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PUBLIC HEALTH ASSESSMENT

UPJOHN CO-FINE CHEMICALS DIVISION
NORTH HAVEN, NEW HAVEN COUNTY, CONNECTICUT


The conclusions and recommendations in this public health assessment (PHA) are basedon the data and information made available to the Connecticut Department of PublicHealth and the Agency for Toxic Substances and Disease Registry. The ConnecticutDepartment of Public Health and the Agency for Toxic Substances and Disease Registrywill incorporate additional information when received. The incorporation of additional data could change the conclusions and recommendations listed in this document.


SUMMARY

The Upjohn Company operated the North Haven Fine Chemical (NHFC) plant in NorthHaven, Connecticut from 1962 to 1993. From the mid-1940's through 1962, the CarwinCompany operated the NHFC facility (1). The Upjohn Company still maintainsownership of the NHFC facility. All buildings except an administration building havebeen demolished. The facility is surrounded by fencing on three sides. The fourth sidecan be accessed via the Quinnipiac River. Signs indicating hazards and restrictingtrespassing have been posted in this area (2). Most of the NHFC facility is covered with asphalt (2).

SRA Technologies completed a cancer incidence study of Upjohn workers in September,1995 (1). The standardized incidence ratio (SIR) is the total number of observed cancercases among Upjohn workers divided by the total number of expected cancer casesamong Upjohn workers. The study found a statistically significant increase in the SIR formale bladder cancer. The SIR for male bladder cancer was 8.3 (95% confidence interval [CI] = 3.3, 17.0) (1).

The study concluded that the increase in bladder cancer was associated with anoccupational exposure. The community is concerned that residents around the Upjohnfacility may be experiencing higher than expected bladder cancer rates.

Benzene was detected in the ambient air during off-site sampling in August, 1989. Benzene was also detected in the ambient air on-site. The Upjohn facility had a history ofbenzene releases. Benzene releases occurred as fugitive emissions during production, aswell as accidental releases. Benzene releases were at or above levels of health concern.

Based on the above information, the Agency for Toxic Substances and Disease Registryand the Connecticut Department of Public Health have concluded that this siterepresented a public health hazard due to past air exposures from the Upjohn NHFCfacility. The site currently represents no public health hazard.

A review of bladder cancer and acute myeloid leukemia incidence in the communityaround the Upjohn facility is recommended because of exposures to benzene airemissions from the facility in the past.


PURPOSE AND HEALTH ISSUES

On September 29, 1995, the North Haven First Selectman requested that the ConnecticutDepartment of Public Health (CTDPH) examine the health impacts of the UpjohnCompany facility on residents (3). This was followed by a similar request by a NorthHaven based community organization (4). The First Selectmen's petition included arequest to "…determine if residents, living in close proximity to the Upjohn plant,possess an unusually high rate of bladder cancer." The later petition requests a bladdercancer incidence study as well as a review of possible well contamination. The scope ofthis public health assessment is to determine if the NHFC facility dischargedcontaminants into the environment, potentially exposing the surrounding community.

The CTDPH initially became involved with the Upjohn facility in the late 1970's. Involvement included attending public meetings, reviewing environmental sampling data,and addressing citizens concerns. This involvement was at the request of citizensconcerned about the odors emanating from the Upjohn facility (5). The CTDPHinvolvement lessened as complaints subsided with the closure of the facility. The plant ceased all production in 1993 (1).


BACKGROUND

A. SITE DESCRIPTION AND HISTORY

For the purposes of this Public Health Assessment (PHA), the site will be referred to asthe Upjohn site or the New Haven Fine Chemical (NHFC). Upjohn's current name isPharmacia & Upjohn Company.

The Upjohn Company operated the North Haven Fine Chemical (NHFC) plant in NorthHaven, Connecticut from 1962 to 1993. From the mid-1940's through 1962, the CarwinCompany operated the NHFC facility (1).

The Upjohn Company still maintains ownership of the NHFC facility. All buildingsexcept an administration building have been demolished. The facility is surrounded byfencing on three sides. The fourth side can be accessed via the Quinnipiac River. Signsindicating hazards and restricting trespassing have been posted in this area (2). Most ofthe NHFC facility is covered with asphalt (2).

The NHFC site is approximately 162 acres. The NHFC site is bordered by the QuinnipiacRiver to the east, railroad tracts to the west, Connecticut Route 40 to the north, andSackett Point Drive to the south (6). A map of the facility and its surrounding areas(Figure 1 Map of Upjohn Facility) is located in Appendix A.

Upjohn acquired The Carwin Chemical Company in 1962. The Carwin ChemicalCompany started in North Haven in 1946 manufacturing chemicals for perfumes. CarwinChemical started manufacturing organic intermediates (chemical compounds used as rawmaterials in industries) for domestic dyestuff and pigment manufacturers. When Upjohnpurchased Carwin Chemical in 1962, they continued the manufacturing processespreviously performed by Carwin. This included the manufacture of dichlorobenzidine(DCB)(2).

Manufacturing of isocyanates was pioneered at the North Haven facility in the mid-1950's. Until its closure in 1993, Upjohn's North Haven Fine Chemical (NHFC)produced raw materials, organic chemical intermediates, and technical grade chemicals(7). Upjohn's products included: dichlorobenzidine, dihydrochloride, o-dianisidinedihydrochloride, 4-sulfophthalic acid, benzophenone, 2,2-diethoxyacetophenone. Upjohnalso produced chemical compounds for instant-photography film, protecting fruits fromdecay, and intermediates for prescription pharmaceuticals (7). Table 1 is a NHFCproduct listing as of July 1979. Information on the products and production start date foreach product was obtained from Upjohn company officers during a site visit on July 16,1979 by CTDPH staff (8).

