Measured or estimated exposure: N/ A Exposure levels: N/ A Statistical methods: Arithmetic means, ranges, geometric means and 95% confidence intervals were calculated. Central tendency and distribution of the data by age, gender, location and their respective interaction terms will be done in the final report. A reliability assessment is also being analyzed.

Other methodological information: N/ A RESULTS Describe results: The mean PFOS serum level was 43.5 ppb. The range was 6.7  515 ppb. Analyses stratified by age, gender, and geographic location will be forthcoming in the final report.

Study strengths and weaknesses: These data are cross sectional data used to determine PFOS levels in U. S. children. No other descriptive information about the subjects is available in this preliminary report. The sample size is relatively small.

Research sponsors: 3M Medical Department, Corporate Occupational Medicine Consistency of results: To date, no other data have been collected on PFOS serum levels in children.

CONCLUSIONS N/ A REFERENCE Olsen, GW, Burris, JM, Lundberg, JK, Hansen, KJ, Mandel, JH, Zobel, LR. Identification of fluorochemicals in sera of children in the United States. Interim Report. June 25, 2001. ENV/ JM/ RD( 2002) 17/ FINAL 344 EPIDEMIOLOGIC DATA Title: Mortality Study of Workers Employed at the 3M Decatur Facility TEST SUBSTANCE Identity: Several perfluorooctanesulfonyl fluoride based fluorochemicals, including PFOS Remarks: This study is an update of the study published by Mandel and Johnson, 1995.

METHOD Study design: Retrospective cohort mortality study.

Manufacturing/ Processing/ Use: The 3M Decatur, Alabama plant began production in 1961. It is made up of the film plant and the chemical plant. The 3 major product groups in the chemical plant are protective chemicals, performance chemicals, and fluoroelastomers. Perfluorooctanesulfonyl fluoride ( POSF) is the major sulfonate fluorochemical manufactured at Decatur and is used as the precursor to the production of a variety of perfluorinated amides, alcohols, acrylates, and other fluorochemical polymers.

Hypothesis tested: To determine whether occupational exposure to fluorochemicals is related to mortality of employees of the 3M facility in Decatur, Alabama Study period: The study population worked at the plant for at least 1 year since it began production in 1961. The cohort was followed through Dec. 31, 1997. Currently employed workers were assigned Dec 31, 1997 as their last date of employment.

Setting: 3M plant in Decatur, Alabama.

Total population: 3512 workers were identified. Of these workers, 2083 worked at the plant for at least one year. Eighty four percent of the cohort was male.

Subject selection criteria: All workers employed at the Decatur plant for at least 1 year. The cohort was followed through Dec. 31, 1997. Currently employed workers were assigned Dec 31, 1997 as their last date of employment.

Comparison population: In SMR analyses, Minnesota population death rates for whites were used. Mortality reference rates from 7 regional counties were also used to rule out large variations based on regional mortality reporting differences.

Participation rate: Death certificates were obtained for 96% ( n = 139) of the cohort who were deceased.

Subject description: 84% of the employees in the cohort were male. The mean age at follow up was 51.1 years, and the mean number of years worked at the plant was 14.9. The number of person years at followup was 50970. There were 145 deaths identified in the cohort. The high exposure group was slightly younger than the other 2 groups but worked 3 years longer at the plant than the other 2 exposure groups.

Health effects studied: Mortality Data collection methods: A review of employee work history records of any employee with at least 1 year employment were abstracted to record the workers' name, SSN, 3M identification number, date of ENV/ JM/ RD( 2002) 17/ FINAL 345 birth, and dates of work history. This cohort was linked to records from the original cohort to update the employment information and verify other data. The National Death Index was searched for all of the workers. Discrepancies with the original cohort were resolved and deaths before 1979 were verified in the Social Security Death Index. A licensed nosologist coded the death certificates to ICD 8.

Exposure period: The potential exposure period was from the plant opening in 1961 to Dec. 31, 1997.

Description/ delineation of exposure groups/ categories: Workers were placed into 3 exposure groups based on job history information: high exposure, low exposure, and no exposure. There were 145 deaths in the cohort: 65 in the high exposure group, 27 in the low exposure group and 53 in the non exposed group.

Measured or estimated exposure: estimated based on job history information.

Exposure levels: Not measured. Employees were placed into 3 exposure categories based on job description: low exposure ( n = 289), high exposure ( n = 782), non exposed ( n = 812).

Statistical methods: Standardized Mortality Ratios ( SMRs) and 95% confidence intervals were derived using the PC Life Table Analysis System software developed by NIOSH. This program computes age, gender, and race specific SMRs using standard life table methods. The expected number of deaths is estimated by multiplying the age, gender, race, and calendar period tabulated person years of follow up to the corresponding cause specific mortality reference rates. Mortality rates for white Minnesotans were used as reference data.

Other methodological information:

RESULTS Describe results: 145 deaths were identified in the cohort: 65 of these deaths were in the high exposure group. When the entire cohort was analyzed, SMRs were not elevated for most of the cancer types and for non malignant causes. SMRs that were above 1 ( cancer of the esophagus, liver, breast, urinary organs, bladder, and skin) were also elevated when the cohort was limited to any employee ever employed in a high exposure job ( except breast cancer). Only 2 or 3 deaths were reported for each of these cause specific categories and were not statistically significant, except for bladder cancer.

Workers who were employed in high exposure jobs were greater than 12 times more likely to die of bladder cancer than the general population of Alabama ( SMR = 12.77, 95% CI = 2.63  37.35). This effect remained when the data were analyzed using county death rates. Three male employees in the cohort died of bladder cancer, and all of the deaths occurred in employees who had worked in high exposure jobs for at least 5 years ( SMR = 24.49, 3 observed deaths, 0.12 expected). All of them had worked at the Decatur plant for more than 20 years. In the previous cohort mortality study, 1 bladder cancer death was reported.

Two deaths were reported for liver cancer. One was in the low exposure group and one in the high exposure group. The SMR for workers who were employed in either high or low exposure jobs was 3.08 ( 95% CI = 0.37   11.10). Five cases of cirrhosis of the liver were reported in this cohort, 2 in the high exposure group, 1 in the low exposure group, and 2 in the non exposed. The observed did not exceed the expected mortality experience in any of these groups.

Study strengths and weaknesses: A larger cohort was followed in this update of the original study, thus reporting twice as many deaths; however, the cohort is fairly young and the number of deaths is still small. There were small numbers of deaths in many of the categories for males and especially for females in all categories, thus limiting the power of the study. Death certificates were located for 96% of the cohort, but ENV/ JM/ RD( 2002) 17/ FINAL 346 the 6 not obtained could greatly impact the results of the analyses since the number of deaths in most of the sub cohorts was very small. Biological measurements of fluorochemicals were not available; therefore, exposure categories based on job descriptions were used as a surrogate for exposure. The categories are more specific in this update of the study; however, there is still a potential for misclassification of exposure. Based on the results of the biomonitoring conducted on employees in a random sample of Decatur employees in 1998, the geometric mean of PFOS in film plant employees was 0.136 ppm. However, in this study, film plant employees are considered non exposed. In addition to fluorochemicals, workers were exposed to other chemicals in the workplace.

Research sponsors: University of Minnesota Consistency of results: In the first study, there was an excess of bladder cancer; however, this was based on only 1 death. Three additional deaths have now been reported.

CONCLUSIONS Workers employed at the Decatur plant who are employed in jobs with high exposure to POSF based fluorochemicals are at increased risk of death from bladder cancer.

REFERENCE Alexander, B. H. April 26, 2001. Mortality study of workers employed at the 3M Decatur facility. Final Report. Division of Environmental and Occupational Health, School of Public Health, University of Minnesota.

