence of D5 released to the water compartment was 24 days.

Potential for Long-Range Transport The Level III simulations indicated that the environmental compartment of concern for D5 is air.

For example, it was predicted that D5 released directly to soil would be found in air and soil.

Similarly, it was predicted that D5 released directly to water would be found in air, water, and sediment. It is expected that environmental release of D5 from dry cleaning applications would be directly to air and that release to other compartments would be insignificant. Because of its volatility and partitioning properties, D5 accidentally released to water or soil would readily partition to the atmosphere. This preferential partitioning to air raises speculation that D5 may undergo long-range atmospheric transport and deposit to remote regions.

Long-range transport (LRT) and deposition of a chemical to a remote region is a complex interaction between the physical-chemical properties of the chemical and the environmental conditions in which the chemical is released. The process of atmospheric LRT to remote regions consists of three distinct steps (Wania 2003): (1) In source regions the chemical must reach the atmosphere from the medium to which it has been emitted.

(2) The chemical must be transported through the atmosphere to the remote region.

(3) The transported chemical must have the potential to be significantly deposited in the remote region in order to have a noticeable impact on the local ecosystem.

Most techniques for evaluating LRT focus on the second step of the overall process by relying on estimates of atmospheric degradation and advection to define the distance that a chemical can be

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transported in the atmosphere. The need for deposition to the remote ecosystem (i.e., the final step of the process) is virtually always ignored. Simple advective transport models coupled with the degradation half-life in air (T0.5) only consider the potential for a substance to undergo longrange transport and cannot identify the potential for a substance transported to a remote region to partition out of the atmosphere and deposit in the biosphere. Substances with an atmospheric half-life of greater than 2 days, may be transported long distances, but may not partition out of the atmosphere. If there is no back-deposition, then there is no potential for exposure to organisms, including humans.

Deposition of a substance depends on physical and chemical properties that control the ability of the substance to partition out of the atmosphere and into the biosphere, for example partitioning from the gas phase to an aqueous phase. The non-dimensional Henryâ&#x20AC;&#x2122;s Law constant (H; also known as the air-water partition coefficient, Kaw) describes the equilibrium partitioning of a chemical between the gas phase and an aqueous solution. When evaluating the combined potential for long-range transport to, and subsequent deposition in, remote regions, both T0.5 and H can be used. The strong influence of the combined effects of T0.5 and H on the potential for long-range transport and deposition of a substance into a remote region can be illustrated by expanding a simple transport model coupled with the degradation half-life in air to include partitioning (DiToro and Hellweger 1999). Results from the illustrative model demonstrate that for substances with log H >0, 1% or less will be deposited into the biosphere of a remote region (i.e., greater than 99% remains in the atmosphere), regardless of T0.5. For D5 (log Kow = 5.2, log H = 1.1), less than 0.1% would be expected to deposit). In contrast, the model predicts that deposition of known POPs, for example DDT, PCBs and hexachlorobenzene, all of which have log H < -1.0, would be greater than 50%. These model results also demonstrate the importance of log Kow (i.e., partitioning between octanol and water) on the potential for deposition. Log Kow is important because it represents the potential for the substance to partition from water to organic (i.e., biological) materials, such as plants, animals and organic coatings on soils. Results from this simple model, which incorporates the combined effects of T0.5, H, and log Kow, suggest that substances with a non-dimensional Henryâ&#x20AC;&#x2122;s Law constant greater than 1 and log Kow greater than 5, including D5, will not deposit into the biosphere of remote regions, regardless of the half-life of the substance in the atmosphere.

The conclusion that D5 will not deposit into the biosphere of remote regions, regardless of the half-life of the substance in the atmosphere, is further supported through a comprehensive investigation of model uncertainty and sensitivity relative to phase partitioning properties. This is achieved by defining a two-dimensional hypothetical chemical space as a function of the equilibrium partition coefficients between air, water, and octanol (i.e., Koa, Kaw, and Kow).

Multimedia models are used to calculate the range of partitioning coefficients across the entire chemical space to construct maps showing the relation between hypothetical chemical properties and environmental phase distributions that occur within the bulk environmental compartments air, water, soil, and sediment (Van de Meent et al. 1999; Wania 2003; Meyer et al. 2005). Each point in these partitioning space maps corresponds to a hypothetical chemical with a specific combination of partitioning properties. Real chemicals can then be placed within this partitioning space, provided their partitioning properties are known, in order to assess the environmental phase distributions expected to exist across air, water, soil, and sediment.

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Wania (2003) used a dynamic, zonally averaged global distribution model (Globo-POP; Wania and Mackay 2000) to produce a partitioning space map for a range of hypothetical chemicals assuming perfect persistence (no degradation) and equal emission to air, water, and soil. When the partitioning properties of D5 (log Kow = 5.2, log Kaw = 1.1, log Koa = 3.7) are plotted on the space map it is apparent that D5 falls within the partitioning space defining chemicals that will be found predominantly in the atmosphere. Wania (2003) concluded that chemicals such as D5 that have log Koa <5.5 and log Kaw >-1 will be found predominantly in the atmosphere and will not have the potential for long range transport and deposition in the biosphere of remote regions.

Wania (2003) also used the Globo-POP model (Wania and Mackay 2000) to identify chemical partitioning properties and emission scenarios that favor enrichment in Arctic ecosystems and to define a target-oriented Arctic Contamination Potential (ACP). An immediate and long-term ACP was developed and defined as the fraction of the total chemical mass in global surface media that is in the Arctic after 1 and 10 years of steady emissions (ACP1 and ACP10, respectively). A partitioning space map was developed showing the calculated ACP for perfectly persistent chemicals as a function of log Koa and log Kaw, with emissions occurring either entirely to air, water, or soil. When the partitioning properties of D5 (log Kow = 5.2, log Kaw = 1.1, log Koa = 3.7) are plotted on the space map it is apparent that D5 falls within the partitioning space defining chemicals that will not partition to, or accumulate in, the Arctic surface media, regardless if the material is emitted to air, water, or soil. Wania (2003) concluded that chemicals such as D5 that have log Koa <5.5 and log Kaw >-1 will be found predominantly in the atmosphere and will not have the potential for long range transport and subsequent deposition in the biosphere of remote regions. Moreover, the potential for such chemicals to accumulate in remote regions is limited by failure to deposit to the Earth’s surface even at the low-temperatures prevalent in the Arctic. Wania (2006) categorizes D5 as a “flier”, indicating that it has little potential for back deposition in remote regions (arctic) assuming it is persistent enough to reach there.

