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PUBLIC HEALTH ASSESSMENT

RODALE MANUFACTURING COMPANY INC.
EMMAUS, LEHIGH COUNTY, PENNSYLVANIA

ENVIRONMENTAL CONTAMINATION AND OTHER HAZARDS

The tables in this section list the contaminants of concern. However, their listing does not imply that a health threat exists. This public health assessment evaluates these contaminants in subsequent sections and determines whether exposure to them has public health significance. PADOH selected these contaminants based upon the following factors: on- and off-site concentrations; field and laboratory data quality and sample design; comparison of site-related concentrations with background concentrations; and comparison of site-related concentrations with comparison values for carcinogenic and noncarcinogenic endpoints. When selected as a contaminant of concern in one medium, that contaminant will be reportable in all media. Comparison values for public health assessments are contaminant concentrations in specific media that are used to select contaminants for further evaluation. The comparison values include environmental media guides (EMEGs) and cancer risk evaluation guides (CREGs), among others. EMEGs are media-specific comparison values used to select contaminants of concern (25). A reference dose media evaluation guide (RMEG) is a contaminant concentration in water or soil which is calculated from EPA's Reference Dose (RfD). EMEGs and RMEGs are used to select contaminants for evaluation of the contaminant's potential to cause noncancer, adverse health effects if people are exposed to the contaminant through an environmental medium such as water. CREGs are estimated contaminant concentrations (derived from Cancer Slope Factors) expected to cause no more than one excess cancer in a million persons exposed over a lifetime (70 years).

EPA developed Maximum Contaminant Levels (MCLs). MCLs are federal drinking water standards established under the Safe Drinking Water Act. Generally, an MCL is the maximum concentration of a toxic chemical that is allowed in public drinking water supplies. The MCL is the contaminant level considered protective of public health and is based on exposure of a 154-pound adult who drinks 2 liters of water per day. In addition to health factors, an MCL is required by law to reflect the technological and economic feasibility of removing the contaminant from the water supply.

In the data tables in the On-Site Contamination and Off-Site Contamination subsections, the listed contaminant does not mean that it will cause adverse health effects upon exposure. Instead, the list indicates which contaminants will be evaluated further in the public health assessment. When selected as a contaminant of concern in one medium, that contaminant will be reported in all media.

The EPA Toxic Chemical Release Inventory data base was accessed by PADOH through the National Library of Medicine's Toxicology Data Network and searched for estimated annual releases of toxic chemicals to the environment from industries within a 2-mile radius of the Rodale Manufacturing site. The purpose of the data base search was to identify possible facilities that could contribute to environmental contamination near the site. No significant releases were reported in the 1987, 1988, and 1989 data bases.

A. On-Site Contamination

In March 1988, limited sludge sampling was conducted by AnalytiKEM at the plating and rubber milling pits. Sludge samples contained copper (5,300 mg/kg), mercury (790 ug/kg), and zinc (5,300 mg/kg). However, standing liquid samples from the pit did not contain more than trace amounts of these materials. The material from these pits was removed by IT Corporation in July 1988 and disposed of at ChemClear in Baltimore, Maryland. Laboratory report forms have not been located for these samples. The results are listed in the text of the report entitled Groundwater Monitoring Plan (SNR Company, March 17, 1989) (2). The contamination has been removed and the contaminants in the liquid did not exceed groundwater comparison values; therefore, those contaminants are not addressed further in the public health assessment.

A soil boring sample was taken during the installation of monitoring well #1 and submitted for laboratory analysis of Hazard Substance List compounds. This analysis did not reveal high levels of contaminants, and the samples ranged in depth from 5 feet to 62 feet. The analysis performed during remediation did not adequately characterize the site. No surface soil data were collected. A soils investigation is planned as part of the RI/FS, which is scheduled for spring 1995; the Hazardous Ranking System site score was based, primarily, on the groundwater contamination (2).

Groundwater - Injection Wells and Other On-Site Wells

On January 23 and January 24, 1989, Square D personnel obtained filtered and unfiltered samples from three on-site wells #1, #4, and #6. All groundwater samples were analyzed by an EPA Contract Laboratory Program (CLP) for volatile and semi-volatile organic compounds and metals. Figure 2 shows the sampling locations, and Table 1 reports the maximum concentrations of contaminants. Appendix A provides a summary of information available on these wells.

