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PUBLIC HEALTH ASSESSMENT

January 5, 2002 Air Release

DIAZ CHEMICAL CORPORATION
(a/k/a FMC C/O DIAZ CHEMICAL C/O FMC)
VILLAGE OF HOLLEY, ORLEANS COUNTY, NEW YORK


SUMMARY

On January 5, 2002, the Diaz Chemical Corporation facility in the Village of Holley, Orleans County, New York, accidentally released a mixture consisting primarily of toluene, water (steam), and 2-chloro-6-fluorophenol (CFP) into outdoor air. Soon after the chemical release, people complained of acute health effects such as sore throats, headaches, eye irritation, nosebleeds, and skin rashes.

In response to the visible contamination and odors from the January 5, 2002 release, Diaz relocated people from about 15-20 homes and, working with the New York State Department of Environmental Conservation (NYSDEC), cleaned some exterior surfaces contaminated and stained from the release. The New York State Department of Health (NYSDOH) and Orleans County Health Department (OCHD) received calls from citizens and physicians with health concerns about the release and complaints about the odors. NYSDOH laboratories at the Wadsworth Center developed analytical methods so that air, soil, surface, water, and urine sampling could be undertaken to define the extent of contamination and evaluate people's exposure.

In March, on behalf of the State of New York, the New York State Attorney General's Office filed a complaint against the Diaz Chemical Corporation in the New York State Supreme Court. Diaz Chemical Corporation was ordered to clean up the spill, pay for temporary relocation of residents, and conduct additional environmental sampling. This work was to be done under the direction of NYSDEC with technical assistance from NYSDOH.

On May 16, 2002, the United States Environmental Protection Agency (USEPA) began conducting additional site characterization and paying for relocation expenses, when Diaz Chemical Corporation announced their inability to fund these efforts. USEPA conducted air, soil, and surface wipe sampling in May and June 2002. In June 2003, the USEPA collected additional environmental samples for the purposes of evaluating the site as a potential site for inclusion on the National Priorities List (NPL) of hazardous waste sites. This evaluation is currently on-going.

Air, soil, water, wipes from surfaces, vegetation, and miscellaneous household articles were sampled and analyzed for CFP. Results confirmed that CFP could be found in the samples, particularly if they were taken in the neighborhood immediately to the northeast of the facility along Jackson Avenue. The sampling results showed that the highest levels were in the area with visible contamination and that either no or very little CFP could be found in samples collected from other areas of the Village.

NYSDOH completed five rounds of urine sampling beginning on January 17, 2002, with the last round occurring in December 2002. Urine results showed that people living in the area of greater impact were more likely to have CFP in their urine. Generally, the amount of CFP in urine samples decreased from January to December. The NYSDOH also developed another method to account for more of the CFP in metabolite form and is reanalyzing samples. The results of the reanalysis are expected to be distributed by the end of 2003.

Health effects information about CFP is limited. However, some information exists about the health effects of chlorophenols, which are similar in chemical structure to CFP. Since structurally similar chemicals often can cause similar health effects, we used the available information on chlorophenols to evaluate the potential health risks from exposure to CFP.

Virtually no information concerning short-term, high-level exposure and long-term, low-level exposure to CFP is available. However, some information about the health effects of chlorophenols is available. Laboratory studies have shown adverse reproductive and immunological effects in rats when they were given drinking water containing high levels of 2-chlorophenol or 2,4-dichlorophenol. High levels of 2,4,5-trichlorophenol given to rats in their diet affected their livers and kidneys. Male rats fed a diet containing high levels of 2,4,6-trichlorophenol every day of their lives had an increased incidence of cancer (lymphomas or leukemia). Other information from computer-based analysis, comparing the size, shape, and chemical characteristics of CFP to other chemicals, suggests that CFP is not likely to cause cancer, mutations or developmental effects.

Residents reported health outcomes such as sore throat, headache, nose irritation, and eye irritation from the exposure. These symptoms were commonly reported immediately after the release in January, with some more common among persons who had a greater exposure potential. Persons with a greater exposure potential were more likely to report sore throat in January and sinus problems and eye irritation in May than were persons with less exposure potential. Additionally, in May, those with a detectable level of CFP in urine were more likely to report eye irritation than those without a detectable level of CFP. Finally, a smaller proportion of people with a greater exposure potential reported symptoms in May than they did in January.

The data from environmental and urine samples indicate that people were exposed to CFP and that as of the last urine sampling, December 2002, some probably continue to be exposed, although to a lesser extent. The amount of exposure to CFP was estimated from soil, air, and urine levels, including the maximum CFP level in urine and the average CFP level found among the 12 urine samples with detectable levels out of the 250 total samples collected in May. Based on this assessment of exposure and using health effects information on chlorophenols, current exposures of Village residents present a minimal to low risk for non-cancer health effects. If exposures were to continue for 30 years, which is unlikely, the risk of cancer is very low to low. Even lower risks would be estimated for the majority of people who provided urine samples in May 2002 and who did not have CFP detected. Uncertainties in evaluating the public health risks associated with this site arise because of limited information about the toxicity of CFP, limited information about past and present exposure estimates, and limited information about future exposures (both the level and the amount of time). Currently, the status of the release is consistent with ATSDR's category of an indeterminate public health hazard. Reductions in contamination, especially indoors and in the area of greater impact, could reduce any on-going exposures.

In response to community concerns about long-term health effects due to the CFP release, NYSDOH has offered enrollment in the New York State Volatile Organic Compounds Exposure Registry. Registry enrollment involves completing a detailed survey about health status and providing additional information approximately every two years, thus allowing NYSDOH to track changes in health status over time. NYSDOH has contacted households eligible for participation.

NYSDOH has offered to analyze urine samples, using the most appropriate validated method, for individuals whom had detectable CFP in their last round of urine sampling and has offered the same for people who move into homes vacated since the release. The offer is to collect samples within the week prior to and one week after moving back into the house. Although the urine results are of limited usefulness in understanding an individual's risk of experiencing an adverse health effect, the urine results can be an indicator of exposure. As such, some individuals may find this information of value. The test for CFP is non-routine, and no other laboratory has demonstrated proficiency to analyze this chemical in urine.

In June 2003, Diaz closed the Holley facility and the USEPA has assumed control of the site. Bulk chemical wastes are currently stored on-site and the USEPA is evaluating options on what should be done with these wastes. The USEPA is maintaining the groundwater treatment system Diaz had installed to address environmental contamination not related to the January 5, 2002 release. The NYSDOH recommends that the State Emergency Management Office (SEMO) and the Orleans County Emergency Planning Office review the emergency procedures for chemical releases from Diaz Corporation to determine if changes are needed to minimize exposures if an accidental release occurs in the future. The USEPA is currently evaluating the site to determine whether it should be placed on the National Priorities List (NPL) of hazardous waste sites. ATSDR and NYSDOH will work with the USEPA to evaluate the results of the sampling, including the dioxin sampling. Additionally, USEPA should review its procedures under TSCA to determine if changes are necessary so that adequate toxicological data are available for chemicals manufactured in the United States.


PURPOSE AND HEALTH ISSUES

The purpose of this document is to summarize the health issues resulting from the accidental release of 2-chloro-6-fluorophenol (CFP) at the Diaz Chemical Facility in the Village of Holley, Orleans County, New York. The United States Environmental Protection Agency (USEPA) has performed environmental sampling, has paid for relocation of individuals since May 2002, and has requested assistance from the Agency for Toxic Substance and Disease Registry (ATSDR) in evaluating the public health implications of the environmental data. The New York State Department of Health (NYSDOH) conducted environmental and biological (urine) sampling, and under a cooperative agreement with the ATSDR, prepared this public health assessment to characterize the potential health risks associated with exposure to the chemical release. Additionally, NYSDOH, Orleans County Health Departments (OCHD), New York State Department of Environmental Conservation (NYSDEC), ATSDR, USEPA, and the New York State Office of the Attorney General (NYSOAG) worked together to help investigate the problems caused by the release.


BACKGROUND

A. Site Description and Background

The Diaz Chemical Corporation (Diaz) is a chemical manufacturing and storage facility on the southwestern perimeter of the Village of Holley, Orleans County, New York (Appendix A, Figure 1). The Diaz property is a six-acre site bordered on the north and east by homes along Jackson and South Main Streets. Conrail railroad tracks border the site on the south and west; beyond that is undeveloped land. The site was originally an industrial facility built in the 1890's for tomato processing and cider vinegar production. Diaz purchased the property in 1974 and has manufactured specialty organic chemicals for the agricultural and pharmaceutical industries. A variety of chemicals have been produced, but the primary products have been halogenated aromatics and substituted benzotrifluorides.

In July 1992, the site was added to the New York State Registry of Inactive Hazardous Waste Disposal Sites as a Class 2 because of groundwater contamination. This site classification means that contaminants at the site present a significant threat to public health or the environment for which action is required. The registry site investigations are not related to the January 5, 2002 release of CFP and will not be discussed in this report.

In November 2001, Diaz began production of CFP for a European pharmaceutical manufacturer. Several batches had been produced and were being stored in a heated vessel prior to purification. On January 5, 2002, at approximately 10:45 PM, a pressure build-up in the storage vessel at the Diaz facility caused a pressure disc to rupture. The rupture resulted in a chemical discharge that visibly contaminated surfaces in the nearby neighborhood and produced odors that were reported as far as 12 miles away. At the time of the release, the wind was blowing towards the east-northeast at approximately 5-8 miles per hour (Appendix A, Figure 1). The plume was reportedly transported east-northeast of the Diaz facility. The NYSDEC and local emergency services responded and began to evaluate the impact of the release. According to Diaz, approximately 80 gallons of liquid were released. The mixture was reported to be mostly water (in the form of steam), toluene, and CFP. Droplets of CFP deposited on cars, houses, and other surfaces to the east-northeast of Diaz. On January 6 and 7, fifteen to twenty families voluntarily relocated with assistance from Diaz. Following the release, the OCHD and Western Regional Office of the NYSDOH began receiving calls from citizens with health concerns and responded to calls from physicians about medical testing.