E. Summary and Conclusions of Environmental Risk Evaluation D5 has a very high air-water partition coefficient (log KAW > 1), extremely low water solubility (0.017 mg/L), a high octanol-water partition coefficient (log KOW >5), but a relatively small octanol-air partition coefficient (log KOA < 5.0 at room temperature). Depending on its mode of release, D5 will distribute almost entirely into two environmental compartments. When released to air, D5 will remain in air and not partition appreciably to other environmental compartments.

If released to water, D5 will rapidly volatilize to air or partition to suspended solids that deposit to sediments in the area where released. This partitioning behavior has lead to D5 being identified in the literature as a “flyer”, with the atmosphere being the only feasible medium for long range transport and little potential to back-deposit to the terrestrial compartment.

Laboratory studies have been conducted in an attempt to understand the fate of D5 in the atmosphere. Currently, demethylation by OH radicals in the atmosphere is the major process that has been identified for the degradation of D5. The half-life or persistence of D5 will depend on the reaction rate with OH radicals, which is dependent on the concentration of OH radicals in the atmosphere. The OH radical concentration varies between remote, urban and rural settings.

If the OH radical concentration from remote areas is used, the D5 half-life in air is about 10 days.

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However, since D5 is predominantly released in urban settings, more realistic urban and rural atmospheric OH radical concentrations provide predicted half-lives as short as a few hours to one day.

D5 does not accumulate in soil. When soil moisture is low, degradation is rapid with half-lives from hours to a few days. When soil is wet, degradation rates are reduced, but rapid volatilization (half-life of 2-4 days) from soil becomes a predominant removal mechanism.

D5 undergoes hydrolysis in water, but hydrolysis is not the main removal mechanism from water.

If released to water, D5 is expected to either volatilize into the atmosphere or to adsorb onto particles and be removed into the sediment. Model estimates for volatilization of D5 from water are fairly rapid with half-lives as short as 3 hrs to 6 days, depending on water depth and the amount of mixing in the water bodies.

D5 can be considered practically non-toxic to aquatic or sediment-dwelling organisms. Due to its unique properties of high volatility, low water solubility and preference for adsorption to solids, D5 is not expected to remain in a freely bioavailable form in natural aqueous environments.

Likewise due to these same properties it is unlikely that aquatic or sediment-dwelling organisms would be exposed to concentrations that would cause adverse effects. A laboratory study (Drottar, 2006) and environmental monitoring (Nordic Council of Ministers, 2005) indicate that D5 is not likely to bioaccumulate appreciably or exhibit significant biomagnification within the food chain.

VI. Summary and Conclusions The purpose of this investigation was to conduct a safety assessment to evaluate the potential environmental risk and hazard to selected workers, consumers, and the general public who may be exposed to D5 from dry cleaning either in the workplace, through the wearing of clothes cleaned with D5-based solvent or exposed to D5 in ambient air. This involved a critical review of the available environmental toxicity, mammalian toxicity, carcinogenicity, pharmacokinetic, and mode-of-action studies.

The environmental modeling and testing, as well as results of field sampling, clearly indicate that there are no significant environmental risks from the use of D5 in dry cleaning.

Exposure for all three populations evaluated was considered to occur via dermal and/or inhalation exposure. As with the dose-response assessment, a PBPK model was used to estimate the internal dose associated with dermal or inhalation exposures for each population. These were then compared to information developed from the rat bioassay, resulting in the calculation of appropriate MOS. A MOS is the ratio of the internal dose associated the animal study to the internal dose estimated for each relevant exposure scenario. A MOS of >100 is generally considered to be sufficiently protective of human health.

Under the exposure scenarios defined in this assessment, typical exposure to D5, whether occupationally, to consumers, or to the general public, would not result in a significant human health risk.

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Margin of Exposure calculations for workers, consumers, and general public exposed to D5 Type of Exposure

Population

Dry cleaner Consumer General Public Adult General Public Child Dry Cleaner Dermal Consumer General Public Adult General Public Child NA: Not Applicable Inhalation

MOS Men 9.8X103 NA 1.3X106 3.2X106

Women 2.0X104 NA 1.8X106 3.7X106

3.4×107

3.8×107

NA NA NA

NA NA NA

Based on the extensive data available for D5, the safety of the GreenEarth® system is supported.

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Dow Corning Corporation. 2004a. Non-Regulated Study: Measurement of D5 Binding to the Estrogen Receptor Alpha. Technical Report Number 2004-STEC-2608.

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Dow Corning Corporation. 2003d. In Vivo Percutaneous Absorption of 14CDecamethylcyclopentasiloxane in the Rat. Technical Report Number 2003-I0000-52915.

Dow Corning Corporation. 2000. Summary of the Histopathological Results for a 1-Month and 3Month Repeated Dose Inhalation Toxicity Study with Decamethylcyclopentasiloxane (D5) in Rats.

Technical Report Number 2000-I0000-48891.

Dow Corning Corporation. 1999. Absorption of Decamethylcyclopentasiloxane (D5) Using the FlowThrough Diffusion Cell System for In Vitro Dermal Absorption in Human Skin. Technical Report Number 1999-I0000-47642.

Dow Corning Corporation. 1990a. A 14-day Subchronic Oral Gavage Study with Decamethylcyclopentasiloxane in Rats. Technical Report Number 1990-I0000-35074.

