HEALTH CONSULTATION

Blood Lead Results for 2002 Calendar Year

HERCULANEUM LEAD SMELTER SITE

HERCULANEUM, JEFFERSON COUNTY, MISSOURI

STATEMENT OF ISSUES AND BACKGROUND

Statement of Issues

In March 2003, the Missouri Department of Health and Senior Services
(DHSS), in cooperation with the Agency for Toxic Substances and Disease
Registry (ATSDR), presented to the Herculaneum Community Advisory Group
preliminary results of all known blood lead data collected in 2002 from
Herculaneum, Missouri residents. This   HYPERLINK
"http://www.atsdr.cdc.gov/glossary.html" \l "Health Consultation"
health consultation  will further evaluate that data and compare it to
the 2001 blood lead data. Additionally, this health consultation will
evaluate the blood lead data collected for children under 72 months of
age who were serially tested in both years 2001 and 2002. Conclusions
and recommendations in this document were made on the basis of data
available as of March 14, 2003.

Background

The Herculaneum lead smelter is an active facility that has been in
operation in the community since 1892. The Doe Run Company currently
owns and operates the smelter. The facility is located at 881 Main
Street in Herculaneum, Missouri, approximately 25 miles south of St.
Louis, Missouri, on the Mississippi River. It abuts residential
neighborhoods on the north, west, and south, with the Mississippi River
on the east. A lead ore concentrate, consisting of approximately 80%
lead sulfide, is processed at the smelter. The ore is transported by
truck from eight lead mines operated by the company near Viburnum,
Missouri, approximately 75 miles south-southwest of Herculaneum. The
52-acre Herculaneum facility consists of a smelter plant, a 24-acre
waste slag storage pile, and an onsite sulfuric acid plant [1].

The city of Herculaneum has an estimated   HYPERLINK
"http://www.atsdr.cdc.gov/glossary.html" \l "Population"  population  of
2,805 people, according to the 2000 US Census. Several homes are within
200 feet of the smelter plant, and currently at least three homes are
within 200 feet of the slag pile, of which one is being occupied.
HYPERLINK "http://www.atsdr.cdc.gov/HAC/PHA/herculaneum3/lss_p1.html" \l
"F1#F1"  Figures 1  and   HYPERLINK
"http://www.atsdr.cdc.gov/HAC/PHA/herculaneum3/lss_p1.html" \l "F2#F2"
2  display the location of the smelter in relationship to the community
[2]. Three schools are in the city: a high school, a middle school, and
a junior high school. The elementary school is in nearby Pevely. No
licensed day-care facilities are in the city of Herculaneum.

Environmental sampling has indicated that there is lead contamination
throughout the community. For example, lead has been found in yard soils
at   HYPERLINK "http://www.atsdr.cdc.gov/glossary.html" \l
"Concentration"  concentrations  up to 33,100 parts per million (ppm)
[3]; in air ranging from non-detectable (ND) to 85 micrograms per cubic
meter (µg/m3) [4]; and in dust on streets up to 300,000 ppm [5].
Although multiple sources of lead could be contributing to the overall
contamination (e.g., lead-based paint), an   HYPERLINK
"http://www.atsdr.cdc.gov/glossary.html" \l "Exposure Investigation"
Exposure Investigation (EI)  conducted by ATSDR in 2001 indicated that
lead in paint and water at the two homes evaluated did not appear to be
significant sources of lead   HYPERLINK
"http://www.atsdr.cdc.gov/glossary.html" \l "Exposure"  exposure  in the
children with elevated blood lead concentrations from these homes [6].
Additionally, it has been documented that proximity to the smelter
appears to be associated with higher blood lead levels (BLL) [2]. In
2001, 28 percent of the children in this community under 72 months of
age who were tested had BLLs equal to or above 10 micrograms of lead per
deciliter of blood (10 µg/dL) [7]. In the area closest to the smelter,
east of U.S. Hwy 61/Commercial Blvd., 45% of the children under 72
months of age who were tested in 2001 had BLLs equal to or above 10
µg/dL [7]. BLLs above 10 µg/dL have been associated with the
development of   HYPERLINK "http://www.atsdr.cdc.gov/glossary.html" \l
"Adverse Health Effect"  adverse health effects  [8].