Examples of the manufacturing processes to create the products are contained in Table 2. Raw materials used in the Upjohn production facilities include chlorine, caustics, organicand inorganic acids, and various hydrocarbons (2). These materials were shipped toUpjohn by truck or rail car.

Waste was stored on site in a series of lagoons. A total of nineteen lagoons were in useduring the operating period of NHFC. By January 17, 1986, seven years beforeoperations at the facility were permanently suspended, many of the lagoons had beenfilled. Table 3 lists the status of the lagoons as determined by the EnvironmentalProtection Agency (EPA) site analysis, as of January 17, 1986. The site analysis wasconducted from a review of aerial photos. The aerial photos were analyzed from 1949through 1986. The lagoons were contained in approximately 15 - 20 acres out of a totalof 162 acres (6).

Not all of the lagoons were concurrently in use. Over time lagoons were drained andfilled. Once filled, some of the older and smaller lagoons (L1 - L3) were used for other purposes such as non-covered storage areas.

Table 1.

Upjohn's North Haven Facility Product List
Product Product Description Production Start Date
Benzophenone - Perfume Grade additive to soaps, toiletries and perfume to prevent loss of fragrance 1977
Benzophenone Technical - Flaked additive to ultraviolet curable ink, coating and adhesive formulations 1977
O-Chloroaniline Technical (OCA) intermediate compound (dyes, pigments, and urethane curing agent) 1978
Dichlorbenzidine intermediate compound (curing agent for plastics) 1946
D-300 Concentrate (4-Sulfophthalic Acid -50% Solution) forms a decorative and protective coating on structural aluminum parts; pigment intermediate; leather tanning agent early 1950's
O-Dianisidine Dihydrochloride intermediate compound (organic pigments - textile and paper inks; blue textile dyes) 1948
Dichlorobenzidine Dihydrochloride (DCB) intermediate compound (yellow pigments - textile and paper inks) 1947
2, 6 Dichloro-4-Nitroaniline (DCNA) intermediate compound (orange dyes - for nylon & polyester fiber; fabric); as trade name "Botran" (agricultural fungicide) 1965
Diethoxyacetophenone (DEAP) photo initiator or catalyst in ultraviolet curable coatings (floor tiles, cans, and paper products) 1979
2,5 Dimethoxybenzaldehyde (DMB) products for photographic film 1960
Diosgenin steroid pharmaceutical products 1977
Diphenamid Technical (N,N-Dimethy1-2,2-Diphenylacetamide) agricultural herbicide 1964
Photographic Dye Intermediates dyes 1970
p-Toluene Sulfonyl Isocyanate (PTSI) additive in urethane adhesives, coatings and sealants; drug intermediate 1970

Data obtained from an Upjohn Company Product List (7/12/1979)


Table 2.

Manufacturing Process
Manufacturing Process * Example
Chemical Reactions Reductions
Oxidation
Neutralization
Condensation
Physical Processes Drying
Filtration
Decanting
Distillation
Extraction

* Data from Rust Environment & Infrastructure: Human Health Risk Assessment, July 1996.


Table 3.

On-Site Lagoon Status, 1986
Lagoon Number Purpose of Lagoon Status
L1 not available filled
L2 contained liquids drained
L3 contained liquids filled
L4 contained liquids n/a1
L5 probable pickle liquor lagoon filled
L6 probable pickle liquor lagoon filled
L7 probable pickle liquor lagoon filled
L8 not available n/c2
L9 probable settling basin - sludge filled
L10 probable settling basin - sludge filled - partial
L11 probable settling lagoon - sludge filled
L12 probable settling lagoon - sludge partially covered
L13 probable pickle liquor lagoon filled
L14 probable pickle liquor lagoon filled
L15 sludge receiving area filled
L16 aeration lagoon dome constructed to contain caustic vapors
L17 not available filled
L18 unlined primary sludge settling n/c
L19 old sludge disposal area filled

1 data not available
2 no significant change from previous aerial photos

The Upjohn facility operated an on-site wastewater treatment facility. This facility,constructed in the mid-1980's, treated wastewater generated from production prior tobeing discharged into the Quinnipiac River. Before the treatment facility was active,wastewater was treated in several lagoons. The sludge generated from treatingwastewater was disposed of on-site in two waste piles (North & South Waste Piles). Thepractice of disposing sludge in the on-site waste piles ended in 1985. After 1985, thesludge was disposed of off-site in a licensed facility (2). Other wastes generated duringthe last several years of production are listed in Table 4. Previous disposal methodsinclude using the lagoons and waste piles.

Currently, the wastewater treatment facility is operating to remove contamination fromthe groundwater. The wastewater treatment consists of a fluidized bed reactor. It is anenclosed bio-treatment process that releases the water into an activated sludge lagoon. This lagoon is surrounded by a containment bubble. The water is then released into the Quinnipiac River (9).

Table 4.

Production Waste Disposal Methods During the Last Years of Production
Waste # Approximate Amount
(lbs. per year)
Stored On-Site   Disposal Method
Spent Aromatic Solvents 300,000 Yes * Off-site Incineration
Spent Chlorinated Solvents 100,000 Yes * Off-site Incineration
By-product Solvents 700,000 Yes * Off-site Incineration
Still bottoms 450,000 Yes * Off-site Disposal
Sulfuric Acid 4,000,000 Yes * Off-site Recovery
Sulfuric Acid 50,000,000 Yes   On-site Recovery
Muriatic Acid 7,500,000 Yes   On-Site Recovery

# Data from Rust Environment & Infrastructure: Human Health Risk Assessment, July 1996.
* Material was stored on-site in drums and tanks for bulk shipping.

B. COMMUNITY HEALTH CONCERNS

There is currently citizen and local political concern over bladder cancer in the residentialcommunity around the facility. These concerns were further heightened with the strongassociation found in the occupational study conducted on the NHFC workers.

