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PETITIONED PUBLIC HEALTH ASSESSMENT
CABOT-WROUGHT PRODUCTS - DIVISION OF CABOT CORPORATION
(a/k/a NGK METALS/CABOT BERYLCO, INCORPORATED)
MUHLENBERG, BERKS COUNTY, PENNSYLVANIA


APPENDIX D

Comments Received During the ATSDR Public Comment Period
September 1 - November 12, 1993

Note: The comments in this appendix were received during the public comment period for the NGK Metals Petitioned Public Health Assessment dated September 1, 1993. Therefore, comments refer to text discussions, pages numbers, tables, and figures of that document. Based on the comments, new data and information, and further toxicological research, revisions were made to the public comment release petitioned public health assessment and are reflected in this (final) document. Unless otherwise noted, ATSDR's responses reference page numbers, tables, and figures contained within this document.


Comment 1: In referring to the company as "Cabot" etc., you completely neglect to mention two1990 indictments of NGK by the Pennsylvania Attorney General for solid waste violations forwhich NGK pleaded "no contest" and paid heavy fines. You have attributed all dangers to thecommunity to past owners when, in fact, the dangers have continued with the present owners.

Response to comment 1: ATSDR indicates on page 3, the names of former companies, as well asthe company presently operating the facility. The Site Description and History subsection (pages3 and 4) provides a brief overview of the site and its operation. ATSDR public healthassessments are developed to assess environmental and health data. Although some enforcementitems are highlighted and discussed, public health assessments are not intended to chronicleregulatory and compliance issues. In the Environmental Contamination and Other Hazardssection, ATSDR reports past and present contamination and maximum concentration levels, basedupon available health data, rather than regulatory compliance. In this assessment, ATSDR hasattempted to focus on current environmental data that characterize the current condition of thesite and surrounding community, as well as indicate any past levels that may have presented ahealth hazard.

Comment 2: The site history does not include the role of the Department of Defense (DOD)during the years in the 1940's when they operated the plant. Your report indicates you didn't evenask for records from the DOD concerning field spreading and dumping (page 37, community concern number 22).

Response to comment 2: As stated in the response to comment 1, ATSDR provides a briefoverview of the site history and discusses environmental contamination, with particular emphasison the current site condition. In discussing site history, ATSDR referenced (reference number 1)the "NGK Metals Corporation RCRA Facility Investigation." Although ATSDR does notquestion or dispute that DOD contracted work or was in some way involved with the facility, theRCRA Facility Investigation (RFI) does not report any DOD involvement or more importantly, itdoes not report any environmental data during that time period that might be useful to thisassessment. Under "Waste Management History," during the time period in question the RFIstates, "Prior to the early 1950's, detailed information describing waste management activities atthe Reading plant is scarce. Reportedly, during the early 1940's, a retention basin existed alongthe eastern edge of the plant property adjacent to the Tuckerton Road. There are no files in theplant records indicating what materials flowed into the pond. The only record of the pond existson a Beryllium Corporation drawing showing the location and approximate outline of the pond." It is likely that a variety of waste practices and subsequent contamination have taken place at thesite during the past 50-60 years; however, there is very little documented record of what hasoccurred. In an effort to address this concern, ATSDR recommended surface soil sampling atuncovered on-site waste areas, as well as other areas where migration may have occurred. However, due to information provided in Comment 44 and due to pending remediation ATSDRhas revised that recommendation. In recommendation number 1, ATSDR is also requestingrepresentative on-site surface soil sampling when remedial activities are complete.

Comment 3: Assessments are made using "assumptions about quality control issues" and"insufficient data."

Response to comment 3: Since ATSDR does not conduct its own environmental sampling wemust rely on available data collected by various agencies and organizations. Of the data reviewedby ATSDR, it is assumed that adequate quality assurance and quality control measures werefollowed with regard to chain-of-custody, laboratory procedures, and data reporting. However,questions or problems, regarding data, that are identified are discussed in the QualityAssurance/Quality Control subsection (page 19). ATSDR is sometimes required to make adecision based on limited information and data; however, if data are too limited or are in someway "insufficient," ATSDR will state those facts when evaluating a site.

Comment 4: Valid conclusions cannot be reached in the light of: a) improper air sample tests, b)no off-site biota data, c) only one off-site surface sample, and d) no smoke stack monitoring.

Response to comment 4: It is ATSDR's belief that the conclusions made in this petitioned publichealth assessment are accurate and valid, based upon the data and information reviewed. ATSDRacknowledges the need for some of the above mentioned items, specifically off-site biota samplingand additional off-site surface soil sampling (arsenic, cadmium, copper, and lead only, based onrecent sampling), and therefore no conclusions were made in that regard. ATSDR has evaluatedair data as analyzed and reported by NGK, but indicated in the Quality Assurance/Quality Controlsubsection (page 20) that some questions regarding that data are being investigated by EPA. ATSDR will reassess that data if the results of EPA's investigation warrant reassessment. Sinceambient air data is available, ATSDR has not requested stack monitoring. Although ambient airmonitoring alone generally cannot be directly linked to a single source, it commonly provides abetter indicator of exposure to the general public than stack monitoring.

Comment 5: In your section on community concerns no mention was made about birth defects astold to you at your public hearing.

Response to comment 5: At the public availability session held on June 8, 1993, ATSDR notedyour concern as being more specific than birth defects. You stated that three out of a family withchildren had diabetes and that two out of three children from another family had congenital heartdefects. Those concerns were addressed, along with other specific health concerns, in number 16on page 39. None of the chemicals of concern identified at the site are known to be associatedwith birth defects in humans at the concentrations detected off-site.

Comment 6: No mention is made of an available test (blood test) approved by the ATSDR toshow if a person has been exposed to beryllium.

Response to comment 6: The beryllium lymphocyte proliferation test is mentioned in the "Public Health Implications" section of the final petitioned public health assessment (page 29 under the beryllium "Inhalation Exposure" subsection). See also the responses to comments 7-9 below.

Comment 7: Item number four [page 32] addresses the concerns that residents living in theReading area may develop sarcoidosis from exposure to beryllium oxide. In your response yousay that beryllium disease may be an immune response and from 1973-77 only one documentednonoccupational case was reported nationwide. Beryllium disease is well known to be animmunologically-mediated disease. The bronchoalveolar lavage cells, is an invitro measure of thisberyllium-specific, cellular immune response and had become the principal diagnostic tool indifferentiating beryllium disease from sarcoidosis. There has been a non-occupational case ofberyllium disease recently reported in the literature by our group. The patient carried a diagnosisof sarcoidosis for many years before diagnosis of beryllium disease was made. Enclosed is areprint of that case report [see Appendix E]. You state in your response, "the amount ofberyllium exposure needed to cause beryllium disease is uncertain." We agree, as we have seencases of beryllium sensitization and disease in persons with a wide range of exposures, someseemingly quite trivial. Anyone with sarcoidosis who has plausible beryllium exposure, eitherfrom living near the plant or having a person in the home who worked in the plant, should betested for beryllium sensitization to rule out beryllium disease.

Response to comment 7: This issue is addressed in the "Public Health Implications" section of the final petitioned public health assessment (page 29 under "Inhalation Exposure" and revised in number 4, page 35 under "Community Health Concerns Evaluation"). The symptoms of nonoccupational CBD are very similar to those of sarcoidosis so it is possible that the former disease may readily be misdiagnosed as the latter. However, it is currently possible to distinguishbetween sarcoidosis and chronic beryllium disease (CBD) using the beryllium lymphocytetransformation (or proliferation) test. This test may be performed on a blood sample, but resultsare more reliable when performed using bronchiolar/alveolar lavage fluid. Any long-termresidents who have been diagnosed as having sarcoidosis and who suspect that they may havebeen exposed to clinically significant levels of beryllium in the past may want to considerconsulting an occupational/environmental medicine specialist to determine whether specializedtesting for beryllium sensitivity is appropriate.

Comment 8: Item number 18 [page 36] addresses concerns that dust carried home from theberyllium plant may have resulted in illness. Again, the enclosed case report (see Appendix E)addresses the potential for this type of non-occupational exposure.

Response to comment 8: Current industrial hygiene practices are designed to eliminate suchpathways of off-site exposure. However, at this late date, it is not possible to determine who, ifanyone, was exposed to beryllium via this pathway decades ago. Any long-term residents whosuspect they have been exposed in this way, especially if they have since been diagnosed withsarcoidosis, may want to consider consulting an occupational/environmental medicine specialist todetermine whether specialized testing for beryllium sensitivity is appropriate.

