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PUBLIC HEALTH ASSESSMENT

MONSANTO COMPANY/SOLUTIA INCORPORATED
[a/k/a ANNISTON PCB SITE (MONSANTO COMPANY)]
ANNISTON, CALHOUN COUNTY, ALABAMA


FIGURES

Solutia Owned Property
Figure 1. Solutia Owned Property

Areas Sampled Under the Second Consent Order
Figure 2. Areas Sampled Under the Second Consent Order


APPENDIX A: GLOSSARY

Cancer Risk Evaluation Guides (CREGs):
Estimated contaminant concentrations that would be expected to cause no more than one excess cancer in a million (10-6) persons exposed over a 70-year life span. ATSDR's CREGs are calculated from EPA's cancer potency factors.


CERCLA:
The Comprehensive Environmental Response, Compensation, and Liability Act of 1980, also known as Superfund. This is the legislation that created ATSDR.


Comparison Values:
Estimated contaminant concentrations in specific media that are not likely to cause adverse health effects, given a standard daily ingestion rate and standard body weight. The comparison values are calculated from the scientific literature available on exposure and health effects. The conclusion that a contaminant exceeds the comparison value does not mean that it will cause adverse health effects. Comparison values represent media-specific contaminant concentrations that are used to select contaminants for further evaluation to determine the possibility of adversepublic health effects.


Concentration:
The amount of one substance dissolved or contained in a given amount of another. For example, sea water contains a higher concentration of salt than fresh water.


Contaminant:
Any substance or material that enters a system where it is not normally found, or that is found in greater concentrations than background levels.


Environmental Contamination:
The presence of hazardous substances in the environment. From the public health perspective, environmental contamination is addressed when it potentially affects the health and quality of life of people living and working near the contamination.


Exposure:
Contact with a chemical by swallowing, by breathing, or by direct contact (such as through the skin or eyes). Exposure may be short term (acute) or long term (chronic).


Hazard:
A source of risk that does not necessarily imply potential for occurrence. A hazard produces risk only if an exposure pathway exists, and if exposures create the possibility of adverse consequences.


Media:
Soil, water, air, plants, animals, or any other parts of the environment that can contain contaminants.


Potentially Exposed:
The condition where valid information, usually analytical environmental data, indicates the presence of contaminant(s) of a public health concern in one or more environmental media contacting humans (e.g., air, drinking water, soil, food chain, surface water). There is evidence that some of those persons may have an identified route(s) of exposure (e.g., drinking contaminated water, breathing contaminated air, having contact with contaminated soil, or eating contaminated food).


Public Health Assessment:
The evaluation of data and information on the release of hazardous substances into the environment in order to assess any current or future impact on public health, develop health advisories or other recommendations, and identify studies or actions needed to evaluate and mitigate or prevent human health effects; also, the document resulting from that evaluation.


Route of Exposure:
The path in which a person may contact a chemical substance. For example, swallowing (ingestion) and touching (direct contact) are two different routes of exposure to contaminants that may be found in soil.

APPENDIX B.

ASSUMPTIONS USED IN CALCULATING EXPOSURE DOSE ESTIMATES
Location Media Potentially Exposed Population Estimated Frequency of Exposure Ingestion Rate
Area A Subsurface soil Adults none none
Children none none
Surface soil Adults 1 day a week 50 mg/day
Children 1 day a week 200 mg/day
Area B Surface soil Adults 7 days a week 50 mg/day
Children 7 days a week 200 mg/day
Children with pica behavior 3 days a week 8000 mg/day
Area BN Subsurface soil Workers none none
Surface soil Workers 5 days a week 50 mg/day
Area C Surface soil Adults 7 days a week 50 mg/day
Children 7 days a week 200 mg/day
Children with pica behavior 3 days a week 8000 mg/day
Sediment Adults 1 day a week 50 mg/day
Children 1 day a week 200 mg/day
Area CP Surface soil Workers 5 days a week 50 mg/day
Sediment Workers 1 day (intermittent exposure) 50 mg/day
Area D Surface soil Adults 7 days a week 50 mg/day
Children 7 days a week 200 mg/day
Children with pica behavior 3 days a week 8000 mg/day
Area E (Commercial) Surface soil Workers 5 days a week 50 mg/day
Sediment Workers 1 day (intermittent exposure) 50 mg/day
Area E (Residential) Surface soil Adults 7 days a week 50 mg/day
Children 7 days a week 200 mg/day
Children with pica behavior 3 days a week 8000 mg/day
Area GASCO Surface soil Workers 1 day (intermittent exposure) 50 mg/day
Area LF Surface soil Workers 1 day (intermittent exposure) 50 mg/day
Adults 1 day (intermittent exposure) 50 mg/day
Area MDN Surface soil Workers 1 day (intermittent exposure) 50 mg/day
Adults 1 day (intermittent exposure) 50 mg/day
Children 1 day (intermittent exposure) 200 mg/day
Area NP Surface soil Adults 1 day a week 50 mg/day
Children 1 day a week 200 mg/day
Area XE Surface soil Workers 5 days a week 50 mg/day
Trespasser 1 day (intermittent exposure) 50 mg/day
Line A Subsurface soil Adults none none
Children none none
Sediment Adults 1 day (intermittent exposure) 50 mg/day
Children 1 day (intermittent exposure) 200 mg/day


APPENDIX C: PUBLIC COMMENTS

Public health assessments are released in draft form to the public for comment. For this publichealth assessment, the required 30 day public comment period was doubled, allowing the public60 days to submit comments. This appendix contains public comments in the order they werereceived and responses from ADPH/ATSDR.