C. DEMOGRAPHICS AND LAND USE

According to the 1990 U.S. Census, approximately 6451 people live within one mile ofthe Upjohn facility (10). Table 5 contains information on the population breakdown forthe area within one mile of the Upjohn facility. Maps of the demographic data can befound in Appendix A.

North Haven potable water is supplied by a public water supply. There are no publicwater supply wells within two miles of the Upjohn facility (11). The nearest resident tothe Upjohn facility is approximately 620 feet.

Table 5.

Demographic Statistics Within One Mile of Site
Demographics * Frequency
Total Population 6,493
White 6,151
Black 147
American Indian, Eskimo, Aleut 0
Asian, Pacific Islander 154
Other Race 2
Hispanic Origin 39
Children Aged 5 and Younger 327
Adults Aged 65 and Older 1,251
Females Aged 15-44 1,317
Total Housing Units 2,705

* Demographic data obtained from the 1990 U.S. Census, STF3A. Demographics were calculated using an area-proportion spatial analysis technique.

Most of the area surrounding the NHFC facility is classified as residential, industrial,marsh/wetlands, water, and forest. The land use and land cover information can be foundin Figure 2 Map of Land Use/Land Cover in Appendix A. The land use/land cover is arepresentation of satellite imagery.

D. HEALTH OUTCOME DATA

The Connecticut Department of Public Health, formally Department of Health Services,published a study on cancer in North Haven. The study, published in ConnecticutMedicine, January 1981, reviewed cancer in North Haven and its surrounding towns. Thereview of cancer was conducted because of a suspicion of excess cancer cases near theUpjohn facility.

Cancer mortality was studied during the time periods 1969 - 1971 and 1974 - 1976. Seven primary cancer sites were reviewed. Age adjusted rates by tumor site, town,gender, and time period are presented. Cancer morbidity was studied during the timeperiod 1973 - 1978. Nineteen primary sites were compared to expected values based onConnecticut state rates (Standard Morbidity Ratios - SMR). The ratios were adjusted tothe North Haven age distribution for males and females (12). While not significant, theSMR for male leukemia was 2.0 p <=0.095.

The study concluded that "...the data provided no convincing evidence that North Havenhas had a cancer experience different from surrounding towns or from the State as awhole.". However, the study also concludes that more sensitive methods need to bederived to examine the effect of low-level carcinogens in small area analyses (12).

SRA Technologies completed a cancer incidence study of Upjohn workers in September,1995 (1). The study was initiated after three employees developed bladder tumors afterbenzidine, a known bladder carcinogen, production had been discontinued. The studyexamined the relationship between arylamine exposure such as dichlorobenzidine, ortho-tolidine, and ortho-dianisidine and cancer. These arylamine exposures were selectedbecause they were being produced at the Upjohn facility after production of benzidine hadstopped in mid-July, 1965 (1).

The study cohort consisted of 704 workers employed at the Upjohn North Haven facilitybetween July 1, 1965 and December 31, 1989. This time frame allowed researchers toexamine the effects of arylamine exposure other than benzidine. This cohort study found27 confirmed cancer cases. Case data were ascertained through a worker survey, deathcertificates, the Connecticut Tumor Registry, and the company health/surveillance program (1).

The researchers used the standardized incidence ratio (SIR) in their analysis. An SIR isthe total number of observed cancer cases among Upjohn workers divided by the totalnumber of expected cancer cases among Upjohn workers. The study found a statisticallysignificant increase in the SIR for male bladder and testicular cancer. A non-significantSIR was found for breast cancer. The elevated SIRs for testicular and breast cancer werebased on three or fewer cases. They were also not associated with arylamine exposure. The SIR for male bladder cancer was 8.3 (95% CI = 3.3, 17.0) (1).

The study concluded that the increase in bladder cancer was associated with anoccupational exposure (1).


DISCUSSION

A. ENVIRONMENTAL CONTAMINATION & EXPOSURE PATHWAYS

The Connecticut Department of Environmental Protection archived data on the Upjohnsite. This data comes from a variety of sources. All of the data were collected forpurposes other than this PHA.

Ambient Air

Ambient air samples were not taken on a routine basis around the Upjohn facility. However, during the time period August 8-11, 1989, ambient sampling was conducted bythe Environmental Protection Agency (EPA) (13). Samples were collected both on theUpjohn property and in the surrounding neighborhoods utilizing the EPA TraceAtmospheric Gas Analyzer (TAGA). Table 6 contains information on elevated airsampling results. Because of the industrial nature of the area, other industrial facilitiesmay be responsible for some of the ambient air findings.

Table 6.

Chemicals Detected in Air
Sample Location Chemical Maximum Concentration ppb Comparison Value ppb Source EPA Group
On-site Benzene 5,500 0.03 CREG A
Chlorobenzene 350 # # Not Classified
1,2-Dichloroethane 0.07 0.01 CREG B2
Off-site Benzene 300 0.03 CREG A
Dichlorobenzene * 30 100@ CEMG Not Classified
1,4-Dioxane 18 # # B2
Toluene 1,700 1,000 Chronic MRL Not Classified
1,1,1-Trichloroethane 1,100 700 Int MRL Not Classified
# There are no ATSDR health comparison values for these compounds
* Unspecified isomer
@ For 1,4-dichlorobenzene
A Human carcinogen
CEMG Chronic Environmental Media Guideline
B2 Probable human carcinogen
Chronic MRL Chronic Minimal Risk Level
CREG Cancer Risk Evaluation Guideline
Int MRL Intermediate Minimal Risk Level
ppb parts per billion

The TAGA is designed to identify air contaminant plumes. The results represent an instantaneous sample for the space and time it was collected. In a 1989 Health Consult, the Agency for Toxic Substances and Disease Registry (ATSDR) evaluated these data. ATSDR concluded the data were difficult to interpret with regards to public health implications. ATSDR also concluded that the benzene readings, both on and off site, may reflect a public health concern to area residents (13). The off-site reading of 300 ppb benzene was taken south of the site, north of Republic Drive. It is a non-residential area. There is limited information available regarding the sampling location. It is unknown if the sampling location was selected because it would represent off-site emissions.