Comment 9: Finally, item 30 [page 39] addresses CD4+ T cell levels and beryllium in lung tissueof sarcoidosis cases. We agree with your response that CD4+ T cell levels are not helpful inscreening for beryllium disease. However, the beryllium lymphocyte transformation test onperipheral blood can be used as a screening test for residents who may have signs or symptoms ofberyllium disease. We have also looked at measurable beryllium in lung tissue of berylliumdisease cases. Although many patients have beryllium in lung tissue, we do have some patientswho have negative beryllium levels, possibly due to sampling error. However, these patients havepositive response to beryllium in blood or bronchoalveolar lavage cells as demonstrated with thelymphocyte transformation test. Thus tissue levels of beryllium are not helpful in diagnosing orexcluding beryllium disease. If persons living around the NGK plant have concerns aboutberyllium disease or question a previous respiratory diagnosis, the beryllium lymphocytetransformation test is available for both screening and diagnostic purposes.

Response to comment 9: This issue is addressed in the "Public Health Implications" section ofthe final petitioned public health assessment (page 29 under "Inhalation Exposure" and page 42under "Community Health Concerns Evaluation", number 30). CD4+ T cells may accumulate inthe lungs in response to many factors other than beryllium exposure. Such a nonspecific indicatorof exposure to beryllium would be of little use in identifying beryllium lung disease. Sarcoidosispresents much the same signs as does beryllium disease, except for the demonstrable presence ofberyllium in the lungs. Thus, in order for a granulomatous lung disease to be diagnosed asberyllium disease, the presence of beryllium in lung tissue must be directly or indirectlydemonstrated. Currently, the easiest way to do that is to test for beryllium sensitivity in whitecells from blood or bronchoalveolar lavage fluid.

Comment 10: I do not think the Public Health Assessment is complete and accurate. I wasunaware of any potential link to sarcoidosis until I read a recent article in the newspaper. Ibelieve all physicians should be surveyed for sarcoidosis patients and then those patients should bechecked for possible links to NGK Metals.

Response to comment 10: ATSDR believes that this assessment is both complete and accurate. Completeness, however, is based on ATSDR's evaluation of available data and theacknowledgement of data gaps, where additional data is needed (and is requested) to makefurther conclusions. ATSDR discusses sarcoidosis on page 29 under "Inhalation Exposure" andpage 35, under "Community Health Concerns Evaluation," number 4. ATSDR public healthassessments evaluate environmental data, exposure pathways, possible adverse health effects, andhealth outcome data to determine whether a hazardous waste site may present a health threat. AnATSDR public health assessment is not the same thing as a medical exam or a community healthstudy. However, it can sometimes lead to those things, as well as other public health activities.

Comment 11: I have worked and/or lived near NGK Metals since August 1965. I worked atMetropolitan Edison Company, 2800 Pottsville Pike (Route 61), from 1965 to about 1972. Ihave lived in the Riverview Park area of Muhlenberg Township since 1971. I lived at 1051Grandell Ave. from September 1985 to the present. I have attended two churches in the area, themost recent one being across the highway (Route 61) from NGK Metals. I have spentconsiderable time in the NGK Metals area shopping, eating out, attending movies, etc. Duringpreadmission testing for surgery in 1989, my chest x-ray led to additional tests and my doctorinformed me that I have sarcoidosis. This aggravated a bronchial asthma condition whichsurfaced in 1985. Since, as a male, I am not supposed to have sarcoidosis, I thought you shouldbe aware of my situation. I wonder how many others remain unaware of any potential linkbetween NGK Metals and their health.

Response to comment 11: Thank you for your comment and information regarding this illness. However, it should be noted that sarcoidosis is not a disease that is peculiar to women. Amongamerican blacks, it does appear to be more common among women, but recent studies tend torefute this. Among caucasians, the incidence is very similar in both sexes. The incidence andexpression of sarcoidosis varies more between ethnic groups and nationality than it does betweenoccupations, which is consistent with the greater importance of genetic factors over exposurevariables in this disease. Sarcoidosis is the result of an overzealous immune response to one ormore of a variety of provoking agents or tissue insults, and genetic factors may be of primaryimportance.

Comment 12: After reading the report I have come to the conclusion that the ATSDR has donean outstanding investigative job of proving that the NGK plant in Muhlenberg Township has beendischarging highly toxic pollutants in the air and in the groundwater since its inception, but hasdone such a pitiful and insignificant job in proving that people, human beings, have gotten seriousillnesses as a result of it. What value is this report if you site only two residents, found on pagethirty-two number four, "Residents living in the Reading area may develop sarcoidosis fromexposure to Beryllium Oxide." If I had not supplied this information, your report would not havehad any validity. Can you imagine submitting to the public, a health assessment that shows no onegetting ill from the effects of Beryllium?

Response to comment 12: The quoted statement - "Residents living in the Reading area maydevelop sarcoidosis from exposure to Beryllium Oxide" - is listed in the petitioned public healthassessment as an identified community health concern (pages 8 and 35), and not as a medicalconclusion of ATSDR. In fact, none of the evidence available to ATSDR supports the conclusionthat "people, human beings, have gotten serious illnesses as a result of it [i.e., off-site berylliumexposure near NGK]." As discussed in the "Public Health Implications" section of the finalpetitioned public health assessment, chronic beryllium disease does mimic the symptoms ofsarcoidosis, but it should neither be equated with the latter disease nor even viewed as evidence ofexposure to beryllium. A clinical test (the beryllium lymphocyte transformation test) is nowavailable that can distinguish between sarcoidosis and beryllium lung disease. As stated in the"Response to comment 10," the evaluation of environmental data, exposure pathways, andpossible adverse health effects are a primary part of an ATSDR public health assessment. Evaluating health outcome data is another area of emphasis. This is done primarily through thereview of available databases, health studies, and community concerns, such as those reported tous by you and other residents. It should be noted again that a public health assessment is not amedical exam or a community health study, but its health outcome data review does sometimesshow trends that may prompt health follow-up, such as a community health study.

Comment 13: This part of your report is thoroughly remiss. I'm appalled and shocked that yourinvestigative team could not come up with any other residents who are suffering from Berylliumrelated illnesses or who may have died as a result of Beryllium poisoning. Did your team botherto talk to any local Muhlenberg Township barbers? All I had to do was ask my barber. When Iasked him the question, "do you know anyone who lives near the NGK plant or works there whomay have a breathing problem." Off the top of his head he named six residents who either workthere or live near the plant that were ill. Two of them have died. Did any member of theinvestigative team bother to go to the Berks County Courthouse to research how many residentssued or are presently suing NGK in Civil Court for causing their illness. In my research I filledtwo papers on both sides with names of local residents. People who settled out of court were notlisted in the files. Who knows how many settled out of court? Did your team bother to checkwith any local Pulmonary Specialist to see how many Muhlenberg Township residents they maybe treating or have treated in the past for acute breathing problems? I had no authority to do that,but during my own investigation of how my wife could have gotten this illness, I had severalMuhlenberg Township women call me on what course they should take for fear of havingsymptoms of sarcoidosis. And none of these women were African-Americans. In fact in my eightyears of researching and investigating this illness, out of all the people I came into contact withwho were suffering from this disease not one was an African-American female. In fact, out ofthousands of pages of research that I acquired through the Freedom Of Information Act, not onegave the statistic of ninety percent of sarcoidosis cases occur in African-American women. Iwould like you to send me a copy of that study. I just can't believe your information.

Response to comment 13: Please refer to the responses to comments 10 and 12 regarding what apublic health assessment is and does. ATSDR staff has not talked with local barbers or localpulmonary specialists, nor has it checked courthouse records. Although some of these actionscould prove to be reasonable sources of information, they are not typically used in gatheringinformation for a public health assessment. Sources that were used in developing this publichealth assessment are enumerated in the References section on page 50. Actions that have beentaken by ATSDR in an effort to collect information include: contact and file reviews of federaland state environmental and health agencies, contact with local municipalities, reviewing federaland state health databases, visiting the NGK facility, personal conversations with concernedcitizens during the site visit and public availability sessions, initiating telephone calls to concernedcitizens, receiving letters and telephone calls from concerned citizens, and issuing the petitionedpublic health assessment for public comment.

Statistics on the incidence and prevalence of sarcoidosis are highly uncertain due to the relativerarity of this chronic disease, the variable severity of its symptoms, the potential for misdiagnosis,and non-representative nature of most study populations. It is clear, however, that the incidenceof sarcoidosis in the U.S. is much higher in blacks than in whites (47). The statement in an earlierdraft to the effect that sarcoidosis occurs only in women was in error. That error has beencorrected in the final document. There is no sex predominance in the incidence of sarcoidosisworldwide, and, in caucasian populations, cases of sarcoidosis are almost equally divided betweenmen and women. Although the disease has been reported to be 2-3 times as common amongblack females as black males, this finding may only reflect the fact that most of the early studieswere done in large urban hospitals where the majority of patients seeking medical attention forany ailment happened to be females, especially black females. The current consensus is that thereis no predominance of sarcoidosis among women in general or black women in particular (47). Of all the potential risk factors studied (i.e., genetic, racial, infectious, environmental,occupational, smoking, and presence of other disease), only genetics and possibly geography arewell established risk factors for sarcoidosis.