Ms. Barnett once again did a super job in preparing this report and Ms. Browder was all toovaluable! Ms. Barnett will be greatly missed. I would like to make my medical records availableto the ATSDR as "so far" I have and still suffer from health effects.

Response: Thank you for the complements. Thank you also for offering medical records. On those occasions when ADPH and ATSDR reviewed medical records, we appreciate people who are willing to participate.

What about the people and property on Montrose Avenue? What are you going to do? Now!

Response: The people and property on Montrose Avenue were tested during an exposureinvestigation in 1995-1996. Because the exposure investigation showed that people wereexposed to PCBs, ADPH recommended that those people relocate and/or allow cleanupto prevent further exposure. Unfortunately, a few people did not agree to allow theirproperty to be remediated. They continue to be at risk for exposure. ADPH and ATSDRcontinue to recommend that steps be taken to stop exposure.

Will I need testing?

Response: ADPH is concerned about the many people who have not been tested forPCBs, and we all want more information about how PCB exposure might affect health. The tests are very expensive and ADPH has requested assistance to fund more work.

It's a little confusing to read and understand all the facts.

Response: Unfortunately, that comment is correct. Thank you for your honesty. Therewere different kinds of property sampled: residential, business, municipal, and utility. For each property, ADPH identified people who might go to the area and how they mightcome into contact with contaminated soil. ADPH regrets the confusion caused by ourefforts to describe each location.

Probably no clear answers but it is not clear what health effects really are. Also, newerinformation regarding extensive testing. Would have liked a clearer map.

Response: The comment is correct, there are few clear answers on human health effectsof PCB exposure. ATSDR has prepared a health consultation on the newer information. They have received comments on that report and are responding to the comments. ADPHregrets that details on the maps are not very clear, making them difficult to read.

The 5 ppm detection limit--who determined this? and how? Who regulates landfills? Need a health study to be done for Calhoun County. Since manufacture of PCBs discontinued and people continue to be exposed--remove landfill. What took so long for this study? There needs to be updated data--this report was done several years ago.

Response: The 5 ppm detection limit referred to in the report is for samples that werecollected and analyzed quickly in the field by a field screening method. The fieldscreening kit read the results of each sample as less than 5 ppm or greater than 5 ppm. Newer field screening kits currently being used in Anniston by the EPA have a lowerdetection limit.

The landfills are regulated by the Alabama Department of Environmental Managementunder the Resource Conservation and Recovery Act. Any decisions regarding thelandfills, including removal, are currently under the authority of ADEM.

The samples evaluated in this public health assessment were collected and reported toADPH in 1996. ADPH regrets that a shortage of workers delayed the completion of thispublic health assessment.

ATSDR wrote a health consultation on updated environmental and blood sampling. ATSDR has also written several other reports on environmental issues in Annistonincluding childhood exposure to PCBs, lead in soil, etc. Several of these reports werereleased for public comment.

TITLE

The use of the word "aliases" is inappropriate in a document of this type. In addition, thedescription of the site in the title is inaccurate and misidentifies the assessment area. The name ofthe owner of the site is Solutia Inc. The area which this assessment addresses is more properlydenoted as near-site areas, rather than "Snow Creek Area." Snow Creek is the subject of Solutia'songoing off-site RFI process and is not included in the area described in the present document.Solutia suggests that the title of the document be changed to the following: Public HealthAssessment for Solutia Inc. (formerly known as the chemical businesses of Monsanto Company)Near-site Areas Anniston, Calhoun County, Alabama CERCLIS No. ALD 004 019 048

Response: The site name for this document is changed to Monsanto Company/Solutia Inc. The samples evaluated in this document were collected by Monsanto Company in 1996. The facility is now named Solutia Inc. ADPH will include both names in the title toreflect their involvement.

Background, Site Description and History

Page 1, second paragraph of section: The second sentence implies that the manufacture ofpolychlorinated biphenyls (PCBs) and other chemicals by Monsanto at the Anniston site onlybegan after the purchase of Swann Chemical Company by Monsanto in 1935. In reality, thosechemicals had been manufactured by Swann for several years at the time of the purchase, and,more correctly, Monsanto continued the manufacturing of those chemicals.

Response: Comment noted.

Page 2, first full sentence: The draft PHA mischaracterizes the relationship between Monsantoand Solutia Inc. (not Solutia, Incorporated as denoted in the document). On September 1, 1997,Monsanto spun off its former chemical businesses as Solutia Inc., which is a totally separatebusiness entity.

Response: Comment noted.

Page 2, first full paragraph: Solutia believes the West End Landfill was used only until 1960, not1961 as denoted in the document. Solutia suggests replacing "exchanged to" to "exchanged with"in the next-to-last line.