In December, 1988, Upjohn reported an accidental release of benzene (2,197 lbs) to theair. The CTDPH, conducted a risk assessment on the release. The CTDPH concludedthat because the benzene release occurred early on a winter morning (approximately4:00am), the potential for acute exposure was averted. This was due to most individualsbeing indoors (14). The CTDPH report raised the issue of process and fugitive benzeneemissions as being a potential problem.

People living near the UpJohn facility may have been exposed to elevated levels ofbenzene and other compounds in the air. These exposures occurred as a result of fugitiveemissions as well as accidental releases.

Since comprehensive ambient air sampling, both on and off site, were not conducted,little information is known regarding which contaminants became airborne, what thelevels may have been in the community, and for how long residents may have beenexposed. While it is important to note that air exposures from the facility have beeneliminated, the lack of historical data will limit the evaluation of this completed exposurepathway.

Ground Water Monitoring Wells

Ground water samples have been collected from fifteen on-site monitoring wells. Groundwater sampling occurred quarterly from 1984 to the present. These data were obtainedfrom two of the sampling reports, July 1993 and April 1995 (15,16). There were fourchemicals detected above health comparison values (benzene, 1,4 dioxane,chlorobenzene, and manganese). Because of difficulties in obtaining historical data, theground water monitoring well evaluation is limited to two of the sampling reports. Table7 lists the chemicals that were identified above health comparison values. The WaterSupplies Section of the Connecticut Department of Public Health reviewed the areaaround the Upjohn site. There are no public water supply wells in the Upjohn site area(11). The public water supply exposure pathway has been eliminated (17). Therefore,this addresses one of the petitioners request to review possible public well contamination.

Table 7.

Chemicals Detected in Groundwater Monitoring Wells
Chemical Maximum Concentration ppb Comparison Value ppb Source EPA Group
Benzene 200 1 CREG A
Chlorobenzene 100 100 LTHA Not Classified
1,4-Dioxane 100 3 CREG B2
Manganese 200 50 RMEG Not Classified
A Human carcinogen
B2 Probable human carcinogen
CREG Cancer Risk Evaluation Guideline
LTHA Lifetime Health Advisory for Drinking Water
ppb parts per billion
RMEG Reference Dose Media Evaluation Guideline

Ground Water Private Wells

There are historical documents that suggest that private wells (residential) in the area ofthe site were active while Upjohn was still operational. The CTDPH collected samplesfrom eight private wells in the area of Upjohn during the end of 1979. Two of the wellswere used for gardening and not as the main source of potable water for the household. Additional sampling was done during the summer of 1982. The wells were sampled fororganohalides, cyanide, phenol, and heavy metals. In all cases, the wells were determinedto be potable. There are very few private water supply wells in North Haven (17). Currently, there are a few residents in the Upjohn area serviced by a private well forpotable water (13,17). These wells are located over one-half mile from the site, east andupstream of the Quinnipiack River. The Upjohn facility is west of the Quinnipiack River. Therefore, we are eliminating private wells as an exposure pathway.

Of the eight wells sampled, only one had a chemical detected above health comparisonvalues. The chemical detected was chloroform (13.0 ug/L). This was found only duringthe 1982 sampling period. It was not detected during the previous sampling period(1979).

Sediment

The Upjohn Company conducted a Quinnipiac River sediment study in the early 1980's. This was accomplished in accordance with National Pollutant Discharge EliminationSystem (NPDES) permit requirements (19). Upjohn discharged treatment system effluentinto the Quinnipiac only when the treatment system malfunctioned. In 1984 there were34 permitted NPDES discharges into the Quinnipiac River. Of the 34, 21 were industriesupstream from Upjohn's discharge point. Because of this, lead and calcium were selected as indicators of Upjohn waste (19). Upjohn used lead in itselemental form and it easily settled in the river making it an ideal indicator of Upjohnwaste. Upjohn also used large quantities of lime to neutralize sulfuric acid. Due to this,calcium was also selected as an indicator of Upjohn waste (19). Elevated levels of leadwere detected in the sediment. Table 9 contains data on the sediment sampling. Becauseaccess the this area is restricted by a fence or very difficult to reach, exposure to sedimentis being eliminated as a pathway of concern.

Table 8.

Indicator Chemicals Detected in Sediment
Chemical Maximum Concentration ppm
Calcium 7,700
Lead 2,100
ppm parts per million

 

B. PUBLIC HEALTH IMPLICATIONS-Adult and Children's Health Issues

We evaluated the possible exposure pathways for the following media: air, ground water,private wells, and sediment. After evaluating environmental sampling data for these mediaas well as the ways in which residents could come in contact with these media, it was determined that the pathway that posed a risk to the community was off-site air. Privatewells and groundwater were eliminated as pathways because no one is using groundwater forpotable purposes and sediments were eliminated because of restricted access.

Toxicologic Evaluation

To evaluate health effects, the ATSDR has developed Minimal Risk Levels (MRLs) forcontaminants commonly detected at hazardous waste sites. The MRL is an estimate ofdaily human exposure to a contaminant below which non-cancerour, adverse healtheffects are unlikely to occur. MRLs are developed for each route of exposure such asingestion, inhalation, and dermal absorption. MRLs are also developed for the length ofexposure, such as acute (less than 15 days), intermediate (15 to 364 days), and chronic(greater than 364 days).