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Dow Corning Corporation. 1990b. A 28-Day Subchronic Oral Gavage Feasibility Study of Various Low Molecular Weight Silicone Oligomers in Rat. Technical Report Number 1990-I0000-35105.

Drottar, K. 2005. 14C-Decamethylcylcopentasiloxane (14C- D5): Bioconcentration in the fathead minnow (Pimephales promelas) under flow-through test conditions. HES Study No. 9802-102.

Health and Environmental Sciences. Dow Corning Corporation.

Drottar K.R. 2006. 14C-Decamethylcyclopentasiloxane (14C-D5): Dietary bioaccumulation in the rainbow trout (Oncorhynchus mykiss) under flow-through test conditions. HES Study No. 10057108, Health and Environmental Sciences, Dow Corning Corporation.

Experimental Pathology Laboratories. 1996a. 1-Month Repeated Dose Inhalation Toxicity Study on Decamethylcyclopentasiloxane (D5) in Rats. Pathology Report. Dow Corning Corporation. RCC Project 365635.

Experimental Pathology Laboratories. 1996b. 28-Day, 1-Month and 3-Month Inhalation Toxicity Studies in Fischer 344 Rats with Decamethylcyclopentasiloxane (D5). Pathology Working Group Report. Dow Corning Corporation. Project No. 8453, RCC Project 365635, RCC Project 367615.

Flaningam, OL. 1986. Vapor pressures of poly(dimethylsiloxane) oligomers. J. Chem. Eng. Data, 31, 266.

International Fabricare Institute (IFI). 2002. Research Fellowship No. F-47. GreenEarth® Fellowship.

IUCLID. 2005. IUCLID Dataset for decamethylcyclopentasiloxane. Epona Associates LLC. Jager, R. and E. Hartmann. 1991. Subchronische toxikologische Untersuchungen an Ratten (Magensondenapplikation über 13 Wochen). Bayer AG. Technical Report Number 20204.

Kochetkov, A, Smith, JS, Ravikrishna, R, Valsaraj, KT, Thibodeaux, LJ. 2001. Air-water partition constants for volatile methyl siloxanes. Environ. Toxicol. Chem. 20(10), 2184-2188.

Kozerski, G. 2006. Hydrolysis of Decamethylcyclopentasiloxane (D5). Dow Corning Technical Report (in preparation).

Litton Bionetics Inc. 1978. Mutagenicity Evaluation of Decamethylcyclopentasiloxane (Me2SiO)5.

Dow Corning Corporation. Technical Report Number 20893.

Machado, M. 2002. Decamethylcyclopentasiloxane – Acute Toxicity to Daphnids (Daphnia magna) Under Static Conditions. Springborn Smithers Laboratories, Wareham, MA. Report No. 12023.6129.

Mackay, D, Di Guardo, A, Paterson, S, Cowan, CE. 1996. Evaluating the environmental fate of a variety of types of chemicals using the EQC model. Environ. Toxico. Chem. 15:1627-1637.

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Meek, M, Bucher, J, Cohen, S, Dellarco, V, Hill, R, Lehman-McKeeman, L, Longfellow, D, Pastoor, T, Seed, J and Patton, D. 2003. A framework for human relevance analysis of information on carcinogenic modes of action. Crit Rev Toxicol 33 (6): 591-653.

Maxim, L, Mazzoni, S, Dunham, D. 1998. D4, D5, and D6 exposure in the manufacture and use of personal care products. Everest Consulting Associates (ECA). Dow Corning Corporation.

Technical Report number 1998-I00000-45430.

Meyer, T, Wania, F, Breivik, K. 2005. Illustrating sensitivity and uncertainty in environmental fate models using partitioning maps. Environ. Sci.Technol. 39(9), 3186-3196 Nordic Council of Ministers. 2005. Siloxanes in the Nordic Environment. TemaNord 2005:593 (A report that can be found at www.norden.org/publications).

Patnode, WI, Wilcock, DF. 1946. Methylpolysiloxanes. J. Amer. Chem. Soc., 68, 358-363.

Plotzke, K., R. Looney, and M. Utell. 2002. Non-Regulated Study: Human Dermal Absorption of Decamethylcyclopentasiloxane (D5). Dow Corning Corporation. Technical Report Number 2002I0000-51781.

Prinn, R.; Cunnold, D.; Simmonds, P.; Alyea, F.; Boldi, R.; Crawford, A.; Fraser, P.; Gutzler, D.; Hartley, D.; et al. 1992. Global average concentration and trend for hydroxyl radicals deduced from ALE/GAGE trichloroethane (methyl chloroform) data for 1978-1990. J. Geophys. Res. [Atmos.] 97(D2), 2445-2461.

Putt, A.E. 2003. Decamethylcyclopentasiloxane (D5) â&#x20AC;&#x201C; The full life-cycle toxicity test with midge (Chironomous riparius) under static conditions. Springborn Smithers Study No. 12023.6140.

Silicones Environmental Health and Safety Council, Reston VA. RCC. 1995a. 3-Month Repeated Dose Inhalation Toxicity Study with Decamethylcyclopentasiloxane in Rats with a 1-Month Recovery Period. Dow Corning Corporation. Technical Report Number 1995-I0000-40182.

RCC. 1995b. 1-Month Repeated Dose Inhalation Toxicity Study with Decamethylcyclopentasiloxane in Rats. Dow Corning Corporation. Technical Report Number 1995-I0000-40185.

Reddy, M., R. Looney, M. Utell, M. Jovanovic, S. Crofoot, D., McNett, J. Tobin, M. Utell, P. Morrow, K. Plotzke, and M. Andersen. 2005a. Physiological modeling of the inhalation kinetics of decamethylcyclopentasiloxane (D5) in rats and humans. Toxicological Sciences (in preparation).

Reddy, M., R. Looney, M. Utell, M. Jovanovic, J. McMahon, D. McNett, K. Plotzke, and M. Andersen.

2005b. Physiological modeling of the dermal absorption of octamethylcyclotetramethylsiloxane (D4) and decamethylcyclopentasiloxane (D5). Toxicological Sciences (in preparation).