OTHER This study is the second update of the mortality study. ENV/ JM/ RD( 2002) 17/ FINAL 347 EPIDEMIOLOGIC DATA Title: Identification of Fluorochemicals in Human Sera. I. American Red Cross Adult Blood Donors TEST SUBSTANCE Identity: PFOS and 6 other fluorochemicals Remarks: This is a final report. The preliminary report was dated June 25, 2001.

METHOD Study design: Cross sectional Manufacturing/ Processing/ Use: N/ A Hypothesis tested: To determine the levels of PFOS in the serum of American Red Cross blood banks in 6 regions of the U. S.

Study period: 2000 Setting: N/ A Total population: 6 ARC blood banks in various geographic regions in the US provided 645 serum samples from adult donors. The 6 regions included: Los Angeles, CA; Minneapolis/ St. Paul, MN; Charlotte, NC; Boston, MA; Portland, OR, and Hagerstown, MD.

Subject selection criteria: Unknown Total # of subjects in study: 645 donors, age 20 69 years Comparison population: N/ A Participation rate: N/ A Subject description: The only demographic factors known were age, gender, and location.

Health effects studied: Levels of 7 fluorochemicals in human blood serum, including PFOS. The other chemicals were: PFOA, PFOSAA, M570, M556, PFOSA, PFHS.

Data collection methods: Each blood bank was requested to provide approximately 10 samples per 10 year age intervals ( 20 29, 30 39, etc.) for each sex.

Details on data collection: Blood sera samples were analyzed using high pressure liquid chromatography/ electrospray tandem mass spectrometry ( HPLC/ ESMSMS). 24 samples were split and analyzed to provide an estimate of the reliability of the analyses conducted. The analytical lab was blind to the identity of these split samples. These analyses were performed concurrently with all other analyses of the study to minimize experimental error.

Exposure period: Unknown PFOS serum levels used as surrogate for exposure. ENV/ JM/ RD( 2002) 17/ FINAL 348 Description/ delineation of exposure groups/ categories: 332 male donors, 313 female donors. There were 10 or more subjects for both males and females in each age category ( 20 29, 30 39, etc.) except the 60 69 age group where there were fewer.

Measured or estimated exposure: N/ A Exposure levels: N/ A Statistical methods: A reliability assessment was done. Geometric means, 95% confidence intervals of the geometric means, range, interquartile range, raw cumulative 90th percentile, and frequency distributions, were calculated. Central tendency and distribution of the data by age, gender, and location were presented. Bootstrap analysis was done to calculate mean serum PFOS values for each 6 locations adjusted for 10 year age intervals, gender, and their interaction terms. Multivariable regression analyses. A reliability assessment was also done for the chemical analyses.

Other methodological information: N/ A RESULTS Describe results: The results of the reliability analysis indicate that there was a strong correlation between the split samples ( r = .9) for PFOS ( as well as PFOA and PFHS).

PFOS is the only chemical that met the criteria for a log normal distribution based on the Shapiro Wilk test.

The geometric mean serum PFOS level for all locations and gender was 34.9 ppb ( 95% CI, 33.3 36.5 ppb). The range was < LLOQ ( 4.3 ppb) to 1656 ppb. Males had significantly higher ( p < .05) geometric mean PFOS levels than females. The geometric mean for all males was 37.8 ppb ( 95% CI, 35.5 40.3) and was 31.3 ppb for all females ( 95% CI, 30.0   34.3). Age was not an important predictor of adult serum fluorochemical concentrations.

When stratified by geographic location, the highest geometric mean for PFOS was in the samples from Charlotte, NC ( 51.5 ppb, range: 19.3   166.0) and the lowest from Boston ( 28.0 ppb, range: 4.3   87.2). The other PFOS geometric means and ranges by location were: Los Angeles, 40.4 ppb ( 6.6   205.0); Minneapolis/ St. Paul, 33.1 ppb ( 7.7   207.0); Portland, 27.0 ppb ( 6.0   1656); Hagerstown, 35.3 ppb ( 7.6   226.0). The cumulative 90% were highest for Charlotte ( 105.3), Minneapolis/ St. Paul ( 71.7), Los Angeles ( 70.1), and Hagerstown ( 69.8). Portland and Boston were much lower ( 49.4 and 48.7, respectively).

The results from a bootstrap analysis, done to calculate mean serum PFOS values for each 6 locations adjusted for 10 year age intervals, gender, and their interaction terms, resulted in similar means for Boston ( 29.0 ppb), Los Angeles ( 35.0 ppb), Minneapolis/ St. Paul ( 34.8 ppb), and Hagerstown ( 34.9 ppb). However the mean for Charlotte was much lower ( 39.0 ppb) and the mean for Portland was slightly higher ( 32.8 ppb).

Bootstrap analyses for PFOS calculated a mean of the 95% tolerance limit of 88.5 ppb with an upper 95% confidence limit of 100.0 ppb. The mean of the 99% tolerance limit was 157.3 ppb with an upper 95% confidence limit of 207.0 ppb. At the lowest tolerance limit analyzed ( 90%), the mean for PFOS was 70.7 ppb with an upper 95% confidence limit of 74.3 ppb.

The highest serum PFOS measurement in this sample was 1656 ppb from a male blood donor, 67 years old ENV/ JM/ RD( 2002) 17/ FINAL 349 from Portland. The next highest donor level was 329 ppb from a male donor, 62 years old also from Portland. The next 8 highest serum PFOS values ( range 139   226 ppb) were measured in 4 females and 4 males representing Charlotte ( n= 4), Hagerstown ( n= 2), Los Angeles ( n= 1) and Minneapolis/ St. Paul ( n= 1).

PFOS and PFOA were strongly correlated ( r = .63) PFOS had a lower correlation with PFOSAA ( r = .42) and M570 ( r = .20). Both PFOSAA and M570, adjusted for age, gender, and their interaction, were significant predictors of PFOS in a multivariable model. PFOSAA was the stronger of the 2 independent variables. Age and gender were not significant predictors in models that examined the significant association between PFOS and PFOA.

Study strengths and weaknesses: Blood donors cannot be considered representative of the general population of the US.

Research sponsors: 3M Medical Department, Corporate Occupational Medicine Consistency of results: Mean PFOS levels reported in this study are similar to those reported in other pooled blood samples.

CONCLUSIONS N/ A REFERENCE Olsen, GW, Burris, JM, Lundberg, JK, Hansen, KJ, Mandel, JH, Zobel, LR. Identification of fluorochemicals in human sera. I. American Red Cross adult blood donors. Final report. February 25, 2002. ENV/ JM/ RD( 2002) 17/ FINAL 350 EPIDEMIOLOGIC DATA Title: Identification of Fluorochemicals in Human Sera. II. Elderly Participants of the Adult Changes in Thought Study, Seattle, Washington TEST SUBSTANCE Identity: PFOS and 6 other fluorochemicals Remarks: The results reported are final.

METHOD Study design: Cross sectional.

Manufacturing/ Processing/ Use: N/ A Hypothesis tested: To determine the serum concentrations of selected fluorochemicals in a sample of elderly persons to provide a more specific understanding of the distribution of these compounds in this age group.

Study period: 9/ 29/ 2000 Setting: N/ A Total population: 238 serum samples from elderly adult donors from the Adult Changes in Thought study.

Subject selection criteria: Donors were 65 96 years old. Subjects were identified during an enrollment phase of this community based prospective cohort study of dementia and normal aging conducted collaboratively between the U. of Washington and Group Health Cooperative ( HMO). Eligible individuals were those with no known history of neuropsychiatric disease or dementia.