Response: The sentence addressing the property exchange has been rewritten.

Page 2, second full paragraph: In this paragraph and elsewhere, the PHA refers to the drainageditch which ran through the area east of the Solutia facility as the "Eastern Drainage Ditch" and,alternatively, as the "East Drainage Ditch." Solutia suggests that a consistent name be used andthat "East Drainage Ditch" is more consistent with previous documents submitted to the AlabamaDepartment of Environmental Management (ADEM) and the Alabama Department of PublicHealth (ADPH).

Response: The wording has been changed to "East Drainage Ditch."

Previous Investigations, South Landfill

Page 2, last paragraph: The wording of the last sentence, "closing the ditches with PCBcontaminated sediment," is subject to misinterpretation. Solutia suggests that a more completedescription of the remediation process would be appropriate. The East Drainage Ditch was linedwith a geotextile liner and then covered with up to 6 feet of clean soil and an impermeablegeomembrane liner. Tributary ditches were also lined with a geotextile liner and were filled withclean soil. All areas, including the ditches, were then covered with a minimum of 14 inches of clean soil and were seeded.

Response: Comment noted.

West End Landfill

Page 3, first paragraph: In this paragraph and elsewhere, the PHA refers to "storm water,""storm-water," and "stormwater." Solutia suggests consistent terminology ("storm water") be used.

Response: The wording has been changed to storm water.

In the fourth line from the end of the paragraph, "line" should read "liner."

Response: The word has been changed to liner.

Off-site Areas Sampled

Page 3, second paragraph of this section: In the third line, "Clydesdale Road" should read"Clydesdale Avenue." The penultimate sentence mischaracterizes Solutia's current activity withregard to purchase of property. Solutia is no longer actively negotiating to purchase eitherresidential or commercial properties, although Solutia would consider the purchase of propertiesin the original Property Purchase Programs areas, if the owners wished to reconsider participatingin the Program. In addition, the cited reference for that sentence, "[2]," does not appear to becorrect. Solutia suggests deleting the sentence and reference.

Response: The paragraph has been revised to clarify and update information.

Page 5, first paragraph after the list of areas: The cited reference at the end of the paragraph,"[2]," does not appear to be correct. The correct reference would appear to be number 7 on thelist on Page 28.

Response: Because references 2 and 7 are both appropriate to cover the series of actions listed, reference 7 has been added.

Alabama Department of Public Health Involvement

Page 7, first paragraph, first line: Solutia's proper corporate name is "Solutia Inc.", not "SolutiaCompany." At the time of the contact, the representatives would have been employees ofMonsanto.

Response: The sentence has been corrected.

Page 7, second paragraph: The reference cited at the end of the paragraph, "[6]," does not appearto be correct. The correct reference may be number 4 on Page 28.

Response: Reference 6 has been changed to 1 and 4 as both are appropriate.

Page 7, fourth paragraph: There are several citations to reference [6] in this paragraph, none ofwhich appears to be correct. The correct reference may be number 4 on Page 28.

Response: The reference has been changed to 4.

Page 7, fifth paragraph: Solutia suggests replacing "an exam" with "a medical examination" inthe first sentence and replacing "PCB exam" with "medical examination" in the second sentence.

Response: The paragraph has been rewritten to clarify activities conducted by theUniversity of Alabama at Birmingham, Occupational and Environmental Medicine Clinic.

Page 8, first paragraph: The reference cited at the end of the paragraph, "[6]," does not appear tobe correct. The correct reference may be number 4 on Page 28.

Response: The reference has been changed to 4.

Page 8, second paragraph: This paragraph somewhat mischaracterizes the timing and nature ofMonsanto Company's Property Purchase Program. The Property Purchase Program was institutedin October of 1995 to acquire residential properties in the area east of the Anniston facility inorder to facilitate management and control of the PCB impacted soils and sediments in the area.This Program was instituted prior to the ADPH health consultations. The area to which theProgram applied was generally defined by the presence of PCBs in soils and sediments above thescreening level of the immunoassay tests being used to determine the extent of PCB-impactedsoils. Subsequent to the signing of Consent Order No. 96-054-CHW between Monsanto andADEM, Monsanto extended the Property Purchase Program to Montrose Avenue, which is eastof and upgradient of the original area. Many of the property owners on Montrose Avenue agreedto participate in the Program. None of the properties purchased was "in the immediate vicinity of Snow Creek."

Response: The paragraph has been rewritten to reflect the expanded area.

Discussion, Polychlorinated Biphenyls (PCBs)

Page 8, first paragraph of this section: Although natural sources of PCBs are probably minor,there are literature reports of naturally-occurring PCBs.

Response: Comment noted.

