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| PUBLIC HEALTH ADVISORYTRINITY AMERICAN CORP.GLENOLA INDUSTRIAL DRIVERANDOLPH COUNTY, NORTH CAROLINA*October 20, 1997*U.S. Department of Health and Human ServicesAgency for Toxic Substances and Disease RegistryDivision of Health Assessment and ConsultationAtlanta, Georgia  30333**TABLE OF CONTENTS****EXECUTIVE SUMMARYINTRODUCTIONBACKGROUND**- Site Location and History
- Processes at the Foam Facility
- Processes at the Fiber Facility
- Demographics
- Reported Health Effects
- Environmental Monitoring
- Biological Monitoring
- Public Health Implications
**BASIS FOR THE ADVISORYCONCLUSIONSRECOMMENDATIONS AND PROPOSED ACTIONSREFERENCES**

**EXECUTIVE SUMMARY**
The Agency for Toxic Substances and Disease Registry (ATSDR) is issuing this public healthadvisory to notify the U.S. Environmental Protection Agency; the National Institute forOccupational Safety and Health; the State of North Carolina Department of Environment andNatural Resources; the Randolph County Health Department; and the public of the Glenolacommunity in Randolph County of ATSDR's concerns regarding potential adverse impacts on thehealth of residents living near the Trinity American Corp. (TAC) facility on Glenola IndustrialDrive in Randolph County, North Carolina. TAC is the parent company of Trinity Foam ofCarolina, Inc.  and Trinity Fibers of Carolina, Inc. Data and information obtained and reviewed byATSDR strongly suggest that hazardous substances are being released into the air and possiblyinto other environmental media as a result of operations at the TAC facility, and that thesehazardous substances are impacting residential areas at levels that may pose a significant risk tohuman health. Furthermore, ATSDR believes that substantial releases of hazardous substancesinto the environment have occurred in the past and that environmental media other than air mayhave been contaminated.
ATSDR is concerned that residents are being exposed to toxic substances such as 2,4- and 2,6-toluene diisocyanate (TDI) and other isocyanates known to exacerbate or cause obstructiveairway disorders and sensitization reactions. ATSDR is also concerned that residents are beingexposed to other air contaminants that have been measured at levels of health and safety concernbut have not been identified. During plant operations, the local residents report intermittentlyexperiencing  headaches, dizziness, rashes, throat irritation, and chest tightness that are temporallycorrelated with the detection of odors and elevated levels of unidentified substances measured inoff-site air. ATSDR and other agencies are concerned about chemical exposures of  workerswithin the TAC facility as well as exposures of local residents. 
ATSDR issues a public health advisory for sites where a release or threatened release ofhazardous substances may pose a serious threat to human health. The agency uses the followingcriteria to determine the need for an advisory:- Hazardous materials on a site are known to be toxic to human health, or physical conditionsexist that may pose a serious threat to public health. An established or plausible exposure pathway exists between the contaminant and the nearbyhuman population.
People are being or could be exposed to hazardous substances at levels that pose either anurgent public health hazard or a public health hazard.
There are no plans for immediate remediation or removal.
The public health advisory is ATSDR's best option for ensuring a rapid response to safeguardpublic health.
**INTRODUCTION**
This public health advisory is to notify the U.S. Environmental Protection Agency (EPA); theNational Institute for Occupational Safety and Health (NIOSH); the State of North CarolinaDepartment of Environment and Natural Resources  (DENR); the Randolph County HealthDepartment; and the public of the Glenola community within Randolph County of an ongoingpublic health hazard. The public health hazard is associated with the past, current, and potentialfuture exposures to hazardous air pollutants emitted from the Trinity American Corp. (TAC)foam and fiber facility on Glenola Industrial Drive in Randolph County. The Agency for ToxicSubstances and Disease Registry (ATSDR) is issuing this public health advisory in response torequests for assistance from the DENR, the Randolph County Health Department, and theGlenola community.