Total # of subjects in study: 238 Comparison population: N/ A Participation rate: N/ A Subject description: 238 adults 118 males, 120 females. The mean age was 76 years. Female subjects had resided in the Seattle area for 53.3 years, males 50.2 years.

Health effects studied: PFOS serum levels in blood, as well as 6 other fluorochemicals.

Data collection methods: Blood sera samples were collected using high pressure liquid chromatography/ electrospray tandem mass spectrometry ( HPLC/ ESMSMS).

Exposure period: N/ A ENV/ JM/ RD( 2002) 17/ FINAL 351 Description/ delineation of exposure groups/ categories: 65 75 years ( n= 121), 75+ to 85 years ( n = 93), 85+ to 96 years ( n = 24).

Measured or estimated exposure: N/ A Exposure levels: N/ A Statistical methods: Arithmetic means, ranges, geometric means and 95% confidence intervals were calculated. Central tendency and distribution of the data by age, gender, location and their respective interaction terms. A reliability assessment was also done.

Other methodological information: N/ A RESULTS Describe results: The geometric mean of PFOS for all samples was 31.0 ppb ( 95% CI, 28.8 33.4). The range was 3.4   175 ppb. There was no significant ( p < .05) difference in geometric means for males and females. In simple linear regression analyses, age was negatively ( p < .05) associated with PFOS in men but not in women. The mean of the 95% tolerance limit for PFOS was 84.1 ppb with an upper 95% confidence limit of 104.0 ppb.

Study strengths and weaknesses: These data are cross sectional data used to determine PFOS levels in elderly. Very little descriptive information about the subjects is available. The subjects only characterize PFOS levels in the Seattle region. To date, they are the only data available characterizing serum PFOS levels in the elderly.

Research sponsors: 3M Medical Department, Corporate Occupational Medicine Consistency of results: To date, no other data have been collected on PFOS serum levels in elderly.

CONCLUSIONS PFOS levels in these Seattle residents are similar to those found in adults and children in the U. S.

REFERENCE Olsen, GW, Burris, JM, Lundberg, JK, Hansen, KJ, Mandel, JH, Zobel, LR. February 25, 2002. Identification of fluorochemicals in human sera. II. Elderly participants of the Adult Changes in Thought study, Seattle, Washington. Final Report. 3M Company, Medical Department. ENV/ JM/ RD( 2002) 17/ FINAL 352 EPIDEMIOLOGIC DATA Title: Identification of Fluorochemicals in Human Sera. III. Pediatric Participants in a Group A Streptococci Clinical Trial Investigation TEST SUBSTANCE Identity: PFOS and 6 other fluorochemicals Remarks: The results reported are final.

METHOD Study design: Cross sectional.

Manufacturing/ Processing/ Use: N/ A Hypothesis tested: To determine the serum concentrations of selected fluorochemicals in a sample of children to provide a more specific understanding of the distribution of these compounds in children.

Study period: Child sera samples were collected from January 1994 to March 1995. The sera samples were analyzed in Spring 1999.

Setting: N/ A Total population: Not reported Subject selection criteria: The sera samples were provided to 3M by the University of Minnesota Department of Pediatrics. They were obtained from a large clinical trial on Group A streptococcal infections in children. The children were residents of 23 states in the US. These children presented with signs and symptoms of acute onset pharyngitis. All of the children had positive throat cultures at the initial visit.

Total # of subjects in study: n = 599 children, age 2 12 years Comparison population: N/ A Participation rate: N/ A Subject description: 299 male children, 300 female children from 23 states and the District of Columbia.

Health effects studied: PFOS serum levels in blood, as well as 6 other fluorochemicals.

Data collection methods: Blood sera samples were collected using high pressure liquid chromatography/ electrospray tandem mass spectrometry ( HPLC/ ESMSMS). Sera were frozen at   20 degrees C prior to the request for analysis.

Exposure period: N/ A ENV/ JM/ RD( 2002) 17/ FINAL 353 Description/ delineation of exposure groups/ categories: Blood sera samples were collected from children 2   12 years old.

Measured or estimated exposure: N/ A Exposure levels: N/ A Statistical methods: Arithmetic means, ranges, geometric means and 95% confidence intervals were calculated. Central tendency and distribution of the data by age, gender, location and their respective interaction terms. A reliability assessment was also done.

Other methodological information: N/ A RESULTS Describe results: The geometric mean of PFOS for all of the participants was 37.5 ppb ( 95% CI, 33.3 36.5). The range was 6.7 to 515.0 ppb. Male children had significantly ( p<. 01) higher geometric mean PFOS levels than females: 40.1 ppb and 35.2 ppb, respectively. In bootstrap analyses, the mean of the 95% tolerance limit for PFOS was 88.5 ppb with an upper 95% confidence limit of 97.0 ppb. When stratified by age, the geometric mean tended to rise for each age group from age 2 ( 28.6 ppb) through age 9 ( 42.8 ppb) where it was highest, and then started to decrease gradually to 32.8 ppb at 12 years. In simple linear regression analyses, age was not significantly ( p < .05) associated with PFOS. Although the data were not provided, a graphical presentation of log PFOS levels for each state by gender were similar across the states, however, it is difficult to interpret these data given the limited sample size for each gender/ location subgroup.

Study strengths and weaknesses: These data are cross sectional data used to determine PFOS levels in U. S. children. Very little descriptive information about the subjects is available. To date, they are the only data available characterizing serum PFOS levels in children.

Research sponsors: 3M Medical Department, Corporate Occupational Medicine Consistency of results: To date, no other data have been collected on PFOS serum levels in children.

CONCLUSIONS N/ A REFERENCE Olsen, GW, Burris, JM, Lundberg, JK, Hansen, KJ, Mandel, JH, Zobel, LR. Identification of fluorochemicals in sera of children in the United States. Interim Report. June 25, 2001. ENV/ JM/ RD( 2002) 17/ FINAL 354 EPIDEMIOLOGIC DATA Title: A Cross sectional analysis of serum perfluorooctanesulfonate ( PFOS) and Perfluorooctanoate ( PFOA) in relation to clinical chemistry, thyroid hormone, hematology, and urinalysis results from male and female employee participants of the 2000 Antwerp and Decatur fluorochemical medical surveillance program TEST SUBSTANCE Identity: PFOS, PFOA Remarks:

METHOD Study design: cross sectional Manufacturing/ Processing/ Use: Facilities in Decatur, Alabama and Antwerp, Belgium which manufacture perfluorooctanesulfonyl fluoride products. These fluorochemicals can metabolize in the body to PFOS.

Hypothesis tested: To provide an aggregate analysis of the hematology, clinical chemistries, and hormonal parameters of volunteer employees in relation to serum PFOS and PFOA levels as measured in the medical surveillance examinations of Antwerp and Decatur employees in 2000.

Study period: March 1, 2000. End date was not reported.

Setting: Occupational. 3M plants located in Antwerp, Belgium and Decatur, Alabama.

Total population: 340 Antwerp employees and 500 Decatur employees working in the chemical plant area were eligible for inclusion in the surveillance.

Subject selection criteria: Voluntary participation in medical surveillance program in Y2000.

Total # of subjects in study: 255 Antwerp employees ( 206 male and 49 female) and 263 Decatur employees ( 215 male and 48 female).

Comparison population: N/ A Participation rate: 75% of employees at the Antwerp plant and 50% of the employees at the Decatur plant who were eligible participated. 73% of the participating Antwerp male employees and 75% of the Decatur employees were engaged in production activities. Only 12% of the participating Antwerp female employees were engaged in production activities compared to 63% of the Decatur female employees.