In mid-January, NYSDOH obtained a pure sample of CFP from Diaz and a sample of the residues washed from the storage tank. NYSDOH laboratories at the Wadsworth Center developed analytical methods for measuring CFP in air, soil, surface wipes, and urine. NYSDOH collected environmental (ambient air, indoor air, surface soil, surface wipe, water) and biological (urine) samples from residents in the Village of Holley. Urine samples were collected in January (round 1), March (round 2), April (round 3), May (round 4), and December (round 5). The most extensive urine sampling was done in May when NYSDOH collected 250 additional urine samples from people living and/or working in the Village of Holley. Along with the urine sampling, exposure surveys were administered to assist in identification of likely exposure pathways for participants. NYSDOH provided individual results to participants and their physicians and provided summary reports to residents of the Village.

In March, NYSOAG filed a complaint against Diaz with the New York State Supreme Court. Diaz was ordered to clean up the spill, pay for temporary relocation of residents, and conduct additional environmental sampling. This work was to be done under the direction of the NYSDEC with technical assistance from NYSDOH. On May 16, 2002, USEPA began conducting additional site characterization and paying for relocation expenses, when Diaz announced its inability to fund these efforts any longer. The USEPA conducted air, soil, and wipe sampling in May and June, 2002. In March 2003, the NYSOAG sampled foam from two mattresses and one pillow, each of these being from one of three homes. In June 2003, the USEPA began collecting soil, water and air samples to determine if the Diaz facility should be placed on the National Priorities List (NPL) of hazardous waste sites.

Diaz arranged to clean properties. In January and February, the exteriors of approximately 30 homes were power washed in an attempt to remove the droplets of CFP. Exterior power washing included garages, driveways, porches, decks, and other outdoor items. Several automobiles were also cleaned both on the exterior and interior. Diaz's consultants cleaned heating ducts, carpets, drapes, and upholstery in about 20 homes. From April 8 through April 19, an additional cleaning effort was performed on six homes on Jackson Street and three homes on South Main Street. The exterior siding and roofs of houses, outbuildings, trees/shrubs, driveways, and lawns were power washed with an all-purpose detergent. Plastic sheeting was used during washing to help collect the wash water, which was subsequently collected by a vacuum truck.

In June 2003, Diaz closed the Holley Facility and the USEPA assumed control of the site (e.g. USEPA is providing site security). Bulk chemical wastes were left on-site and USEPA is deciding what should be done with them. The USEPA also is maintaining a groundwater treatment system to address environmental contamination not related to the January 5, 2002 CFP release and is currently evaluating the site including collecting samples to determine whether it should be listed on the NPL.

B. Site Visit(s)

On numerous occasions since January 5, 2002, staffs from NYSDOH and OCHD have visited the Diaz facility, as well as the area affected by the chemical release. On January 10, 16, and 31, 2002, NYSDOH, OCHD, NYSDEC, and NYSOAG met with relocated families and other interested parties to explain what actions were being taken and to respond to questions. On January 14, March 8, and March 21 visits were made to collect environmental samples. NYSDOH collected urine samples provided by residents of Holley in January, March, April, May, and December. In May and early June, USEPA visited Holley to collect additional wipe and soil samples and take real-time air measurements. The USEPA since that time has also visited the site several times to evaluate on-going air releases and most recently to evaluate if the site should be placed on the NPL. NYSOAG collected samples from select residences in 2002 on April 4, April 24, and August 6 and they also collected samples in March 2003.

C. Demographics for the Village of Holley, Orleans County, NY

NYSDOH estimated, from the 2000 Census, that 1,802 people live in the Village of Holley, Orleans County, New York, of which 412 were females of reproductive age (ages 15-44). The age distribution of the village is similar to that of the whole of New York State; however, the village has a lower proportion of minorities (5%) compared to the rest of the state (38%). A smaller percentage of the population of the village is living below the poverty level as compared to New York State as a whole, but the median household income is lower. These comparisons are provided in Appendix B, Table 1. Regarding high-risk populations, there are three schools, but none are located in the area of greater impact, and there are no nursing homes in the village.


DISCUSSION

A. Environmental Data Evaluation

All of the locations for which at least one environmental sample between January 2002 and November 2002 (i.e., soil, air, surfaces, pool water) were collected are identified in Appendix A, Figure 2. In June 2003, the USEPA started an extensive sampling program and the results of that sampling are not included in this report. Appendix A, Figure 2 also shows the approximate area of greater impact used in the evaluation of the urine results.

Storage Vessel Material

After the release of material from the storage vessel, Diaz staff washed the container with toluene to recover any remaining product. Diaz provided a 0.5-liter sample of this solution to NYSDOH along with a sample of pure CFP. The toluene used to wash the vessel may also have contained trace amounts of chemicals, but a sample of the toluene used to wash the vessel was not analyzed prior to the washing. Analysis of the remaining product in the storage vessel indicated that, in addition to CFP, other compounds were also in the residue (Appendix B, Table 2). These tentatively identified compounds (TICs) included another chlorofluorophenol and some other chemicals whose exact molecular structure have not been determined. CFP was the compound found in the greatest quantity and the only one of the compounds from the storage vessel detected in air. However, the TICs and the other chlorofluorophenol were part of the material released and some soil and wipe samples collected from the neighborhood contained these compounds. Most of the environmental data on these compounds are in the NYSDOH report released to the public in late January 2002, in Appendix C.

NYSDOH laboratories at the Wadsworth Center also analyzed one sample of the solution from the storage vessel for chemicals known as chlorinated dibenzodioxins (dioxins) and chlorinated dibenzofurans (furans). There are 210 different dioxins and furans. The most studied and most toxic is 2,3,7,8-tetrachlorodibenxo-p-dioxin. The remaining individual dioxins and furans are not equally toxic. Because the dioxins and furans generally affect the body in similar ways, scientists describe approximately how toxic each one of these chemicals is by comparing what is known about its toxicity to 2,3,7,8-tetrachlorodibenzo-p-dioxin (2,3,7,8-TCDD). The toxicity of a mixture of dioxins and furans is estimated by expressing the amount of each dioxin and furan as if each were 2,3,7,8-TCDD and adding these amounts; this is called the toxicity equivalent (TEQ).

The concentration of the individual dioxins and furans and the TEQ concentrations are presented in Appendix B, Table 3. The most toxic forms (2,3,7,8 substituted) of dioxin and furans were only a small percentage of the total of all dioxins and furans found. The TEQ for the storage vessel wash sample is about 2 nanograms per liter (ng/L) (Appendix B, Table 3). The total concentration of CFP in this sample was 130,000,000,000 ng/L. The ratio of CFP to dioxin/furan equivalents shows that about 65,000,000,000 (65 billion) more CFP was present than dioxin equivalents. This ratio is used in the section on soil results to estimate the TEQ in soil concentrations resulting from the January 5, 2002 release.

Air Sampling

Toluene, a solvent, is known to have been in the January 5, 2002 release. It is more volatile than CFP and would have dispersed quickly. No sampling was done during the release for toluene or other contaminants. Unless samples were collected during or immediately after the release, we would not expect to find this compound as a result of the release in any of the air samples collected.

Air samples for CFP analysis were collected using adsorbent cartridges at 24 different buildings and at four locations outside homes (Appendix A, Figures 3 and 4). Additionally, real-time air measurements for CFP were collected using a mobile Trace Atmospheric Gas Analyzer (TAGA) technique in indoor air samples at 23 residences.

On January 14-15, 2002, NYSDOH and OCHD staff collected indoor air samples from the living rooms and basements of four homes along Jackson Street and South Main Street. An outdoor air sample was collected from the yard of each home. Results from the January 14-15 sampling showed no detectable concentrations (less than 30 micrograms per cubic meter (mcg/m3)) of CFP in the indoor and outdoor air samples. Staff noticed a chemical-type odor of varying strength while sampling outdoors at the Jackson Street location next to the Diaz facility and at various times during the day at other outdoor locations on Jackson Street. Odors were not detected at sampling locations east of South Main Street. Some visible evidence of the contamination was still present at the properties sampled on Jackson Street. Aside from homes bordering Jackson Street, no visible evidence of contamination was observed at any of the locations sampled on South Main Street. These observations suggested that either some CFP was present in the air or some other compound or combination of compounds was the source of the odor.

Subsequent to the analysis of January 14 and 15 samples, NYSDOH laboratories at the Wadsworth Center improved the analytical methodology to detect much lower concentrations of CFP (0.2 mcg/m3) in air. On March 8, NYSDOH collected air samples from the living rooms of four homes along Jackson and South Main Streets (Appendix A, Figure 3). Two outdoor air samples were also collected during the March 8 sampling from two residences where outdoor samples were not previously taken. On March 21, 2002, air samples were collected from the living rooms of an additional five homes on Jackson, Geddes, and East Streets. Samples collected in March were analyzed using the more sensitive method. CFP was detected in two homes along Jackson Street (0.90 mcg/m3 and 0.20 mcg/m3) and in the outdoor sample (0.20 PL mcg/m3) taken in the rear of the residence on Jackson Street. The "PL" designation means a level of CFP was present, but below the reportable quantification limits. A quantification limit is the minimum concentration required in order for the concentration to be accurately and reliably measured (quantified). The detection limit is the minimum concentration at which the presence of the substance can be detected.

As noted above, USEPA performed real-time air measurements for CFP using the TAGA technique in 23 residences located on Jackson, South Main, Thomas, Geddes, and Van Buren Streets from May 21-23, 2002. A signal on the instrument corresponding to CFP was detected in the air at 11 of the 23 residences. Of the 11 findings, five had levels below the quantification limit. Four residences with CFP above the quantification limit were located on Jackson Street and had measurable concentrations of CFP ranging from 0.06 - 0.83 mcg/m3. In the remaining two homes where CFP was reported, the smell of mothballs was noted. Mothballs may contain the chemical dichlorobenzene, which interferes with the TAGA measurement of CFP. Twelve homes had no CFP detected in the air samples.

In addition to the TAGA measurements, USEPA collected samples from 22 of the 23 residences to analyze in the laboratory. Four homes along Jackson Street had detectable levels of CFP in their indoor air ranging from 0.21 mcg/m3 to 0.40 mcg/m3. No CFP was found in any of the other samples.

Surface Soil

USEPA and NYSDOH collected soil samples from the properties identified in Appendix A, Figures 5A and 5B.

NYSDOH collected soil samples on January 14 - 15, 2002, from four homes bordering Jackson Street and a home on Perry Street. Approximately 250 grams of bare surface soil (0 - 0.25 inches) were collected from an area ranging from less than one square foot to four square-feet for each sample. In general, soil samples taken from the area of greater impact had the highest concentrations, while those farther from the release point had lower concentrations (range: 4.0 - 8900 mcg/kg). The soil samples containing CFP also contained the other compounds that were found in the storage vessel material (see Storage Vessel Section (page 6) and Appendix C).