Page 8, third paragraph of this section, continuing to Page 9: Solutia believes this paragraphmischaracterizes the amount and nature of the scientific and medical literature concerning PCBs.It is not correct that the information available on the human health implications of exposure toPCBs is "very limited." That literature is voluminous, and several excellent reviews have alsobeen published, for example, "Polychlorinated Biphenyl Exposure and Human Disease," James,R. C., et al., J. Occup. Med., 1993, 35(2):136-148. Much of the literature has also beensummarized in ATSDR's Toxicological Profile for Polychlorinated Biphenyls, which is cited asreference 9 on Page 29 of the draft PHA. Although the draft PHA properly notes some of thelimitations of the various publications describing the potential human health effects of PCBs, itdoes not give appropriate weight to the strengths of those same studies, including the fact that thesubjects of most of those studies were occupationally exposed persons whose exposures weresignificantly higher than those of most environmentally exposed persons. As Dr. James observedin the abstract of the paper cited above, ". . . [T]he weight of evidence suggests the only adversehealth effects attributable to high, occupational PCB exposures are dermal . . . [T]he collectiveoccupational experience with PCB fluids provides no evidence for adverse PCB effects on any other organ systems."

Response: The public health assessment is based on a balanced public health assessment of the literature. No changes are necessary.

Page 9, first full paragraph: Although this paragraph correctly notes that the studies discussedtherein are studies of laboratory animals and wildlife, the paragraph could be incorrectlyinterpreted. Solutia suggests adding the phrase "in animals" after the words "toxic effects" in thesecond sentence and at the end of the third sentence.

Response: It is clear that animal studies are the subject of the entire paragraph. No changes are necessary.

Page 9, second full paragraph: This paragraph also mischaracterizes the results of the studies ofpersons exposed occupationally to PCBs. The paper by James et al., which was cited above,provides a thorough review of the studies of such workers. The only organ system for which theweight of the evidence suggests the potential for an adverse human health effect is the skin. Theother systems mentioned in this paragraph of the PHA are only reported in isolated studies, if atall. Several studies do report transient elevations in levels of certain liver enzymes; however, theelevations are not clinically significant and are inconsistent with regard to the particular enzymespotentially affected. The sporadic reports of possible effects on other organ systems do not meetwell established criteria for causation and cannot be relied upon to suggest that exposure to PCBsis associated with adverse effects on those systems. Solutia suggests the following wording:"Studies of laboratory animals have suggested that there is a potential for effects on the thyroidgland, the liver, the skin, the eyes, the blood, and the immune system. However, clinical studiesof occupationally exposed populations have found that the only adverse health effects attributableto high occupational exposures to PCBs are dermal (e.g., chloracne)."

Response: The public health assessment is based on a balanced evaluation of therelationship between animal studies and human health. No changes are necessary.

Page 9, third full paragraph: While this paragraph correctly notes that the isolated reports ofassociations of occupational exposure to PCBs with cancer in a variety of physiological sites " . .. have not been observed consistently across studies," Solutia feels the weight of the evidence ofthose studies should be conveyed in a more positive manner. As Dr. Renate Kimbrough observedin a 1995 review, Polychlorinated Biphenyls (PCBs) and Human Health: An Update, "Thesestudies (in the reviewer's opinion) have not provided any convincing evidence that PCBs arehuman carcinogens." (Emphasis added.) Kimbrough, R. D., Crit. Rev. Toxicol., 1995,25(2):133-163. Ironically, while this paragraph of the PHA cites Dr. Kimbrough's recentlypublished study of the largest group of electrical workers exposed to PCBs to summarize thesporadic findings from other studies, it does not include the results of that study itself. Theabstract of Dr. Kimbrough's 1999 study concludes, "None of the previously reported specificexcesses in cancer mortality were seen. This is the largest cohort of male and female workersexposed to PCBs. The lack of any significant elevations in the site-specific cancer mortality ofthe production workers adds important information about the human health effects of PCBs."Kimbrough, R. D., et al., J. Occup. Environ. Med., 1999, 41(3):161-171.

Response: ADPH's balanced public health assessment of the carcinogenicity of PCBs isbased on a weight of evidence approach; it is not based on limited studies. The publichealth assessment text further states that PCBs have been designated as probablecarcinogens or reasonably anticipated to be carcinogens by the Department of Health andHuman Services, the International Agency for Research on Cancer, and EPA. Nochanges are necessary.

Environmental Contamination and Exposure Pathways

Page 10, third paragraph: It is unclear why ADPH/ATSDR has chosen ATSDR's Cancer RiskEvaluation Guide (CREG) as the comparison value for non-cancerous health effects. The use ofthis conservative CREG in conjunction with other conservative assumptions used to evaluatesome of the areas addressed by this document results in overly restrictive evaluations.

Response: A comparison value is used as a screening tool. Conservative screening toolsare desired and needed in order to be protective of public health. We disagree that the evaluations contained in this PHA are overly restrictive.

Page 10, fourth paragraph: While Solutia understands the need to deal appropriately with thelarge number of soil PCB concentrations that were below the screening level of 5 ppm, theuniform application of one-half of the detection limit (2.5 ppm) to those values almost certainlyexaggerated the exposure estimates in many of the areas evaluated, especially those where mostof the samples had no PCBs detected above the screening level. Solutia recommendsrecalculating the values using zero ppm (0 ppm) as the surrogate value and reporting both resultsin the PHA. This calculation would provide a range of average PCB values and would allowmore appropriate ranges of estimated doses. Solutia also questions the use of average PCB soillevels to estimate "exposure doses" in the evaluated areas without some analysis of distributionof soil level results. It is not possible to determine by examining the data as presented in the PHAwhether the average value is a fair representation of the distribution of results or whether one or two relatively high values biased the average.