Comment 14: I would like to point out what I think is a glaring contradiction in your report. Onpage thirty-two, number four, "Residents living in the Reading area may develop sarcoidosis fromexposure to Beryllium Oxide," the report states that Beryllium causes a sarcoidosis like condition. In fact, a letter that I received from a military doctor, a copy which I submitted to the ATSDR,specifically states, "the only known cause of sarcoidosis is beryllium," so I agree with yourstatement. However, the very next line in the report states, "Sarcoidosis is a chronic disease ofunknown cause..." How can you state in one sentence that Beryllium causes sarcoidosis and thenext sentence states it is a disease of unknown cause. I'm confused. Either there is a cause orthere isn't a cause. It can't be both.

Response to comment 14: On page 32, under community concern number 4 (of the publiccomment draft petitioned public health assessment), you accurately point out that ATSDR states,"beryllium causes a sarcoidosis-like condition." The sarcoidosis-like condition that ATSDR isreferring to is chronic beryllium disease (or Berylliosis). ATSDR does not state that sarcoidosis iscaused by beryllium. Sarcoidosis and chronic beryllium disease are separate illnesses with similarsymptomology. Because of their similarity, chronic beryllium disease is sometimes misdiagnosedas sarcoidosis (for further reference you can review the article, "Nonoccupational BerylliumDisease Masquerading as Sarcoidosis: Identification By Blood Lymphocyte ProliferativeResponse to Beryllium," in Appendix E). The cause of sarcoidosis is unknown.

Comment 15: In the second paragraph on page thirty-two, the report again states, "one type ofsarcoidosis like disease is caused by Beryllium." The next sentence states that the ATSDR hasexamined sarcoidosis as a potential site-related health effect. Then the report states the amount ofBeryllium exposure needed to cause Beryllium Disease is uncertain. The last sentence in theparagraph states, "Current data did not allow ATSDR to find a relationship between the site andthe case."

Response to comment 15: Because the symptoms of sarcoidosis (which has an unknowncausative agent or agents) are very similar to those of beryllium disease (which is caused byberyllium exposure) and since cases of sarcoidosis have been reported in the area, ATSDR hasexamined sarcoidosis as a potential site-related health effect. It is typically quite difficult to makea definitive link between an illness and an environmental exposure even when the causative agentis known. Current data does not allow ATSDR to determine a link between the site and thereported cases of sarcoidosis.

Comment 16: This report is a sham. Whoever wrote it and whoever investigated it wasted theirtime. The report has dismissed the only two cases as not being applicable to the NGK plant. How can you publish a health assessment concerning a toxic substance but can't prove anyresidents suffer ill effects from it? Why bother at all? I'm tired of relating my wife's case to provebreathing Beryllium Oxide is extremely hazardous to ones health. She lived a half a mile from theNGK plant on Seventh Avenue in Temple for half of her life. She breathed the air and played inthe dry dirt. At the age of thirty-four she has one-third breathing capacity compared to a normaladult. A biopsy of her lungs shows that she has Beryllium in her lungs. How much Berylliumdust does it take for a person to lose two-thirds of their breathing capacity? According to Dr. LeeNewman, an occupational medicine specialist at the National Jewish Center for Immunology andRespiratory Medicine, a very minute amount of Beryllium can cause the disease. I am shockedand appalled that your team of investigators can make a statement that current data does notallow ATSDR to find a relationship between the site and my wife's illness. In my opinion, thebottom line is this, if your team had done an adequate investigative job, interviewing the rightpeople, the report should have stated that the residents of Muhlenberg Township who live withina radius of five miles from the NGK plant are getting ill and will continue to get ill. They may notget a breathing disorder such as sarcoidosis or Berylliosis. Brain tumors and certain cancers havebecome prevalent to some residents who live near the plant.

Response to comment 16: ATSDR has not dismissed sarcoidosis as a potential site-related healtheffect. As stated in the response to comment 15, current data does not allow ATSDR todetermine a link between the site and the reported cases of sarcoidosis. ATSDR commonlycannot prove that a toxic chemical in the environment is causing a particular illness. However, ifthere is sufficient environmental and health data, ATSDR is able to determine whether a toxicchemical is likely to cause an adverse health effect. The available data at this site does notcurrently allow ATSDR to make that determination. ATSDR is requesting additional data thatmay enable ATSDR to determine whether adverse health effects are likely to result from currentconditions at or around the site. ATSDR appreciates the information you have providedregarding your wife's illness. Although additional information is needed to evaluate whether thesite may pose a health threat to the public, it is important to know what concerns and illnesses arebeing reported by the community. As with all ATSDR's comparison values, the comparisonvalues for beryllium are conservative levels that should be protective of public health. ATSDRwould agree that even lower levels of beryllium might be hazardous to individuals geneticallypredisposed toward a hyperactive immune response to beryllium. However, it is not possible toquantify the threshold dose of any antigen that would cause adverse health effects in a personhypersensitive to that antigen. Furthermore, it is possible to have sarcoidosis without havingberyllium in the lungs. It is also possible to have beryllium in the lungs without having asensitivity reaction to it that results in granulomatous lung disease. The presence of beryllium inthe lungs of a patient diagnosed with sarcoidosis strongly suggests that the patient may havechronic beryllium disease (CBD) masquerading as sarcoidosis. However, a firm diagnosis ofCBD requires the demonstration of beryllium hypersensitivity. A clinical test (the berylliumlymphocyte transformation test) is now available that is capable of demonstrating such sensitivityand distinguishing between sarcoidosis and CBD.

Comment 17: In the third paragraph [page 1], ATSDR states, quote, "No adverse health effectsare expected from exposure to the contaminants at the concentrations currently detected inambient air and are not believed to represent a public health hazard." First off, no contaminantsbut beryllium have ever been continuously monitored in accordance with federal programs. TheEPA RCRA Statement of Basis Corrections in Appendix B confirms the above and suggests thatfuture NESHAP regulations will correct this and additional monitoring requirements will beapplied to the NGK Metals for inorganic substances. I believe it is fitting for ATSDR toacknowledge the lack of monitoring in ambient air for other toxics and to support EPA's call foradditional monitoring. Secondly, ATSDR is in possession of two documents that cast doubt onthe accuracy of laboratory results since 1979 for beryllium in ambient air. I call attention to theletter of Dec. 21, 1992 from Dr. Hugh Archer, Regional Director of the Pa. Dept. ofEnvironmental Resources, and a letter to ATSDR of May 25, 1993, from Catherine Brown ofEPA's Region III Environmental Services Division. The first letter from Dr. Archer concludesthat the analytical procedure used for 14 years by the contract laboratory hired by the company toanalyze ambient air samples for beryllium was determined to be less accurate than another one. The letter from EPA's Catherine Brown concludes, quote, "EPA concurs that the analyticalprocedure used to determine beryllium concentration in the ambient air samples may not berevealing the total concentration of beryllium, particularly beryllium oxide. Investigation into thisissue continues and will notify ATSDR with any conclusions reached." The implications thatresults have been considerably on the low side are frightening to say the least. But until EPA andPa. DER complete their investigation and report conclusions ATSDR has absolutely no basis hereor any place else in this health assessment to reach conclusions or express opinions about dangersand hazards affecting the population, surrounding and outside the fences of the NGK plant, fromberyllium in the ambient air breathed by people.

Response to comment 17: Based upon the air data evaluated by ATSDR, the levels of bothberyllium and chromium are not believed to represent a public health hazard. ATSDR willevaluate any air data provided for additional toxics. ATSDR acknowledges that concerns havebeen raised regarding the analysis of beryllium in ambient air (page 20, under the "Quality Assurance/Quality Control" subsection). As ATSDR also indicates, the data will be evaluated asreported until a final conclusion is reached by EPA. If it is determined that the concentrations areunrepresentative of the actual beryllium concentration in off-site air, ATSDR will reassess thedata at that time.