Efforts to address the overall contamination in the community have been
ongoing since September 2001, when the Missouri Department of Natural
Resources (MDNR) and the Environmental Protection Agency (EPA) confirmed
that spillage of lead concentrate was occurring along transportation
routes in the city [9]. This information prompted DHSS to alert MDNR
that the risks to the public surrounding the site were clear and present
and that they were an imminent and substantial endangerment to the
health of residents of Herculaneum [9]. Subsequently, MDNR and EPA
directed the Doe Run Company to expedite activities to clean up existing
contamination and reduce/eliminate future contamination throughout
Herculaneum. The Doe Run Company, with oversight from MDNR and EPA, has
implemented several exposure reduction activities since that time,
including the following:

smelter air emissions and fugitive dust have been reduced by
installation of a number of equipment up-grades and process
modifications [9]. Only since the fall of 2002 has the facility come
into compliance with the National   HYPERLINK
"http://www.atsdr.cdc.gov/glossary.html" \l "Ambient"  Ambient  Air
Quality Standards for lead emissions of 1.5 micrograms per dry standard
cubic meter (quarterly average);

soil removal and replacement is being performed by the Doe Run Company
(with oversight by EPA) in public and private yards, parks, and schools,
as well as along roadsides, where lead levels are greater than 400 ppm
(as determined by established methods). First priority was given to
those yards where children under 72 months reside [9];

in-house dust is being removed by the Doe Run Company in accordance with
established methods, with oversight from EPA, in those residences with
elevated lead dust levels [9];

residences are being offered HEPA filter vacuums, regardless of whether
their homes have been cleaned, to assist in controlling interior dust
levels [9];

the Doe Run Company has made modifications in the handling and
transportation of the lead ore concentrate [9]; and,

the Doe Run Company is offering a voluntary property acquisition of
homes within a specified geographic area approximately 3/8 mile around
the smelter. Priority was placed on those homes where children under 72
months of age reside [9].

Additionally, DHSS, in cooperation with ATSDR, has initiated   HYPERLINK
"http://www.atsdr.cdc.gov/glossary.html" \l "Health Education"  health
education  for area residents and physicians to increase their awareness
of public health issues associated with lead and the benefits of routine
blood lead testing. In the past, DHSS and the Jefferson County Health
Department (JCHD), in cooperation with ATSDR, have offered blood lead
testing to the residents of Herculaneum and surrounding communities. One
such testing effort occurred in Herculaneum in the past year. In
September 2002, DHSS and JCHD offered a voluntary community-wide venous
blood lead testing event.

According to Missouri state regulation 19 CSR 20-20.020, the results of
all persons' blood lead tests, regardless of age or BLL, must be
reported to DHSS by physicians, laboratories, and hospitals. The State
Public Health Laboratory (SPHL), private physicians, and various
laboratories have provided BLL data to the DHSS Office of   HYPERLINK
"http://www.atsdr.cdc.gov/glossary.html" \l "Surveillance"  Surveillance
, which maintains databases on all reported blood lead tests.

The data set evaluated in this health consultation includes blood lead
data collected by and/or reported to DHSS over the course of calendar
year 2002, as required by the state regulation, as well as results from
the screening event conducted in Herculaneum in September 2002.
Additionally, this health consultation will include a comparison of the
blood lead data collected in both 2001 and 2002 for children under 72
months of age. Laboratory analytical methods are not described, and they
vary for all the data. However, the data are sufficient to permit a
determination of whether BLLs in the community were elevated in 2002,
and they are adequate to permit performance of a comparison of blood
lead data of children serially tested in both 2001 and 2002.

Only data for Herculaneum residents are considered in this analysis (zip
code 63048). For individuals who have multiple BLL results for the year,
the highest BLL reported for the individual has been used in the summary
of the 2002 data and in the comparison of the 2002 data with data from
2001. The evaluation of blood lead data for children under 72 months of
age and serially tested in both 2001 and 2002 includes all blood lead
data for those children tested in both years. For those children who
have multiple BLL results for each year, the highest BLL reported in
2001 was compared to the last BLL reported in 2002. This comparison
method was chosen in order to determine the overall decline in BLLs from
the highest in 2001 to the most recent in 2002. Only test results from
venous blood draws were used; any capillary test results have been
removed from the data set.

2002 Blood Lead Data Summary

A total of 340 people were tested in 2002; 58 of these were children
under the age of 72 months, 129 were children between the ages of 6 and
17 years, and 153 were adults age 18 or more. Of the children under 72
months of age, 8 had BLLs of 10 µg/dL or higher (14%). The children in
this age group had BLLs ranging from 2-28 µg/dL, with an average BLL of
approximately 6.4 µg/dL. Among children between the ages of 6 and 17
years, 2 had BLLs of 10 µg/dL or higher (1.5 %). The BLL range for this
age group was from 2 to 14 µg/dL. Of the 153 adults tested, 6 had BLLs
of 25 µg/dL or higher. The BLLs of men ranged from 2 to 33 µg/dL, and
women's BLLs ranged from 1 µg/dL to 42 µg/dL.