Table 1. On-Site Contamination in Wells (1)

CHEMICAL MAXIMUM CONCENTRATIONS COMPARISON VALUE
Unfiltered
(µg/L)
Filtered
(µg/L)
µg/L Source
Benzene 14 NA 1 CREG
Trichloroethene (TCE) 20,000 NA 3 CREG
Trans-1,2-Dichloroethene (tDCE) 5,000 NA 100 MCL
Vinyl Chloride 390 NA 02.0 EMEG
Tetrachloroethene (PCE) 52 NA 0.7 CREG
Lead 57.4 24.8 0.0 MCLG

µg/L - micrograms per liter or parts per billion (ppb)
NA - Not Analyzed.
CREG - Cancer Risk Evaluation Guide.
MCL - Maximum Contaminant Level.
EMEG - Environmental Media Evaluation Guide.
MCLG - Maximum Contaminant Level Goal.

B. Off-Site Contamination

Groundwater - Monitoring Wells

On January 23 and January 24, 1989, Square D personnel obtained filtered and unfiltered samples from the four monitoring wells immediately around the site (MW#1, MW#2, MW#3, and MW#4). Figure 2 shows the sampling locations, and Table 2 reports the maximum concentrations of contaminants.

Table 2. Off-Site Contaminants in Monitoring Wells (1)

CHEMICAL MAXIMUM CONCENTRATIONS COMPARISON VALUE
Unfiltered
(µg/L)
Filtered
(µg/L)
µg/L Source
Benzene ND NA 1 CREG
Trichloroethene (TCE) 35,000.0 NA 3 CREG
Trans-1,2-Dichloroethene (tDCE) 1,600.0 NA 100 MCL
Vinyl Chloride 42.0J NA 02.0 EMEG
Tetrachloroethene (PCE) 420.0 NA 0.7 CREG
Lead 62.5 5.5 0.0 MCLG

µg/L - micrograms per liter or ppb.
NA - Not Analyzed.
ND - Not Detected.
J - Analyte present. Reported value may not be accurate or precise.
CREG - Cancer Risk Evaluation Guide.
MCL - Maximum Contaminant Level.
EMEG - Environmental Media Evaluation Guide.
MCLG - Maximum Contaminant Level Goal.

Groundwater - Public Supply Wells and Private Wells

On January 23 and January 24, 1989, Square D personnel obtained unfiltered samples from three public supply wells and three private wells. Figure 3 shows the sampling locations, and Table 3 reports the maximum concentrations of contaminants.

A water quality study, which included a private well survey, was completed in 1993. The study was conducted over a 3-mile radius of the site. Low levels (below comparison values) of VOCs were detected in some of the wells. Current levels of VOCs in the public water supply are at or near zero.

Table 3. Off-Site Contaminants in Public Supply Wells and Private Wells (1)

CHEMICAL MAXIMUM CONCENTRATIONS COMPARISON VALUE
Public Supply
Wells
(µg/L)
Private
Wells
(µg/L)
µg/L Source
Benzene ND ND 1 CREG
Trichloroethene (TCE) 29.0* 11.0 3 CREG
Trans-1,2-Dichloroethene (tDCE) 2.0 1.0 100 MCL
Vinyl Chloride ND ND 02.0 EMEG
Tetrachloroethene (PCE) 2.0B ND 0.7 CREG
Lead 7.3 3.3B 0.0 MCLG

Note: Samples Unfiltered.
µg/L - micrograms per liter or ppb.
*      - Public Supply Well #5 had a TCE concentration of 150 ppb in 1981 and was taken out of service.
ND     - Not Detected.
B     - Not detected substantially above the level reported in laboratory or field blanks.
CREG - Cancer Risk Evaluation Guide.
MCL - Maximum Contaminant Level.
EMEG - Environmental Media Evaluation Guide.
MCLG - Maximum Contaminant Level Goal.

C. Quality Assurance and Quality Control

The laboratory data for organics have been fully reviewed to determine the utility of results. Although there were several problems noted during the review of the laboratory data, most did not result in major impacts on the overall data quality or utility. Overall, detection capability was acceptable for most compounds, as demonstrated by meeting criteria for holding times, matrix spike and surrogate compound recoveries, and instrument tuning and performance. Quantitative accuracy and precision were acceptable for most results.

The principal areas of concern were identified as field blank contamination, low response factors for 2-butanone in the volatile analysis calibrations, low surrogate compound recoveries in both the semi-volatile and pesticide analyses, and two positive results flagged (R - unreliable result) on the sample data summary.