On March 21, 2002, a consultant hired by Diaz collected surface soil samples from three homes on Geddes, Jackson and East Streets. CFP was not detected in these samples (detection limit: 448 - 478 mcg/kg).

USEPA collected 80 soil samples between June 3-6, 2002, from 16 properties. Samples from six of these properties had detectable levels of CFP in their soil. The range of detectable levels was from 4.4 mcg/kg to 860 mcg/kg. Most of these samples were collected from surface soils, less than four inches in depth. The soil with the 860 mcg/kg concentration was collected at four inches below the surface and located at the end of a gutter down spout on the house closest to the Diaz facility.

Soil samples were not analyzed for dioxins and furans, although these chemicals were detected in the storage vessel material. Based on the storage material analysis, the ratio of CFP to dioxin/furan equivalents shows that about 65,000,000,000 (65 billion) more CFP was present than dioxin equivalents. To estimate the amount of dioxin contributed to soil from the release, we assumed that the ratios of dioxins and furans to CFP in the soil were the same as in the storage vessel. The NYSDOH soil sample with the highest CFP concentration was from Jackson Street and contained 8900 mcg/kg of CFP. Using the ratio of CFP to dioxin in the storage material, the dioxin TEQ in this soil sample would be 0.0000001 mcg/kg (i.e 8900 mcg/kg divided by 65 billion). ATSDR (1998) uses an action level of 1 part per billion (ppb) (1 ppb equals 1 mcg/kg) dioxin TEQ in soil. An action level is a level that if exceeded, prompts consideration of remedial actions and or institutional controls to reduce the potential for exposure. The dioxin TEQ concentration estimated to be in the soil from the CFP release is well below (about 7 million times) the 1 ppb level. ATSDR (1998) also reports that 2,3,7,8-TCDD is not usually found in rural soil, but is typically found in industrialized area soils at levels ranging from 0.001 to 0.01 mcg/kg, levels 10,000 to 100,000 times higher than the levels we estimate the release could contribute to the soils. In summary, the dioxin TEQ concentration estimated from the CFP release is well below the ATSDR action level and also well below what we might expect to find in the soils before the release.

Surface Wipes

Wipe samples were collected from 16 different properties (Appendix A, Figure 6).

On January 14-15, 2002, NYSDOH collected water-moistened wipe samples from exterior surfaces at four homes bordering Jackson Street, from one home on South Main Street, and at a park gazebo near the corner of East Street and Perry Street. Wipe samples were collected from surfaces that residents were likely to contact such as doorknobs, railings, etc. Some wipe samples contained CFP and other compounds that were found in the storage vessel material. Wipes from surfaces reported to have been washed still showed the presence of the released contaminants. In most cases, samples collected from surfaces not washed tended to have more CFP than samples from washed surfaces (see NYSDOH surface wipe data in Appendix C). CFP was not found in two wipe samples collected from surfaces lacking visible contamination. The highest level of CFP found in the wipe sample collected from a tree on Jackson Street (Appendix A, Figure 6).

On March 21, 2002, a consultant, hired by Diaz, collected four interior and one exterior water-moistened surface wipes from three homes on Geddes, Jackson and East Streets. CFP was not detected in these samples (detection limit: 10 mcg/wipe). USEPA also collected 20 surface wipe samples from inside 14 homes in which indoor air samples were collected. Two types of wipe samples were collected: one using water-moistened wipes and the other using toluene-moistened gauze pads. The surfaces wiped were hard, non-porous surfaces. No CFP was found in any of the wipe samples, including those samples from homes with the detectable levels of CFP in the indoor air.

Vegetation

During the January 14 - 15, 2002 sampling, NYSDOH staff collected two samples of vegetation with visible signs of contamination. One sample was leaves from shrubbery on a Jackson Street property, and the other sample was bark from a tree at another Jackson Street property. NYSDOH laboratories at the Wadsworth Center took pieces of the leaves and bark that showed contamination and extracted them in a solvent. The two vegetation samples contained the same compounds found in storage vessel sample.

Water Samples (pool water and pool cover water)

On March 15, 2002, NYSDOH staff collected water samples at three different area pools in response to concerns from homeowners. The pools were on Van Buren, Geddes, and Jackson Streets. Two water samples were from the water on top of pool covers and one water sample was taken directly from a pool that did not have a cover at the time of sampling. The samples were analyzed for CFP and some of the other compounds found in the material from the storage vessel. Only one of the three water samples had a detectable level of CFP (0.77 mcg/L); it was a water sample collected on top of a pool cover on the pool from Jackson Avenue. This pool was the only pool sampled in the area of greater impact (Appendix A, Figure 2). The water from this particular pool cover was emptied and the pool has since been removed. Several tentatively identified compounds were detected in all of the samples, but none that were associated with the Diaz chemical release.

Household Items

USEPA analyzed extracts from a teddy bear and stuffing from both a pillow and a seat cushion in May 2002. The teddy bear contained 170 micrograms of CFP per kilogram of cover. That is, for every kilogram (about 2.2 pounds) of cover material there was 170 micrograms (0.00000037 pounds) of CFP. Likewise, there was about 300 mcg of CFP per kilogram of teddy bear stuffing. The pillow stuffing had 280 mcg/kg and the seat cushion had 190 mcg/kg.

In April and August of 2002, the NYSOAG had several household materials analyzed for CFP. These materials were collected from homes in the area of greater impact. The results were: 2 mcg CFP /kg of toy bear, 10 mcg/kg of pillow, 90 mcg/kg of sawdust, about 3000 mcg/kg of a foam furnace filter, 9.7 mcg/kg of a composite of cellulose insulation, about 500 mcg/kg of a foam pad, and 39 mcg/kg of fiberglass insulation. These analyses were on extracts, which means that a solvent was used to get the CFP out of the material. It is unknown how much of this CFP without the solvent extraction would leave these items under normal use and therefore could potentially result in exposure from handling or by inhalation.

During the USEPA May 2002 TAGA sampling effort, air analyzed from a plastic bag containing clothes provided by a resident contained CFP at a concentration of 0.26 mcg/m3. Air samples from the residence showed the presence of CFP but not at a concentration above the quantification limit.

In May of 2003, the NYSOAG reported finding CFP at a concentration of 11 mcg/kg in the foam from a mattress pad, 27 mcg/kg in the foam from a couch pillow, and 12 mcg/kg in foam from a mattress pad. These samples were collected in March 2003, one each from three different Holley residences.

B. Pathway Analysis

This section of the public health assessment identifies completed exposure pathways associated with the January 5 release of CFP. This evaluation includes looking at exposure pathways in the past, present and potentially in the future. An exposure pathway is defined as completed when all of the following five elements occur: (1) a contaminant source, (2) environmental media and transport mechanisms, (3) a point of exposure, (4) a route of exposure, and (5) a receptor population.

In the case of the CFP release, the storage vessel was the source of contamination and air carried the contamination to the neighborhood. This resulted in the contamination of other media such as soil and exterior surfaces (buildings, trees, shrubs, lawns, etc.). Evaporation of CFP from these surfaces contaminated outdoor air and may be continuing to do so. Indoor air of homes became contaminated by infiltration of outdoor air and by porous materials in the home (fabrics, soft furniture, carpets, insulation, etc.) that absorbed CFP. This reservoir of CFP is a source of CFP to indoor air, particularly in close proximity to the contaminated porous material. Homes along Jackson Street had the greatest amount of contamination.

Breathing contaminated indoor or outdoor air is one route of exposure. Dermal contact and ingestion of contaminated items, such as soil, are other potential routes. CFP is likely to be dermally absorbed and the contamination of surfaces that people contact (such as handrails) was documented in January.

Volatilization of CFP from porous surfaces may cause a very local increase in air concentration and exposure could occur if held near the breathing zone of a person. Also, skin contact with these items could increase the chance for a dermal absorption.

Although not relevant at the time of the initial release, it is also possible that persons may be exposed to CFP in soil while gardening and as a result of consuming fruits and vegetables grown in contaminated soil. Some of the factors that affect actual exposures include: how much of the garden is contaminated, the contaminant concentration in the soil; how much of the contaminant is transferred from the soil into the edible tissue of the fruit/vegetable (related to soil properties and to vegetable type); and how much homegrown produce is consumed.

C. NYSDOH Biomonitoring Sampling (urine)

NYSDOH collected and tested urine for CFP and creatinine at five distinct times (rounds). The goal of urine sampling was to learn more about human exposures that occurred during and after the accidental release of CFP on January 5, 2002. Urine sampling efforts were initially directed toward persons with higher potential for exposure, persons with specific health concerns, and persons with detectable levels of CFP in a previous urine test. In the fourth round of sampling, all persons residing or working in the Village of Holley were offered the opportunity for urine sampling. Urine sampled in all five rounds was analyzed using an acid extraction methodology for detecting CFP developed by the NYSDOH Wadsworth Center for this investigation. Since the completion of the round four sampling analyses, Wadsworth Center researchers developed a method called enzyme digestion for detecting CFP. More detail on the findings of urine sampling for all five rounds and currently available information about the newly developed method are presented below.

For all rounds, participants were provided sampling containers and directed to collect first morning voids. The amount of water in urine and therefore the concentration of all chemicals in the urine excreted vary depending on how much liquid the individual consumes. If an individual is dehydrated, the urine output will be low. A low volume of urine will result in an increase in the chemical concentrations in the urine; conversely a high urine volume will decrease the concentration. The normal concentration of creatinine, a compound excreted by humans, in urine is well described. It is common practice to standardize urine test results to the creatinine levels to account for low and high urine volume output. This was done for the CFP measurements NYSDOH made. The detection limit for the CFP test is approximately 1.0 mcg/L. This means that if a sample contained approximately 1 mcg/L of CFP or more, it would have been detected by our test and if the sample contained less than 1 mcg/L, no CFP would have been detected.

The next five sections present the results of each of the five rounds of urine sampling. Sometimes an analysis in these sections is based on a small number of samples, which if released, may not protect the confidentiality of individuals. Therefore, when NYSDOH reports on a count of fewer than six individuals, the specific number is not released. In these cases, NYSDOH will report "fewer than 6" which indicates a number of individuals between one and five.