Response: Any sample result that is reported to be below the 5.0 ppm detection limitrepresents an unknown quantity that could actually be any concentration between 0.0 ppmand 4.9 ppm. By assigning these samples a value of 2.5 ppm, the average concentrationcan be calculated with the least potential for either underestimating or overestimating the unknown. No changes are necessary.

Page 11, Tables 1,2, and 3: There appear to be errors in at least some of the averageconcentrations reported on these tables. In Table 3, for example, the average concentration forArea A and Line A are the same as the highest value reported for the concentration range, whichcannot be the case. Solutia suggests confirming the calculations of averages using 2.5 ppm forthe "non-detects," repeating and reporting the average concentrations using 0 ppm for the"non-detects," and providing some information about the distribution of the values in the concentration ranges.

Response: The average concentrations for subsurface soil at Area A and Line A wererecalculated assigning the value of 2.5 ppm for the non-detects. The corrected averages have been entered into Table 3.

Determining Public Health Implications

Page 12, second paragraph, first sentence: Insert "upper bound" between "theoretical" and"cancer risk" to clarify that the cancer risk estimates calculated using the EPA cancer slope factorfor PCBs are upper bound risk estimates. The paragraph should also indicate that according tothe EPA the true risk could be as low as zero.

Response: Appropriate language has been added to the PHA.

Page 12, fourth paragraph: This paragraph should also include a statement that the risk estimatescalculated using the EPA cancer slope factor are upper bound risk estimates and that the true riskcould be as low as zero. Solutia notes that the discussion of "background" cancer risks provides appropriate perspective.

Response: Similar language was inserted in paragraph 2 as requested in the commentimmediately before this one. No changes were made to paragraph 4 in response to thiscomment.

Page 13, first paragraph, fifth sentence: This sentence provides an example of how the decisionto use 2.5 ppm as the default concentration when PCBs were not detected above the screeninglevel of 5 ppm could result in an overly conservative estimation of "exposure dose." If, in fact,the use of 2.5 ppm as the surrogate for non-detection exaggerated the true level of PCBs in agiven area, the "estimated exposure dose" would also be exaggerated, leading eventually to anexaggerated calculation of estimated risk. Solutia again suggests repeating the calculations ofaverage concentrations using zero ppm (0 ppm) as the surrogate for non-detection and reporting both values in the PHA.

Response: Any sample result that is reported to be below the 5.0 ppm detection limitrepresents an unknown quantity that could actually be any concentration between 0.0 ppmand 4.9 ppm. By assigning these samples a value of 2.5 ppm, the average concentrationcan be calculated with the least potential for either underestimating or overestimating the unknown. No changes are necessary.

Past, Present, and Potential Future Exposures (Area LF)

Page 14, first paragraph of this section: In the sixth line of this paragraph, the second occurrenceof the word "workers" should be deleted. The infinitive phrase should read " . . . to dispose of waste and . . . "

Response: The duplicate word has been deleted.

Area NP

Page 14, second paragraph of this section: Solutia suggests changing "To reduce . . . " to "To eliminate. . ."

Response: The description of actions taken does not support the suggested wordsubstitution.

Past, Present, and Potential Future Exposures (Area NP)

Page 14, second paragraph of section, continuing to Page 15: The discussion of the potential foradverse non-cancerous health effects for preschool children mischaracterizes the animal andhuman scientific literature on these potential effects, even if one assumes the validity of thestudies. There are several issues which need to be considered before ADPH and ATSDR suggest,as they do in this document, that neurobehavioral effects could have resulted from exposure toPCBs in this area or in areas B, C, D, and E below, for which the same characterization ispresented. Reviews of the studies of potential neurobehavioral effects in humans associated withexposure to PCBs and other chemicals by Dr. Susan Schantz (Schantz, S. L., Neurotoxicol.Teratol., 1996, 18(3):217-227) and Dr. Richard Seegal (Seegal, R. F., Crit. Rev. Toxicol., 1996,26(6):709-737) discussed in great detail the various criticisms of those studies, noted the smallmagnitude of the changes noted, and concluded that the studies, taken as a whole, areinconclusive. Further, even if one assumes that the various studies reviewed by Schantz andSeegal do have some validity, the subtle effects were reported to be associated with prenatalexposure to the chemicals, not to postnatal exposures, such as incidental ingestion of surface soil.Finally, many of the animal studies on which the agencies seem to rely for the description ofpotential non-cancerous effects were carried out at dosage levels much higher than thoseassociated with potential incidental ingestion of surface soils. Solutia believes the suggestion thatneurobehavioral effects could have resulted from exposures to soil in Area NP and other areas is not supported by the scientific literature.

Response: The reports cited in the comment point out the uncertainty and somewhatconfusing nature of our understanding of the health effects associated with PCBexposures. Part of the difficulty of obtaining definitive evidence is related to the lowdose exposures encountered in environmental scenarios, and variations in individualresponses to PCB exposures. These factors hinder the ability to produce a definitiveassessment for health effects an individual may experience related to PCB exposures.