ATSDR has concluded that the presence of hazardous substances in the community's ambient airwarrants this public health advisory [1, 2, 3]. Unidentified volatile organic compounds (VOCs) andsemi-VOCs have been detected in the air and are assumed to be at levels of public health andsafety concern [4]. Compounds such as isocyanates; methylene chloride; 1,1,1-trichloroethane;acetone; benzene; ethylene oxide; formaldehyde; and other VOCs have been identified in theambient air at levels that may pose a serious threat to public health [3, 5]. 
The National Contingency Plan (40 CFR Part 300.400-420) describes the types of activitiesrequired and authorized in response to a hazardous substance release at a potentially hazardoussite. Activities include notification of a release (Section 300.405(f)(1)); evaluation of the site(Section 300.410); and factors to be considered related to a removal action (Section 300.415).These factors include the migration of contaminants, the threat of fire or explosion, and otherevents that could threaten public health.
Based on the review of the available information, ATSDR recommends the use of statutory,regulatory, or administrative authorities as appropriate to protect the public's health and tocharacterize these exposures further. Specifically, ATSDR recommends that appropriate agenciestake the following actions:- Use their statutory, regulatory, or administrative authorities to implement measures that willimmediately reduce or eliminate opportunities for residential exposures to hazardous substancesemitted from the TAC facility. Conduct environmental sampling as appropriate (air, private well water, surface water, surfacesoil, and biota) to facilitate qualitative and quantitative estimates of residential exposures under avariety of scenarios.
Investigate the TAC facility and interview employees to assess occupational exposures.
Provide local health care providers and public health officials with necessary information on thediagnoses and treatment of symptoms and health effects associated with environmental exposuresto the specific chemicals and classes of chemicals identified.
Conduct biomedical testing (analyses of blood) for biomarkers of exposure to TDI and otherisocyanates among residents and TAC employees.
Consider conducting studies (including biomarkers of effect) for the prevalence of variouschemical exposure-related health effects among residents and TAC employees.
**BACKGROUND**
Site Location and History
In 1981, the TAC facility began operations at 5275 Glenola Industrial Drive in the unincorporatedcommunity of Glenola, Randolph County, North Carolina [6]. The site consists of 15.7 acres usedfor the production of fiber padding and the production and fabrication of foam for the beddingand furniture industries. Four primary operations occupy the site: a fiber production facility, apolyurethane foam production facility, a warehouse, and a tenant's business (GuilfordFabricators). Thomasville Products (foam manufacturer) owned the property from 1973 to 1981.The site was undeveloped before that time [6].
Processes at the Foam Facility
Polyurethane foam is manufactured by reacting a resin, typically a polyether such aspolyoxypropylenetriol, with TDI and water. Small quantities of an emulsifying agent, apolymerization catalyst, and a silicone lubricant are also added [7]. For certain higher qualitygrades of foam, methylene chloride (MeCl) is used as a blowing agent [7]. For fire retardant foam,a tin catalyst is added. The ingredients are mixed and deposited onto a moving conveyor, and thepolyoxypropylenetriol resin and the TDI polymerize and cross-link to form the urethane resin inthe shape of a continuous foam-like structure called a loaf [7]. 
The loaf dries in a cooling chamber, where exhaust fans draw off chemical emissions for 20 to 30minutes. These emissions peak during the first 2 minutes of the blow-off, when pressure inside thefoam bubbles exceeds the pressure outside [7]. The foam continues to off-gas rapidly for the next5 to 10 minutes [7]. After this period, off-gassing becomes diffusion controlled. Emissions aredirected to stacks, which direct them to the ambient air; no emission controls are in place. Themanufacturing processes at the foam facility occur in batches which result in episodic releases ofemissions.
Processes at the Fiber Facility
The TAC fiber facility processes scrap fibers in the manufacturing of Spansadeck fiber insulatorpads for the bedding and furniture industries [5]. ATSDR is gathering data on the specificprocesses and engineering controls used in this operation.