Springborn Laboratories, Inc. 2000. Decamethylcyclopentasiloxane (D5) â&#x20AC;&#x201C; 14-Day Prolonged Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss) Under Flow-Through Conditions. Study No. 12023.6125

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Springborn Smithers Laboratories, Inc. 2003a. Decamethylcyclopentasiloxane (D5) â&#x20AC;&#x201C; Full Life Cycle Test with Water Fleas (Daphnia magna) Under Static-Renewal Conditions. Study No. 12023.6141.

Springborn Smithers Laboratories, Inc. 2003b. Decamethylcyclopentasiloxane (D5) â&#x20AC;&#x201C; Full Life Cycle Toxicity Test to Midge (Chironomus riparius) Under Static Conditions. Study No. 12023.6140.

U.S. Environmental Protection Agency. 2005. Guidelines for Carcinogen Risk Assessment. United States Environmental Protection Agency Risk Assessment Forum. Technical Report Number EPA/630/P-03/001b NCEA-F-0644b: Utell, M. 2004. Clinical Studies on the Respiratory Effects of Decamethylcyclopentasiloxane (D5) Vapor: Mouthpiece Inhalation. Dow Corning Corporation. Technical Report Number 2004I0000-53544.

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Environ. Toxicol. Chem. 15(8), 1263-1265.

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Wilcox, P. Naidoo, A, Wedd, D and Gatehouse, D. 1990. Comparison of Salmonella typhimurium TA102 with Escherichia coli WP2 tester strains. Mutagenesis 5(3) : 285-291.

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Xu, S.; Chandra, G. 1999. Fate of cyclic methylsiloxanes in soils. 2. Rates of degradation and volatilization. Environ. Sci. Technol. 33, 4034-4039.

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Frequently Asked Questions 1. What is GreenEarth? GreenEarth is the brand name for liquid silicone solution, decamethylpentacyclosiloxane, or D5. It is an exclusive, patented dry cleaning process whose name and logo are trademarked (there are no “generic” forms of GreenEarth).

2. Why is it better for the earth? GreenEarth liquid silicone is a safe, natural byproduct of sand.

Liquid silicone degrades into sand (SiO2) and trace amounts of water and carbon dioxide within days if spilled or disposed of. It is not a VOC and is safe for air, soil and water--so the EPA does not need to regulate it.

3. Why is it better for clothes? GreenEarth solution is different from dry cleaning solvents in that it is chemically inert, meaning it does not interact with textiles or dyes during the cleaning process.

This helps preserve the quality of garments, eliminate problems with color loss, maintain a soft “hand” and prevent shrinkage. Unlike petroleum based solvents like perc or hydrocarbon, D5 is odorless and does not leave a chemical smell on clothes.

4. Why is it better for dry cleaners? GreenEarth machine costs are similar to those of perc machines used today, so operators can convert to it affordably. And, it is easier for dry cleaners to operate profitably with GreenEarth. Why? Because it produces a noticeable difference that is highly marketable, sales go up. Also, it requires less labor to process and finish items cleaned in GreenEarth and operating efficiencies are higher.

5. Why is it better for landlords? GreenEarth’s non-toxic, non-hazardous rating means no liability issues. This enables landlords to allow leases at locations where dry cleaners previously were not allowed. Because dry cleaning involves two separate trips, each a planned destination, landlords benefit from the strong weekly traffic a GreenEarth store would bring. And, because GreenEarth Cleaning is the premiere brand of dry cleaning in the U.S., our strong quality image attracts upscale and wonderfully loyal customers.

6. How does GreenEarth ensure the success of its Affiliates? The GreenEarth Cleaning system is a patented process, and our name and logo are trademarked, helping to ensure the protection of the exclusivity of our brand as we build a solid network of quality operators. GreenEarth Affiliates have access to a network of quality cleaners who share information, ideas and best practices.

They receive free operational and technical support as well as free customer service support and expertise. Of particular value to Affiliates, and the landlords leasing to them, is the free planning and design of high quality, customizable store marketing materials. GreenEarth makes it easy for stores to market their difference, build trial and communicate with their customers. Affiliates also have access to top quality direct mail fulfillment services, a website that boosts their quality image and professionalism and a “store look up” feature that directs customers to their store 24/7.

7. How many GreenEarth Affiliates are there? There are more than 1300 active licenses world wide. Approximately 700 Affiliate locations are in the United States.

8. How does GreenEarth compare to other “green” alternatives like CO2, 100% wet cleaning and hydrocarbon? CO2 and 100% wet-cleaning are very good choices environmentally, but less than one-third of one percent of dry cleaners use them today. The processes

are very different with these systems and equipment, production and finishing costs are significantly higher, making it hard for operators to convert and/or turn a profit.

Hydrocarbon solvent has, until recently, been popular with dry cleaners looking for an alternative to perc because it is affordable and petroleum-based, so they are familiar with it. The concern about hydrocarbons today is that they’re not as “green” as everyone thought originally. While certainly a big improvement over perc, hydrocarbons are classified by the EPA as a VOC, and are a likely contributor to smog formation. Of particular concern to landlords is the likely necessity of a clean up if spilled. Like perc, hydrocarbon is also listed by the EPA as a neurotoxin and skin and eye irritant for workers. On the plus side, most machines designed to use hydrocarbon solvent are also designed to use GreenEarth solution, so the health and environmental concerns with hydrocarbon can be alleviated without significant investment in machinery.

9. How profitable are GreenEarth stores? GreenEarth stores are more successful because they cost less to operate and realize better sales volume. GreenEarth’s gentler process produces garments with a softer fabric “hand” and fewer wrinkles, so finishing and special handling costs go down, as do expenses for claims. Because there is significantly less need to classify loads by color with GreenEarth, fewer loads need to be run, and productivity goes up. Waste hauling costs are significantly lower, and there is no need for environmental insurance.