Despite this confusion, numerous, more recent reports of laboratory and epidemiologicalinvestigations have added to the weight of evidence indicating that concerns overenvironmental exposures to PCBs are warranted (for general reviews see: J. P. Giesy andK. Kannan. 1998 Critical. Rev. Toxicol. 28:511-569; L. J. Fischer, R. Seegal, p. Ganey,I. Pessah, and P. Kodavanti. 1998. Toxicol. Sci. 41:49-61). It must be noted thatalthough some investigators conclude that the published reports describe subtle effects ofquestionable consequence, others consider the results "adverse" responses. Someinvestigators conclude that the evidence from animal experiments leads to strongsuspicions that similar effects may occur in humans. Included in these documented andsuspected responses to PCBs are neurodevelopmental effects (A. Brouwer, M.Longnecker, L. Birnbaum, J. Cogliano, P. Kostyaiak, S. Schantz, and G. Winneke. 1999. Envir.. Health Perspect. 107:639-649;) and altered thyroid homeostasis (N,. Osius, W.Karmaus, H. Kruse, J. Witten. 1999. Envir. Health Perspect. 107:843-849; S.Poprterfield, 2000. Envir.. Health Perspect. 108:433-438). Of importance are reportsindicating that pre-and postnatal exposures to PCBs may be of particular concern (A.Brouwer, M. Longnecker, L. Birnbaum, J. Cogliano, P. Kostyaiak, S. Schantz, and G.Winneke. 1999. Envir.. Health Perspect. 107:639-649).

Based on a limited review of the newer evidence, ADPH and ATSDR believe that it isreasonable to suspect that exposures to PCBs can induce a variety of responses in bothanimals and humans, and that some of those responses may occur as a result of exposuresto environmental PCBs.

Residential Areas, Area A

Page 15, first paragraph of this section: In the third line from the bottom of the paragraph, theproper name of the church is the First Missionary Baptist Church (not "Mission").

Response: The name of the church has been corrected.

Page 15, second paragraph, second sentence: It should be noted that the "contaminated soil"which was removed contained PCBs at far less than the 50 ppm regulatory limit for TSCA(Toxic Substance Control Act)-regulated wastes.

Response: The PCB concentrations are listed in the previous paragraph. No changes are necessary.

Area B

Page 16, second paragraph of this section: In the penultimate sentence, it is stated that "Solutiawas not provided access. It would be more correct to note that Solutia was refused access to theproperty to remediate the isolated spot where PCBs were present above the screening level butwell below the 50 ppm regulatory limit.

Response: One word of the sentence was changed.

Past, Present, and Potential Future Exposures (Area B)

Page 16, first paragraph of this section, third sentence: It is an exaggeration to state that " . . . acurrent completed pathway of exposure exists . . . " because the low levels of PCBs are onlypresent in an isolated spot in the yard, not in the whole yard. The isolated nature of this spot ofsoil containing 9 ppm of PCBs should be noted specifically.

Response: The public health assessment correctly identifies a completed exposurepathway. Subsequent to identifying pathways of exposure, PCB concentrations andfrequency of contact are evaluated to calculate dose. No change is necessary.

Page 16, second paragraph of this section, continuing to Page 17: Please see comment for Past,Present, and Potential Future Exposures (Area NP), Page 14.

Response: The reports cited in the comment point out the uncertainty and somewhatconfusing nature of our understanding of the health effects associated with PCBexposures. Part of the difficulty of obtaining definitive evidence is related to the lowdose exposures encountered in environmental scenarios, and variations in individualresponses to PCB exposures. These factors hinder the ability to produce a definitiveassessment for health effects an individual may experience related to PCB exposures.

Despite this confusion, numerous, more recent reports of laboratory and epidemiologicalinvestigations have added to the weight of evidence indicating that concerns overenvironmental exposures to PCBs are warranted ( for general reviews see: J. P. Giesy andK. Kannan. 1998 Critical. Rev. Toxicol. 28:511-569; L. J. Fischer, R. Seegal, p. Ganey,I. Pessah, and P. Kodavanti. 1998. Toxicol. Sci. 41:49-61). It must be noted thatalthough some investigators conclude that the published reports describe subtle effects ofquestionable consequence, others consider the results "adverse" responses. Someinvestigators conclude that the evidence from animal experiments leads to strongsuspicions that similar effects may occur in humans. Included in these documented andsuspected responses to PCBs are neurodevelopmental effects (A. Brouwer, M.Longnecker, L. Birnbaum, J. Cogliano, P. Kostyaiak, S. Schantz, and G. Winneke. 1999. Envir.. Health Perspect. 107:639-649;) and altered thyroid homeostasis (N,. Osius, W.Karmaus, H. Kruse, J. Witten. 1999. Envir. Health Perspect. 107:843-849; S.Poprterfield, 2000. Envir.. Health Perspect. 108:433-438). Of importance are reportsindicating that pre-and postnatal exposures to PCBs may be of particular concern (A.Brouwer, M. Longnecker, L. Birnbaum, J. Cogliano, P. Kostyaiak, S. Schantz, and G.Winneke. 1999. Envir.. Health Perspect. 107:639-649).