Demographics
Glenola is an unincorporated community in Randolph County, North Carolina. The 1990 U.S.Census listed the county population as 115,548 people [8]; approximately 500 of these people livein Glenola. Approximately 1,650 people live within a 1-mile radius of the TAC facility. Thispopulation includes 162 children less than 6 years old and 120 adults more than 65 years old [8].
Reported Heath Effects
Since June 1997, ATSDR has received more than 200 telephone calls from residents near theTAC facility. The residents have reported a number of symptoms, including dizziness,breathlessness, headaches, nausea, loss of memory, flushing of the face and neck, fatigue,lethargy, sleeping difficulties, and difficulty breathing. They report a significant reduction ofsymptoms after leaving the area near the facility. The health effects described during thesetelephone calls are similar to those described by residents in one-on-one sessions with ATSDRstaff during a public availability session in May 1997 [9].
Personnel from the State of North Carolina Air Toxics Analytical Support Team have beenconducting air sampling near the TAC facility since January 1995. While conducting samplingactivities near the TAC facility, these personnel have at times reported symptoms similar to thosedescribed by the residents [10]. Furthermore, ATSDR employees have been conducting airsampling near the TAC facility since May 1997 and have at times reported similar symptoms andobservations of a visible plume during episodic events [11].
Environmental Monitoring
Environmental monitoring to date has detected TDI, hexamethylene diisocyanate (HDI), MeCl,and total hydrocarbons in the community's air. ATSDR has identified a completed exposurepathway for TDI and other volatile and semi-volatile organic compounds at levels that may pose aserious threat to public health in areas around the TAC facility.
During an ATSDR/EPA environmental sampling event, residents contacted sampling personnel atapproximately 10 pm on August 11 to indicate that strong odors were present and that they wereexperiencing adverse health effects similar to those previously reported. EPA and ATSDRpersonnel confirmed the presence of the strong odors and a visible plume of material in theambient air.
EPA personnel had two flame ionization detector monitors (FoxboroTM organic vapor analyzers,or OVAs) to monitor the ambient air for volatile organic vapors. EPA personnel had calibratedthose screening instruments when they arrived in the site area on the morning of August 11. Atapproximately 10:00 pm , August 11, the OVAs detected total volatile organic compounds in theambient air at the residential location at levels from 2 to 6.2 units, or parts per million (ppm). The2 OVAs were then recalibrated (with methane) at an upwind location. After recalibration, OVAinstrument readings were as high as 2.5 units (ppm). OVA readings remained elevated (greaterthan 1.0 unit [ppm]) for several hours. EPA and ATSDR personnel continued to monitor usingthe OVAs until approximately 1 am on August 12 [5].
A few weeks later (approximately 10 pm on September 3), an environmental scientist and anenvironmental engineer from the North Carolina Department of Environment and NaturalResources (DENR) observed the following OVA readings:- from 3.5 to 5 ppm in the community air;  from 5 to 10 ppm at the fenceline of the TAC facility; and,up to 100 ppm inside the foam curing facility.
Based on these concentrations of unidentified contaminants, ATSDR recommendedimplementation of the Glenola Community Contingency Plan. The local fire department initiatedvoluntary evacuation of  individuals living in 107 homes within a 1/4-mile radius of the facility andof facility employees. 
On September 3, 1997, the State Health Director issued a public nuisance order directing theTAC facility to cease all manufacturing (foam and fiber) operations. State health officialsindicated that the facility will remain closed until TAC can demonstrate that the operations are nolonger a public nuisance [12].