Comment 18: On page 3, final paragraph, exception is taken to the statement that quote, "theplant shut down furnaces that were used for casting and heat treatment of the beryllium metals"and to the following statement, quote, "This process is now primarily cold rolling of metals." Ibelieve that record will show that the plant continues to heat treat and anneal metal alloys and thata major part of plant processes is acid cleaning of the metal alloys. The distinction is importantbecause heat treating, annealing and acid cleaning result in toxic discharges that must be treatedsatisfactorily or human health hazards may result. The company was heavily fined for impropertreatment and handling in recent years resulting in exposure to hazardous substances for both theenvironment and human beings.

Response to comment 18: ATSDR has revised the public health assessment (page 3) to indicatethat NGK only shut down their melting furnaces and hot rolling operations.

Comment 19: On page 4, fourth paragraph, exception is taken to the statement, quote, "Thatdrain field and the Pond 6 waste pile are the only contaminated waste areas that are not currentlycovered with mushroom soil, pavement, or gravel." Mushroom soil was put down many yearsago and is, because of its organic composition, certain to decompose and dissipate, so little if anymushroom soil remains. There are indeed bare areas in the field at the south and southwest areasof the plant and more along the railroad tracks inside the plant. ATSDR notes that the RCRAstudy produced no surface soil test at the 0-3" depth and until these tests are run I believe it isimpossible to say exactly where or where not contaminated areas exist.

Response to comment 19: Information has been provided that indicates that Pond 6 has beenconsolidated and contained and that the Disposal Area Drain Field is the only area that has notbeen covered. ATSDR acknowledges some uncertainty as to where contamination of surface soilon-site may exist. Therefore ATSDR recommends (page 45, number 1) on-site surface soilsampling. In light of pending remediation of on-site soils, ATSDR also recommends on-sitesurface soil sampling subsequent to remedial activities.

Comment 20: Bottom of page 23, under "On-site Soil," on-site workers may have been exposedto toxic substances in the past due to construction and other practices that disturbed the toxic soil;EPA attributes the two violations of the federal standard for beryllium in ambient air out in thecommunity (that NGK was charged with in 1989) to excavation and construction on-site. Respondent checked with OSHA and there is no record that air monitoring was conducted on-siteto protect workers during these periods in 1989 when plant soil was disturbed. This healthconcern merits ATSDR's attention.

Response to comment 20: Indeed, excavation in waste areas for construction or other purposeswould also fall within the "On-site Soil," potential exposure pathway. As indicated by the HealthActivities Recommendation Panel (page 47), ATSDR has recommended that this assessment "...be referred to the National Institute for Occupational Safety and Health for investigation of workrelated health concerns."

Comment 21: On page 28, under "Beryllium," ATSDR notes that beryllium is quote, "relativelyinsoluble." NGK's soil and groundwater has high amounts of fluoride because the plant employeda fluoride ore extraction process to remove beryllium from ore years ago and discarded ore-extracts on the plant site. Much of the beryllium therefore in the soil and groundwater is there asa fluoride; beryllium fluoride is infinitely soluble in water. Acid cleaning residues and spentsolutions were also dumped on the plant property accounting for the large amounts of sulfate inthe groundwater. Beryllium sulfate formed in the cleaning process is quite soluble. Taking bothof the above into account, contrary to the impression created by ATSDR, much of the berylliumassociated with the NGK Metals plant on and off-site is likely to be quite soluble.

Response to comment 21: ATSDR recognizes that beryllium fluoride, as discussed on page 30of this document (and page 29 of the public comment draft petitioned public health assessment), issoluble. There, its solubility, relevance to the site, and its public health significance are alldiscussed. On page 28, some of the uses and physical characteristics of beryllium are mentionedas an introduction to beryllium. Beryllium metal, as well as a number of its compounds, includingberyllium oxide, beryllium hydroxide, and beryllium carbonate are insoluble or only slightlysoluble.

Comment 22: On page 28, also under "Beryllium," fourth paragraph, with documents in handfrom government agencies noting that the validity of ambient air monitoring data for beryllium isin serious question and an investigation is under way, ATSDR still endeavors to assure the publicthat quote, "Levels at other sampling points and during all other time periods was insufficient topose an elevated cancer risk." The levels are what is now in question - can ATSDR assure thepublic that those levels will not be raised as a result of EPA's and Pa. DER's investigation? In thesame paragraph ATSDR expresses the belief that exposure to four times the federal ambient airstandard for beryllium in 1981 (which was repeated incidentally in 1989) is "of no healthconcern." This respondent would like to see that study data, including data on exposure toberyllium at that level by babies, children and elderly persons, and those with asthmaticconditions, upon which ATSDR bases its belief. Can ATSDR produce such inclusive but essentialstudy data?

Response to comment 22: As indicated in the petitioned public health assessment (page 20) andin the "Response to comment 17," the concern regarding analysis of the data has been raised. Thedata will be evaluated, as reported, until a final conclusion is reached by EPA. If it is determinedthat the concentrations are unrepresentative of the actual beryllium concentration in off-site air,ATSDR will reassess the data at that time.

As indicated in the "Off-site Contamination" subsection under "Ambient Air" (page 18), theNESHAPs regulatory standard is based on 30-day averages. Records indicate that NGK and thefacility's former owners have only exceeded that standard twice, both times in 1989. Forclarification it should be pointed out that ATSDR evaluates data based on public healthinformation, regardless of regulatory limits and violations. In Table 9, ATSDR has notedindividual, maximum concentrations for each monitor during each year of sampling.

In addressing public comment number 53, ATSDR again reviewed ambient air data andconsequently revised Table 9. In this process ATSDR identified a higher overall individualconcentration than the one discussed in the "Toxicological Evaluation" subsection, under"Beryllium" (page 28, of the public comment release draft petitioned public health assessment), towhich your comment refers.

The new high value is 0.08143 µg/m3 (Table 9), rather than 0.04279 (Table 7 of the publiccomment release petitioned public health assessment). Given the relatively brief duration of thepotential exposure, this higher level should still be of no public health concern. This is not to saythat some individual or individuals with a genetically-determined hypersensitivity to berylliumcould not possibly have an adverse reaction to extremely low levels of the element or itscompounds. However, such a response would, by definition, be unpredictable, i.e., it would beindependent of dose in much the same way as that of an allergic response. No standard short ofzero, an unattainable goal, could preclude any possibility of such a reaction.

Comment 23: On page 29, third full paragraph, ATSDR notes that quote, "Beryllium levels inoff-site soil were determined by a contract laboratory for a citizen and represent a singlesampling." Can ATSDR confirm that this is the same laboratory that was hired by NGK toanalyze ambient air samples for beryllium and is thus the same laboratory now being investigatedby EPA in large part because of the laboratory procedure they have been using to determineberyllium? If so then I believe any conclusions or opinions about the amount of beryllium foundin the soil at the citizen's home must await the result of EPA's investigation.

Response to comment 23: The laboratory used to analyze the citizen's soil sample is the samelaboratory contracted to analyze NGK's ambient air samples. However, it is our understandingthat it is the air sampling procedure rather than the laboratory that is under question and that soiland air sample analyses are conducted differently. Furthermore, 50 additional off-site surface soilsamples have been recently collected, analyzed, and evaluated in this assessment.

Comment 24: Under "The chemicals...", in the first paragraph [page 31, number 1], there is thisstatement, quote, "Fluoride was found in off-site groundwater at elevated levels but these are nothigh enough to cause health effects under the exposures that are likely to occur." The private wellmentioned in the same paragraph had nearly twice the EPA recommended concentration fordrinking water. Recently some EPA toxicologist have called into question the advisability offluoridating water supplies because of health concerns. The mottling of children's teeth andskeletal degeneration are serious health concerns as aired recently over CBS News during whichsome scientist pointed out the rising health concerns about fluoride in drinking water. RecentlyEPA decided to reexamine the whole premise of the safety of fluoridating water and is conductingstudies. In light of all this I believe it is ill-advised for ATSDR to make any judgements related tohealth effects from fluoride in drinking water.

Response to comment 24: The fact that an EPA-recommended concentration for drinking wateris exceeded, even by 2-fold, does not necessarily indicate that adverse health effects may beexpected to result. Health-based standards are not thresholds of toxicity, i.e., they cannot be usedto predict adverse health effects. Rather, they are conservative screening values designed to givepublic health officials the opportunity to take appropriate actions to protect the public's healthbefore any adverse health effects have occurred.

Excessive fluoride intake over a long period of time can cause dental or skeletal fluorosis. Themost sensitive adverse health effect, tooth mottling or dental fluorosis in children exposed duringtooth formation, is considered a cosmetic effect that is not necessarily a precursor of skeletalfluorosis. Dental fluorosis may occur at fluoride concentrations as low as 0.8 to 1.6 mg/L. Although precise dose thresholds are not well defined, it has been estimated that daily ingestion of10-80 mg fluoride for more than 10 years will cause crippling skeletal fluorosis, a serious healtheffect (52).