GreenEarth can successfully process more suede, leather, vinyl and beaded garments, allowing operators to keep the revenue in-store rather than having to send them out. The big benefit however, is what GreenEarth can do for sales when stores market the GreenEarth difference. Affiliates who market the GreenEarth odor-free, eco-friendly difference see sales go up immediately; reports range from the lower double digits to numbers as high as 50-70%. And because customers can actually see, touch and smell the difference in their clothes, they tend to bring more things in more often. Even better, they recommend it to their friends and family. GreenEarth doesn’t just attract customers, it attracts loyal customers.

10. Do customers really care about eco-friendly dry cleaning? Consumers today are increasingly concerned about the environment and the business practices of companies with which they do business. Demand for “green” products and services has risen dramatically, in fact, 49% of consumers feel that it is “important for companies to not just be profitable, but to be mindful of their impact on the environment and society,” according to a study done by the National Marketing Institute.

11. I’ve heard that GreenEarth doesn’t clean as well as perc, is that true? No. GreenEarth solution has different chemical properties than perc, so working with it is somewhat different. When GreenEarth was first introduced, the process was unfamiliar, detergents had not yet been developed to work with it, and cleaning results did vary. Water soluble stains were a particular problem. With proper training on how to process garments in GreenEarth, and the advent of second, third and even fourth generation detergent additives developed with the help of Procter & Gamble, cleaning results, including removal of water soluble stains, are excellent. A recent independent evaluation of alternative solvents by the IFI in 2007 rated GreenEarth as “excellent” in the categories of cleaning and ability to handle a variety of fabrics and trims.

12. What is the regulatory outlook for dry cleaning and GreenEarth? Dry cleaning is under increasing regulatory scrutiny. California’s ban on the use of perc and the purchase of perc machines

is widely regarded as the beginning of the end of perc solvents. New Jersey, Massachusetts, New York and Toronto have all recently announced similar bans under consideration. If the industry continues to drag its feet when it comes to adopting “more environmentally-friendly alternatives”, regulators can be expected to grow increasingly concerned and increase legislative pressure.

GreenEarth continues to meet and exceed all regulatory requirements and regulations.

13. Has there been much testing done on GreenEarth? GreenEarth is the only alternative solution to perform and openly report extensive testing on its health, environmental and safety profile. Over $30 million worth of independent testing and research has been done on D5 solvent to confirm that it is ecologically friendly and safe to use in all of its many applications, including dry cleaning.

GreenEarth also underwrote a comprehensive, 2002 IFI Fellowship Study, which compared the GEC system to the industry standard “perc system”. The IFI declared GreenEarth to be “as effective as perc with no environmental concerns”. Independent waste stream and air exposure testing confirmed that D5 as used in daily dry cleaning operation exceeds all federal, state and local requirements for water and air safety.

14. I’ve heard that GreenEarth causes cancer, is that true? No. This rumor originated from news coverage around the release of a voluntary 2-year bioassay study commissioned by Dow Corning, a manufacturer of D5. News reporters like to create controversy, and an erratic finding of this study allowed them to do just that. The study tested the effects of chronic inhalation of D5 at 160 ppm (parts per million) on lab rats. What is important to understand is that this test was designed to study effects of total air saturation of D5 as a chemical, not its use in a dry cleaning application, where workplace or consumer exposure is less than 2 ppm. Some of the female rats in the study developed pre-cancerous indicators; they did not develop cancer. The same pre-cancerous indicators were also seen in female rats in the control cells of the test, leading many to conclude that other factors, not D5, caused the effect. Follow up research was conducted by the Silicones Environmental, Health and Safety Council (SEHSC), and concluded that the effects observed in the Dow Corning study were rat-specific (they occurred through a biological series of pathways that do not exist in humans) and declared that D5 does not pose a health risk to humans. The bioassay study was first issued in 2003, with a final report in 2005. The EPA has been fully engaged with the manufacturers of silicone on all technical studies and reports and continues to not regulate silicone’s use in dry cleaning or any other application.

15. I am seeing a lot of “organic” dry cleaning claims, is GreenEarth organic?

No. And that is a good thing. Organic, as it relates to chemistry, refers to anything with a carbon backbone. Gasoline and asphalt are organic. Dry cleaners who market themselves this way are purposefully misleading the consumer.

16. What do operators need to do to convert to GreenEarth? The first step will be to get acquainted to make sure that the “fit” is right. We like to partner with like-minded business owners who put customers, quality and environmental responsibility first; this is the best way we know to protect their investment and ours. Next they will want to learn about any local regulations they would need to comply with and assess their equipment and supply compatibility. GreenEarth has done extensive testing and has pre-approved a number of different machines, detergents and spotting agents, to make selection of a quality system easier. The final step is to sign a letter of understanding, making the membership application official. Once they join as an Affiliate, operators will receive a membership kit and we will begin working with them to make sure their installation and conversion go smoothly.

GreenEarth® Cleaning System Fact Sheet Composition–––––––––––––

• Silicone composition • Modified liquid silicone similar to the base ingredients used in underarm deodorant, cosmetics, shaving lotion, etc.

Properties–––––––––––––––

• Clear liquid • Odorless • Specific gravity---- .95 • Flash point--------- 170º F • Fire point---------- 190º F • Boiling point------ 410º F • Surface tension---- 17.42 dynes/cm at 77º F (25º C)

Safety–––––––––––––––––––

• Non-toxic (oral, dermal, inhalation) • Non-irritating to skin • Non-sensitizing • No immunosuppressant effects

Environmental–––––––––––

• RCRA non-regulated • CERCLA non-regulated • Non-VOC: Specifically exempted by EPA; degrades in the atmosphere.

• EPA lists as a “SNAP” material; a good substance to use in place of ozonedepleting chemicals • In most areas, no special permits required.

• In certain states, may qualify as alternative technology for special funding or tax breaks.

• Most comprehensive testing ever done in the history of drycleaning industry by independent labs on waste streams and exposure levels.

• Not listed on California Proposition 65.