First Round

On January 16, 2002, at a public meeting, NYSDOH distributed approximately 100 exposure surveys to people living or working near the Diaz facility. Consent forms, exposure surveys, and urine sampling jars were distributed to approximately 40 people who wished to participate in urine sampling. Exposure survey questions asked about each person's activities and health symptoms for the 12 days after the accidental release on January 5, 2002, or for the 12 days prior to providing the urine sample. During this meeting, NYSDOH, OCHD, and NYSDEC provided information about follow-up activities to Holley residents.

In the first round, 25 (69%) of the 36 individuals who provided urine samples did not have detectable levels of CFP in their urine. Eleven individuals (31%) had detectable levels of CFP in their urine and the majority of those values were less than 4 mcg/L (less than 3 mcg/g creatinine).

Of the 36 urine samples collected in the first round, 29 were from Holley residents and seven were from individuals with potential occupational exposures to CFP after the release. The urine sampling results for the 29 residents were compared in two groups - those living in the area of greater impact and those living outside of this area. The area of greater impact was defined based on visual observation of droplets deposited on homes, yards, vehicles, etc. from the release on January 5, 2002. The addresses within this area include Jackson Street from the facility eastward and portions of South Main Street and Thomas Street (Appendix A, Figure 2). Based on addresses provided by the 29 residents who supplied urine samples, 17 were classified as residing in the area of greater impact and 12 resided outside the area. Approximately half of the group from the area of greater impact had detectable levels of CFP in their urine. None of the people residing outside the area of greater impact had CFP detected in their urine. This difference is statistically significant; that is, it is not likely due to chance.

Of the 17 people who gave urine samples and resided in the area of greater impact, exposure surveys provided information about relocation. More than 80% of the people who stayed in their homes had detectable levels of CFP in urine. Sixty percent of the people who relocated on January 7 or later showed detectable levels. In contrast, fewer than 20% of the people who relocated earlier (January 5 or January 6) had a detectable level of CFP. The declining trend among these three groups is statistically significant. All of the people who relocated reported visiting their homes at least briefly, and almost all reported visiting within one or two days before the urine sample. A small number reported visiting their homes 3 to 5 days before urine sampling. The results indicated that 80% of persons who stayed in their homes had detectable levels of CFP compared with 44% of the people who visited their homes one or two days before urine sampling and none of the people who visited their homes 3 to 5 days before sampling. The declining trend among these three groups is statistically significant.

Second Round

From March 8 through March 22, 2002, a second round of urine samples was collected. Most of the people who provided urine samples were from homes in the area of greater impact.

Sixteen urine samples were collected in the second round. Nine (56%) of the 16 individuals who provided urine samples did not have detectable levels of CFP in their urine. Seven individuals (44%) had detectable levels of CFP in their urine, and the majority of those values were less than 4 mcg/L (less than 5 mcg/g creatinine). Fewer than six individuals submitted a sample in both the first and second rounds. For those that did, most of the CFP levels (adjusted for creatinine) declined. Among the people whose levels declined, the average percent of CFP decline, adjusted for creatinine, was 79%. Most of those persons sampled in round one and round two lived in the area of greater impact.

Third Round

From April 22 to April 29, 2002, a third round of urine samples was collected. Most of the people who provided urine samples were from homes in the area of greater impact.

Twenty-five urine samples were collected in the third round. Greater than 19 of 25 (greater than 76%) individuals who provided urine samples did not have detectable levels of CFP in their urine. (Exact numbers are not presented to protect confidentiality.) Fewer than 6 of 25 samples (less than 24%) had detectable levels of CFP in their urine. Nine of the 25 samples were from people with a detectable level of CFP in their most recent previous sample. Among these nine individuals, seven showed a decline in creatinine-adjusted CFP level from the earlier test. For the individuals whose sample levels declined, the average percent of CFP decline was 93%.

Fourth Round

In the fourth round (May 22 to May 23), urine sampling was offered to all interested individuals living or working in Holley. In previous rounds, the urine sampling was targeted more toward individuals living in the area of greater impact. In the fourth round of sampling, 238 (95%) of the 250 individuals who provided urine samples did not have detectable levels of CFP in their urine. Twelve individuals (5%) had detectable levels of CFP in their urine and the majority of those values were less than 4 mcg/L (less than 3 mcg/g creatinine). Fifty-six children younger than age 18 were sampled in the fourth round. The percentage of children with detectable levels of CFP was less than the percentage of adults with detectable levels of CFP.

To better understand these findings, we looked separately at individuals currently living in the area of greater impact and at people living outside this area. For this comparison, we did not include people who were still relocated outside the area of greater impact. Approximately 16% of individuals providing samples who live in the area of greater impact had detectable levels of CFP in the fourth round. Approximately 4% of individuals providing samples that live in Holley but outside this area had detectable levels of CFP. This difference is considered to be statistically significant; that is, it is unlikely to be due to chance.

In the first three rounds of sampling, a total of 60 individuals provided urine samples, and 15 (25%) of these individuals had detectable levels of CFP in their urine. Of the 15 individuals who had detectable levels of CFP in one or more of the first three rounds, almost all (14) had repeated sampling completed by the fourth round. Almost all (12) of those who had repeat sampling did not have detectable levels of CFP in their urine by the end of the fourth round.

Fifth Round

Ten urine samples were collected in the fifth round of urine sampling on December 11, 2002. Samples were collected from individuals who had a detectable level of CFP in their last round of urine sampling. Fewer than six of the ten urine samples showed detectable levels of CFP. (Exact numbers are not presented to protect confidentiality.) All of the samples showed a decline in the level of CFP as compared to an earlier test. Of the fewer than six individuals who continued to have detectable levels in their urine, all saw a decline from their previous levels.

Advances in Laboratory Methods for Measuring CFP in Urine

Since May 2002, advances have been made in the NYSDOH laboratory method for analyzing CFP in urine. A new method, known as enzyme digestion, has been developed and validated. Validation means that repeated analyses have demonstrated that the method produces findings that meet recognized standards for accuracy and precision. Enzyme digestion more efficiently releases CFP bound as metabolites than the previous method. Consequently, this new method will account for more of the CFP in the urine. The results from enzyme digestion may be a more complete measure of exposure to CFP at the time the urine sample was collected.

Due to requests from some residents who participated in the urine sampling program, NYSDOH offered to all previous participants in the urine sampling program the opportunity to have a remaining portion of their sample analyzed using enzyme digestion. The NYSDOH is now analyzing the urine samples using the new enzyme digestion method. While the reanalysis may show a different level of CFP in urine than the previous analysis, this additional information will provide residents with little, if any, additional insight about the likelihood or risk of health effects as a result of exposure to CFP. Details regarding this reanalysis were mailed to participants on two occasions. Results of the reanalysis are expected to be distributed by the end of 2003.

The urine sampling data are summarized in Appendix B, Table 4.

D. Public Health Implications: Adult and Children's Health Issues

Potential Health Effects

Little information on the health effects from exposure to CFP and the other compounds detected in the area impacted by the release is available. However, there is some information about the health effects of chlorophenols, which are similar in chemical structure to CFP. Since structurally similar chemicals often can cause similar health effects, we used the available information on chlorophenols to evaluate the potential health risks for exposure to CFP (Faustman and Omenn 2001; McKinney et al. 2000). This is consistent with the analysis presented in the affidavit prepared for Diaz Corporation by Dr. Lorenz Rhomberg. In particular, CFP is probably most similar to the chlorophenols which have one, two or three chlorine atoms. This is because fluorine is expected to have properties somewhat similar to chlorine when attached to a phenol molecule (Park and Kitteringham 1994). Therefore, information on the possible health effects associated with exposure to CFP is supplemented here by information on the possible health effects associated with these chlorophenols. CFP is not as likely to have toxic properties similar to phenols with four or five chlorines (e.g., tetrachlorophenols, pentchlorophenols) because the presence of four or five chorines changes the structure, characteristics and toxicity of the molecule (ATSDR, 1999).

Toluene, the solvent in the reaction vessel, was another contaminant released on January 5. Toluene is a highly volatile solvent that has been associated with short term effects such as fatigue, headache and dizziness in individuals exposed to high levels (about 380 mg/m3 or more in air) (ATSDR 2000). It is not known whether levels of toluene resulting from the release were high enough to have caused these types of effects. If they were, these effects would have diminished quickly as toluene was broken down and/or carried away in the wind. Toluene is rapidly broken down in the atmosphere so that even if there were no wind, after about 3-4 days levels of toluene resulting from the release would be very low. This makes long term exposures to elevated levels of toluene unlikely so that long term health effects are unlikely to occur.

Short-term Effects

Information from the Material Safety Data Sheet (MSDS) made available from Diaz indicates that exposure to high levels of CFP is likely to cause irritation of the nose, respiratory tract, eyes, and skin (Diaz Chemical Corporation 2000). This is based on its structural similarity to chlorophenols, which are well recognized as irritants (Diaz Chemical Corporation, personal communication, 8/15/2002; ATSDR 1999). Following skin contact, workers with CFP have reported skin irritation (an inflammatory reaction in the skin characterized by swelling and redness). Also, workers who treated wood with a chlorophenol solution reported more eye or respiratory irritation and/or skin effects than other workers (Kleinman et al. 1986). Whether or not irritation is likely to develop if CFP gets on the skin or is breathed in depends mainly upon how much gets on the skin or is in the air, how frequent and long the exposure is, and on the sensitivity of the individual to the chemical. Irritating effects resulting from short-term exposure to CFP usually clear up once the exposure stops.

The MSDS from Diaz also indicates that CFP has a characteristic phenolic odor. No specific odor threshold was identified for CFP, but odor thresholds for chlorinated phenols, which are similar in chemical structure to CFP, have been reported to range from 19 mcg/m3 to 1400 mcg/m3 (ATSDR 1999).