Subject description: Male Antwerp employees had lower PFOS and PFOA levels, were significantly younger than Decatur male employees, had lower BMIs, worked fewer years, had higher self reported daily consumption of alcohol, had lower mean alkaline phosphatase, GGT, AST, ALT and triglyceride values and higher total bilirubin and HDL values. Comparable results were observed for Antwerp female employees vs. Decatur females.

Health effects studied: To determine if there were differences in the following parameters based on ENV/ JM/ RD( 2002) 17/ FINAL 355 PFOS/ PFOA levels: hematology ( hematocrit, hemoglobin, RBCs, WBCs, platelet count), clinical chemistries ( alkaline phosphatase, gamma glutamyl transferase, aspartate aminotransferase, alanine aminotransferase, total and direct bilirubin, blood urea nitrogen, creatinine, glucose, cholesterol, low density lipoproteins, high density lipoproteins, and triglycerides), and thyroid hormones ( thyroid stimulating hormone, serum thyroxine, free thyroxine, serum triiodothyronine, thyroid hormone binding ratio, and free thyroxine).

Data collection methods: Medical questionnaire, work history questionnaire, blood sera samples, measurements of height, weight, and blood pressure, urinalysis ( Decatur only), and standard clinical chemistry and hematology tests, thyroid hormone measurement, and pulmonary function tests. Values used for reference ranges were not provided.

Details on data collection: The site specific work history questionnaire was administered to all participants. The data were self reported. Questionnaire content, design, administration, etc. were not provided in this report. Data on blood collection ( amount, etc.) not provided. Urinalysis was only assessed for Decatur employees via standard urine microstick analysis which tested for urine glucose, albumin, and RBCs.

TSH, free T4 and T3 were determined by immunochemiluminometric assay. T4 and THBR were determined by a cloned enzyme donor immunoassay. FTI was calculated by multiplying T4 and THBR.

Sera samples were extracted using an ion pairing extraction procedure. In addition to PFOA and PFOS, the extracts were also analyzed for PFHS, PFOSAA, PFOSA, and M556 ( perfluorooctanesulfonamidoacetate) using high pressure liquid chromatography electrospray tandem mass spectrometry and evaluated versus an extracted curve from a human serum matrix. All serum values for PFOS and PFOA were above the LLOQ.

Exposure period: Unknown. PFOS/ PFOA serum levels indicate exposure.

Description/ delineation of exposure groups/ categories: Workers were stratified by plant location as well as by serum PFOS distribution, production status ( production vs. non production workers), and gender.

Mean serum PFOS levels for all employees participating in this study at Antwerp ( n = 206) and Decatur ( n = 215) were 0.96 and 1.40 ppm, respectively. Levels among production employees were higher. At Antwerp, the mean PFOS level of male production employees was 1.16 ppm and 1.63 ppm at Decatur.

Mean PFOA levels for all employees were 1.03 and 1.90 ppm at Antwerp and Decatur, respectively. Levels among production employees were higher. At Antwerp, the mean PFOA level of male production employees was 1.28 ppm and 2.34 ppm at Decatur.

Measured or estimated exposure: Serum PFOS and PFOA levels were used to estimate exposure.

Statistical methods: Descriptive simple and stratified analyses, Pearson correlation coefficients, analysis of variance, and multivariable regression were used to evaluate associations between PFOS and PFOA and each hematological and clinical chemistry test and thyroid hormone assay. For stratified analyses, employees were divided into quartiles of their serum PFOS distribution. Potential confounding factors considered in the analyses included: age, BMI, alcohol consumption, cigarette use, years worked at either plant, and type of job.

Multivariable regression models were fitted with PFOS/ PFOA analyzed as continuous variables. Natural ENV/ JM/ RD( 2002) 17/ FINAL 356 log transformations of the dependent variables were performed, when necessary, to normalize variables and to enhance model fit. SAS was used to analyze the data.

Other methodological information:

RESULTS Describe results: Antwerp and Decatur employees were different in several ways ( see " Subject description" above). Therefore, univariate analyses were initially stratified by location and then those analyses were stratified by gender and production status. They were placed into quartiles depending on production status. Therefore, the PFOS values in the quartiles are different for male production, non production, and female employees.

Antwerp The mean PFOS level for all employees at this plant was 0.96 ppm ( range 0.04  6.24 ppm). When stratified by production status, the mean was 1.16 ppm for production employees and 0.42 ppm for nonproduction employees. The mean for female employees was 0.13 ppm.

Male production employees were placed into the following quartiles based on PFOS levels: Q1 ( mean, 0.29 ppm; range, 0.04   0.41 ppm), Q2 ( mean, 0.58 ppm; range 0.41   0.78 ppm), Q3 ( mean 1.18 ppm; range 0.79   1.66 ppm), Q4 ( mean, 2.61 ppm; range, 1.67   6.24 ppm).

In male production employees ( n = 150), the highest quartile mean serum PFOS level was 2.61 ppm ( range 1.76   6.24 ppm) and the lowest was 0.29 ppm ( range 0.04   0.41 ppm). Production employees in the highest quartile were significantly ( p < .05) older and worked more years at Antwerp than employees in the lowest quartile. The only difference in clinical chemistries for production workers was in BUN. When compared by quartile of serum PFOS distribution, no significant ( p <. 05) differences among male production employees were observed for thyroid ( TSH, T4, free T4, T3, THBR, FTI) or for hematology ( HCT, HGB, RBC, WBC, platelets). The same held true for non production employees ( n = 56).

For all female employees, BUN was significantly different ( higher) between 1st quartile and 3rd and 4th quartile. Thyroid and hematology results were not significantly different between any of the quartiles for females.

Decatur The mean PFOS level for all employees at this plant was 1.40 ppm ( range 0.11   10.06 ppm). When stratified by production status, the mean was 1.63 ppm for production employees and 0.73 ppm for nonproduction employees. The mean for female employees was 0.93 ppm. 75% of male employees worked in production jobs ( n = 161) and 63% of female employees worked in production jobs.

Male production employees were placed into the following quartiles based on PFOS levels: Q1 ( mean, 0.55 ppm; range, 0.11   0.75 ppm), Q2 ( mean, 1.01 ppm; range 0.76   1.30 ppm), Q3 ( mean 1.74 ppm; range 1.32   2.29 ppm), Q4 ( mean, 3.22 ppm; range, 2.31   10.06 ppm).

When male production workers were placed into quartiles, the only significant ( p < .05) difference between the quartiles was in ALT ( highest quartile different from all 3 others). No significant differences between quartiles were observed for thyroid ( TSH, T4, free T4, T3, THBR, FTI), hematology ( HCT, HGB, RBC, WBC, platelets), or urinalysis ( albumin, blood, sugar). ENV/ JM/ RD( 2002) 17/ FINAL 357 For female employees ( both production and non production employees), there were no significant differences among quartiles for demographics, thyroid, hematology, or urinalysis except for mean platelet count where the third quartile was significantly lower than the 1st quartile, but the 4th was not.

When results were analyzed by number of employees who had values above the reference range for hepatic clinical chemistry tests and liver enzyme and bilirubin tests, there was a higher percentage of male Decatur production workers in the highest PFOS quartile for ALT, GGT, and total liver panel than the other quartiles. Most notable were the results for ALT where 8% of employees in the lowest exposure group ( Q1) and 28% in the highest exposure group ( Q4) had values above the reference range, while the percentages for total liver panel ( which includes alkaline phosphatase, AST, ALT, GGT, and total and direct bilirubin) were 18% and 35%, respectively. This trend was not evident in Decatur non production employees ( although the n was only 54), in Decatur females, or in any of the Antwerp employees. However, each sub population had a different serum PFOS quartile distribution. Therefore, they cannot be directly compared.