Summary

The public health concern of interest is benzene and acute myeloid leukemia (AML). While residents near the Upjohn site may have been exposed to other chemicals, thosechemicals may not be associated with AML. Because of the limited nature of theavailable data, the effects of multiple chemcial exposures and interactions were notevaluated.

Exposure Assumptions

The exposure pathways examined in this section is the inhalation route. The exposureperiod is assumed to coincide with the start of the chemical manufacturing process in1946. The exposure period for the inhalation route of exposure terminated in 1993, whenthe facility ended chemical production. Consequently, the maximum exposure durationused in this analysis is 46 years.

Benzene

Benzene was measured in the ambient air adjacent to the Upjohn facility at amaximum concentration of 300 ppb. The sample was collected in 1989, andrepresents the only sampling event for benzene measured near the UpJohn facility. During that sampling event, there were several locations where benzene was alsodetected at elevated levels. The elevated levels of benzene were: 14, 25, 45, 60,110, 200, 240, and 300 ppb. While these levels are above the intermediate MRLof 4 ppb, it is unlikely that non-cancer health effects will occur. Adverse healtheffects of benzene exposure include the blood forming tissues including areduction in various cellular components of the blood. Occupational studies ofworkers exposed to benzene at concentrations up to 500 ppb for as long as 15years indicated that exposures at these levels did not result in adverse effects.

Carcinogenicity Classification:
Benzene has been classified by the EPA as a known human carcinogen (EPAgroup A). The cancer risks were calculated for residents living near the Upjohnfacility, and being exposed to benzene in the ambient air. We used the maximumbenzene concentration (300 ppb), and conclude that there is a moderate increasedrisk for developing acute myeloid leukemia (AML). The risk estimation wasbased on the maximum detected benzene during the 1989 sampling round, andalso the value based on an estimate of the annual average benzene concentration.

Brief Description of Chemical:
Benzene is a colorless liquid with a sweet odor. This compound dissolves inwater easily and evaporates readily into the air. Benzene is a highly flammableliquid and is a component of gasoline (20). Benzene has been linked to thedevelopment of AML and other adverse affects related to the hematopoietic(blood related) system.

Toluene

Elevated levels of toluene were measured in the ambient air off-site at a maximumconcentration of 1,700 ppb. The sample was collected in 1989, and represents theonly sampling event for toluene measured near the Upjohn facility. Thisconcentration (1,700 ppb) exceeds the chronic minimum risk level for toluene(1,000 ppb). Sensitive individuals may experience reversible non-canceroushealth effects including headaches and dizziness. These symptoms usuallydisappear when exposure is stopped (21).

Occupational studies have been conducted examining the effects of long-termexposure to toluene. These investigations examined exposure to concentrationsfive times higher than the measured concentration in the ambient air off-site fromthe Upjohn facility. Some of the workers in these investigations were exposedday-after-day for as long as 43 years, and they reported experiencing headachesand dizziness (21).

Carcinogenicity Classification:
Scientific investigations involving workers and animals exposed to toluene indicatethat this compound does not cause cancer. The EPA has determined that toluene isnot classifiable as to its human carcinogenicity.

Brief Description of Chemical:
Toluene is a clear solvent with a distinctive smell. This compound is one of manycompounds added to gasoline. Toluene is found in the tolu tree and in crude oil. Itis also produced during the production of gasoline and other fuels from crude oil.Toluene is used in many products including: paints, paint thinners, nail polish,lacquers, and adhesives (21).

1,1,1-Trichloroethane

Elevated levels of 1,1,1-trichloroethane were measured in the ambient air off-siteat a maximum concentration of 1,100 ppb. The sample was collected in 1989, andrepresents the only sampling event for 1,1,1-trichloroethane measured near theUpjohn facility. This concentration (1,100 ppb) exceeds the intermediateminimum risk level for 1,1,1-trichloroethane (700 ppb exposure >7 days up to 1year). Occupational studies have been conducted examining the effects of long-term exposure to 1,1,1-trichloroethane. These investigations examined exposureto concentrations one hundred times higher than the measured concentration in theambient air off-site from the Upjohn facility. These workers were exposed day-after-day for as long as 6 years and experienced no adverse health effects.Consequently, residents living near the Upjohn facility are not likely to experienceadverse non-cancerous health effects resulting from airborne exposure to 1,1,1-trichloroethane (22).

Carcinogenicity Classification:
Scientific investigations involving workers and animals exposed to 1,1,1-trichloroethane indicate that this compound does not cause cancer. The EPA hasdetermined that 1,1,1-trichloroethane is not classifiable as to its humancarcinogenicity.

Brief Description of Chemical:
1,1,1-Trichloroethane is a clear liquid that has a noticeable sharp, sweet odor. This chemical evaporates quickly and becomes a vapor. It is also known asmethyl chloroform, methyltrichloromethane, and trichloromethylmethane. 1,1,1-Trichloroethane is not a naturally occurring chemical. It is used in themanufacture of in many common products including: paint, glue, industrialdegreasers, and aerosol sprays. 1,1,1-Trichloroethane is one of several compoundsthat have been determined to adversely effect the atmospheric ozone layer.

1,4-Dioxane

Elevated levels of 1,4-dioxane were measured in the ambient air off-site at amaximum concentration of 18 ppb. The sample was collected in 1989, andrepresents the only sampling event for 1,4-dioxane measured near the Upjohnfacility. The concentration at which people first notice this compound in the air is24,000 ppb. 1,4-Dioxane can be irritating to the mucus membranes, skin, andlungs at high levels (23). These adverse effects would not be expected at thelevels identified around the site.