A computer-based analysis performed by ATSDR (ATSDR 2002) suggested that CFP might cause a reaction in the skin known as sensitization. Skin sensitization is an allergic, inflammatory reaction in the skin, varying from mild irritation and redness to rash and/or blisters. Skin sensitization occurs upon exposure to a sensitizing chemical after an initial exposure or after several repeated exposures. Whether or not a person becomes sensitized or allergic to a chemical depends upon many factors. These factors include their genetic make-up, how much chemical they initially got on their skin, how much skin was initially exposed, whether their skin was damaged, and whether the skin was covered. The computer program compared the size, shape, and chemical characteristics of the CFP molecule to other molecules known to cause sensitization and found that CFP has some similar characteristics (e.g., the presence of a hydroxyl and/or chlorine substituent). This type of computer-based analysis can only suggest that a chemical might be a sensitizer. Although there is some evidence from animal studies that trichlorophenol can cause skin sensitization (Kimber and Weisberger 1991), no information was found indicating that sensitization to CFP or any other chlorophenol occurs in humans, despite their widespread use.

Long-term Effects

There is no information available about the possible long-term effects of exposure to CFP. A computer-based analysis comparing the size, shape and chemical characteristics of CFP to other chemicals known to cause cancer, mutations or developmental effects predicted that CFP was not likely to cause these effects (ATSDR 2002). As noted above, this type of analysis only predicts that CFP would not cause these types of effects based on the chemical's structural characteristics. We do not know with certainty whether or not long-term CFP exposure might increase the likelihood of experiencing these or other types of long-term adverse health effects in humans.

There is some information about long term effects in animals when they are exposed to chlorophenols. Laboratory studies have shown adverse reproductive and immunological effects in rats when they are given drinking water containing 2-chlorophenol for about 13 weeks, or 2,4-dichlorophenol for up to about 6 months, respectively (Exon and Koller 1982; 1985). Another study in rats given 300 milligrams or more per kilogram of body weight (mg/kg/day) 2,4,5-trichlorophenol everyday in their diet for 13 weeks found effects in the liver and kidney (McCollister et al. 1961). CFP has not been studied for its potential to cause cancer. However, 2,4-dichlorophenol (2,4-DCP) and 2,4,6-trichlorophenol (2,4,6-TCP) have been studied in animals. 2,4-DCP did not cause cancer in animals fed high doses of this chemical for a long time (NTP 1989). In one laboratory study, male rats fed a diet containing 200 mg/kg/day 2,4,6-TCP or more every day for their entire lifetimes had an increased incidence of lymphomas or leukemia (NCI 1979).

Chronic reference doses (RfDs), which are estimates of daily oral exposure for a lifetime that are unlikely to cause long term adverse non-cancer effects (even in sensitive populations), have been derived for chlorophenols based on available laboratory studies. As summarized in Appendix B, Table 5a, chronic RfDs for chlorophenols range from 3 to 100 mcg/kg/day (USEPA a,b,c, 2002). Chronic RfDs incorporate uncertainty factors to account for the possibility that humans may be more likely to experience toxicity than rats, that some people may be more sensitive than others (e.g., the elderly and children), and that adverse effects may have occurred at lower doses if the experiment was carried out for a longer time. Uncertainty factors are usually factors of 10 that are applied to exposures having no adverse effect in the study (i.e., No-Observed-Effect-Levels or NOELs). NOELs are divided by uncertainty factors to derive the chronic RfD. Chronic RfDs are frequently 100 to 1000 times or more lower than exposures associated with adverse effects in animal studies. The lowest levels of exposure that are actually associated with an adverse effect are called Lowest-Observed-Effect Levels or LOELs. As shown in Appendix B, Table 5a chronic RfDs for chlorophenols are one thousand to ten thousand times below the lowest dose level used in the studies, i.e., the LOELs, that produced an adverse effect.

Estimated CFP Exposures and Potential Health Risks Based on CFP Levels in Soil and Air

Due to the lack of information on the toxicity of CFP, we used information on chlorophenols to characterize the potential health risks (non-cancer and cancer) of exposure to CFP in soil and air. To examine potential non-cancer health risks, we used the oral RfDs for three chlorophenols (2-chlorophenol; 2,4-dichlorophenol; and 2,3,5-trichlorophenol). To examine potential cancer risks, we assumed that CFP is carcinogenic and we used information on the cancer causing potential of 2,4,6-trichlorophenol.

The assessment of potential non-cancer risks for exposure to CFP by soil ingestion is shown in Appendix B, Table 5b. The soil ingestion exposure estimate is based on the maximum measured level of CFP in soil (8,900 mcg/kg). This is clearly a very conservative approach because it assumes that all of the soil to which a person is exposed contains that level of CFP. Also, the maximum soil CFP level was in a soil sample collected in January; soil exposure during winter months is unlikely. Samples collected by the USEPA in June 2002 contained lower levels of CFP in soil. Table 5b also shows the assessment of potential non-cancer risks for exposure to CFP by soil ingestion and homegrown vegetable ingestion. In this case, we based the exposure estimate on the maximum level of CFP in soil measured by the USEPA in the June 2002 sampling (860 mcg/kg). This approach also is conservative because the single highest value is used to estimate exposure, while other measurements by USEPA showed much lower values, as low as 'not detected' for the only sample that seems to represent a 'garden soil' sample (see Appendix B, Figure 5b). In both cases (soil ingestion; soil plus vegetable ingestion), the estimated exposures are much lower than the oral RfDs for the three chlorophenols. Thus, the risk of non-cancer health effects by these exposure pathways is minimal.

The assessment of potential non-cancer risks for exposure to CFP through the air is shown in Appendix B, Table 5c. Inhalation exposure estimates are based on oral toxicity values for chlorophenols because toxicity values based on inhalation exposure are not available. Oral toxicity values can be expressed in terms of corresponding air concentrations that would result in equivalent exposure. Air concentrations estimated to result in the same intake as the oral RfDs for chlorophenols are much higher than the highest detected level of CFP in air, as shown in Appendix B, Table 5c. This suggests that the risk of experiencing long-term non-cancer health effects as a result of inhaling CFP also appears to be minimal. This evaluation assumes that oral and inhalation exposures are equivalent and that people are always exposed to the highest measured level of CFP in air.

The assessment of potential cancer risks for exposure to CFP by soil ingestion and soil plus vegetable ingestion is shown in Appendix B, Table 5d. For this assessment, we used the same soil concentrations that we used to estimate non-cancer risks. We also assumed that these soil concentrations do not change with time (even though the January 2002 and June 2002 sampling results suggest that soil levels of CFP are decreasing), and that exposure occurs for 30 years. The estimated cancer risk for the soil ingestion pathway is 4 in 100 million, and the estimated cancer risk for the soil plus vegetable ingestion pathway is 3 in 10 million. Thus, the estimated cancer risk for these exposure pathways is very low.

The assessment of potential cancer risks for exposure to CFP through the air is shown in Appendix B, Table 5d. For this assessment, we use the same maximum air concentration that was used to estimate non-cancer health risks. If exposures to the highest detected air level (0.9 mcg/m3) were assumed to occur over a 30 year period, the estimated cancer risk would be about one in one million, which is considered very low (Appendix B, Table 5d). Although uncertain, these estimates of risk assume that people are exposed to the highest levels of CFP in soil and air for 30 years, which is unlikely. Thus, the risks presented here are likely higher than the actual cancer risks posed by ingestion and inhalation to these chemicals.

There is considerable uncertainty associated with estimates of CFP exposure based on environmental data and the many assumptions used in calculating CFP exposure. However, because estimates of exposure were based on maximum detected levels of CFP in soil and air, and on the assumption that exposures would occur every day for 30 years, CFP exposures were probably not underestimated. There is also uncertainty associated with the assumption that CFP will have non-cancer or cancer effects similar to other chlorophenols. CFP may, in fact, be less toxic or more toxic, than chlorophenols. Nevertheless, because estimated CFP exposures based on maximum detected soil and air levels are below levels of exposure unlikely to cause adverse effects for chlorophenols (i.e. RfDs, NOELs, LOELs), the risk of long-term non-cancer health effects appears to be minimal. Similarly, maximum estimated exposures based on maximum detected levels of CFP in soil and air are associated with a very low to low estimated cancer risk.

Estimated CFP Exposures and Potential Health Effects Based on CFP Urine Levels

The pattern of CFP levels in urine is useful in understanding exposures that occurred during and after the release of January 5, 2002. As summarized in Appendix F, most CFP present in urine is probably present as metabolites of CFP. The continued, gradually decreasing levels of CFP in urine probably reflects continued, declining exposure to CFP. The likelihood that the continued presence of CFP in urine is not from continuing exposure was thoroughly evaluated and found to be small (see Appendix F). Included in this evaluation was consideration of whether CFP or CFP metabolites have a relatively long residence time in the body and the possibility that the CFP in urine is from the breakdown of other compounds that may have been absorbed.

Urine CFP levels depend on how much CFP is absorbed into the body, how CFP is distributed to different tissues within the body, how much CFP is metabolized, and how much of the CFP and its metabolites are excreted. Another consideration is how fast these processes occur. There is no specific information on how rapidly CFP would be absorbed, metabolized, and excreted in urine after single, repeated, or continuing exposures. However, information available for a closely related chlorofluorophenol and other chlorophenols suggests that CFP is probably quickly taken into the body through breathing and through skin contact (ATSDR 1999; Soffers et al. 1994). After a single exposure event, most of the CFP is probably fairly quickly metabolized in the body and eliminated in the urine, assuming no further exposure occurs (ATSDR 1999; Soffers et al. 1994). However, if exposures continue, CFP would likely be continually absorbed, metabolized, and eliminated in urine. The amount of CFP present in urine would depend upon the level and conditions of exposure, the time of urine sampling with respect to exposures, and variations among individuals in the rate they metabolize and excrete CFP.

Some residents of Holley continued to have CFP in their urine four months after the January release. Although a relatively long residence time for CFP cannot be completely ruled out as a possible explanation for the continued presence of CFP in urine, this seems unlikely. First, information for other chlorophenols indicates they do not accumulate in the body (ATSDR 1999). Second, the CFP detected in urine is likely in the form of metabolites (glucuronide and sulfate conjugates) that are recognized as being relatively rapidly formed and excreted in urine (i.e., they do not accumulate in the body) (Rozman and Klaassen 2001). In addition, thorough consideration of scientific literature did not reveal metabolic pathways that could result in other types of metabolites that would be excreted more slowly in urine (see Appendix F). Moreover, a few individuals returning to the area of greater impact after having been away showed an increase in CFP in urine. All of this information suggests that a continuing source of CFP exposure was present that could account for the continuing presence of CFP in urine.