Most of the fluoridated water supplies of the largest U.S. cities contain less than 1 mg/L fluorideand most water supplies that are not intentionally fluoridated contain less than 0.3 mg/L (52). Assuming a consumption rate of 2 L/day, concentrations of 1 and 0.3 mg/L would correspond,respectively, to 0.2 and 0.06 mg/kg/day for a 10-kg child, and 0.03 and 0.01 mg/kg/day for a 70-kg adult. Thus, the levels of fluoride in some water supplies may exceed ATSDR's MRL of 0.05mg/kg/day and may even be sufficient to cause dental fluorosis in some children, particularly whenadditional sources of fluoride are considered. Indeed, in surveyed cities with water containing 0.7to 1.2 mg/L (the level to which water is fluoridated), 10-20% of children had barely noticeablechanges in their teeth, while up to 1% had brown spots due to fluoride (53). However, theoptimal fluoridation of public water supplies has well-established public health benefits forindividuals of all ages and socioeconomic groups that justify the continuation of this practice. Nevertheless, in areas with fluoridated water supplies, it may be prudent to avoid additionalsources of fluoride, such as toothpaste and other products supplemented with fluoride.

In Reading, Pennsylvania, where public water is not fluoridated, the groundwater that constitutesthe public water supply contains only 0.1 mg/L fluoride. With few exceptions, Private well wateris below ATSDR's comparison values for lifetime exposure to fluoride. The maximum fluorideconcentrations (1700 µg/L) measured in water from the Reading Crest well and public well 1 doexceed one of these comparison values (600 µg/L for children and 2,000 µg/L for adults). However, the Reading Crest Well has never been used as a source of drinking water, and privatewell 1 was used for drinking water for only 8 years before an alternative water supply wasprovided. Thus, in the opinion of ATSDR, if no mottling of teeth has occurred as a result ofresidents' past exposure to the water in private well 1, then no mottling or any other adversehealth effect should be expected in the future.

Comment 25: Under "Airborne dust...", the last paragraph on page 31, I find this statementquote, "Pond 6 waste pile and the Disposal Area Drain Field are the only two waste areas on-sitethat have not been covered." This is simply not true and many bare areas remain subject toreleasing air-borne beryllium and other toxics into the air as dust. It's noted that "no surface soilsamples have been taken to characterize the top 3 inches of those waste areas or other potentiallycontaminated areas." Until there are, there remain potentially contaminated areas not covered.

Response to comment 25: Please refer to the "Response to comment 19" regarding the status ofPond 6 waste pile and discussion about characterization of the site.

Comment 26: Under "Deposition from air emissions...", page 35, second complete paragraph, Itake exception to the recommendation that surface soil sampling be conducted "downwind" only. Of the eight air monitoring stations surrounding the NGK plant, at least half are not located in thedownwind direction. Yet these also without fail show beryllium deposits every month sincemonitoring began 14 years ago. The private home where beryllium was found in the lawn soil isnot downwind, neither are the residents of the community living closest to NGK's contaminatedsoil. There has been 50 years of beryllium being emitted from that plant into the community and ithad to settle somewhere. I take strong exception to ATSDR's expressed willingness to apparentlywrite off the health concerns of one segment of the population living around that contaminatedplant, namely those living in a loosely defined upwind direction.

Response to comment 26: In ATSDR's assessment of this site, we came up with a number ofdata gaps where information was/is needed in order to determine the public health impact. One ofthe data needs was off-site surface soil sampling. ATSDR needed a reasonable number of thesesamples to indicate how much beryllium may exist in the soil and what that data may mean inregard to public health. Fifty off-site surface soil samples were collected and are adequate forATSDR's evaluation (see pages 30-31 under "Ingestion Exposure" for the toxicologicalevaluation of that data). Samples were collected downwind (regarding the prevailing winddirection) of NGK, as well as in other directions (see Figure 7 of Appendix A for samplinglocations).

Comment 27: Under "There are no air monitors...," page 35, sixth complete paragraph, ATSDRmakes the surprising statement that concentrations of beryllium which are representative of on-site ambient air at the southern portion of the site are "likely to be similar to concentrations alongWater Street, which is just off-site." This is a remarkable statement since at several places in thisHealth Assessment and indeed several sentences later, ATSDR decries the fact that the winddirection was not recorded during on-site monitoring and the monitoring was a short, one monthevent both casting doubt on the validity of the data. If ATSDR's assurances are meant to comfortthe people along Water Street, they shouldn't, because the data is meaningless as ATSDRacknowledges. Furthermore, the community concern that ATSDR was responding to was thatthere are no monitors due south of the plant to protect the residents along Water Street and I donot believe ATSDR's response addressed that concern. There are still no monitors there!

Response to comment 27: The on-site data is very useful as on-site data; however, it providesonly limited insight as to what the concentrations are like off-site. Given the information availableand having described some of the limitations, ATSDR was able to submit a reasonable evaluationof what air quality just south of the site may have been like during that time period. Data for winddirection during the time period of the on-site sampling has been obtained and included in thisdocument.

Comment 28: Under "Dust carried home...," page 36, last paragraph, ATSDR states that quote,"it is NGK's current procedure to provide protective garments that are collected and to requireshowers and clean change of clothing at the end of each work day for those employees that mightbe exposed to beryllium." High management personnel do not take showers, do not changeshoes, even though they have walked outside on contaminated surfaces or walked through theplant. It is a fact that ambient air inside the plant and surfaces within the plant contain berylliumand other toxics. ATSDR is in possession of a Pa. DER inspection report that shows berylliumand other toxics coming off roofs and parking lots after a short period of rain. Thus, somepersonnel could still be carrying beryllium outside the plant on shoes, hair, etc, or on theirvehicles.

Response to comment 28: In this public health assessment, ATSDR identified contamination ofworkers' clothing as a potential completed pathway in the past for family members. ATSDRrecognized this as a potential pathway under the assumption that significant amounts of berylliumwere being retained on the workers and their clothes. Current exposures to the public, viaworkers who are following the safety precautions or "high management personnel," appear to beunlikely and will not be considered as a pathway of exposure in this assessment. However, just asstated in the "Response to comment 20," this assessment will be referred to the National Institutefor Occupational Safety and Health for investigation of work related health concerns.

Comment 29: Under "Possible health hazards...," pages 37 and 38, beginning with last paragraphon page 37, ATSDR does not respond adequately to the question and concern. In 1989 NGKMetals violated the federal community ambient air standard for beryllium twice, during twoseparate months, by magnitudes of three and four. The public has never been told and those wholive in the vicinity of the monitor with the highest beryllium numbers cannot even alert theirdoctors if they experience breathing problems, that they may have been exposed to high levels ofberyllium. That was the concern ATSDR was asked to address by someone in the community,and the person wanted to know if ATSDR could put out a health advisory.

Response to comment 29: On page 30 (under the beryllium "Inhalation Exposure" subsection),ATSDR discusses on-site and off-site ambient air conditions. Short term exposures to the levelsdetected in 1989 are not believed by ATSDR to present a health threat.

An ATSDR public health advisory is not simply an announcement of a hazardous substancerelease, but is notification to other health and environmental agencies when hazardous substancesreleased into the environment pose an immediate and significant danger to people's health.

Comment 30: Under "Orange and green colored smoke...," page 38, sixth paragraph, ATSDRstates, quote, "No colored smoke or heavy ash have been associated with the site in recent years." I believe if ATSDR will check with the Pa. DER office in Reading they will learn that complaintsabout "Orange colored smoke" coming from NGK stacks and acrid smells have been received inrecent years by DER from local residents and in fact for a time DER was monitoring the plant byhaving personnel drive by periodically.

Response to comment 30: The statement, "no colored smoke or heavy ash have been associatedwith the site in recent years," was a result of a conversation with personnel at the Reading Officeof the Pennsylvania Department of Environmental Resources.

Comment 31: Under Conclusion # 3 [page 40], ATSDR notes that quote, "A past completedexposure pathway existed for users of private well 1." Chromium is mentioned. Yet nowherehere or in any other part of this Health Assessment does ATSDR mention that members of theprivate family who drank unknowingly from their well for eight years have had high levels ofchromium in their blood according to extensive medical tests. I believe in a Health Assessmentsuch as this a subject such as that must be included. The subject is not unknown to ATSDR sinceat the family's request ATSDR suggested a list of doctors and clinics for the family to consult,hence I cannot understand why in this Health Assessment I find no mention of it.

Response to comment 31: ATSDR does not routinely collect or review medical records,although they are sometimes shared with our agency. The medical records of the family referredto above have not been requested, volunteered, or reviewed and therefore are not reported in thisdocument.