Several samples required dilution and re-analysis in the volatile analysis because instrument levels for one or two compounds in each sample were greater than the highest initial calibration standard concentration.

Inorganic analysis was also fully reviewed to determine the utility of the results. Only minor problems were noted during the review of the data. Data quality and utility were acceptable for the contaminants of concern discussed in this public health assessment.

D. Physical and Other Hazards

The site is locked and surrounded by a 8 to 10-foot high fence so that there is no access except for authorized persons.

PATHWAYS ANALYSES

To determine whether residents are exposed to contaminants migrating from the site, PADOH and ATSDR evaluate the environmental and human components that lead to human exposure. A pathway consists of five elements: a source of contamination; transport through an environmental medium; a point of exposure; a route of human exposure; and a receptor population.

PADOH and ATSDR identify exposure pathways as completed, potential, or eliminated. Pathways are complete when all pathway components are present or likely present. Potential pathways exist where one or more elements are possible but are not identified in the data available at the time the public health assessment is conducted. The pathway is eliminated if the missing component is never likely to occur. The only completed human exposure pathway at the Rodale Manufacturing site is through the use of groundwater. Surface water, soil, sediment, and air pathways are not significant, based on currently avaiable data, at the Rodale Manufacturing site. Nearly the entire site is concrete or gravel so that surface soil is limited to a small area at the extreme southwest corner of the site. This area is not accessible to the public.

A. Completed Exposure Pathways

Table 4. Completed Exposure Pathways

PATHWAY TIME SOURCE MEDIA &
TRANSPORT
POINT OF
EXPOSURE
ROUTE OF
EXPOSURE
EXPOSED
POPULATION
Emmaus Borough Water System (EBWS) Past
Present
Future
Rodale (Square D) & Perhaps Other Sources Groundwater Tap Ingestion
Inhalation
Dermal
Over 16,000 People Served By EBWS
Home
Wells
Past
Present
Future
Rodale (Square D) & Perhaps Other Sources Groundwater Tap Ingestion
Inhalation
Dermal
Less Than 100 People

Public Supply Pathway

A past completed exposure pathway exists because of use of contaminated groundwater in public supply wells. Current and future completed exposures are possible through use of contaminated groundwater. The people using the contaminated well water were exposed to contaminants through ingestion, inhalation of volatilized compounds, and direct skin contact.

The contamination was believed to be the result of movement of a plume linked to improper disposal of contaminants from 1961-1966 (1). We do not know when the contamination of public supply well #5 first occurred. However, estimated travel times of contaminants (primarily TCE) were calculated to be 0.45 feet per day, and at this travel rate, contaminants would have reached well #5 in 18 years. This time period corresponds with use of injection well #1 (1961-1966) for waste disposal (1). The contamination was first found in 1981 sampling of the Borough of Emmaus public water supply wells (2). The estimated movement time of contaminants and sampling data are not sufficient to conclusively determine when the EBWS was first contaminated.

Contamination also migrated to public supply well #7. Currently, an air stripper is operating on the well. The most recent sampling data indicate that the air stripper is functioning properly, and contaminant levels in the treated and blended water are at or near zero.

Private Well Pathway

Most private wells identified in the area to date are east and south of the site and are not in the direction of groundwater flow from the site. However, during the site investigation, two homes, approximately 1.2 and 1.6 miles west-northwest of the site, were found to use contaminated private wells. The private wells are in the approximate flow direction of local groundwater, and the plume of contaminants, from the site (1). Most area residences are connected to the EBWS. A 1993 water quality study of a 3-mile radius around the site provided additional information on private wells. Some low levels (below comparison values) of VOCs were identified in some private wells. People who do use contaminated private well water for drinking water and household purposes are exposed to contaminants through ingestion, inhalation of volatilized compounds, and direct skin contact.

B. Potential Exposure Pathway

A future completed exposure pathway is possible as the contaminants migrate further from the site. As the contaminants continue to migrate, additional wells may be impacted. Implementation of the on-site groundwater pump and treat system may reduce the chance that further migration of contamination at levels of public health concern will occur.

PUBLIC HEALTH IMPLICATIONS

A. Toxicological Evaluation

Introduction

In the Public Health Implications section, we discuss the possible health effects in people exposed to specific contaminants, evaluate state and local health data bases, and address specific community health concerns.