Because urine CFP levels may reasonably be assumed to reflect total daily CFP exposure, exposure to CFP can be estimated from levels of CFP measured in urine (see Appendix F). Estimated levels of CFP exposure via all pathways can then be compared to levels of chlorophenol exposure unlikely to cause adverse effects if experienced daily over a long period of time (i.e., chronic RfDs) and to NOELs and LOELs (Appendix B, Table 5a). Estimated CFP exposures based on CFP urine levels can also be used to estimate cancer risk, assuming CFP has cancer potency equivalent to 2,4,6-TCP, that exposures occur over an entire lifetime, and that the levels of CFP in urine remain constant over time.

An initially developed analytical method for quantifying CFP in urine indicated that no individual providing a urine sample had urine levels greater than 20 mcg CFP/g creatinine by April 2002 and that most individuals had no CFP in their urine. The average CFP urine level among those where CFP was detected is about 5 mcg CFP/g creatinine. If it is assumed, as detailed in Appendix F, that exposures to CFP occur for a 30 year period, that excretion of CFP in urine is constant and no greater than 20 mcg/g creatinine (i.e., that exposures and therefore urine levels are constant over time), exposure of any individual providing a urine sample is estimated to be below 0.4 mcg/kg/day for children and 0.6 mcg/kg/day for adults (Appendix F, Table F-1). If it is assumed that urine CFP levels average 5 mcg CFP/g creatinine, exposures are estimated to be about 0.07 mcg/kg/day for children and 0.1 mcg/kg/day for adults (Table F-1, Appendix F). Maximum estimated exposure is at least five times smaller than the chronic RfDs for chlorophenols; average estimated exposures for individuals whose CFP was detected in urine are 15 times or more smaller than chronic RfDs. This suggests that the risk of long term non-cancer health effects is minimal (Appendix E).

An improved, validated analytical method suggests that urine levels may be greater than originally determined. Re-analyses of a small number of previously analyzed urine samples suggests that individual urine CFP levels may be between one and eight times higher (with an average of four times) than originally determined. This means that maximum estimated exposures based on urine levels in April may be up to eight times higher than originally determined and that average estimated exposures may be up to four times higher than originally determined. Maximum estimated exposures based on the improved method suggests exposures are likely to be below 3 mcg/kg/day for children (0.4 mcg/kg/day x 8) and below 5 mcg/kg/day for adults (0.6 mcg/kg/day x 8). Average exposures based on the improved method are estimated to be about 0.3 mcg/kg/day for children (0.07 mcg/kg/d x 4) and 0.4 mcg/kg/day for adults (0.1 mcg/kg/d x 4). Maximum estimated levels of exposure based on the improved method are in the range of chronic oral RfDs for chlorophenols derived from animal studies, but average estimated exposures are slightly below the range of RfDs. These findings suggest the risk of long term non-cancer health effects is minimal to low.

The RfDs do not represent definitive values that separate exposures that cause health effects from exposures that do not. Rather, exceeding the chronic RfDs indicates the need to further evaluate the likelihood of an adverse effect at the estimated exposure levels on a case-by-case basis. One way to further evaluate the potential for an adverse effect to occur is to compare estimated exposures to actual experimental exposures associated with adverse effects. This type of comparison provides an estimate of the magnitude of the difference between estimated exposures and exposures associated with adverse effects, which is termed the "margin of exposure". As shown in Appendix B, Table 5e, maximum estimated CFP exposures based on the improved analytical method are 600 times or more below the lowest chlorophenol exposure levels (LOELs) associated with adverse effects in animal studies. The margins-of-exposure based on estimated average exposure are even greater. This 600 fold or greater margin of exposure between maximum estimated exposures and levels of exposure to chlorophenols that are associated with long term adverse effects suggests that the likelihood of experiencing these types of effects in humans is low.

It is also possible to estimate cancer risk based on estimates of CFP exposure derived from CFP in urine. Assuming that no individual providing a urine sample in April 2002 had CFP levels exceeding 20 mcg/g creatinine, that CFP has cancer potency equivalent to 2,4,6-TCP, and that exposures occur for 30 years, the estimated cancer risk is three in one million which is considered to be a low risk (Appendix B, Table 5d). Even when the elevated exposures occurring soon after the release are averaged into the exposure estimates, the estimated cancer risk does not exceed three in one million. Estimated cancer risks are about two in one hundred thousand if it is assumed that urine levels may be up to eight times greater than originally determined, as the improved analytical method suggests. Average estimated cancer risk based on average CFP urine levels in individuals where CFP was actually detected in April 2002 are about five in ten million. These estimates of cancer risk are also considered to be low (Appendix B, Table 5d).

The analytical data used in estimating exposure to CFP from urine levels are limited and many assumptions were used in these calculations. There is, therefore, considerable uncertainty associated with estimates of CFP exposure based on CFP urine levels. However, because estimates of exposure included a CFP urine level unlikely to be exceeded after April 2002, and are based on the assumption that exposures would occur every day for 30 years, CFP exposures were probably not underestimated.

There is also uncertainty associated with the assumptions that CFP will have non-cancer or cancer effects similar to other chlorophenols. CFP may be less toxic or more toxic, than chlorophenols. Nevertheless, because maximum estimated chronic exposures based on CFP urine levels are below levels of exposure unlikely to cause adverse effects for structurally related chlorophenols, the risk of long-term non-cancer health effects appears to be minimal. It is not known whether CFP can cause cancer. Since not all chlorophenols that have been studied caused cancer, CFP may not pose any cancer risk. If it is assumed that CFP does cause cancer, the cancer risks presented are likely higher than actual risks might be since they include estimates of the maximum possible exposures that are unlikely to be exceeded.

E. Health Outcome Data Evaluation

Health symptom reporting data were collected on exposure surveys administered during each round of urine sampling. Analysis of health symptom reporting data was completed for data collected at the time of the first and fourth round of urine sampling (January and May). Sixty-five symptom reports were submitted in the first round and 244 symptom reports were submitted in the fourth round. Thirty individuals submitted exposure surveys without urine samples in the first round. Seven individuals (1 in the first round and 6 in the fourth round) had their urine sampled for CFP, but did not fill out exposure surveys and therefore could not be included in the symptom analysis.

For the purposes of health symptom analysis, individuals submitting an exposure survey were categorized into two groups according to their relative potential for exposure to CFP. In the first round, those individuals categorized as having a greater potential for exposure included those residing in the area of greater impact and those with a potential occupational exposure to CFP. Individuals who resided in the area of greater impact and relocated were included as part of the group with greater potential exposure for the first round analyses, since the first round surveys collected symptom reports on the January 5, 2002 release and the days immediately following. In the fourth round, only individuals currently residing in the area of greater impact were categorized as a greater potential for exposure. Individuals who relocated due to the Diaz release were not included in the fourth round analysis, as their exposure to the area of greater impact varied.

Round 1 Symptom Reporting (January 2002)

At the time of the first exposure survey that asked about health symptoms for the 12 days following the release on January 5, 2002, the most widely reported health symptoms among the 65 people submitting an exposure survey were: sore throat (78%), headache (68%), nose irritation (58%), eye irritation (58%), difficulty breathing (40%), nausea (38%), chest pain (23%), nose bleed (23%), and skin rash (17%). For discussion of this first round, those who either lived in the area of greater impact or had an occupational exposure are grouped together as having greater exposure potential (see above). These individuals were 33% more likely to report a sore throat than those with less potential for exposure. This difference is statistically significant, or unlikely due to chance. Additionally, those who had a greater exposure potential were 31% more likely to report nose irritation, 31% more likely to report eye irritation, and 24% more likely to report a headache; however, these differences are not statistically significant, meaning that chance may explain these differences. (1) There was no difference in symptom reports among those who had a detectable level of CFP in their urine and those who did not have a detectable level of CFP in their urine. See Appendix B, Tables 6a - 6d for details on symptom reports.

Round 4 Symptom Reporting (May 2002)

In the shorter survey used in the fourth round of sampling, a checklist of symptoms was not provided as in the first round. This difference in format may affect the comparability of symptom reporting between the first and fourth rounds. However, it is important to note that the percentage of participants who reported health symptoms in May was considerably less than the percentage of participants reporting health symptoms immediately after the release in January. In the week prior to the fourth round of sampling, the most widely reported health symptoms among those submitting a urine sample were headache (9%), sore throat (6%), eye irritation (6%), stomach complaint (4%), skin problem (4%) and sinus problem (4%).

Part of the explanation for smaller percentages of symptom reports in the fourth round may also be that in the fourth round of sampling, a smaller proportion of participants had a greater potential for exposure than in the January survey. In the earlier symptom reporting survey that accompanied the first round of sampling in January, approximately 54% of the participants had a greater potential for exposure, but in round four, approximately 9% of the participants had a greater potential for exposure. Limiting the reported health symptoms to only people who had a greater potential for exposure also suggests that people were experiencing fewer symptoms by May. For example, in January, 74% of people with a greater potential for exposure reported headaches, while in May 5% reported headaches. Also, among those with a greater potential for exposure, the percentage of reporting sore throat declined from 89% to 10%, nose irritation reports declined from 66% to 5%, eye irritation reports declined from 66% to 14%, and respiratory problem reports declined from 49% to 5% (Appendix B, Table 6a).

Additional evaluation of the data shows that in the fourth round, those with a greater potential for exposure were about 5 times more likely to report sinus problems and about 4 times more likely to report eye irritation than people with a lower potential for exposure. The differences for sinus problems and eye irritation were statistically significant. Those with a greater potential for exposure were also about 5 times more likely to report fatigue, 3 times more likely to report nose irritation, and 2 times more likely to report sore throat, dizziness or lightheadedness, and respiratory problems; however, these differences are not statistically significant (Appendix B, Table 6b). Although the number of people with a detectable level of CFP in the fourth round is very small, those with a detectable level were 5 times more likely to report eye irritation, 6 times more likely to report fatigue, and about 4 times more likely to report dizziness or lightheadedness than those without a detectable level of CFP. The difference for reporting of eye irritation is statistically significant, but is not statistically significant for reporting of fatigue and dizziness or lightheadedness (Appendix B, Table 6d).