• Degrades to S1O2 (sand) with trace amounts of H2O and CO2

Cleaning Features–––––––

• Cycle time – Class IIIA machines: 50-65 minutes dry-to-dry • Great cleaning – whites and colors • Mix colors and fabrics – very little load classification • Gentle on all fabrics • No special handling for buttons, trim, sequins, or other difficult garments • No shrinkage • Very little wrinkling – less finish required • Soft hand • Low surface tension – faster penetration and soil removal • Static-free • Very little lint • No odor – even shoulder pads

Cost and Production Benefits–––––––––––––––––– • Increased productivity and efficiency:

• Full loads • Can clean by lot or by customer order

• More consistent and efficient assembly of orders • Decreased labor costs:

• Less finishing time • Less sorting time • Less assembly time

• Lower utility bills due to fewer loads • Decreased claims:

• Significantly fewer damaged garments • Fewer claims from misassembly

• Quicker delivery of garments to customers • Significantly decreased disposal costs • Solvent mileage: Reported figures to date indicate 1,200-2,200 pounds per gallon, depending upon machine configuration • No additional expensive equipment required • Special benefits for Affiliates:

• On-line ordering • Listing of Affiliate locations of GreenEarth® website • Website bulletin board for information exchange between Affiliates • Use of GreenEarth® logo for store displays and marketing materials

Equipment Required– –––– • GreenEarth® preferred machine capable of operating with a Class IIIA fluid • Base tank(s) must be galvanized or stainless steel • Filtration – cartridge, spin disc, all carbon • Vacuum distillation, Kleen Rite System, or powder/clay system • Can use transfer equipment, subject to local regulations

Distribution–––––––––––––– • Available through local industry distributors ® Cost–––––––––––––––––––––– • $2,500 Annual Affiliation Fee per machine using GreenEarth

• Second machine at same location is $1,250

Market Advantages–––––– • GreenEarth® provides a wide array of professional, high-quality, customizable

marketing materials to differentiate affiliates from their competition • Affiliates who advertise the benefits of GreenEarth® report double digit sales increases • Affiliates can obtain or keep prime locations not available to other solvents • Affiliates are able to differentiate themselves from their competition

For additional information contact: GreenEarth Cleaning ®

51 W. 135th Street Kansas City, MO 64145 Phone: (816) 926-0895 Fax: (816) 926-0754 E-mail to: info@greenearthcleaning.com Website: www.greenearthcleaning.com

© Copyright 2008 GreenEarth Cleaning. All rights reserved.

Environmental Fate Antiperspirants, Skin Care, Other Personal Care

D5 Production

>99%

>1%

Wastewater Treatment Plant

Air 8-10 days

Landfill Incineration

Sludge

Photodegradation

Soil Hydrolysis and Biodegradation SiO2 CO2 H2O

Various Silanols

GE Silicones General Electric Company 10550 Barkley

Overland Park, KS 66212 913 967-6206 Fx: 913 967-6211

September 6, 2001

I am writing to clarify several aspects of Cyclic Silioxane as an alternative to Perchlorethylene in the dry-cleaning process.

Cyclic Siloxane (SB-32) is a Class IIIA solvent. It is not a Hazardous Air Pollutant (HAPS) and it is not a RCRA hazardous waste. The EPA has listed several VMS (Volatile Methyl Silicones) as substitutes for ozone depleting substances under the program known as the "Significant New Alternative Policy (SNAP), 59CFR13044, March 1994. In addition, Cyclic Siloxane is odorless and classified as a non-VOC (Volatile Organic Compound) unlike petroleum based products.

The Cyclic Siloxane cleaning process uses equipment similar to that of the perchlororethylene cleaning process with slight modifications which take into account the physical property differences of the silicone.

GE Silicone, SB-32 is nontoxic from an oral, dermal and inhalation standpoint as based on EPA protocol. This solvent is used extensively in personal care products such as antiperspirants, hair care, and skin care.

Approximately 150 sites across the country are currently using the Cyclic Siloxane dry cleaning process.

I hope you find this information helpful. Please do not hestitate to call me with any questions or concerns.

Regards,

Greg A Wegener Program Manager

MSDS NO: EU-06-05300614

PRODUCT NAME: GEC-5 MATERIAL SAFETY DATA SHEET

SECTION 1. COMPANY IDENTIFICATION COMPANY IDENTIFICATION MANUFACTURER’S NAME: Shin-Etsu Chemical Co., Ltd. ADDRESS: 6-1, 2-Chome, Ohtemachi, Chiyodaku, Tokyo, JAPAN EMERGENCY TELEPHONE NUMBER: 330-630-9860(Shin-Etsu Silicones of America, Inc.) 800-424-9300(CHEMTREC)(24hrs)(Washington, D.C. USA) TELEPHONE NUMBER FOR INFORMATION: 03-3246-5121(Tokyo,JAPAN) 330-630-9860(Shin-Etsu Silicones of America, Inc.) DATA PREPARED : 11/26/2003 LAST REVISION : 11/26/2003 DATA ISSUED : 11/26/2003 ISSUE NO 200207000742 BASE NO 7 PRODUCT NAME : GEC-5 PRODUCT CLASSIFICATION: Silicone Fluid SECTION 2. COMPOSITION SINGLE OR MIXTURE: Single CHEMICAL IDENTIFICATION: Dimethylcyclopolysiloxane HAZARDOUS COMPONENT(S)/(CAS No.): Decamethylcyclopentasiloxane/ (541-02-6)[Combustible Liquid] : 100% (See Section 8 of this MSDS for Exposure Guideline) SECTION 3. HAZARDS IDENTIFICATION HAZARDS CLASSIFICATION: None (based on IMO) Combustible Liquids (based on DOT) FIRE AND EXPLOSION: Combustible POTENTIAL HEALTH EFFECT: INHALATION ; No significant irritation expected from a single exposure.

SKIN contact ; May cause slight skin irritation.