To evaluate health effects, either Minimal Risk Levels (MRLs) for contaminants developed by ATSDR or Reference Doses (RfDs) developed by EPA, when available, have been used. The MRL is an estimate of daily human exposure to a contaminant below which noncancer, adverse health effects are unlikely to occur. EPA's Reference Dose (RfD) is an estimate of the highest daily exposure to a contaminant that is unlikely to cause noncancer adverse health effects. To evaluate the potential for exposed people to develop cancer as a result of exposure to site contaminants, Cancer Slope Factors are used to calculate the risk.

In the following discussion, we are addressing two of the chemicals which were selected as contaminants of concern. They are trichloroethene (TCE) and lead. These contaminants were above their comparison values in public supply wells and private wells. Tetrachloroethene (PCE) was found at a level above the comparison value, but the contaminant was also present in the field blank. Another sample is necessary to determine if that contaminant is actually in water supplies at levels above comparison values. Benzene and vinyl chloride were not detected in public supply wells or private wells. Trans-1,2-Dichloroethene was detected in wells but at levels below comparison values.

Trans-1,2-Dichloroethene, vinyl chloride, and PCE were detected at high levels in monitoring wells adjacent to the site. Currently, no other off-site data indicate that people are exposed to these contaminants. If these contaminants migrate to potable water sources, the public health implications of exposures would be evaluated.

Trichloroethene (TCE)

People have been and are now exposed to TCE through use of contaminated private well water and the EBWS. The EBWS serves an estimated population of 16,762. The EBWS includes a well that has an air stripper to reduce contaminant levels. People using contaminated private wells have been provided information by EPA on the contamination and how to reduce exposure. The people are exposed to the contaminants through ingestion, inhalation of volatilized compounds, and direct skin contact.

The maximum level of TCE found in the public water supply was 150 ppb. Exposure to that level stopped when the contamination was found in 1981. The length of time that level was in the water is unknown, but because of dilution with other distribution water, people were not likely exposed to that level. In assessing possible public health effects, however, the assumption is made that people were exposed to that level. The maximum concentration of TCE found in private well water to date is 11 ppb. At the maximum levels of TCE found in drinking water supplies, no noncancer adverse health effects are expected to occur. The estimated daily exposure for adults and children would not exceed the MRL (11).

Occupational studies of workers exposed to TCE (levels which are much higher than the levels found in the environment) have not shown TCE-induced cancer, while some animal studies have shown that TCE can produce lung and liver cancer (11). Animal studies also have shown that TCE can cause leukemia, a cancer of the tissues that form white blood cells. In reviewing the animal studies, the Department of Health and Human Services (DHHS) National Toxicology Program could not find clear evidence that TCE causes cancer in animals. The International Agency for Research on Cancer (IRAC), an agency which classifies chemicals for their carcinogenicity, has decided that TCE is not classifiable as to human carcinogenicity (11). However, EPA classified TCE as a probable human carcinogen based upon some animal studies. Recently, EPA has withdrawn this classification while conducting a review of the carcinogenicity of TCE. A Cancer Slope Factor has been developed for TCE exposure. If exposure to the maximum levels of TCE occurred over a 70-year period, little or no increased risk of developing cancer is expected.

Lead

People are being exposed to low levels of lead through use of the contaminated EBWS water supply and possibly through use of contaminated private well water. The private well water lead levels have not been confirmed. Lead was detected in the blank when private well samples were analyzed. People are exposed to lead through ingestion of the contaminated groundwater. Inhalation and skin contact are not significant routes of exposure for lead in groundwater.

The maximum levels of lead detected in the EBWS water supply is 7.3 ppb. The maximum level found in private well water (assuming the level is verified) is 3.3 ppb. Although those levels are above the MCLG, the levels are below EPA's Action Level of 15 ppb. No MRLs or RfDs have been established for lead (12). However, exposure to lead should be reduced to the lowest level possible. High blood lead levels are associated with a decrease in intelligence quotient (IQ) scores, slow growth, and hearing problems. Lead exposure is especially dangerous for unborn children because they can be harmed during fetal development. Pregnant women exposed to lead can transfer lead to unborn children, causing premature birth, low birthweight, and miscarriages (12). Although lead levels found in both the public water supply and in private well water are not likely to cause such effects, exposure to the lead through use of groundwater could add to any other lead exposure the people may have. Because little is known about correlations between lead in environmental media and blood lead levels, exposure should be avoided when possible (12).

Lead is classified as a probable human carcinogen. No Cancer Slope Factor has been developed to help evaluate carcinogenic potential from exposure to the levels of lead in the water supplies (12). However, the levels are very low and likely do not pose an increased risk.