Analyses combining employees from both plants When clinical chemistry results of all male employees from both plants were combined ( both production and non production) ( n = 421) and placed into quartiles ( n = 105 per quartile), mean values for triglycerides, alkaline phosphatase, total bilirubin, and ALT were significantly ( p < .05) higher in the 4th quartile ( mean PFOS level 2.69, range 1.69   10.06 ppm) than in the first ( mean PFOS level 0.27 ppm, range 0.04   0.42 ppm). It should be noted that the number of Antwerp production employees were evenly distributed among the quartiles while this was not the case for Decatur employees. The highest number of Decatur employees was in the 4th quartile. In addition, overall the employees in the 1st quartile were slightly younger, had a lower BMI, and worked fewer years than employees in the other quartiles.

Thyroid results for this same group indicated that T3 was significantly higher ( p < .05) and THBR was significantly lower ( p < .05) in Q4 than Q1. In female employees combined for both plants ( n = 97), alkaline phosphatase and GGT were significantly higher ( p < .05) and total bilirubin significantly lower in Q4 than in Q1. Most of the Decatur female employees worked in production jobs while most of the Antwerp females worked in non production jobs. Therefore, Q4 was 92% female production workers and all of them worked at the Decatur plant.

The combined plant data were analyzed for employees who had values above the reference range for alkaline phosphatase, AST, ALT, GGT, and total liver panel. For male employees for all of these measures, the levels increased from Q1 to Q4. In Q1, 4% of the employees had values above the reference range for ALT and 6% for GGT, while 12% was reported for Q4 for both of these tests. For total liver panel, 14% of the employees had values above the reference range in Q1 as compared to 23% in Q4. The numbers of female employees with values above the reference range was very small ( n = 8).

The above data were not adjusted for potential confounders; therefore, multivariable regression analyses were conducted. There was a positive significant ( p = .04) association between PFOS and cholesterol and also a positive significant ( p = .05) association between PFOA and cholesterol. When both PFOS and PFOA were included in the model, neither were statistically significant at p=. 05. PFOS was not significant with HDL although PFOA was negatively associated with HDL ( p = .04). Triglycerides were positively associated with PFOS ( p = .01) and PFOA ( p = .002). When both were left in the model, PFOA remained significant ( p = .02). Total organic fluorine ( TOF) was highly significant for triglycerides ( p = .0009). No significant associations were observed with PFOS, PFOA, or TOF in relation to alkaline phosphatase, GGT, AST or total bilirubin. A significant ( p = .02) positive association was observed for TOF and ALT. A positive significant ( p = .04) association between T3 and PFOS was observed. Plant location was highly significant ( p < .0001) in the model. BMI, cigarettes/ day, alcohol/ day were also significant. [ In the ENV/ JM/ RD( 2002) 17/ FINAL 358 univariate analyses, Antwerp employees had higher mean T3 levels than Decatur employees overall. However, for each plant ( individually) T3 values increased by quartile as PFOS serum levels increased, although the differences were not statistically significant.] THBR, as well as the other thyroid hormones, were not significant in the regression analyses. Most of the thyroid hormones, including TSH, T4, THBR, and FTI, were not significantly associated with PFOS, PFOA, or TOF. However, PFOS, PFOA and TOF were positively associated ( p = .04, .01, and .004, respectively) with T3.

Study strengths and weaknesses: Cross sectional design, voluntary participation, the Decatur and Antwerp populations were significantly different in certain demographic and clinical chemistry results as well as in PFOS serum levels, PFOS serum levels are declining thereby making it harder to detect an effect if one is present, plant populations cannot be compared because quartiles are different for each subgroup, only one measurement at a certain point in time was collected for each test, other perfluorinated chemicals, such as PFOA, are present in the plants.

Research sponsors: 3M Consistency of results: These results are somewhat consistent with those of the 1995 and 1997 crosssectional medical surveillance data, in that all of them conclude that there were no significant abnormalities in hematological and clinical chemistry parameters of the Antwerp or Decatur workers. No decline in cholesterol levels was observed as PFOS serum levels increased. The hormone data collected in 1995 was different from that collected in 2000 and therefore cannot be compared. A longitudinal analysis of these data did not reveal any significant changes in hepatic or lipid clinical chemistry values; however, there were many limitations to the study.

CONCLUSIONS The authors concluded that these data continue to suggest that Antwerp and Decatur fluorochemical production and non production employees do not have significant changes in serum cholesterol, lipoproteins, or hepatic enzymes that are consistent with toxicological findings in laboratory animals.

REFERENCE Olsen GW, Burlew MM, Burris JM, Mandel JH. October 11, 2001. A cross sectional analysis of serum perfluorooctanesulfonate ( PFOS) and perfluorooctanoate ( PFOA) in relation to clinical chemistry, thyroid hormone, hematology and urinalysis results from male and female employee participants of the 2000 Antwerp and Decatur fluorochemical medical surveillance program. Final report. 3M Medical Department. ENV/ JM/ RD( 2002) 17/ FINAL 359 EPIDEMIOLOGIC DATA Title: A Longitudinal Analysis of Serum Perfluorooctanesulfonate ( PFOS) and Perfluorooctanoate ( PFOA) Levels in Relation to Lipid and Hepatic Clinical Chemistry Test Results from Male Employee Participants of the 1994/ 95, 1997, and 2000 Fluorochemical Medical Surveillance Program TEST SUBSTANCE Identity: PFOS, PFOA Remarks:

METHOD Study design: longitudinal Manufacturing/ Processing/ Use: 3M Decatur, Alabama plant and Antwerp, Belgium plant.

Hypothesis tested: To determine whether occupational exposure to fluorochemicals over time is related to changes in clinical chemistry and lipid results in employees of 2 3M facilities.

Study period: There were 3 time periods during which medical surveillance took place at the plants   1994/ 95, 1997, and 2000.

Setting: 3M plants in Decatur, Alabama and Antwerp, Belgium.

Total population: 175 male employees participated in 2000 and at least one of the other sampling periods.

Subject selection criteria: Employees participated voluntarily.

Comparison population: n/ a Participation rate: 106/ 175 ( 61%) participated in 1994/ 95, 110/ 175 ( 63%) participated in 1997, and 175 participated in 2000. 24% participated in all 3 sampling periods ( n = 41, Antwerp 20, Decatur 20), 37% in 1994/ 95 and 2000 ( n = 65, Antwerp 45, Decatur 20), and 39% ( n = 69, Antwerp 34, Decatur 35) in 1997 and 2000.

Subject description: Male employees volunteered to participate in biomonitoring offered at the plants. In general, Antwerp male employees were significantly younger, had lower BMIs and a higher daily consumption of alcohol reported than Decatur male employees. Antwerp male employees also had lower mean alkaline phosphatase and triglyceride values and higher total bilirubin and HDL values than the Decatur male employees.

Health effects studied: To determine whether workers' lipid and hepatic clinical chemistry results are affected by PFOS and PFOA levels.

Data collection methods: Clinical chemistries and hematology collected   cholesterol ( mg/ dl), high density lipoproteins ( HDL, mg/ dl), triglycerides ( mg/ dl), alkaline phosphatase ( IU/ L), gamma glutamyl transferase ( GGT, IU/ L), aspartate aminotransferase ( AST, IU/ L), alanine aminotransferase ( ALT, IU/ L), total and direct bilirubin ( mg/ dl). Demographic data collected via questionnaire. ENV/ JM/ RD( 2002) 17/ FINAL 360 Details on data collection: Details on data collection methods including questionnaire content, design, administration, etc. and blood collection methods were not provided.