ATSDR has conducted air monitoring and confirmation sampling in residential areas near theTAC facility to quantitate ambient air TDI concentrations resulting from foam production.ATSDR used tapemeters with diisocyanate-specific chemcassettes and the TDI calibrationprogram to monitor for TDI on a continuous realtime basis during these short release periods[13]. Results from a confirmation sampling methodology that speciates and specifically identifieseach of the isocyanates have confirmed the presence of TDI and HDI in the community's air [14, 15, 16]. Analysis of air samples collected using the confirmation methodology have confirmed thepresence of TDI and HDI in short-term air samples (2-45 minutes) [16].  Because the efficiencyof isocyanate capture on the sampling device used in the confirmation methodology is low,measured concentrations may underestimate the actual air concentrations [14, 15, 16].  Thirtyconfirmation air samples were collected and analyzed for TDI; TDI was detected in 6 samples atconcentrations ranging from 0.0026 to 0.18 µg/m3.  Twenty of the 30 confirmation air samples were also analyzed for HDI; HDI was detected in 9 samples at concentrations ranging from 0.05to 0.45 µg/m3.
Biological Monitoring
DENR has entered into an agreement with Duke University's Department of  Occupational andEnvironmental Medicine to provide high quality standard clinical evaluations of residentsreporting health symptoms thought to be associated with exposure to environmentalcontaminants.  Duke University has begun clinical evaluations of certain residents within the air-shed of the TAC facility who have reported adverse health effects consistent with exposure tothese substances. 
These clinical evaluations being conducted by Duke University include analysis of blood samplesfor the presence of antibodies that are produced by the body as a result of exposure to TDI. TheseTDI antibodies (Immunoglobulin G (IgG) and Immunoglobulin E (IgE)) are produced as aspecific response to TDI exposure. Exposure to other chemicals will not result in production ofTDI-specific antibodies. The analysis of the blood samples uses an enzyme-linked immunosorbentassay (ELISA) [17]. The ELISA tests are both very sensitive (most individuals with TDI-specificantibodies test positive) and very specific (most individuals without the TDI-specific antibodiestest negative) [18]. However, the ELISA test cannot be considered a sensitive biomarker forexposure to TDI, because many individuals exposed to TDI do not develop these antibodies. Only14% of TDI-exposed individuals in occupational settings exhibit the presence of TDI antibodies[19]. In nonoccupational settings, exposure to significant levels of TDI (i.e., TDI levels thatwould cause health effects or production of TDI antibodies) is very rare, because the compound isvery volatile (dissipates rapidly into the air) and very reactive (reacts readily and breaks downwith other substances). The presence of TDI-specific antibodies found in individuals with noknown occupational exposures to TDI is a strong indication that significant exposures to TDI areoccurring in individuals living near the TAC facility.
To date, one resident has tested positive for both the TDI antibodies (IgG and IgE); threeseparate evaluations of the resident's blood serum have confirmed the results. In addition, one ofthe two ATSDR employees who reported TDI-like health effects while in the community hastested positive and has been confirmed for one of the two TDI antibodies.
To further characterize the residential exposure to TDI and other isocyanates, ATSDR is working to augment Duke University medical evaluations by gathering additional biologicalsamples to be analyzed for antibodies to isocyanates (TDI, HDI, and DiphenylmethyleneDiisocyanate [MDI]). ATSDR worked with the Randolph County Health Department to conductthis exposure investigation September 21 - 22; 112 blood samples were collected.
Public Health Implications
The exact amount of TDI required to cause adverse health effects is unknown. People havebecome sensitized after being exposed to as little as 20 parts per billion (ppb) [17]. Aftersensitization there is no amount of TDI that one may be exposed to safely [18]. Studies haveshown that in sensitized individuals, asthmatic attacks can occur after exposure to TDI airconcentrations as low as 0.l ppb [20].
Individuals who live near the TAC facility or are otherwise near the TAC facility for significantperiods of time have reported a number of adverse health effects, including but not limited todizziness, breathlessness, headaches, nausea, loss of memory, flushing of the face and neck,fatigue, lethargy, sleeping difficulties, and asthma. These adverse health effects are consistent witheffects resulting from inhalation exposure to hazardous substances such as TDI/isocyanates andmethylene chloride. These individuals include residents as well as personnel from DENR andATSDR.