B. Health Outcome Data Evaluation

The Rodale Manufacturing site is located in Emmaus Borough, Lehigh County. Twenty-one years of all cause mortality and cancer mortality (total cancer and eight cancer sites) were collected for Emmaus Borough (13). The 1979-1989 Emmaus Borough data were analyzed using Pennsylvania's 1979-1981 mortality experience as a standard and the 1980 Census population for age and sex.

Total deaths (all causes) were considerably below the expected number of deaths for the 1979-1989 period for Emmaus Borough. There were 1,201 deaths observed in Emmaus Borough for the period and 1,321 deaths would be expected. (An "expected" death is a statistical term used for measuring mortality among a specified population. In this case, the age-sex specific death rates by 5 year age groups for a selected cause of death for Pennsylvania is applied to the same age-sex population in Emmaus Borough to obtain an "expected" number of deaths. This tells the investigator how many deaths one would expect to see in Emmaus Borough if the mortality experience was the same as in the standard population--Pennsylvania. This is known as the indirect method of mortality adjustment.)

Total cancer deaths in the 1979-1989 period for Emmaus Borough were nearly identical to the expected number of cancer deaths when compared to Pennsylvania's age-sex specific cancer rates. There were 298 cancer deaths observed in Emmaus Borough and 297 deaths expected. None of the eight cancer sites analyzed differed greatly in the number of deaths observed in Emmaus Borough when compared to the number of deaths expected based on Pennsylvania's mortality experience (14). The cancer sites were: (1) buccal cavity and pharynx; (2) digestive system; (3) respiratory system; (4) bone, connective tissue, skin, and breast; (5) genitourinary system; and (6) other and unspecified sites; (7) leukemia; and (8) other lymphatic and hematopoietic tissues. These eight cancer sites are those routinely reported and made available through the State Health Data Center. However, through special request, a specific cancer could be obtained for a city, borough, or township. Specific cancer sites are addressed as pertinent information or community health concerns warrant such an investigation.

An individual report (or reports) of a former Rodale employee being diagnosed or dying of cancer cannot be addressed by the above mortality adjustment. The problem of answering individual health concerns is addressed in the Community Health Concerns Evaluation section.

C. Community Health Concerns Evaluation

The community has expressed some concerns about the site. Those concerns, and a response to those concerns, are as follows:

  1. Is my health currently at risk as a result of exposure to TCE in the Borough water supply?

    No. PADOH and ATSDR feel your water is safe to drink. Currently, the treatment system that is operating on the contaminated well is working properly. No contamination has been found in recent sampling. The water is sampled regularly to be sure that the treatment system continues to work properly.

  2. An individual worked at Rodale Manufacturing Company in the early 1970s and developed a tumor in 1977 and had a number of operations since. Could this individual's tumor have resulted from exposure to chemicals at the plant?

    We cannot determine if the tumor resulted from exposure to chemicals at the site. Occupational exposure data are not available. Through the use of the Pennsylvania Industrial Directory, we can obtain the approximate number of persons working at Rodale Manufacturing. These directories indicate there were 393 employees in 1975 and only 200 employees in 1977 (15). There is no way to reconstruct employee duties and the chemicals used or handled over a time period since such records are not available. In addition, the latency period for cancer in particular (period from exposure to development of a disease) is usually, but not always, longer than the time period cited. As noted in the Toxicological Evaluation section, occupational studies of workers exposed to TCE have not found TCE-induced cancer.

    The cancer mortality data for Pennsylvania in 1990 indicates that 24.5 percent of all deaths, nearly one in four deaths, was due to cancer. In 1976, 20 percent, or one in five deaths, was due to cancer. Since cancer is so prevalent in our society and some carcinogens are organ-specific, much would have to be known of employees' medical and health histories to attempt to evaluate cause and effect.

  3. I am concerned about children who may play near the site. Should I be concerned?

    No. The site is fenced and not accessible. There are no volatilizing gases emanating from the site or exposure through runoff from heavy rains. The site is paved or gravel-covered. Only a small area in the southwest corner near the electric transformer is grass covered (see Figure 2). Historically, subsurface pollution in on-site injection wells was the environmental concern. No lagoons or surface contamination have been identified to date. All wells and cisterns are covered, and manufacturing at the site ended in 1986. However, as a safety precaution and until investigations are complete, parents should instruct children not to play in areas adjoining the site.


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