In general, biological testing and the results can be important to ATSDR, such as in determiningwhether exposure has occurred, levels of exposure, and the potential health impact of anyexposure incurred. However, tests specifically for chromium exposure are not able to determinethe precise levels that an individual may have been exposed to or predict whether health effectswill occur (43). In this instance there is a well defined pathway (Off-site Groundwater, pages 21-22) and exposure reported as having occurred.

ATSDR does not provide primary health care and would therefore encourage this family toconsult with their private physician, if they have not already done so, regarding any chromiumtesting they have had conducted.

Comment 32: Under Conclusion # 5 [page 40], ATSDR concludes quote, "Based on anevaluation of the maximum weekly beryllium concentrations detected in ambient air for each yearthat data are available (1979-93), no increased risk of cancer is expected." Since EPA is nowundertaking an evaluation of the results and an investigation of the laboratory that obtained them,I believe it is inappropriate for ATSDR to make such a conclusion until EPA finishes its review.

Response to comment 32: In conducting a public health assessment, it is ATSDR's objective toreview the available environmental and health data in order to come to some conclusion regardingthe impact that a site or facility may have on public health. ATSDR has evaluated andsummarized a wealth of data for the NGK Metals Petitioned Public Health Assessment. The datareferred to above have been evaluated by ATSDR, as reported. However, ATSDR has identified(page 20 under the "Quality Assurance/Quality Control" subsection) the concerns and questionsregarding the data and has indicated that if EPA renders a decision indicating the data areunrepresentative of the actual air quality, that the data will be reassessed accordingly.

Comment 33: Under Conclusion # 6 [page 41], ATSDR states, quote, "Beryllium in this soilsample is within natural background levels, but could also be related to the site." It is difficult tosee how ATSDR can declare the beryllium within background levels when underRecommendation #2 they call for the local background value for beryllium to be determined in thefuture. If we have no local beryllium background level as yet, how can any value we nowreceived be declared with confidence to be within a value we don't have?

Response to comment 33: As discussed on page 23 (under the "Off-site Soil" subsection of the"Pathways Analyses" section), ATSDR uses background ranges for the eastern United States,which includes samples throughout Pennsylvania. This is used in the absence of more location-specific background data. Local background data would be helpful in characterizing soilconditions and potential site-related impacts. However, based purely upon public healthsignificance, local data will not be necessary, since ATSDR's toxicological evaluation of recentsoil sampling indicated that no adverse health effects are expected from exposure to berylliumdetected in surface soils.

Comment 34: Under Recommendation # 2 [page 42], ATSDR calls for extensive soil tests andhousehold dust tests, with numerous toxics including beryllium being determined. UnderRecommendations # 7 and # 8, ATSDR calls for tests of Laurel Run sediment and fish tissuesamples from Laurel Run. I concur with these recommendations but I believe that fish tissuestudies must also be done on samples from fish caught in the Schuylkill River at the confluencewith Laurel Run. These tests are in essence also called for by EPA in the RCRA remediationorder served on NGK Metals nine months ago. According to newspaper accounts recently, afternine months of fruitless negotiations with EPA, NGK has decided to further stall the remediationplan by appeals. Therefore I believe it is incumbent on ATSDR to recommend that the testsATSDR deems necessary be implemented by an order on NGK apart from the stalled remediationorder. I believe this is possible under the Consent Order setting up the RCRA study which has aprovision for further studies.

Response to comment 34: Surface soil sampling has been conducted and evaluated in thisassessment (page 31 under beryllium "Ingestion Exposure" of the "Public Health Implications" section) Based upon that evaluation household dust tests will no longer be necessary.

ATSDR will evaluate the analyses of fish tissue from any fish collected in Laurel Run or itsconfluence. However, at this time, ATSDR is only making recommendations for the sampling offish from Laurel Run at locations adjacent to and downstream of NGK. Fish tissue sampling,along with a number of other types of environmental sampling, needs to be conducted in order forATSDR to evaluate the potential public health threat. ATSDR has no authority to "order" orindicate the funding by which fish tissue samples are to be collected.

Comment 35: Under Recommendation # 6 [page43], ATSDR calls for restrictions on propertiesin EPA's well inventory area and west of EPA's well inventory area extending to the SchuylkillRiver in regard to groundwater use. I concur that this is absolutely necessary. However, toprevent some family right now or within the next few weeks from moving into this area from faraway and drilling a well at an existing home, or building a home and drilling a well, for drinkingwater purposes, I believe it is essential that ATSDR issue a public health advisory carried in allprint media and broadcast by all TV and radio stations serving the area that groundwater in EPA'sdesignated area is absolutely unsafe as drinking water. A special effort should be made to reachall real estate offices also.

Response to comment 35: ATSDR releases public health advisories only in cases wherehazardous substances released into the environment pose an immediate and significant danger topeople's health. ATSDR has not determined, at this time, that the NGK Metals facility warrants apublic health advisory. A public health advisory could be issued in the future if such adetermination were made.

Comment 36: ATSDR espouses a worthy goal under 3, final paragraph on page 44, to, quote,"Use this petitioned public health assessment as an educational tool for the community to makethem aware of the possible hazards present, the likelihood of exposure, and to assist thecommunity in assessing possible health outcomes associated with exposure to hazardoussubstances." After a two and one-half year wait and the expenditure of thousands of dollars ofpublic (taxpayers') money the goal is certainly not unreasonable. The goal, however, will not berealized unless ATSDR provides adequate public notice and removes all stops to communicate tothe public the availability of the Health Assessment document and the places where it is repositedfor the public to review and become educated, so that meaningful public comment and responsewill ensue. A public notice in the only local newspaper consisting of a legal notice in fine printthat some will need a magnifying glass to read, buried in the back pages next to the obituaries,will hardly serve the purpose. After ATSDR makes a case for the importance of the HealthAssessment and spends much time and money to produce it, I find the excuse given for the lack ofadequate public notice, "Insufficient funds," totally unacceptable.

Response to comment 36: The final release of the NGK Metals Petitioned Public HealthAssessment will be sent to individual citizens on our mailing list in addition to sending thedocument to the same six repositories used during the public comment period. As is standardprocedure, ATSDR will send press releases to the local and regional media sources to announcethe release and availability of the petitioned public health assessment. Moreover, in order toensure adequate public notice, ATSDR will purchase an advertisement in the local paper (ReadingEagle/Times).

Comment 37: In the line of education I find the title page of the Health Assessment to beconfusing. Under PETITIONED PUBLIC HEALTH ASSESSMENT I find, Quote, "Cabot-Wrought Products Division of Cabot Corp.," and beneath that, (a/k/a NGK METALS/CABOTBERYLCO, INC). The plant is solely owned by NGK Metals and has been since 1986, longbefore the health assessment took place. It's not a Cabot plant also known as NGK Metals, it isNGK Metals and it was under the name NGK Metals not Cabot that the plant committed grossviolations of state and federal laws that contributed to the conditions now cited by ATSDR asreason to classify the plant as a potential present and future public health hazard as a proven pastpublic health hazard. This brings me to a very crucial public comment related to the Backgroundyou define. Included in the site history must be the fact that in 1990 NGK Metals (note: notCabot) was indicted by the Attorney General for two serious crimes, one a felony, related toviolations of the state Solid Waste Laws. Nowhere do I find your mention of this fact that NGKMetals paid heavy fines. The magnitude of these violations can not be over-emphasized. One, theillegal handling and storage at the plant of cadmium cyanide resulted in the loss of enoughcadmium cyanide to plant soil and groundwater to contaminate to the federal limit for cadmiummore than a billion gallons of drinking water! Cadmium was found by EPA in soil andgroundwater during the RCRA study. The second involved the loss of thousands of gallons oftoxic waste daily into groundwater and soil on not one but two extended occasions when anunderground pipe was broken and not repaired expeditiously. Both these crimes have seriousimplications for human health yet ATSDR omitted any mention whatsoever in the HealthAssessment.

Response to comment 37: The U.S. Environmental Protection Agency lists this site as "Cabot-Wrought Products Division of Cabot Corp." in their Comprehensive Environmental Response,Compensation, and Libility Information System (CERCLIS). ATSDR is required to use the namethat is indicated in CERCLIS; however, ATSDR will continue to include the other names bywhich the site is known (i.e., NGK Metals and Cabot Berylco Inc.).

Regarding your other concerns, it should be noted that ATSDR is not involved in criminalinvestigation and therefore makes little attempt to describe or enumerate violations of regulatorylaw. The focus of an ATSDR public health assessment is to evaluate environmental and healthdata and to assess whether a public health threat exists.