Analytical data of HDI/TDI in off-site air, along with the health complaints of residents in thecommunity near the foam plant which are consistent with TDI exposure, indicate that the TrinityFoam Plant may pose a serious threat to public health for people in the surrounding communityand possibly for workers at the facility.
The OVAs do not indicate which specific organic compound the instrument is detecting andmeasuring. However, the unknown nature of the organic compound or compounds beingmeasured at levels above 1.0 unit (ppm) by the OVA requires that ATSDR assume they are ofpotential health and safety concern and thus implement certain employee health and safety policiesand procedures. Until the specific organic contaminants in the ambient air are identified andcharacterized, any agency personnel present during elevated OVA readings (1 - 5 ppm) must wearEPA Level C respiratory protection. Use of EPA Level C respiratory protection requires  propertraining and medical clearance; agency personnel who are not properly trained and medicallycleared are required to leave the area  immediately when OVA readings indicate volatile organiccompounds at levels of 1 - 5 ppm [21]. This ATSDR policy is consistent with
the EPA's guidelines: "A range of background to 5 ppm above ambient backgroundconcentrations of vapors/gases in the atmosphere has been established as guidance for selectingLevel C protection. Concentrations in the air of unidentified vapors/gases approaching orexceeding 5 ppm would warrant upgrading respiratory protection to a self-contained breathingapparatus" [22].
Because the OVA readings that exceed 1.0 unit (ppm) were taken near residences, the potentialfor exposure of community members is also of public health concern. The episodic nature of these"contaminant release" events makes it difficult to characterize the potential for human exposurefully and to implement appropriate protective public health responses consistently.
**BASIS FOR THE ADVISORY**
ATSDR issues this public health advisory based on the following:- available information regarding the past, current, and potential future air emissions fromthe TAC facility on Glenola Industrial Drive;   the frequency and severity of adverse health effects reported by local residents;  
the consistent relationship between hazardous substances such as TDI and methylenechloride known to be emitted by this facility and the acute and chronic symptoms reportedby residents (including difficulty breathing, difficulty concentrating, poor memory, and dullheadaches);
the confirmed measurement of isocyanates in the ambient air of the community at levelsknown to produce the reported health effects in sensitized individuals, such as bronchialhyperresponsiveness, and declines in lung function; and
the presence of biomarkers of exposure to isocyanates in the blood of some individualswho reside or otherwise spend time near the TAC facility and who have reported healtheffects that are plausibly related to exposure to isocyanates and other hazardouscontaminants.
**CONCLUSIONS**
Based on the available information, ATSDR concludes that hazardous substances are beingemitted from the Trinity American Corp. facility on Glenola Industrial Drive in Randolph County,North Carolina. These emissions are resulting in off-site air concentrations of contaminants atlevels that may pose a serious threat to public health.
**RECOMMENDATIONS AND PROPOSED ACTIONS**
ATSDR recommends that appropriate agencies take the following actions:****- Use their statutory, regulatory, or administrative authorities to implement measures that will immediately reduce or eliminate opportunities for residential exposures to hazardous substancesemitted from the TAC facility. Conduct environmental sampling as appropriate (air, private well water, surface water, surfacesoil, and biota) to facilitate qualitative and quantitative estimates of residential exposures under avariety of scenarios.
Investigate the TAC facility and interview employees to assess occupational exposures.
Provide local health care providers and public health officials with necessary information on thediagnoses and treatment of symptoms and health effects associated with environmental exposuresto the specific chemicals and classes of chemicals identified.
Conduct biomedical testing (analyses of blood) for biomarkers of exposure to TDI and otherisocyanates among community members and TAC employees.
Consider studies (including biomarkers of effect) for the prevalence of various exposure-relatedhealth effects among residents and TAC employees.