1/7

MSDS NO: EU-06-05300614

PRODUCT NAME: GEC-5 Causes drying of skin.

EYES contact ; May cause slight eyes irritation.

INGESTION ; Low-harmful SECTION 4. FIRST AID MEASURES INHALATION ; Remove to fresh air.

SKIN contact ; Remove product from skin with dry cloth or towel, and wash exposed area with detergent.

EYES contact ; Immediately flush with water for at least 15 minutes.

INGESTION ; Wash out mouth with water provided person is conscious. Never give anything by mouth to an unconscious person. Call a physician immediately.

SECTION 5. FIRE FIGHTING MEASURES FLASH POINT(method used): 77 degrees C (Closed cup) FLAMMABLE LIMITS: LOWER: Not measured UPPER: Not measured EXTINGUISHING MEDIA: Foam, dry chemical or carbon dioxide SPECIAL FIRE FIGHTING PROCEDURE: None UNUSUAL FIRE AND EXPLOSION HAZARD: None SECTION 6. ACCIDENTAL RELEASE MEASURES STEP TO BE TAKEN IN CASE MATERIAL IS RELEASED OR SPILLED: Shut off all ignition sources.

Contain the spill or leak.

Scrape up with rag and place in container.

SECTION 7. HANDLING AND STORAGE PRECAUTION TO BE TAKEN IN HANDLING AND STORING: Keep container closed when not in use.

Store in a cool place.

Keep away from heat, sparks and flame.

Do not lay the container on its side.

Use with adequate ventilation.

Avoid prolonged breathing vapor.

Avoid contact with eyes and prolonged or repeated skin contact.

2/7

MSDS NO: EU-06-05300614

PRODUCT NAME: GEC-5 Keep out of reach of children. * * * * * Information about the emptied container * * * * * Do not re-use this container.

This container will be very hazardous when emptied.

Residues will be explosive or flammable.

Keep away from heat, sparks and flame.

Do not puncture or cut this container, and do not weld on or near this container.

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION EXPOSURE GUIDELINES: ACGIH TLV-TWA : Not established, OSHA PEL : Not established RESPIRATORY PROTECTION(specify type): Use respiratory protection unless adequate local exhaust ventilation is provided.(Organic vapor type) VENTILATION: LOCAL EXHAUST: Recommended MECHANICAL(general): Adequate ventilation system SPECIAL: Unknown OTHER: Unknown PROTECTIVE GLOVES: Plastic film or rubber gloves EYE PROTECTION: Safety glasses OTHER PROTECTIVE CLOTHING OR EQUIPMENT: Eyewash equipment WORK/HYGIENIC PRACTICES: Keep away from heat, sparks and flame.

Avoid prolonged breathing vapor.

Avoid contact with eyes and prolonged or repeated skin contact.

Wash hands and gargle after handling.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES BOILING POINT: 210 degrees VAPOR PRESSURE: 1.0mmHg (20 VAPOR DENSITY(air=1): >1 SPECIFIC GRAVITY: 0.96 (25 MELTING POINT: -38 degrees

C degrees C)

degrees C) C

3/7

MSDS NO: EU-06-05300614

PRODUCT NAME: GEC-5 EVAPORATION RATE: <1 (Butyl Acetate=1) SOLUBILITY IN WATER: Not soluble (<1 ppm) APPEARANCE(color): Colorless, transparent APPEARANCE(form): Fluid ODOR: Essentially odorless SECTION 10. STABILITY AND REACTIVITY STABILITY: Stable CONDITION TO AVOID: None INCOMPATIBILITY(material to avoid): None HAZARDOUS DECOMPOSITION OR BY-PRODUCT: None HAZARDOUS POLYMERIZATION: Will not occur CONDITION TO AVOID: None SECTION 11. TOXICOLOGICAL INFORMATION SKIN IRRITATION: Patch Test(24Hr/Open) : Almost Negative(1%) EYE IRRITATION: EYE-RABBIT : MILD SENSITIZATION: No evidence of sensitization ACUTE TOXICITY(LD50): LD50(Oral/Rat) : >5g/kg ACUTE TOXICITY(LC50): LC50(Inhalation/Rat) : >5g/m3/Hr (estimated by similar dimethylcyclosiloxane) SUBACUTE TOXICITY: Repeated inhalation or oral exposure of mice and rats to octamethylcyclotetrasiloxane and decamethylcyclopentasiloxane produced an increase in liver size. No gross histopathological or significant clinical chemistry effects were observed.

An increase in liver metabolizing enzymes, as well as a transient increase in the number of normal cells (hyperplasia) followed by an increase in cell size (hypertrophy) were determined to be the

4/7

MSDS NO: EU-06-05300614

PRODUCT NAME: GEC-5 underlying causes of the liver enlargement. The biochemical mechanisms producing these effects are highly sensitive in rodents, while similar mechanisms in humans are insensitive.

CHRONIC TOXICITY: No information is available.

CARCINOGENICITY: NTP:Not listed, IARC:Not listed, OSHA REGULATED:Not listed MUTAGENICITY: Negative(Bacteria) REPRODUCTIVE EFFECT: No information is available.

TERATOGENIC EFFECT: No information is available.

OTHER INFORMATION: None SECTION 12. ECOLOGICAL INFORMATION BIODEGRADATION: No evidence of biodegradation BIOACCUMULATION: May cause bioaccumulation.

AQUATIC TOXICITY: No information is available.

OTHER INFORMATION: Vapor undergoes indirectly photolysis in the troposphere.

SECTION 13. DISPOSAL CONSIDERATIONS Can be burned in a chemical incinerator equipped with an afterburner and scrubber.

Do not dispose of the emptied container unless the contents have been completely removed and container has been flushed with a clean neutral solvent and then dried up.

Do not dispose the emptied container unlawfully.

Observe all federal, state, and local laws.