Data Limitations

While the health symptom data appear to point to sharp differences in some symptoms for the people with a greater potential for exposure or who had detectable CFP levels in urine, the numbers of people in this analysis were very small. With small numbers, statistical tests are less likely to show significant results, and with small numbers, one must also be concerned with the highly variable nature of estimated differences among groups. In many of these tests, if one or two individuals answered differently, different conclusions would have been made. For example, in the fourth round, 3 out of 21 individuals with greater potential for exposure reported sinus problems. Six out of 208 individuals with less potential for exposure reported sinus problems. If only one less individual with greater potential for exposure reported sinus problems, the finding would not have been statistically significant. If only two more individuals with less potential for exposure reported sinus problems, the association would not have been statistically significant. This level of variability due to small numbers prevents us from being able to draw strong conclusions from these data.

In addition, several other limitations of this type of investigation need to be considered. Out of the 38 significance tests performed, only 4 had significant findings. When performing numerous tests for significance, the possibility of incorrect conclusions can become magnified. These results assume a willingness to take a 5% chance (1 in 20 chance) of concluding there is a real difference in the reporting of health symptoms when there truly is not any difference. Since there are 38 individual tests for significance, it was anticipated that about two results might appear statistically significant even though the differences in symptom reporting might have been entirely due to random fluctuations in data.

Also important are the limitations of self-reported health symptom data in an investigation such as this one. The first limitation is that people who are more concerned about exposures to CFP are more likely to remember and report health symptoms. In epidemiological terminology, this phenomenon is called reporting bias and it is considered to be an important limitation of self-reported symptoms and conditions. This reporting effect can lead to incorrect interpretation of information, because people who live closer to the facility or who notice odors are aware that they are more likely to have been exposed and are more concerned than other people who live much further away. Because of their concern, they remember and report symptoms more completely.

Another limitation of self-reported symptom data in an investigation such as this one is that people who believe they have been exposed and who feel ill are often more likely to participate in such an investigation. This can lead to misinterpretation since others who have been exposed but are not ill and people who are ill but not exposed are underrepresented. This is called selection bias. The voluntary nature of the urine sampling program and the initial over-sampling of those with potentially greater exposure and other health concerns raise the potential for selection bias.

Bias means systematic error in the design, conduct, or analysis of a study. The result of this type of error is that it can lead to a mistaken estimate of an exposure's effect on the risk of disease. Since bias is almost always a possibility in human studies, recognizing the types of bias and their possible effects is important. When interpreting the findings one must carefully consider the limitations due to bias.

There are also limitations of comparing data across time. In January and May, the formats of the exposure surveys were different. The differences in format may have led to differences in the reporting of symptoms. In addition, the nature of the investigation precluded having participants in sufficient numbers across exposure categories to draw statistically significant inferences. For example, there were not very many participants in urine sampling who remained in the area of greater exposure potential between January and May. The focus of the exposure investigation was rather to follow individuals who were most likely to be impacted by the release, and especially to try to get second urine samples from anyone who had a positive urine sample, so that change on the individual level over time could be checked. Because many people with greater exposure potential relocated between January and May, they were excluded from some round 4 analyses. This change in the make-up of the study population between January and May also limits the conclusions that can be made comparing the first and fourth rounds. Another limitation to making comparisons between January and May is that we have repeat urine levels on a small group of people. A majority of the participants in the urine sampling submitted their first sample in May.

Additional limitations exist with the interpretation of our conclusions. Some people reported symptoms more carefully than others, and filled out the form more completely than others. If parts of the form are left completely blank, it is not possible to know with certainty if they had no symptoms or just chose not to report them. In addition, some people may have left out symptoms if they were sure they were not related to the release, while others reported all symptoms, no matter what they thought caused them.

 

Another issue with the quality of the symptom reporting data is that some participants were more careful than others to state the timeframe of additional symptoms. Symptoms were mostly reported on a daily log page for a set number of days prior to and including the date of urine sampling. However, symptoms were also reported in a separate entry for general comments on exposures and symptoms. In this entry respondents often did not specify the time frame of symptom occurrence. Therefore, in round four if people filled this section out but did not state that the symptoms were current, we could not analyze the symptom reports. This is important because in the round four analyses, we attempt to assess current symptoms, not symptoms that occurred at the time of the release.

Many of these limitations are unavoidable in an exposure investigation because of variations among people in terms of their activities, concerns, and memories about symptoms. Considering the limitations, it is difficult to make conclusions about whether there are short-lived or long-term health impacts related to the release of CFP. However, we do believe that the information on CFP levels in urine has been useful in better understanding individual exposures.

Finally, our urine sampling program and collection of health data are part of an exposure investigation, not a health outcome study. Therefore, our efforts to date have been to characterize exposure potential in the community, but have not been designed to completely characterize health outcomes. We attempted to fully analyze the data collected in the exposure investigation to reveal as much information about reported health symptoms as possible. Symptom reports are useful as indicators of people's health concerns, but are not a definitive measure of health status.


COMMUNITY HEALTH CONCERNS

The January 5, 2002 release of CFP caused concerns among residents of the Village of Holley because of odors and visible contamination associated with the CFP release. Concerns about adverse health effects were heightened in the area with the greater amount of contamination. The initial concerns were about acute health effects (e.g., sore throats, headaches, eye irritation, nosebleeds and skin rashes) and the staining of personal property (e.g., cars, homes, sidewalks). Some personal property, especially items with large surfaces (e.g., cars, homes, and sidewalks), has been cleaned. A smaller proportion of people complained about acute health effects in May than January. CFP was still detected in household items sampled in March 2003 and there is a potential for on-going exposure. Some members of the community remain concerned about this low-level exposure and the potential for long-term health risks, especially related to children.

Residents have expressed concern that Diaz was permitted to manufacture a chemical in their community without having information about its toxicity. The federal Toxic Substances Control Act (TSCA) gives USEPA authority to require toxicity testing of chemicals used in commerce. Manufacturers are required to notify USEPA prior to producing a new chemical or developing a significant new use for an existing chemical and may be required to collect toxicity data about the chemical. However, chemicals may be exempt from the requirements of TSCA for a variety of reasons, including those manufactured chemicals solely for export.

Citizens were also concerned that the emergency response was not well coordinated and that the recommended action to remain in their houses with windows closed did not protect them. The CFP release also heightened concern about the other permitted and fugitive air emissions from the facility.

A draft of this document was released in November 2002. The public was invited to comment on the draft PHA and comments were accepted until February 10, 2003. The comments and responses are provided in Appendix H.


CONCLUSIONS

  1. Residents of the Village of Holley were exposed to 2-chloro-6-fluorophenol and related contaminants when the Diaz Chemical Corporation had an accidental release on January 5, 2002. Visual observation and environmental sampling documented the presence of CFP and related compounds on outdoor surfaces, in outdoor air, in soil, and inside homes. The environmental contamination was greater in the area immediately downwind of the January 5, 2002 release from Diaz.

  2. To address concerns about visible contamination, Diaz cleaned contaminated property and relocated people from their homes.

  3. Residents reported odors and health outcomes such as sore throat, headache, nose irritation, and eye irritation from the exposure. These symptoms were commonly reported immediately after the release in January, especially among persons who had a greater exposure potential. Persons with a greater exposure potential were more likely to report some of these health complaints than were persons with less exposure potential. In May 2002, a smaller proportion of people with a greater exposure potential reported symptoms than they did in January 2002.

  4. CFP was detected in urine during five rounds of sampling, confirming exposure to CFP. People living in the area of greater impact were more likely to have a detectable level of CFP than those outside this area. The urine results suggest that low level exposure to CFP may have still been occurring for a few individuals at the time of the last sampling, December 2002. The overall trend in the urine data is that the number of people and that the concentration of CFP in urine is decreasing.

  5. Measurement of CFP in urine began as a qualitative tool for evaluating exposure. Improvements in the urine methodology improved our ability to use the urine data as quantitative measurements of exposure.

  6. Based on an assessment of exposure from soil, air, urine CFP levels and using health effects information on chlorophenols, current exposures of Village residents present a low to minimal risk for non-cancer health effects. If these exposures were to continue for 30 years, which is unlikely, the risk of cancer is very low to low. The uncertainties with evaluating the public health risks associated with these exposures arise because of extremely limited information about the toxicity of CFP, limited information about past and present exposure estimates, and limited information about future exposures (both the level and the amount of time). These data gaps are not likely to be filled soon, if ever. The current environmental conditions resulting from the January 5, 2002 accidental release are consistent with ATSDR's public health hazard category of an indeterminate public health hazard (Appendix E).

  7. The USEPA is currently evaluating the site to determine whether it should be placed on the National Priorities List (NPL) of hazardous waste sites. This evaluation is not specific to the CFP release.

  8. At the time of the release, emergency procedures, including notification of potentially affected residents, were conducted. It is unclear how effective the notification procedures were at reducing the potential for residents to be exposed.

  9. Toxicity information about CFP is lacking and federal law (TSCA) did not require that information to be developed.

RECOMMENDATIONS

  1. Although the health risks from on-going exposures are not completely understood, they are estimated to be minimal to low for non-cancer health effects and very low to low for cancer. Consideration should be given to remediation that will reduce contamination, especially with porous materials in the indoor environment of homes in the area of greater impact, and may reduce the potential for human exposure. Any decrease in exposure would further reduce the health risks.

  2. NYSDOH validated the new enzyme digestion method for analyzing CFP in urine and should finish reanalyzing previously collected samples. NYSDOH upon completion of the reanalysis should evaluate if additional urine sampling using the new method, if any, would be useful.

  3. The State Emergency Management Office and the Orleans County Emergency Planning Committee should review the emergency procedures for the Diaz facility. Although Diaz has stopped operating at this facility and the USEPA is managing the site, currently there are waste chemicals stored on-site. The emergency management offices should be prepared for any releases associated with the wastes currently on-site, especially if a fire were to occur.

  4. NYSDEC and USEPA should review the past practices and processes at Diaz to determine if other environmental contamination occurred from past Diaz practices. The public is concerned about other releases in addition to the January 5, 2002 release of CFP. NYSDEC and USEPA should provide more information about the other processes and possible releases.

  5. USEPA should review its procedures under TSCA to determine if changes are necessary so that adequate toxicological data are available if needed.

  6. NYSDOH and ATSDR should evaluate the usefulness of the CFP biomonitoring in responding to the CFP release. The evaluation should consider the needs of the citizens and the agencies. The results of the evaluation should be used to help develop criteria and plans for using biomonitoring for responding to future releases.