PFOS and PFOA methods of analysis differed slightly each year. In 1994/ 95, the method used tetrabutylammonium to ion pair with PFOS and PFOA in the serum. The ion pairs were then extracted with ethyl acetate and the abstraction product was then analyzed using high performance liquid chromatograph thermospray mass spectrometry. In 1997, the serum samples were analyzed by liquid chromatorgraphy/ mass spectrometry, using selected ion monitoring in the negative ion mode. In 2000, sera samples were extracted using an ion pairing extraction procedure. High performance liquid chromatography/ electrospray tandem mass spectrometry was used. The samples were evaluated versus an extracted curve from a human serum matrix.

Exposure period: Unknown. PFOS, PFOA levels measured in blood serum.

Description/ delineation of exposure groups/ categories: The groups of employees were broken into subpopulations A, B, and C. A was comprised of the employees who participated in all 3 years of surveillance, B contained those employees who participated in 1994/ 95 and 2000, and C contained those who participated in 1997 and 2000.

Measured or estimated exposure: PFOS and PFOA levels were measured in workers' blood serum. No ambient exposure data are available.

Exposure levels: Mean PFOS levels Antwerp Decatur 1994/ 95 1.87 ppm 2.62 ppm 1997 1.42 ppm 1.85 ppm 2000 1.16 ppm 1.67 ppm Mean PFOA levels Antwerp Decatur 1994/ 95 1.08 ppm 1.90 ppm 1997 1.54 ppm 1.41 ppm 2000 1.43 ppm 1.83 ppm Statistical methods: repeated measures incorporating the random subject effect fitted to a mixed model using SAS. Restricted maximum likelihood estimates of variance parameters were computed. Adjusted regression models were built by introducing all covariates and testing the covariance structure. Covariates included in the model were age, BMI, number of alcoholic drinks per day, and cigarettes smoked per day.

Other methodological information: A total of 175 male employees ( 100 Antwerp and 75 Decatur) who participated in the 2000 surveillance year also participated in at least one previous fluorochemical medical surveillance exam since 1994/ 95. Therefore, this provided an opportunity to undertake a longitudinal assessment. ENV/ JM/ RD( 2002) 17/ FINAL 361 RESULTS PFOS results When mean serum PFOS levels were compared by surveillance year, PFOS levels have been decreasing in the participants in medical surveillance in both plants. When the data were analyzed by the 3 subcohorts ( those who participated in 2 or more medical exams between 1995 and 2000), Antwerp and Decatur employees in each of the 3 subcohorts had lower mean serum PFOS levels in 2000 than at their year of entry.

When analyzed using mixed model multivariable regression and combining Antwerp and Decatur employees, there was no association between PFOS and serum cholesterol or triglycerides in male participants over time. There were also no significant associations between PFOS and changes over time in HDL, alkaline phosphatase, GGT, AST, ALT, total bilirubin, and direct bilirubin.

PFOA results When mean serum PFOA levels were compared by surveillance year, PFOA levels in the employees participating in medical surveillance at the Antwerp plant increased between 1994/ 95 and 1997 and then decreased slightly between 1997 and 2000. At the Decatur plant, PFOA serum levels decreased between 1994/ 95 and 1997 and then increased between 1997 and 2000. When the data were analyzed by plant and the 3 subcohorts ( those who participated in 2 or more medical exams between 1995 and 2000), there were no consistent changes across subcohorts at the Antwerp plant. However, among the 3 Decatur subcohorts, mean PFOA levels tended to increase.

When analyzed using mixed model multivariable regression and combining Antwerp and Decatur employees, there was a statistically significant positive association between PFOA and serum cholesterol ( p = .0008) and triglycerides ( p = .0002) over time. When analyzed by plant and also by subcohort, these associations were limited to the Antwerp employees ( p = .005) and, in particular, the 21 Antwerp employees who participated in all 3 surveillance years ( p = .001). However, the association between PFOA and triglycerides was also statistically significant ( p = .02) for subgroup B ( employees who participated in biomonitoring in 1994/ 95 and 2000). There was not a significant association between PFOA and triglycerides among Decatur workers.

There were no significant associations between PFOA and changes over time in HDL, alkaline phosphatase, GGT, AST, ALT, total bilirubin, and direct bilirubin.

Total Organic Fluorine ( TOF) results When analyzed using mixed model multivariable regression and combining Antwerp and Decatur employees, there was a statistically significant positive association between TOF and serum cholesterol ( p = .007) and triglycerides ( p = .008) over time. However, the interaction term with time ( years) was not significant. This association was more consistent for Antwerp employees than Decatur employees.

Study strengths and weaknesses: Study limitations include the following: 1. A very small number of employees participated in all 3 study periods ( only 24%, n = 41) 2. different labs were used each year for analysis and different analytical techniques for PFOS 3. could not analyze female employees due to small numbers 4. PFOS levels in employees are decreasing over time and are below those levels causing effects in laboratory animals 5. serum PFOS levels were approximately 0.5 ppm lower in Antwerp employees than Decatur 6. more Antwerp employees than Decatur participating in this study ( 57% vs. 43%) 7. PFOA levels fluctuating ( direction depending on the plant) 8. there are several consistent differences between the Antwerp and Decatur male populations ( eg., ENV/ JM/ RD( 2002) 17/ FINAL 362 statistically significant differences in BMI, age, consumption of alcohol, and differences in chemistry profiles) 9. low levels of PFOS and PFOA measured in each program year among these employees as compared with those that cause effects in laboratory animals 10. blood sampling was conducted only once per sampling period at a certain point in time.

Research sponsors: 3M Consistency of results: This is the first longitudinal analysis of the surveillance data and will probably be the last since PFOS is being phased out.

The positive association between PFOA and serum cholesterol and triglycerides is not consistent with the hypolipidemia effect observed in rodents ( and not observed in primates). In addition, this effect has not been observed at 3M's Cottage Grove facility where PFOA serum levels in workers are much higher than at the Decatur or Antwerp plant.

CONCLUSIONS A longitudinal analysis over a six year period of 175 Antwerp and Decatur male employees did not show significant changes, consistent with toxicological data, of lipid or hepatic clinical chemistry values associated with PFOS. A positive statistically significant association was observed between PFOA and cholesterol and triglycerides. When analyzed by plant and also by subcohort, these associations were limited to the Antwerp employees and, in particular, the 21 Antwerp employees who participated in all 3 surveillance years.

REFERENCE Olsen, G. W., Burlew, M. M, Burris, J. M., Mandel, J. H. A Longitudinal Analysis of Serum Perfluorooctanesulfonate ( PFOS) and Perfluorooctanoate ( PFOA) Levels in Relation to Lipid and Hepatic Clinical Chemistry Test Results from Male Employee Participants of the 1994/ 95, 1997, and 2000 Fluorochemical Medical Surveillance Program. 3M Final Report. October 11, 2001.