Comment 38: As far as any Public Health Action Plan goes, it is my opinion expressed in myfinal public comment that while ATSDR has done considerable work resulting in usefulinformation, much more remains to be done. I urge ATSDR to move with all due speed torecommend and pursue those necessary soil, household dust, private well, Laurel Run andSchuylkill River tests. I support a call for studies of disease incidence in the communitysurrounding the NGK Metals plant. I believe a health advisory is called for in relation to thedangerous and highly contaminated aquifer west of the plant onto the Schuylkill River. It isunthinkable that ATSDR would not take every step possible to notify the public, especially realestate companies, through paid public announcements, that drilling private wells and attempting touse the aquifer for drinking water in the affected area, or the use of existing private wells, couldbe extremely dangerous to their health. It is my opinion that with all the unanswered questionsthat ATSDR attributes to lack of data, once that data becomes available ATSDR will be obligatedto do a follow-up health assessment.

Response to comment 38: Through the public health assessment process, telephoneconversations, meetings, and other written communication, ATSDR has recommended andpursued environmental data that is necessary to evaluate the potential public health threat at thissite. Through the Health Activities Recommendation Panel (see page 46), ATSDR has evaluatedthis document in order to determine what health follow-up (e.g., health studies, etc.) might beappropriate. The concern regarding a public health advisory was discussed in the "Response tocomment 35." As described in Numbers 4 and 5 of the "Public Health Action Plan" (page 48),ATSDR will review and evaluate any new data and will revise this petitioned public healthassessment as appropriate.

Comment 39: A study recently done at the Universities of Rome and Modena in Italy is reportedto show a genetic link to beryllium-related lung disease in human beings who have inhaled themetal, beryllium. It is believed by the researchers led by Luca Richeldi after studying 33 peoplewith this lung disease that a common marker on the genes is responsible for triggering theimmunological reaction to beryllium. This finding would seem to have tremendous significancefor workers, former workers, and residents living around the NGK Metals plant, many of whomhave been exposed to beryllium in the air they breathe and some of whom have developed lungdisease. Since it is known that the plant has and continues to, emit beryllium into the air, I believeit is incumbent on ATSDR and the Public Health Service to contact the researchers, discussapplication of the study in regard to NGK Metals, and obtain expeditiously a copy of the study. And then do a comprehensive evaluation of lung disease among workers, former workers andresidents and former residents of the community surrounding the plant, not neglecting the familiesof workers and former workers.

Response to comment 39: Although almost all persons with chronic beryllium disease have themarker in question (HLA-DPß1-Glu69), so do 30% of people without the disease. Thus, while allthe subjects in Richeldi's study were exposed to beryllium, one had the disease but no marker, andmany others inherited the marker but did not develop the disease. The work of Richeldi and co-workers is an important step towards the identification of a biological marker for beryllium-sensitive genetic constitutions. However, more research is required before a useful biomarker ofsusceptibility can be characterized. In the meantime, it would not be particularly useful to identify30% of a workforce as being potentially at risk for a disease that has a prevalence of only 2-5%(33).

Comment 40: It has come to my attention that there has been a development in medical sciencethat I believe has great relevancy to the NGK Metals Health Assessment and should have beenincluded in recommendations for future action by ATSDR. I speak of the Beryllium LymphocyteTesting, which has the potential to distinguish with confidence those human beings who have beenexposed to beryllium and who have retained beryllium in their bodies. As this has been publishedby ATSDR under the auspices of the U.S. Public Health Service I am at a loss to understand whythis was not mentioned in the Health Assessment and furthermore, recommended for widespreaduse among workers at the NGK Metals plant, families of workers, and residents of the communitysurrounding the plant. Kindly furnish me with an explanation since both EPA and ATSDRconfirm that beryllium has been and is emitted into ambient air not only on-site but off-site. Isuggest that along with other recommendations for soil and household dust tests ATSDR alsoshall recommend wide-spread blood testing of residents of the community, and present and formeremployees and their families, using the medical testing procedure named above which has alreadybeen published by ATSDR. I also recommend that you contact the researcher and developer ofthe test, Dr. Lee Newman of the National Jewish Center for Immunology and RespiratoryMedicine in Denver, and seek his help in locating those individuals already afflicted with berylliumlung disease and those in danger in this area in connection with the NGK Metals HealthAssessment.

Response to comment 40: The beryllium lymphocyte proliferation test is mentioned in the"Public Health Implications" section of the final petitioned public health assessment (page 29under the beryllium "Inhalation Exposure" subsection).

The beryllium lymphocyte proliferation test does not identify people "who have been exposed toberyllium and who have retained beryllium in their bodies." The vast majority of workers whohave been exposed to beryllium and have that substance in their lungs do not develop chronicberyllium disease and would not test positive for lymphocyte proliferation in the presence ofberyllium. The beryllium lymphocyte proliferation test shows whether or not the patient has beensensitized to beryllium, thereby enabling the physician to distinguish between sarcoidosis andchronic beryllium disease, which exhibits very similar symptoms.

Since chronic beryllium disease occurs in only 2-5% of exposed workers, it may not be useful toperform a beryllium lymphocyte transformation test on everyone in an asymptomatic, non-occupationally-exposed population. However, any long-term residents who have been diagnosedas having sarcoidosis and who suspect that they may have been exposed to clinically significantlevels of beryllium in the past may want to consider consulting an occupational/environmentalmedicine specialist to determine whether specialized testing for beryllium sensitivity isappropriate.

Comment 41: The ATSDR Assessment concludes preliminarily that the public health hazard is"indeterminate" due to lack of environmental and exposure data for various potentially completedpathways. However, a thorough review of the analytical data and consideration of the cumulativeimpact of NGK's environmental improvement projects supports a conclusion that the facility doesnot pose a significant public health hazard in any respect.

Response to comment 41: Based upon data reviewed by ATSDR, no public health hazardexists. In addition, ATSDR does not consider other media and exposure pathways likely topresent a public health threat; however, additional data and information are needed before such aconclusion can be reached.

Comment 42: The ATSDR Assessment includes numerous statements of a hypothetical orspeculative nature which are presented in the midst of discussions concerning health risks. Suchstatements are at best confusing to the reader and, more often than not, imply that these are realand substantial risks even though the data do not support any such conclusions. The final versionof the Assessment should correct these misimpressions by deleting speculative material, especiallywhere it appears in summaries, conclusions and recommendations. This is especially necessary inlight of the stated purpose of using the Assessment "as an educational tool for the community"(page 44). Obviously, the educational aspect is undermined if the community is not provided witha document which carefully distinguishes between fact and speculation.

The Summary contains statements that are not supported by the data or site conditions asdescribed in the body of the Assessment. For example, references to a potential slight risk ofcancer at an off-site surface soil location is inappropriate where the contaminant discussed(beryllium) is not an oral carcinogen and where the concentration is below acknowledgedbackground levels. References to the site as an "indeterminate public health hazard" is alsoinappropriate for reasons discussed below. The Summary should instead state that the site doesnot pose a public health problem given the data and improved site conditions.

Response to comment 42: Based upon public comments, new data and information, and currenttoxicological research, ATSDR has made necessary revisions to this final petitioned public healthassessment. ATSDR has evaluated the available data and reported the relevant facts as known. Where appropriate, ATSDR has discussed the likelihood of certain exposures and adverse healtheffects. Therefore, ATSDR believes this petitioned public health assessment is a useful tool bywhich to make people aware of the possible hazards present, the likelihood of exposure, and toassist them in assessing possible adverse health outcomes associated with exposure to hazardoussubstances.

Comment 43: ATSDR identifies "contaminants of concern" in various media by comparison ofthe maximum concentration of the substance with the "comparison value". Since maximumconcentrations typically reflect "hot spots" or localized conditions (or even sampling anomalies),this approach presents an artificial and biased picture of potential risk. The Assessment shouldinstead use average or median concentrations to identify potential problems and the reportsfindings and conclusions should be revised to reflect the results of comparisons based uponaverage or median concentrations.

Response to comment 43: The point is well taken; however, as a public health agency, ATSDRtakes a conservative approach in order to protect public health. Therefore, ATSDR evaluates themaximum concentration to which a person might be exposed. Averaging sampling concentrationsis most useful when representative sampling has been conducted and is analyzed by a statisticalapproach. Although ATSDR guidance does not exclude using averaged data, it calls for the rangeof concentrations to also be included. ATSDR guidance explicitly specifies the following, "Forthe purpose of selecting contaminants of concern, the maximum concentration of a contaminantshould be used. This ensures that all potentially significant contaminants will be evaluated."