For additional information, please contact ATSDR at the following address:
Robert C. Williams, P.E., DEEDirector, Division of Health Assessment and Consultation Agency for Toxic Substances and Disease Registry1600 Clifton Road NE (E32)Atlanta, Georgia  30333(404) 639-0610
**REFERENCES**-  Results of Agency for Toxic Substances and Disease Registry/North Carolina Department of Environment, Health and Natural Resources TDI monitoring from May 19, 1997, through June 1,1997. Roy F. Weston.. Memorandum to Beth Mileson, North Carolina Department of Environment, Health and Natural Resources, concerning ambient air sampling results (September 19 - 25, 1996). October 9, 1996.
North Carolina Department of Environment, Health and Natural Resources. Analytical results from Air Toxics Analytical Support Team.
Agency for Toxic Substances and Disease Registry. Draft air consultation released for  30-day public comment period. August 27, 1997.
Roy F. Weston. Memorandum to Lori Cherry, North Carolina Department of Environment, Health and Natural Resources concerning DEECO off-gas study. March 17, 1997.
State of North Carolina, County of Randolph. Trinity American Corporation/special order by consent. July 26, 1996.
North Carolina Department of Environment, Health and Natural Resources, Air Quality Toxics Protection Unit. Air Toxics Analytical Support Team (ATAST) report of investigation, TrinityFoam Company, Glenola, NC, Randolph County, investigation #95005, March 14 - September 15,1996.
US Census Bureau, TIGER/Line Files, 1990 (Archdale, North Carolina), prepared by the Bureau of Census, US Census Bureau, Washington, DC, 1991.
Agency for Toxic Substances and Disease Registry public availability session, Archdale, North Carolina. May 9, 1997.
Agency for Toxic Substances and Disease Registry. Personal communication between Theresa Kilgus and staff of the State of North Carolina Department of Environment, Health and Natural Resources, Air Toxics Analytical Support Team. July 1997.
Agency for Toxic Substances and Disease Registry. Employees incident report concerning exposures to unknown air contaminants identified by OVA readings in exceedance of 5 ppm indicating implementation of Level C personal protective equipment. August 15, 1997.
Levine R, State of North Carolina Department of Environment, Health and Natural Resources. Order of abatement to Trinity American Corp. September 3, 1997.
Zellweger Analytics, Inc. Technical notes on the response verification procedures for chemcassette-based toxic gas monitoring systems. June 3, 1997.
Lesage J, et al. Workers exposure to isocyanates. American Industrial Hygiene Association Journal 1992 Feb; 53:146-53.
Omega Specialty IsoCheck. Marketing information on isocyanate sampling cassette for 2,4 TDI, 2,6 TDI, 1,6 HDI, and MDI. Chelsford, (MA): 1996.
Levine, S.P. et al., "Critical Review of Methods of Sampling, Analysis, and Monitoring for TDI and MDI", American Industrial Hygiene Association Journal 1995 June; 53:146-53.
Unanue ER, Benacerraf B. Textbook of immunology. 2nd ed. Baltimore: Williams and Wilkins, 1984:4.
National Institute for Occupational Safety and Health. Preventing asthma and death from diisocyanate exposure, alert 1996. Department of Health and Human Services; 1996.PublicationNo.: 96-111, pages 1 - 16.
American Conference of Governmental Industrial Hygienists, Inc. Documentation of thethreshold limit values and biological exposure indices. 6th ed. Cincinnati 1991.
Agency for Toxic Substances and Disease Registry. Medical management guidelines for acute chemical exposures (MMGs), toluene diisocyanate. October 1993:1 - 4.
Agency for Toxic Substances and Disease Registry. Health and safety program for hazardous substance field activities: policy and procedures. 1995.
Environmental Protection Agency Office of Emergency and Remedial Response. Standard operating safety guides, PB92-963414. June 1992.
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