[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Notices]
[Page 57377]
[FR Doc No: 2013-22697]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14553-000]

Mid-Atlantic Hydro, LLC; Notice of Competing Preliminary Permit
Application Accepted for Filing and Soliciting Comments and Motions To
Intervene

    On August 30, 2013, Mid-Atlantic Hydro, LLC (MAH) filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the feasibility of the
Dashields Lock and Dam Hydroelectric Project (Dashields Project or
project) to be located at the U.S. Army Corps of Engineers' Dashields
Lock and Dam on the Ohio River in Allegheny County, Pennsylvania. The
sole purpose of a preliminary permit, if issued, is to grant the permit
holder priority to file a license application during the permit term. A
preliminary permit does not authorize the permit holder to perform any
land-disturbing activities or otherwise enter upon lands or waters
owned by others without the owners' express permission.
    MAH's permit application is filed in competition with FFP Project
133, LLC's proposed Dashields Lock and Dam Hydroelectric Project No.
14524-000, which was publicly noticed July 3, 2013. The deadline for
filing competing applications was September 1, 2013. MAH's competing
permit application is timely filed.
    The proposed project would consist of the following: (1) A new
powerhouse located adjacent to the right descending bank immediately
downstream of a 350-linear-foot section of the existing dam; (2)
fourteen Very Low Head (VLH) 4000 turbine units with a total capacity
of 7 megawatts; (3) a permanent submersible magnet generator housed in
each turbine hub; and (4) a new 69-kilovolt transmission line
approximately 2.1 miles long. The estimated annual generation of the
Dashields Project would be 41.4 gigawatt-hours.
    Applicant Contact: Kristina Johnson, Mid-Atlantic Hydro, LLC, 5425
Wisconsin Avenue, Suite 600, Chevy Chase, MD 20815; phone: (301) 718-
4432.
    FERC Contact: Woohee Choi; phone:<PHONE_NUMBER>.
    Deadline for filing comments and motions to intervene: 60 days from
the issuance of this notice.
    The Commission strongly encourages electronic filing. Please file
comments and motions to intervene using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. The first page of any filing should
include docket number P-14553-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14553) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: September 12, 2013.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2013-22697 Filed 9-17-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 17, 2006 (Volume 71, Number 33)]
[Notices]
[Page 8573-8574]
[DOCID:fr17fe06-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

February 10, 2006.
    Take notice that the Commission received the following electric
rate filings
    Docket Numbers: ER01-1147-002.
    Applicants: PECO Energy Company.
    Description: PECO Energy Co submits filing in compliance with
FERC's 12/29/05 letter order.
    Filed Date: 02/02/2006.
    Accession Number: 20060209-0195
    Comment Date: 5 p.m. Eastern Time on Thursday, February 23, 2006.

    Docket Numbers: ER01-1807-020; ER01-2020-017.
    Applicants: Carolina Power & Light Company; Florida Power
Corporation.
    Description: Carolina Power & Light Co dba Progress Energy
Carolinas Inc submits a corrected refund report for that sub-docket
which shows the correct quarterly percentages & revised interest
amounts.
    Filed Date: 02/01/2006.
    Accession Number: 20060209-0196.
    Comment Date: 5 p.m. Eastern Time on Wednesday, February 22, 2006.

    Docket Numbers: ER06-162-001.
    Applicants: Entergy Service, Inc.
    Description: Entergy Services, Inc submits its compliance filing,
pursuant to FERC's 6/3/06 Order.
    Filed Date: 02/02/2006.
    Accession Number: 20060209-0194.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 23, 2006.
    Docket Numbers: ER06-354-002; EL06-44-002.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corp submits
its filing in compliance with FERC's 1/13/06 Order.
    Filed Date: 02/02/2006.
    Accession Number: 20060209-0199.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 23, 2006.

    Docket Numbers: ER06-600-000.
    Applicants: Louisville Gas and Electric Company and Kentucky
Utilities Company.
    Description: Louisville Gas & Electric Co & Kentucky Utilities Co
submit an agreement with the Indiana Municipal Power Agency.
    Filed Date: 02/02/2006.
    Accession Number: 20060206-0180.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 23, 2006.

    Docket Numbers: ER06-601-000.
    Applicants: Louisville Gas and Electric Company and Kentucky
Utilities Company.
    Description: LG&E Energy, LLC & Kentucky Utilities Co submit an
agreement with Illinois Municipal Electric Agency.
    Filed Date: 02/02/2006.
    Accession Number: 20060206-0179.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 23, 2006.

    Docket Numbers: ER06-604-000.
    Applicants: American Electric Power Corporation.
    Description: American Electric Power Corp, as designated agent for
AEP Operating Companies submits an

interconnection & local delivery service agreement with Village of
Republic, OH.
    Filed Date: 02/02/2006.
    Accession Number: 20060206-0176.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 23, 2006.

    Docket Numbers: ER06-606-000.
    Applicants: BlueRock Energy, Inc.
    Description: BlueRock Energy, Inc's petition for acceptance of
initial rate schedule, waivers and blanket authority.
    Filed Date: 02/02/2006.
    Accession Number: 20060206-0175.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 23, 2006.

    Docket Numbers: ER06-607-000.
    Applicants: American Electric Power Service Company.
    Description: American Electric Power Service Corp as designated
agent for AEP Operating Companies submits an Interconnection and Local
Delivery Service Agreement with the City of Wapakoneta, OH.
    Filed Date: 02/02/2006.
    Accession Number: 20060206-0174.
    Comment Date: 5 p.m. Eastern Time on Thursday, February 23, 2006.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-2260 Filed 2-16-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 5 (Monday, January 9, 2012)]
[Notices]
[Pages 1114-1116]
[FR Doc No: 2012-98]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66083; File No. SR-CME-2011-19]

Self-Regulatory Organizations; Chicago Mercantile Exchange, Inc.;
Notice of Filing and Order Granting Accelerated Approval of Proposed
Rule Change To Comply With New CFTC DCO Regulations

January 3, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 20, 2011, the Chicago Mercantile Exchange Inc. (``CME'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change described in Items I and II below, which items
have been prepared primarily by CME. The Commission is publishing this
Notice and Order to solicit comments on the proposed rule change from
interested persons and to approve the proposed rule change on an
accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of Terms of Substance of
the Proposed Rule Change

    CME proposes to amend certain of its rules to comply with new CFTC
Regulations 39.16(d) (Insolvency of a clearing member) and 39.15(d)
(Transfer of customer positions), respectively. The text of the
proposed rule change is below. The italicized text indicates additions.
Bracketed text indicates deletions.

CME Rulebook

Rule 100--Rule 441--No Change.

Chapter 4. Enforcement of Rules

Rule 442. NOTIFICATION OF SIGNIFICANT EVENTS

    Each Member shall provide immediate[ly] notice to [fy] the Market
Regulation Department (and each Member that is a Member Firm or a
Clearing member shall also provide immediate notice to the Clearing
House), in writing upon becoming aware of any of the following events
relating to such Member:
    1. any suspension, expulsion, revocation or restriction of such
Member's trading privileges or any fine in excess of $25,000, through
an adverse determination, voluntary settlement or otherwise, by any
court, commodity or securities exchange or related clearing
organization, the Securities and Exchange Commission, the Commodity
Futures Trading Commission or the securities commission or equivalent
authority of any state, territory, the District of Columbia or foreign
country, the National Futures Association, the Financial Industry
Regulatory Authority, Inc. or any self-regulatory or regulatory
organization;
    2. any indictment of the Member or any of its officers for, any
conviction of the Member or any of its officers of, or any confession
of guilt or plea of guilty or nolo contendere by the Member or any of
its officers to 1) any felony or 2) any misdemeanor involving, arising
from, or related to the purchase or sale of any commodity, security,
futures contract, option or other financial instrument or involving or
arising from fraud or moral turpitude; and/or
    3. any filing of a [involuntary] bankruptcy petition or insolvency,
receivership or equivalent proceeding of which the member is a subject.
[that has been filed against such Member, or i] In the case of a
voluntary bankruptcy, insolvency, receivership or equivalent
proceeding, the Member also shall notify the Market Regulation
Department, and the Clearing House in the case of a Member that is a
Member Firm or Clearing Member) when such Member [has filed or has]
forms[ed] a definite intention to file such proceeding [for
bankruptcy].
    Nothing in this Rule shall limit or negate any other reporting
obligations that any member may have to the Exchange or any other
regulator or person.
* * * * *

Rule 443-Rule 852--No Change.