Based on a limited review of the newer evidence, ADPH and ATSDR believe that it isreasonable to suspect that exposures to PCBs can induce a variety of responses in bothanimals and humans, and that some of those responses may occur as a result of exposuresto environmental PCBs.

Area C

Page 17, second paragraph of this section, second sentence: This sentence should be modified tonote that as part of the remediation process Solutia placed a minimum of 14 inches of clean soilon top of the geosynthetic liner and seeded the property.

Response: The sentence was based on the author's personal communication withSolutia's Manager of Remedial Projects rather than on a document which can beresearched to verify the information. The author has left ADPH and the informationoffered in the comment does not materially change the public health assessment;therefore, the wording will not be changed.

Past, Present, and Potential Future Exposures (Area Q

Page 17, second paragraph of this section continuing to Page 18, first full paragraph: Please seecomment for Past, Present, and Potential Future Exposures (Area NP), Page 14. Also, thescientific literature does not support the statement that " . . .immunological effects have been observed in human studies. . . "

Response: The reports cited in the comment point out the uncertainty and somewhatconfusing nature of our understanding of the health effects associated with PCBexposures. Part of the difficulty of obtaining definitive evidence is related to the low doseexposures encountered in environmental scenarios, and variations in individual responsesto PCB exposures. These factors hinder the ability to produce a definitive assessment for health effects an individual may experience related to PCB exposures.

Despite this confusion, numerous, more recent reports of laboratory and epidemiologicalinvestigations have added to the weight of evidence indicating that concerns overenvironmental exposures to PCBs are warranted ( for general reviews see: J. P. Giesy andK. Kannan. 1998 Critical. Rev. Toxicol. 28:511-569; L. J. Fischer, R. Seegal, p. Ganey,I. Pessah, and P. Kodavanti. 1998. Toxicol. Sci. 41:49-61). It must be noted thatalthough some investigators conclude that the published reports describe subtle effects ofquestionable consequence, others consider the results "adverse" responses. Someinvestigators conclude that the evidence from animal experiments leads to strongsuspicions that similar effects may occur in humans. Included in these documented andsuspected responses to PCBs are neurodevelopmental effects (A. Brouwer, M.Longnecker, L. Birnbaum, J. Cogliano, P. Kostyaiak, S. Schantz, and G. Winneke. 1999. Envir.. Health Perspect. 107:639-649;) and altered thyroid homeostasis (N,. Osius, W.Karmaus, H. Kruse, J. Witten. 1999. Envir. Health Perspect. 107:843-849; S.Poprterfield, 2000. Envir.. Health Perspect. 108:433-438). Of importance are reportsindicating that pre-and postnatal exposures to PCBs may be of particular concern (A.Brouwer, M. Longnecker, L. Birnbaum, J. Cogliano, P. Kostyaiak, S. Schantz, and G.Winneke. 1999. Envir.. Health Perspect. 107:639-649).

Based on a limited review of the newer evidence, ADPH and ATSDR believe that it isreasonable to suspect that exposures to PCBs can induce a variety of responses in bothanimals and humans, and that some of those responses may occur as a result of exposuresto environmental PCBs.

Area D

Page 18, first paragraph of this section: In the penultimate sentence, it is stated that "Solutia wasnot provided access. It would be more correct to note that Solutia was refused access to theproperty to remediate the isolated spot where PCBs were present above the screening level but well below the 50 ppm regulatory limit.

Response: One word of the sentence was changed.

Past, Present, and Potential Future Exposures (Area D)

Page 18, second paragraph of this section and Page 19, first paragraph: Please see comment forPast, Present, and Potential Future Exposures (Area NP), Page 14. Also, the scientific literaturedoes not support the statement that " . . .immunological effects have been observed in human studies. . . "

Response: The reports cited in the comment point out the uncertainty and somewhatconfusing nature of our understanding of the health effects associated with PCBexposures. Part of the difficulty of obtaining definitive evidence is related to the low doseexposures encountered in environmental scenarios, and variations in individual responsesto PCB exposures. These factors hinder the ability to produce a definitive assessment for health effects an individual may experience related to PCB exposures.

Despite this confusion, numerous, more recent reports of laboratory and epidemiologicalinvestigations have added to the weight of evidence indicating that concerns overenvironmental exposures to PCBs are warranted ( for general reviews see: J. P. Giesy andK. Kannan. 1998 Critical. Rev. Toxicol. 28:511-569; L. J. Fischer, R. Seegal, p. Ganey,I. Pessah, and P. Kodavanti. 1998. Toxicol. Sci. 41:49-61). It must be noted thatalthough some investigators conclude that the published reports describe subtle effects ofquestionable consequence, others consider the results "adverse" responses. Someinvestigators conclude that the evidence from animal experiments leads to strongsuspicions that similar effects may occur in humans. Included in these documented andsuspected responses to PCBs are neurodevelopmental effects (A. Brouwer, M.Longnecker, L. Birnbaum, J. Cogliano, P. Kostyaiak, S. Schantz, and G. Winneke. 1999. Envir.. Health Perspect. 107:639-649;) and altered thyroid homeostasis (N,. Osius, W.Karmaus, H. Kruse, J. Witten. 1999. Envir. Health Perspect. 107:843-849; S.Poprterfield, 2000. Envir.. Health Perspect. 108:433-438). Of importance are reportsindicating that pre-and postnatal exposures to PCBs may be of particular concern (A.Brouwer, M. Longnecker, L. Birnbaum, J. Cogliano, P. Kostyaiak, S. Schantz, and G.Winneke. 1999. Envir.. Health Perspect. 107:639-649).