PUBLIC HEALTH ACTION PLAN

The Public Health Action Plan (PHAP) for the Diaz Chemical Release contains a description of actions to be taken by NYSDOH and/or the ATSDR following completion of this health consultation. The purpose of the PHAP is to ensure that this public health assessment identifies public health hazards and provides a plan of action designed to mitigate and prevent adverse human health effects resulting from past, present, and/or future exposures to chemicals released from Diaz. Included is a commitment on the part of NYSDOH and/or ATSDR to follow-up on this plan to ensure that it is implemented.

The public health actions to be implemented by the NYSDOH and/or ATSDR are as follows:

  1. NYSDOH and ATSDR will coordinate with the appropriate agencies to implement the recommendations contained in this public health assessment.

  2. NYSDOH will offer to analyze urine samples, using a validated method, from individuals whom had detectable CFP levels in their last round of urine sampling or who move into homes vacated since the release. Samples will be collected within the week prior to and one week after moving into the house. Although the urine results are of limited usefulness in understanding an individual's risk of experiencing an adverse health effect, the urine results can be an indicator of exposure. As such, some individuals may find this information of value. The test for CFP is non-routine, and no other laboratory has demonstrated proficiency to analyze this chemical in urine.

  3. NYSDOH validated the new enzyme digestion method for analyzing CFP in urine and has offered to analyze previously collected urine samples with the new method. The results of the reanalysis should be provided to the individuals that submitted urine samples. A summary of all the results should be provided to the public at large.

  4. USEPA and NYSDEC will review the past practices and processes at Diaz. USEPA is doing additional site evaluation for the purpose of determining whether Diaz should be placed on the National Priorities List (NPL) of hazardous waste sites. ATSDR and NYSDOH will work with EPA to evaluate the results of the EPA sampling including the dioxin analyses.

  5. In response to community concerns about long-term health effects due to the CFP release, NYSDOH offered enrollment in the NYS Volatile Organic Compounds Exposure Registry. An exposure registry is a resource for research that may help us learn whether exposures to chemicals, like CFP, are related to long-term health effects. Residents of the Village of Holley are eligible to participate in this voluntary registry.
  6. Enrollment in the registry entails completion of a survey about potential exposure to CFP, the health status of each member of the household, and other factors related to health, such as smoking. Residents will then be contacted on a periodic basis to update address information and track changes in health status. NYSDOH contacted households eligible for participation. People who are enrolled in the registry will be kept informed of any research results that come from the registry data. Data gathered for the registry will be kept confidential.

  7. The NYSDOH will work with ATSDR to evaluate the feasibility of a formal analysis of the effectiveness of biomonitoring. Elements of this analysis may include reviewing the scientific literature and contacting other government agencies about how biomonitoring programs have affected communities. The information gained from this effort should be summarized in a report and shared with the public and other agencies.

  8. NYSDOH and ATSDR will provide follow-up to this PHAP, as needed, outlining the actions completed and those in progress. Included in the report will be an evaluation of any new data generated since issuing this PHA. This report will be placed in repositories and will be provided to people who request it.

ATSDR will reevaluate and expand the PHAP when needed. New environmental, toxicological, or health outcome data, or the results of implementing the above proposed actions, may determine the need for additional actions at this site.


PREPARERS OF REPORT

New York State Department of Health Authors

Lloyd Wilson, Jan Storm, Patrick Palmer, Jennifer Hunt, Edward Horn
Research Scientists
Bureau of Toxic Substances Assessment

Elizabeth Lewis-Michl, Karolina Schabses, Karen Nolan, Steve Forand, Ed Fitzgerald
Research Scientists
Bureau of Environmental and Occupational Epidemiology

Don Miles
Public Health Specialist
Bureau of Environmental Exposure Investigation

Nancy Kim
Director, Division of Environmental Health Assessment


Agency for Toxic Substances and Disease Registry

Regional Representative
Arthur Block
Regional Operations
Office of the Administrator

Technical Project Officer
Greg Ulirsch
Technical Project Officer
Division of Health Assessment and Consultation


REFERENCES

ATSDR. 2002. Memorandum. From: Director, Division of Toxicology; To: Jason Broehm, Public Health Advisor, ATSDR/Washington Office; Subject: Structure Activity Relationship Analysis for 2-chloro-6-fluorophenol. January 26, 2002.

ATSDR 1998 Toxicological Profile for Chlorinated Dibenzo-p-Dioxins (update)

ATSDR 1999. Toxicological Profile for Chlorophenols (update)

Diaz Chemical Corporation. Material Safety Data Sheet. 2-chloro-6-fluorophenol.

Exon, J.H.; Koller, L.D. (1982) Effects of transplacental exposure to chlorinated phenols. Environ. Health Perspect. 46;137-140.

Exon, J.H.; Koller, L.D. (1985) Toxicity of 2-chlorophenol, 2,4-dichloropheonl and 2,4,6-trichloropehonl. In: Water Chlorination: Chemistry, Environmental Impact and Health Effects, Jolley et al., Ed. Vol. 5

Faustmann, E.M.; Omenn, G.S. 2001. Risk Assessment. In: Casarett & Doull's Toxicology. The Basic Science of Poinsons (Klaassen, C.D., ed.). 6th Edition. McGraw-Hill

Kimber, I.; Weisenberger, C. 1991. Anamnestic responses to contact allergens: Application in the murine local lymph node assay. J. Appl. Technology 2:129-133.

Kleinman, G.D.; Horstman, S.W.; Kalman, D.A.; Mckenzie, J.; Stansel, D. 1986. Industrial hygiene, chemical and biological assessments of exposures to a chlorinated phenolic sapstain control agent. Am. Ind. Hug. Assoc. J. 47:731-741.

McCollister, D.D.; Lockwood, D.T.; Rowe, V.K. 1961. Toxicologic information on 2,4,5-trichlorophenol. Toxicol. Appl. Pharmacol. 3:63-70.

McKinney, J.D.; Richard, A; Waller, C; Newman, M.C.; Gerberick, F. 2000. The practice of structure activity relationships in (SAR) in toxicology. Toxicological Sciences. 56:8-17.

NCI (National Cancer Institute). 1979. Bioassay of 2,4,6-trichlorophenol for possible carcinogenicity. U.S. DHEW Publ. No. NCI-CG-TR-155

NYSDOH. Report on Sampling Conducted in the Village of Holley, New York, Near the Diaz Chemical Corporation Facility, New York State Department of Health, January 14-15, 2002. February 2002.

NYSDOH. Urine Sampling Findings for People Living or Working Near Diaz Chemical Corporation, Village of Holley, Orleans County, Update: January 15, 203 (5th Round). NYSDOH. January 2003

NYSDOH. Urine Sampling Findings for People Living or Working Near Diaz Chemical Corporation, Village of Holley, Orleans County. Update: April 22, 2002. NYSDOH. April 2002.

NYSDOH. Exposure Survey and Follow-up Activities for People Living and Working Near Diaz Chemical Corporation Facility, Village of Holley, Orleans County. NYSDOH. April 2002.

NYSDOH. Report on Sampling Conducted in the Village of Holley, New York, Near the Diaz Chemical Corporation Facility, New York State Department of Health, March 8 and 21, 2002. April 2002.

NYSDOH. Urine Sampling Findings for People Living or Working Near Diaz Chemical Corporation, Village of Holley, Orleans County. Update: May 14, 2002 (3rd Round). NYSDOH. May 2002.

NYSDOH. Urine Sampling Findings for People Living or Working Near Diaz Chemical Corporation, Village of Holley, Orleans County. Update: July 25, 2002 (4th Round). NYSDOH. July 2002.

NTP. 1989. National Toxicology Program - technical report series no. 353. Toxicology and carcinogenesis studies of 2,4-dichlorophenol in F344/N rats and B6C3F1 mice (feed studies). U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health. Research Triangle Park, NC.

Park, K; Kitteringham, NR. 1994. Effects of fluorine substitution on drug metabolism: pharmacological and toxicological implications. Drug Metab Rev 26:605-643.

Rhomberg, L. 2002. Affidavit of Lorenz Rhomberg, Ph.D. Supreme Court of the State of New York, County of Orleans. May 21, 2002.

Rozman, KK; Klaassen, DC. 2001. Absorption, Distribution and Excretion of Toxicants. In: Casaret & Doull's Toxicology. The Basic Science of Poisons (Klaasen, CD, ed.). 6th Edition. McGraw-Hill.

Soffers, AEMF; Veeger, C; Rietjens. 1994. Influence of the type of halogen substituent on in vivo and in vitro phase II metabolism of 2-fluoro-4-halophenol metabolites formed from 3-halo-fluorobenzene. Xenobiotica, 24:759-774.

Final Analytical TAGA Report, Diaz Chemical Corporation Facility, Holley, NY. USEPA Work Assignment No. 0-256. Prepared by Lockheed Martin/REAC for U.S. EPA/ERTC. July 2002.

Trip Report: Air Sampling and Soil Sampling in Holley, NY. U.S.EPA Work Assignment No. 0-256. Prepared by Lockheed Martin/REAC for U.S. EPA/ERTC. August 2002.

USEPA a. 2-chlorophenol (CASRN 95-57-8). Integrated Risk Information System (accessed 2/27/2002)

USEPA b. 2,4-dichlorophenol (CASRN 120-83-2). Integrated Risk Information System (accessed 2/27/2002)

USEPA c. 2,4,5-trichlorophenol (CASRN 95-95-4). Integrated Risk Information System (accessed 2/27/2002)


CERTIFICATION

The New York State Department of Health has prepared this Public Health Assessment under a cooperative agreement with the Agency for Toxic Substances and Disease Registry (ATSDR). It is in accordance with approved methodology and procedures existing at the time the Public Health Assessment was initiated.

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


The Superfund Site Assessment Branch (SSAB), Division of Health Assessment and Consultation (DHAC), ATSDR has reviewed this public health assessment and concurs with its findings.

Roberta Erlwein
Chief, SPS, SSAB, DHAC, ATSDR


1 In the first round summary, it was reported that those who lived in the area thought to be more affected were four times more likely to report sore throat. It was also reported that those who lived in the area thought to be more affected were two times as likely to report nose irritation, eye irritation, and headache. These statements should have read as follows: The odds of reporting a sore throat among those living in the area thought to be more affected were four times the odds of reporting a sore throat in those living outside the area thought to be more affected. The odds of reporting nose irritation, eye irritation, or headache among those living in the area thought to be more affected were two times the odds of reporting such symptoms among those living outside the area thought to be more affected.

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