Carcinogenicity Classification:
1,4-Dioxane has been classified by the EPA as a probable human carcinogen (EPAgroup B2). There is insufficient information to calculate the carcinogenic health risks of exposure to 1,4-dioxane.

Brief Description of Chemical:
1,4-Dioxane is a liquid with a pleasant odor. This compound is used in theproduction of many industrial compounds, including oils, waxes, and dyes.

1,4-Dichlorobenzene

Elevated levels of dichlorobenzene were measured in the ambient air off-site at amaximum concentration of 30 ppb. The sample was collected in 1989, andrepresents the only sampling event for dichlorobenzene measured near the Upjohnfacility. This concentration (30 ppb) is below the chronic minimum risk level for1,4-dichlorobenzene (100 ppb). Sensitive individuals may experience reversiblenon-cancerous health effects including headaches and dizziness at the levels nearthe Upjohn facility. These symptoms usually disappear when exposure is stopped(24).

Carcinogenicity Classification:
This substance has not undergone a complete evaluation and determination by theEPA's program for evidence of human carcinogenic potential.

Brief Description of Chemical:
1,4-Dichlorobenzene is a white solid with a strong odor like the smell ofmothballs. When 1,4- dichlorobenzene is exposed to the air, it slowly sublimates(changes from solid to gas). 1,4-dichlorobenzene has been detected in somehomes and public rest-rooms at concentrations as high as 270 ppb. The outdoorconcentration of 1,4-dichlorobenzene ranges from 0.02 to 20 ppb. This compoundhas also been detected in foods such as chicken, eggs, and pork. This is due to useof 1,4-dichlorobenzene as an odor control product in animal pens. 1,4-Dichlorobenzene is used mainly as a space deodorant for rest-rooms and trashcontainers, as well as for controlling moths, molds, and mildews. This compoundis also used as an intermediate in many chemical manufacturing processes.

C. COMMUNITY HEALTH CONCERNS EVALUATION

There is currently citizen and local political concern over bladder cancer. These concernsare enhanced due to the strong association found in the occupational study conducted onthe NHFC workers. Concerns exist that those living near the NHFC facility may beexperiencing higher levels of bladder cancer than should be expected.

There is generally a large difference between occupational exposures and environmentalor residential exposures. The occupational exposures are likely to be considerably higherthan what you would find in the residential areas. The exposures are different for manyreasons such as workers being in close contact with the chemicals and poor ventilation. As chemicals are released into the environment, they each react differently depending ontheir properties.

During its operation, past exposures to area residents from the NHFC facility via air werelikely. While we only have actual sampled data for a few compounds, it is likely that airemissions included many other chemicals. The exposures would have occurred fromprocessing and manufacturing, as well as through the handling and storage of waste. These exposures cannot be quantified.

This public health assessment indicates that past air exposure to area residents is likely tohave occurred from chemicals manufactured and stored at the NHFC facility. This publichealth assessment did not review possible emissions from other industrial sources aroundthe NHFC facility.

A Public Comment period for this document was held between September 1999 -November 1999. The public comments received during this period and the responses tothese comments are shown in Appendix B.


CONCLUSIONS

Based on the information reviewed, the CTDPH has concluded that this site represented apublic health hazard in the past due to air exposures from the Upjohn NHFC facility. This conclusion was based on limited data and information. Of primary concern is theincreased risk of AML associated with exposure to benzene. The site currently representsno public health hazard because there are no ongoing exposures to air emissions or otherenvironmental media.

  1. Exposures from production at the NHFC facility ended in 1993.

  2. The occupational epidemiology study found elevated bladder cancer among maleworkers. Bladder carcinogens were used at the facility and disposed in on-site wastepiles. There is a biological plausible association between bladder cancer and thechemicals used at the facility.

  3. The review of cancer rates by the DPH in 1981 found an elevated SMR for maleleukemia. Contaminants that cause acute myeloid leukemia (i.e. benzene) werereleased into the environment. There is a biological plausible association betweenAML and the contaminants released into the environment.

RECOMMENDATIONS

The Agency for Toxic Substances and Disease Registry and the ConnecticutDepartment of Public Health have evaluated the findings of this Public HealthAssessment and recommend that an analysis of bladder cancer and AML beconducted. These two tumor sites are suggested for analysis because of the strongcorrelation between the contaminants and the disease. The past work by the CTDPHwas limited because of methodological restrictions. With the use of GeographicInformation Systems (GIS) in epidemiology, we now have the ability to characterizeexposures and examine cancer data in relation to the exposures.

This analysis will provide a picture of cancer incidence in North Haven. The studywill not determine if the cancers were caused by the NHFC facility. It will onlyprovide an overview of cancer incidence (bladder and AML) in North Haven, inrelation to possible exposures from the NHFC facility.


PUBLIC HEALTH ACTION PLAN

The Public Health Action Plan (PHAP) for the Upjohn site contains a description of theactions to be taken by the ATSDR, the CT DPH, the CT DEP, and/or the EPA in thevicinity of the site. For those actions already taken at the site, please see the Backgroundsection of this Public Health Assessment. The purpose of the PHAP is to ensure that thishealth assessment not only identifies public health hazards, but provides a plan of actiondesigned to mitigate and prevent adverse human health effects resulting from exposureto hazardous substances in the environment. Included, is a commitment on the part ofthe ATSDR and the CT DPH to follow up on this plan to ensure that there isimplementation. The public health actions to be implemented by the ATSDR, the CTDPH, and the CT DEP are as follows:

  1. The CT DPH will evaluate the health statistics in the community around the Upjohnfacility. The findings of this evaluation will be documented and made available tothe public.

  2. The CT DPH will provide environmental health education for local public healthofficials, the local medical community and local citizens to assist the community inassessing possible adverse health outcomes associated with exposures to toxicsubstances.