SECTION 14. TRANSPORT INFORMATION <IMO INFORMATION> ID No.: None CLASSIFICATION AND CLASS: None PACKAGING GROUP: None PROPER SHIPPING NAME:

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MSDS NO: EU-06-05300614

PRODUCT NAME: GEC-5 None TECHNICAL SHIPPING NAME: None MARINE POLLUTANT: None * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * <DOT INFORMATION> ID No.(49CFR 172.101): NA 1993 HAZARD CLASS(49CFR 172.101): None PACKING GROUP(49CFR 172.101): III PROPER SHIPPING NAME(49CFR 172.101): Combustible Liquids, N.O.S. TECHNICAL SHIPPING NAME: Organosiloxane DOT REPORTABLE QUANTITY(49CFR 172.101, APP.) : HAZARD SUBSTANCE(S) NAME / (CAS No.), CONTENTS AND RQ Not applicable SECTION 15. REGULATORY INFORMATION TOXIC SUBSTANCES CONTROL ACT(TSCA) STATUS: Listed on the TSCA Inventory. * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * EUROPEAN INVENTORY OF EXISTING COMMERCIAL CHEMICAL SUBSTANCES (EINECS) STATUS: Listed on the EINECS. LABELING ACCORDING TO EC-REGULATIONS REQUIRED: SYMBOL : Not required R-PHRASE : Not required S-PHRASE : Not required CONTAINS : None * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * SUPERFUND AMENDMENTS AND REAUTHORIZAITION ACT OF 1986(SARA) TITLE III SECTION 313 SUPPLIER NOTIFICATION: This regulation requires submission of annual reports of toxic chemical(s) that appear in section 313 of the emergency planning and community Right-To-Know Act of 1986 and 40 CFR 372.

This information must be included in all MSDS’s that are copied and distributed for the material.

The toxic chemical(s) contained in this product are: CHEMICAL NAME/(CAS No.) AND CONTENTS ** None ** * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * CALIFORNIA PROPOSITION 65:

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MSDS NO: EU-06-05300614

PRODUCT NAME: GEC-5 This regulation requires a warning for California Proposition 65 Chemical(s) under the statute.

The California Proposition 65 Chemical(s) contained in this product are: CHEMICAL NAME/(CAS No.) AND CONTENTS ** None ** SECTION 16. OTHER INFORMATION For Industrial Use Only * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * This materials safety data sheet is offered solely for your information, consideration and investigation.

The data described in this MSDS consist of data on literature, our acquisitional data and analogical inference by data of similar chemical substance or product.

Shin-Etsu Chemical Co., Ltd. provides no warranties, either express or implied, and assumes no responsibility for the accuracy or completeness of the data contained herein.

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Fact Sheet Marc h 2006

D 5 in Dry Cleaning D5 is Used as a Cleaning Agent in Dry Cleaning Decamethylcyclopentasiloxane (D5) is an odorless, colorless non-oily siloxane fluid that carries detergent to clothes and rinses away suspended dirt and oils trapped by the detergent. D5 does not interact with textiles and therefore helps maintain the quality and color of clothes that are dry cleaned.

Research Affirms the Safety of D5 D5 is among the most extensively studied materials used in consumer and industrial applications.

Decades of in-depth research on D5 indicate it is safe when used as intended.

Over 30 studies have been conducted and almost all of these studies showed no effects. However, there were two findings observed in studies with laboratory rats that required further investigation. These two findings, increased liver weight and an increasing trend for uterine tumors, were shown to be effects that are specific to rats and that have no relevance to human health.

The increase in liver weight mentioned above was seen after repeated exposure to high concentrations of D5. This response in rats, which does not affect the animal’s health, is well-documented and widely recognized. It is related to an increase of liver enzymes that metabolize and eliminate a material from the body. The increased liver weight reverses even while the D5 exposure continues. The finding is not adverse, but is considered a natural adaptive change in rats, and does not represent a hazard to humans.

In a two-year, combined chronic/carcinogenicity study, rats were exposed by inhalation up to the highest possible vapor concentrations of D5. There were no findings in male rats. Data showed a statistically significant trend for a certain type of tumor (uterine endometrial adenocarcinoma) in female rats exposed at the highest level—a level much higher than the low levels that consumers or workers might encounter. Based on the finding in female rats, silicone manufacturers conducted extensive follow-up research to determine the cause of the finding. Results of this research indicate that the finding seen in the two-year study occurred through a biological pathway that is specific to the rat and is not relevant to humans. Therefore, this finding does not indicate a potential health hazard to humans. This conclusion is supported by an expert panel of independent scientists who have reviewed the research results and have come to the same conclusion.

D5 is Safe for Workers and Consumers D5 is safe for consumers and workers when used as intended in dry cleaning. The concentration of D5 to which rats were exposed in the studies greatly exceeds workplace or consumer exposure from dry cleaning applications when used as intended. In addition, silicone manufacturers have industrial hygiene and worker exposure guidelines that are set to ensure a high level of safety.

Silicones Environmental, Health and Safety Council of North America 2325 Dulles Corner Boulevard, Suite 500, Herndon, VA 20171 703.788.6570 sehsc@sehsc.com www.sehsc.com

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SEHSC Fact Sheet

March 2006

Silicone Manufacturers are Committed to Worker and Consumer Safety One concrete expression of this commitment is the $30 million voluntary Siloxane Research Program (SRP) that aims to enhance current knowledge about the safety of siloxanes in consumer and industrial applications. As a part of this program, study methods and results are reviewed by a panel of independent scientific experts, and study results are published in peer-reviewed scientific publications.

This initiative represents the largest voluntary health and safety program ever conducted on siloxanes.

Silicone manufacturers continue to communicate the results of this research initiative to regulatory agencies, employees, and customers. Based on the extensive data available for D5, silicone manufacturers continue to support the safe use of D5 when used as intended. Â&#x201E;

SEHSC is a not-for-profit trade association comprised of North American silicone chemical producers and importers. For more than 30 years, SEHSC has promoted the safe use of silicones through product stewardship and environmental, health, and safety research. The organization also is involved in legislative and regulatory issues relating to silicone materials.

Information on D5

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