Comment 44: Page 4 "A. Site Description and History"

The Pond 6 waste pile and the Disposal Area Drain Field are identified as the "only contaminatedwaste areas that are not currently covered with mushroom soil, pavement, or gravel (page 4,paragraph 4). The Pond 6 waste pile is no longer an area of concern because the Pond 6 dirt pilehas been relocated to the south east quadrant of the facility as part of corrective measuresimplementation and capping activities at the facility. Accordingly, this material should no longerbe considered a source area.

Proposed revision: Delete last two sentences of third paragraph, page 4, and insert: "As part ofcorrective measures currently being implemented at the site, this material has been relocated,consolidated and contained on the southeast quadrant of the facility to minimize potentialexposure."

Revise the last sentence of paragraph four as follows: "That drain is the only contaminated wastearea that is not currently covered with mushroom soil, pavement, or gravel (2, 3)."

Similar changes should be incorporated throughout the report wherever reference is made to Pond6 (see, e.g., page 12).

Response to comment 44: Given that information, ATSDR has changed the discussions in thisdocument, regarding Pond 6 waste pile, to reflect the fact that it has been relocated and covered.

Comment 45: Page 5 "B. Site Visit"

NGK's active landfill is a residual waste landfill. Since no hazardous wastes as defined by RCRAhave been placed in the landfill, a RCRA permit is not required for this area. The landfill ispermitted under the Pennsylvania Department of Environmental Resources residual wasteregulations. Paragraph 2, page 5, should be corrected to reflect this.

The acid neutralizing tank referenced on this page is part of a process water conditioning line. This tank is discharged through the wastewater treatment plant and, as such, is not a separatewaste area.

Response to comment 45: ATSDR has corrected the notation that indicated that the landfilloperated under a Resource Conservation and Recovery Act permit to reflect the fact that itoperates under the Pennsylvania Department of Environmental Resources residual wasteregulations. Regarding the acid neutralizing tank, ATSDR does not define it as a separate wastearea, but merely mentions it as something that was identified and discussed during the NGK sitetour.

Comment 46: Page 11 "ENVIRONMENTAL CONTAMINATION AND OTHER HAZARDS,""Contaminants of concern," Comparison Values

The Assessment does not indicate the basis for the Comparison Values. At least some of thevalues that are presented cannot be supported scientifically. ATSDR should provide the basis,origin and derivation for all comparison values in order to allow for meaningful public comment. This is essential for values which, to NGK's knowledge, are not published in the readily availableliterature (e.g. CREG, EMEG, EPA III, IEMEG, and RMEG).

The beryllium comparison value for drinking water is reported in the Assessment as being 0.008ug/l (CREG). EPA recently promulgated the drinking water MCL and MCLG for beryllium at 4.0ug/l, 57 Fed. Reg. 31776 (July 17, 1992), concluding that "the dose response analysis foringestion exposure does not provide adequate evidence of carcinogenicity from a drinking watersource." Accordingly, ATSDR should use a comparison value of 4.0 ug/l (or ug/kg) for berylliumin oral exposure pathways. Apparently, the CREG for beryllium in soils is also based upon thenow discredited notion that beryllium is an oral carcinogen. If so, this value should not be used inthe final Assessment.

Similarly, the comparison value for chromium is inconsistent with the MCL and MCLG, asestablished under the Safe Drinking Water Act. The chromium comparison value in water shouldbe established at 100 ug/l, the MCL and MCLG for chromium. 56 Fed. Reg. 3526 (Jan. 30,1991)

We cannot provide meaningful comment on other comparison values, including the comparisonvalues for chromium and beryllium in other media, without information concerning the origin andcalculations of those values. ATSDR should provide information concerning the origin of thecomparison values and allow for additional comment on those values.

Response to comment 46: In Appendix C, ATSDR lists the names of the comparison valuesused, the source of derivation, and gives a brief description of the comparison value. Comparisonvalues used by ATSDR are health-based values and may not reflect regulatory standards, whichsometimes consider other factors. For example EPA's Maximum Contaminant Levels (MCLs) donot strictly represent health-based concentrations, since the availability and economics of watertreatment technology is also considered in determining those levels. ATSDR uses MCLs in theabsence of more stringent, health-based comparison values.

ATSDR discusses the issue of beryllium as an oral carcinogen on pages 30-31 (under berylliumthe "Ingestion Exposure" subsection). In that discussion, ATSDR identifies the study, and itslimitations, that is used by EPA to develop an oral cancer slope factor. ATSDR develops CancerRisk Evaluation Guides (CREGs) for each chemical that has a published cancer slope factor. Therefore, ATSDR will continue to screen beryllium in this manner. However, furthertoxicological evaluation will be conducted to make a final determination, just as has been done inthe "Public Health Implications" section of this petitioned public health assessment.

As discussed in the "Environmental Contamination and Other Hazards" section (pages 10-11),comparison values are "used to select contaminants for further evaluation." Comparison valuesare used by ATSDR as guidelines for screening purposes and are not predictors of adverse healtheffects. Contaminants selected as contaminants of concern are evaluated further for potentialhealth effects, in the "Toxicological Evaluation" subsection (page 27). In that subsection,ATSDR considers numerous medical, toxicologic, demographic, and environmental factors inevaluating contaminant concentrations and the impact they may have on public health.

The public comment process is intended to address comments regarding this document. If youhave further questions regarding ATSDR's use of comparison values you may refer to the ATSDRPublic Health Assessment Guidance Manual and/or contact ATSDR for a direct reply.

Comment 47: Page 14 "B. Off-site Contamination," "Soil"

There are no Quality Assurance or Quality Control protocols referenced with the off-site soilsample taken on November 18, 1992. If these protocols were not followed or are not available,the validity of this sample must be questioned and its use for evaluative purposes should beappropriately limited. Also, there is no information concerning the sample location or soil type(e.g. native soil versus fill material).

Response to Comment 47: The public health evaluation of off-site surface soil in this version(final) of the NGK Metal Petitioned Public Health Assessment does not rely solely on the abovementioned sample. Fifty other samples were also evaluated.

Comment 48: Page 17 "Ambient Air"

The excursions of the NESHAPS occurred during the excavation of a large area of red mud forthe construction of a new building. No drain line excavation occurred during this time frame. The text should note that this was a one-time event.

Response to comment 48: ATSDR has revised the public health assessment (page 18 under the"Ambient Air" subsection) to indicate that violations of the NESHAP during June and August 1989 occurred during the excavation of red mud for the construction of a new building.

Comment 49: Page 19 "C. Quality Assurance/Quality Control"

As the Assessment notes, the reported results of surface water sampling in 1981 for beryllium andmanganese are highly suspect. It is thus improper from a scientific standpoint to accept thoseresults and use them to draw conclusions regarding current stream conditions (especially wheredata in the intervening 12 years conflicts with the 1981 results). ATSDR should not accept theanomalous 1981 data and should revise the Assessment in keeping with the more recent data. 

Comment 49: Page 19 "C. Quality Assurance/Quality Control"

As the Assessment notes, the reported results of surface water sampling in 1981 for beryllium andmanganese are highly suspect. It is thus improper from a scientific standpoint to accept thoseresults and use them to draw conclusions regarding current stream conditions (especially wheredata in the intervening 12 years conflicts with the 1981 results). ATSDR should not accept theanomalous 1981 data and should revise the Assessment in keeping with the more recent data.

Response to comment 49: The 1981 surface water sampling is discussed in the "Quality Assurance/Quality Control" subsection because a possible reporting error was suspected due to inconsistency with other surface water data. However, ATSDR indicates that there is an 8-10year span between the results being compared, during which time surface water quality may havegreatly improved. ATSDR has included the 1981 surface water concentrations as reported, sincethere is no definitive evidence indicating a reporting error and since there are no other compellingreasons to warrant omission of the data. Furthermore, since ATSDR primarily focuses itsassessment on current and future public health issues, the most recent data is used whendetermining what health threat may currently exist while older data generally provides a historicalperspective on contamination.

Comment 50: Page 20 "C. Quality Assurance/Quality Control"

The air flow of the ambient air samplers is checked and recorded on a daily basis to ensure aconstant velocity and sampling volume. This procedure has been followed since air monitoringcommenced. If need be, adjustments are made to maintain an air flow of 45 cubic feet per minute(CFM). Factors such as particulate loading and humidity can affect the sampler flow rate. If flowdrops below 35 CFM, the filter and/or sampler is replaced as necessary. The text should bemodified to make more explicit that the questions raised about data quality have been addressedby company procedures.

Response to comment 50: The questions raised do not necessarily involve whether the samplersare checked and maintained on a daily basis, but rather the quality of the data that results fromlow flow (below 39 cubic feet per minute [CFM]) or when pumps shut down between daily flowchecks.


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