ATSDR will re-evaluate and expand the Public Health Action Plan when needed. Newenvironmental, toxicological, or health outcome data, or the results of implementing the above proposed actions may determine the need for additional action at this site.


PREPARERS OF REPORT

Gary V. Archambault, M.S.
Epidemiologist
Environmental Epidemiology and Occupational Health
Connecticut Department of Public Health


ATSDR Regional Representative:

William Sweet, Ph.D., DABT
Agency for Toxic Substances and Disease Registry, Region 1, Boston, MA


ATSDR Technical Project Officer:

Tina Forrester, Ph.D.
Office of Regional Operations
Agency for Toxic Substances and Disease Registry, Atlanta, GA

Greg Ulirsch
Superfund Site Assessment Branch
Division of Public Health Assessment and Consultation
Agency for Toxic Substances and Disease Registry, Atlanta, GA


CERTIFICATION

The Public Health Assessment for the Upjohn Co-Fine Chemicals Division, NorthHaven, Connecticut was prepared by the Connecticut Department of Public Health undera cooperative agreement with the Agency for Toxic Substances and Disease Registry(ATSDR). It is in accordance with approved methodology and procedures existing at thetime the public health assessment was initiated.

Gregory V. Ulirsch
Technical Project Officer, SPS, SSAB, DHAC


The Division of Health Assessment and Consultation, ATSDR, has reviewed this PublicHealth Assessment and concurs with its findings.

Richard Gillig
Chief, SPS, SSAB, DHAC, ATSDR


REFERENCES

  1. SRA Technologies, Inc., Cancer Incidence Study of Workers Handling Mono-and Diarylamines Including Dichlorobenzidine, Ortho-tolidine, and Ortho-dianisidine. September 14, 1995.

  2. Rust Environmental & Infrastructure under contract with Pharmacia & UpjohnCompany. Human Health Risk Assessment, July 1996.

  3. Correspondence from: North Haven First Selectman, to: Mr. Stephen A.Harriman, (Commissioner, CT Department of Public Health). September 29,1995.

  4. Correspondence from: A North Haven Citizen's Group, to: Mr. Stephen A.Harriman, (Commissioner, CT Department of Public Health). November 2, 1995.

  5. Conversation with Alan Siniscalchi, CT DPH Staff and Gary Archambault, CTDPH Staff, March 18, 1998.

  6. Environmental Protection Agency. Site Analysis Upjohn Chemical North Haven,Connecticut Volume 1. July 1987.

  7. The Upjohn Company: Upjohn's Background Information. July 1979.

  8. Correspondence from: CTDPH staff, to: CTDPH Division Director, July 18,1979.

  9. Personal communication between Gary Archambault, Connecticut Department ofPublic Health, and Randy Senger, Upjohn, 7/30/98

  10. U.S. Census, 1990 Census of Population and Housing, Summary Tape File 3A.

  11. Personal communication between Gary Archambault, Connecticut Department ofPublic Health, and Tom Reed, Connecticut Department of Public Health, WaterSupplies Section, August 1998.

  12. Gershman ST, Most RS, Lewis JN, Marks JS. An Epidemiologic Review ofCancer in an Industrialized Connecticut Town. Connecticut Medicine, Vol. 45,No. 1. January 1981.

  13. ATSDR, Health Consultation: Evaluation of Air Sampling Data, Upjohn Facility,North Haven, Connecticut, December 18, 1989.

  14. Personal correspondence from Hari Rao, Toxicologist, Connecticut Departmentof Public Health, to Dave Brown, Division Director, Connecticut Department ofPublic Health, April 13, 1989.

  15. GZA GeoEnvironmental, Inc. Tenth Year, Third Quarter Report RCRAGroundwater Monitoring, July, 1993.

  16. GZA GeoEnvironmental, Inc. Twelfth Year, Second Quarter Report RCRAGroundwater Monitoring, April, 1995.

  17. Personal communication between Gary Archambault, Connecticut Department ofPublic Health, and Leslie Balch, North Haven health director, August 19, 1997.

  18. Ebasco Environmental. Waste Pile Characterization, North Haven, CT, Phase ISampling And Analysis Report, February 18, 1992.

  19. NUS Corporation, Superfund Division for EPA Region I. Summary of InspectionActivities, June 11, 1984.

  20. Agency for Toxic Substances and Disease Registry, Toxicological Profile forBenzene - Update, August 1995.

  21. Agency for Toxic Substances and Disease Registry, Toxicological Profile forToluene - Update, May 1994.

  22. Agency for Toxic Substances and Disease Registry, Toxicological Profile for1,1,1-Trichloroethane - Update, August 1995.

  23. Windholz, et al., The Merk Index. Tenth Edition. New Jersey, Merk & Co., Inc., 1983.

  24. Agency for Toxic Substances and Disease Registry, Toxicological Profile for 1,4-dichlorobenzene April 1993.

APPENDIX A: FIGURES

Map of Upjohn Facility
Figure 1. Map of Upjohn Facility

Map of Land Use/Land Cover
Figure 2. Map of Land Use/Land Cover

Demographics A
Figure 3. Demographics A

Demographics B
Figure 4. Demographics B


APPENDIX B: PUBLIC COMMENTS

COMMENTS ON SEPTEMBER, 1999 PUBLIC HEALTH ASSESSMENT

COMMENTS RECEIVED FROM CITIZEN 1

GENERAL COMMENT NO 1.

The health community concerns are broader than just bladder cancer. When I contactedlst selectman Rescigno asking for a somewhat broad cancer study for the surrounding areaof the Upjohn Plant, the high incidence of bladder cancer inside the plant had just beenreported in the newspaper. That bladder cancer report somehow got translated intoResigno's asking for a bladder cancer study instead of the broader cancer study that waswanted. This mistake was never corrected. What is needed is a cancer study, broader thanjust a bladder cancer study, in the geographic area near the plant.