Based on a limited review of the newer evidence, ADPH and ATSDR believe that it isreasonable to suspect that exposures to PCBs can induce a variety of responses in bothanimals and humans, and that some of those responses may occur as a result of exposuresto environmental PCBs.

Area E - Residential

Page 19, second paragraph of this section, second sentence: The wording of this sentence issomewhat misleading. It is clearer to say, "Solutia purchased the properties in this area andremoved all of the structures. Solutia restricted access to the area with a fence."

Response: The sentence has been clarified.

Past, Present, and Potential Future Exposures (Area E-Residential)

Page 19, second paragraph of this section and third paragraph of this section continuing to Page20: Please see comment for Past, Present, and Potential Future Exposures (Area NP), Page 14.Also, the scientific literature does not support the statement that immunological effects have been observed in human studies. . . "

Response: The reports cited in the comment point out the uncertainty and somewhatconfusing nature of our understanding of the health effects associated with PCBexposures. Part of the difficulty of obtaining definitive evidence is related to the low doseexposures encountered in environmental scenarios, and variations in individual responsesto PCB exposures. These factors hinder the ability to produce a definitive assessment for health effects an individual may experience related to PCB exposures.

Despite this confusion, numerous, more recent reports of laboratory and epidemiologicalinvestigations have added to the weight of evidence indicating that concerns overenvironmental exposures to PCBs are warranted ( for general reviews see: J. P. Giesy andK. Kannan. 1998 Critical. Rev. Toxicol. 28:511-569; L. J. Fischer, R. Seegal, p. Ganey,I. Pessah, and P. Kodavanti. 1998. Toxicol. Sci. 41:49-61). It must be noted thatalthough some investigators conclude that the published reports describe subtle effects ofquestionable consequence, others consider the results "adverse" responses. Someinvestigators conclude that the evidence from animal experiments leads to strongsuspicions that similar effects may occur in humans. Included in these documented andsuspected responses to PCBs are neurodevelopmental effects (A. Brouwer, M.Longnecker, L. Birnbaum, J. Cogliano, P. Kostyaiak, S. Schantz, and G. Winneke. 1999. Envir.. Health Perspect. 107:639-649;) and altered thyroid homeostasis (N,. Osius, W.Karmaus, H. Kruse, J. Witten. 1999. Envir. Health Perspect. 107:843-849; S.Poprterfield, 2000. Envir.. Health Perspect. 108:433-438). Of importance are reportsindicating that pre-and postnatal exposures to PCBs may be of particular concern (A.Brouwer, M. Longnecker, L. Birnbaum, J. Cogliano, P. Kostyaiak, S. Schantz, and G.Winneke. 1999. Envir.. Health Perspect. 107:639-649).

Based on a limited review of the newer evidence, ADPH and ATSDR believe that it isreasonable to suspect that exposures to PCBs can induce a variety of responses in bothanimals and humans, and that some of those responses may occur as a result of exposuresto environmental PCBs.

Commercial Areas, Area BN

Page 20, second paragraph of this section, first sentence: This sentence is somewhat awkward aswritten. It might be better to say, "Solutia has completed remediation activities at all theproperties in Area BN to which it has been given access."

Response: The sentence has been clarified.

Area CP

Page 21, second paragraph of this section, first sentence: It is not correct that Solutia has " . . . removed all structures in the area. . ." Although Solutia did remove the structures on the easternend of the area, a warehouse still stands on the western end of the property (the Miller property). It is correct to say, "By November 1999, Solutia had purchased the property and removed all butone of the structures,. . . "

Response: The sentence has been clarified.

Area XE

Page 24, first full paragraph: This paragraph is out of date. It would be better to replace "To-date"with "As of November 1999".

Response: The sentence was changed as noted.

Conclusions

Page 26, Conclusion 1 and Conclusion 2: Solutia disagrees that the concentrations of PCBs in thesoils in the areas denoted in the conclusions could result in adverse noncancerous health effectsfor children. These conclusions are not supported by the scientific literature which discusses thehuman health effects of PCBs. The bases for Solutia's disagreement have been discussed inearlier comments. Solutia is confident that the levels of PCBs in the soils in the near-site areas towhich children had or have access do NOT pose a public health hazard.

Response: This public health assessment was conducted by professionals trained inenvironmental health. Their weight of evidence evaluation of relevant data concludesthat a public health hazard exists for designated populations. However, the word"noncancerous" has been removed from Conclusions 1 and 2.

Public Health Action Plan

Page 27, first paragraph of this section, line three and second paragraph of this section, line six:"Monsanto" should be replaced with "Solutia."

Response: The name has been changed to Monsanto Company/Solutia Inc. to remainconsistent with the title of the public health assessment.


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