Chapter 8. Clearing House and Performance Bonds

Rule 853. TRANSFERS OF TRADES AND CUSTOMER ACCOUNTS

853.A. Transfers of Trades

    1. Subject to the limitations of Rule 854, existing trades may be
transferred either on the books of a clearing member or from one
clearing member to another clearing member provided:
    i[1]. The transfer merely constitutes a change from one account to
another account provided the underlying beneficial ownership in said
accounts remains the same; or
    ii[2]. An error has been made in the clearing of a trade and the
error is discovered and the transfer is completed within two business
days after the trade date.
    [B]2. Subject to the limitations of Rule 854, Exchange staff may,
upon request by the clearing member(s), approve a

transfer of existing trades either on the books of the same clearing
member, or from the books of one clearing member to the books of
another clearing member if the transfer is in connection with, or as a
result of, a merger, asset purchase, consolidation or similar non-
recurring transaction between two or more entities where one or more
entities become the successor in interest to one or more other
entities.
    3[C]. Exchange staff may, with the consent of the clearing
member(s) involved, permit the transfer of existing trades if, in
staff's opinion, the situation so requires and such transfer is in the
best interests of the Exchange.
    4[D]. Provided that the transfer is permitted pursuant to Sections
1[A]., 2[B]. or 3[C]. above, transactions in all physically delivered
futures contracts except for FX futures contracts must be recorded and
carried on the books of the receiving firm at the original trade dates;
all other transactions may be recorded and carried at either the
original trade date or the transfer date. Futures transactions may be
transferred using either the original trade price or the most recent
settlement price; options transactions may be transferred using either
the original trade price or a trade price of zero.
    [E]5. All transfers shall be reported to the Clearing House in a
form acceptable to the Exchange for the type of transactions involved.
The proper indicator must be included in the transfer such that the
transactions, including the transaction(s) to reverse an error, clear
as transfers. The clearing members involved shall maintain a full and
complete record of all transactions together with all pertinent
memoranda.

853.B. Transfers of Customer Accounts

    1. Subject to the limitations of Rule 853.A, after receipt of a
signed instruction from a Clearing Member (the ``Carrying Clearing
Member'') to transfer all or a portion of a customer account to another
Clearing Member (the ``Receiving Clearing Member''), and provided that
such instruction contains the customer's name and account number (and,
if the transfer is not of the entire account, a description of which
portion is to be transferred), and provided that the Receiving Clearing
Member agrees to accept the account, the Exchange shall promptly
transfer the account (or the relevant portion thereof), without
requiring any close-out or rebooking of positions in connection with
the transfer, provided that:
    i. The transferred positions will satisfy Exchange performance bond
requirements at the Receiving Clearing Member; and
    ii. Any remaining positions in the customer account at the Carrying
Clearing Member will satisfy Exchange performance bond requirements.
* * * * *

Rule 854-End--No Change.

II. Self-Regulatory Organization's Statement of Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, CME included statements
concerning the purpose and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item III below. CME has prepared summaries, set forth in sections A, B,
and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of Purpose of, and
Statutory Basis for, the Proposed Rule Change

    CME proposes to amend certain of its rules to comply with new CFTC
Regulations 39.16(d) (Insolvency of a clearing member) and 39.15(d)
(Transfer of customer positions). The new CFTC regulations were part of
a comprehensive set of principle-based regulations adopted by the CFTC
that establish certain standards of compliance for derivatives clearing
organizations (``DCOs'') like CME.
    New CFTC Regulation 39.16(d), which becomes effective on January 9,
2011, requires each DCO to have a rule that requires clearing members
to provide prompt notice to the DCO if the clearing member becomes the
subject of a bankruptcy petition, receivership proceeding, or the
equivalent. New CFTC Regulation 39.15(d), also effective on January 9,
2012, requires each DCO to have rules providing that the DCO will
promptly transfer all or a portion of a customer's account from one
clearing member to another, provided that the conditions in the
Regulation are satisfied. In order to comply with these CFTC
requirements, CME proposes to amend current CME Rules 442 and Rule 853
as set forth above. CME will consider whether any future changes would
be necessary to the language of CME Rule 853 to the extent CME begins
clearing securities products. The proposed effective date for these
revisions is January 4, 2012.
    CME also made a filing, CME Submission 11-491, with its primary
regulator, the Commodity Futures Trading Commission, with respect to
the proposed rule changes.
    CME believes the proposed changes are consistent with the
requirements of the Exchange Act. CME, a DCO, is required to implement
the proposed changes to comply with recent changes to CFTC regulations.
CME notes that the policies of the Commodity Exchange Act (``CEA'')
with respect to clearing are comparable to a number of the policies
underlying the Exchange Act, such as promoting market transparency for
derivatives markets, promoting the prompt and accurate clearance of
transactions and protecting investors and the public interest.

B. Self-Regulatory Organization's Statement on Burden on Competition

    CME does not believe that the proposed rule change will have any
impact, or impose any burden, on competition.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    CME has not solicited, and does not intend to solicit, comments
regarding this proposed rule change. CME has not received any
unsolicited written comments from interested parties.

III. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:
     Electronic comments may be submitted by using the
Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml), or send an email to<EMAIL_ADDRESS>Please include
File No. SR-CME-2011-19 on the subject line.
     Paper comments should be sent in triplicate to Elizabeth
M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street,
NE., Washington, DC, 20549-1090.
    All submissions should refer to File Number SR-CME-2011-19. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than

those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of CME. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-CME-2011-19 and should be
submitted on or before January 30, 2012.

IV. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Change

    In its filing, CME requested that the Commission approve this
request on an accelerated basis for good cause shown. CME cites the
reason for granting this request on an accelerated basis as CME's
operations as a DCO, subject to regulation by the CFTC under the CEA.
These rule changes are being made according to regulations promulgated
by the CFTC, which were previously subject to notice and comment. Not
approving this request on an accelerated basis will have a significant
impact on CME's operations as a DCO.
    Section 19(b) of the Act \3\ directs the Commission to approve a
proposed rule change of a self-regulatory organization if it finds that
such proposed rule change is consistent with the requirements of the
Act and the rules and regulations thereunder applicable to such
organization. The Commission finds that the proposed rule changes are
consistent with the requirements of the Act, in particular the
requirements of Section 17A of the Act,\4\ and the rules and
regulations thereunder applicable to CME. Specifically, the Commission
finds that the proposed rule change is consistent with Section
17A(b)(3)(F) of the Act which requires, among other things, that the
rules of a clearing agency be designed to assure the safeguarding of
securities and funds which are in the custody and control of the
clearing agency because it should allow CME to enhance its risk
management efforts, both in motoring the financial status of clearing
members and porting customer accounts among clearing members.\5\
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    \3\ 15 U.S.C. 78s(b).
    \4\ 15 U.S.C. 78q-1. In approving this proposed rule change, the
Commission has considered the proposed rule's impact on efficiency,
competition, and capital formation. 15 U.S.C. 78c(f).
    \5\ 15 U.S.C. 78q-1(b)(3)(F).
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    The Commission finds good cause, pursuant to Section 19(b)(2) of
the Act,\6\ for approving the proposed rule change prior to the 30th
day after the date of publication of notice in the Federal Register
because the proposed rule change institutes the regulations of another
regulatory agency, and those regulations were subject to notice and
comment.
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    \6\ 15 U.S.C. 78s(b)(2).
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V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change (SR-CME-2011-19) is approved on an
accelerated basis.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-98 Filed 1-6-12; 8:45 am]
BILLING CODE 8011-01-P