RESPONSE TO GENERAL COMMENT NO 1.

Cancer is the uncontrolled growth and spread of abnormal cells anywhere in the body. There are many different types of cancer. Cancer is usually not caused by only one factor,but is almost always caused by a combination of factors including lifestyle (smoking, diet,and exercise), heredity, and environment. The risk factors for development of one type ofcancer are likely to be very different from the risk factors associated with another type ofcancer. Therefore, it is unlikely that a review of all tumors would be meaningful. Thetumor sites that were recommended for study, AML and bladder were selected because ofavailable data on releases to the environment and associations with the tumors sites. Thehealth statistics review will provide information regarding whether residents living closeto the Upjohn facility are experiencing, or did experience more cancer than those livingfurther away.

GENERAL COMMENT NO 2.

The health data outcome from a study such as described in this section (PAGE 12) wouldnever show any significant increase in cancer rates due to the Upjohn plant, because thegeographical area studied was too big. You cannot study a whole town and expect to findany significant cancer data related to a plant in one part of town. That is why a study of atwo mile area around the Upjohn plant needs to be done.

RESPONSE TO GENERAL COMMENT NO 2.

This is a limitation; however, it is a necessary step in reviewing cancer rates in an area. Itis accepted practice to report disease rates by town and compare them to the rate ofdisease for the State of Connecticut. The evaluations of smaller geographic areas werenot conducted by the CT DPH at the time the work was completed in 1981. This wasprimarily due to not having the tools available to conduct analyses other then at the townlevel. The analysis would also not have been able to show an increase in cancer rates dueto the Upjohn facility. It is unlikely that any study would be able to make thatdetermination. However, the CT DPH will employ methods that will reflect the cancerrates around the Upjohn plant.

GENERAL COMMENT NO 3.

As explained above, the concern is broader than bladder cancer. Because we now haveTRI data and we now know what the citizens around the plant were actually exposed to,this current information warrants a broader cancer study.

RESPONSE TO GENERAL COMMENT NO 3.

The goal of TRI (Toxic Release Inventory) was to "… help citizens, officials, andcommunity leaders to be better informed about toxic and hazardous materials in theircommunities." TRI data should not be used as exposure data. Not allchemicals/compounds reported in TRI for Upjohn would have been released into theenvironment. A lot of different chemicals/compounds were used at the Upjohn facility. Not all of these chemicals/compounds found their way into the community. The factremains that we do not know what or how much the citizens around the plant wereactually exposed. It would be inappropriate to base a broader cancer review based on TRIdata.

The cancer review is based on known chemical releases and biological plausibility. Theliterature is reviewed and tumor sites are selected based on whether there is an establishedlink between the chemical and tumor. The two tumor sites selected, bladder cancer andAML meet that requirement.

GENERAL COMMENT NO 4.

Please expand the tumor sites from the two proposed sites which are bladder and acutemyeloid leukemia (AML) to all acute leukemia's as well as AML, to all lymphomas,including non-Hodgkin's lymphoma, colon, bladder, kidney, breast, and ovarian. Becausemany of the chemicals that came out of Upjohn's stacks and lagoons are suspectedendocrine disrupters, the two cancers of reproductive organs, breast and ovarian, need tobe added. As well, many of the chemicals that people were exposed to were ones thataffect the kidneys. Furthermore, we know that there is no health data for the exposures ofone, two, three, or four carcinogens together in the air being taken up into the humanbody as a soup of carcinogens in a single breath, and that is why it is also important tocall for the study to include the expanded list of cancer sites. Many of the chemicals thatpeople were exposed to for twenty years were carcinogens that could have had impacts onthese organ sites.

RESPONSE TO GENERAL COMMENT NO 4.

The methodologies and protocols for the future health statistics review have not beenfinalized. The tumor sites that were recommended for study, AML and bladder, wereselected because of available data on releases to the environment and associations withthe tumors sites. However, the request for additional tumor sites will be considered forthe health statistics review.

GENERAL COMMENT NO 5.

Please contain the study to a radius of two miles around the plant. As there was a dilutionof the contaminants in the air as you moved further and further from the plant, so too, ifthe study is much larger than a two mile radius, there will be a dilution of the statistics.

There also needs to be included in this study the tumor sites of those people who workedin businesses that were located around the Upjohn Plant. There were many people whoworked in businesses on State Street and Sackett Point Road during the years of highexposures. Therefore they too would have been heavily exposed during their workinghours and should be included in the study if possible.

RESPONSE TO GENERAL COMMENT NO 5.

The CT DPH will employ methodologies that will reflect the cancer rates around theUpjohn plant. The suggestion for reviewing tumors of worker in business near theUpjohn facility will not be possible. The health statistics review will be conducted usingexisting data from the Connecticut Tumor Registry (CTR). The CTR does not collectinformation on work place at time of diagnosis. The CTR is an excellent resource for theevaluation of cancer in a community. It is the oldest population based registry in theUnited States, with data going back to 1935. It allows for the historical review of cancerrates within Connecticut. The health statistics review will provide information regardingwhether residents living close to the Upjohn facility are experiencing, or did experiencemore cancer than those living further away.


PUBLIC COMMENTS RECEIVED FROM CITIZEN (2)

GENERAL COMMENT NO 1.

I am concerned about contamination from Upjohn after reading the report. I have aprivate well. I use the well water for drinking. Please consider asking the local healthdepartment to investigate wells in my area.

RESPONSE TO GENERAL COMMENT NO 1.

The local health department has been contacted and made aware of the private well. Anyadditional private well information will be reviewed by CTDPH/ATSDR in a separatehealth consultation for the site.



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