  HYPERLINK "http://www.atsdr.cdc.gov/HAC/PHA/herculaneum3/lss_p1.html"
\l "T1#T1"  Tables 1 ,   HYPERLINK
"http://www.atsdr.cdc.gov/HAC/PHA/herculaneum3/lss_p1.html" \l "T2#T2"
2 , and   HYPERLINK
"http://www.atsdr.cdc.gov/HAC/PHA/herculaneum3/lss_p1.html" \l "T3#T3"
3  contain a summary of these results.

Table 1. Blood Lead Levels of Children less than 72 months of age for
January through December, 2002, reported to DHSS for Zip Code 63048

Blood lead levels in µg/dL 	Number of individuals

0-9	50

10-19	6

20-29	2

30 or higher	0

Table 2. Blood Lead Levels of Children between 6 and 17 years of age for
January through December, 2002, reported to DHSS for Zip Code 63048

Blood lead levels in µg/dL 	Number of Individuals

0-9	127

10-19	2

20-29	0

30 or higher	0

Table 3. Blood Lead Levels for Adults 18 years and older for January
through December, 2002, reported to DHSS for Zip Code 63048

Blood lead level (µg/dL) 	Number of Individuals

0-24	147

25-39	5

40-49	1

50 and higher	0

Data for other sensitive subgroups, such as fetuses theoretically
exposed through women of childbearing age (15-44 years) and the elderly
(i.e., 65 and older), were examined more closely.   HYPERLINK
"http://www.atsdr.cdc.gov/HAC/PHA/herculaneum3/lss_p1.html" \l "T4#T4"
Table 4  summarizes this evaluation. This analysis found that 63 women
of childbearing age were tested. In this group, only 1 had a BLL of 10
µg/dL or higher (42 µg/dL). Twenty-three of the women tested in this
group were aged 15 to 17 years; the remaining 40 were 18 or older.

A total of 36 residents 65 years of age and older were tested. Six had
BLLs of 10 µg/dL or higher, 2 females and 4 males. Twelve µg/dL was
the highest female BLL, and 19 µg/dL was the highest male BLL.

Table 4. Blood Lead Levels for sensitive populations for January through
December, 2002, reported to DHSS for Zip Code 63048

Blood lead level (µg/dL)	Women of child bearing age

15-44 years (n=63)	Elderly, 65 years and older (n=36)

0-9	62	30

10-19	0	6

20-29	0	0

30 or higher	1	0

Comparison of the 2001 blood lead data with 2002 data

In 2001, a total of 935 people were tested; 118 were children under the
age of 72 months, 162 were children between the ages of 6 and 17 years,
and 655 were adults age 18 or higher [7]. There was a 64% reduction in
the number of individuals tested in 2002 compared to those tested in
2001.

Of the children tested in 2001 between the ages of 6 and 17 years, 13 of
162 had BLLs of 10 µg/dL or higher (8%), ranging from 10 to 19 µg/dL
[7]. In comparison and as stated earlier, in 2002, 2 of the 129 children
in this age group had BLLs of 10 µg/dL or higher (1.5%). A comparison
of data from 2001 to 2002 shows an apparent 81% reduction in the
HYPERLINK "http://www.atsdr.cdc.gov/glossary.html" \l "Prevalence"
prevalence  of BLLs of 10 µg/dL or higher for children tested in this
age group.

Additionally, in 2001 there were 655 adults tested. Two had BLLs of 25
µg/dL or higher [7]. The men ranged from non-detect (non-detect = BLLs
too low to be detected by laboratory instrument) to 31 µg/dL, and women
were from non-detect to 55 µg/dL [7]. In 2002, 6 of the 153 individuals
had BLLs of 25 µg/dL or higher. For this age group, there were notably
fewer people tested in 2002 than in 2001. Overall, there were no notable
changes in the ranges of BLLs for the adult age group. However, there
was an increase in the prevalence of adults with BLLs of 25 µg/dL or
higher. Fewer than 1% of the adults tested in 2001 had BLLs higher than
25 µg/dL, compared to slightly less than 4% of adults tested in 2002.
This change in rates could be due to increased awareness and screening
of individuals most at   HYPERLINK
"http://www.atsdr.cdc.gov/glossary.html" \l "Risk"  risk  for exposure
to lead.

In 2001, 197 women of childbearing age were tested (15-44 years) [7].
With the exception of one woman who had a BLL of 55 µg/dL in 2001 and
42 µg/dL in 2002, all other women of childbearing age tested had BLLs
less than 10 µg/dL. Of the 166 residents 65 years and older tested in
2001, 21 had BLLs of 10 µg/dL or higher--5 females and 16 males [7].
Twenty-one µg/dL was the highest female BLL, and 24 µg/dL was the
highest male BLL [7]. Comparatively, in 2002, 6 of the 36 people tested
had BLLs of 10 µg/dL or higher, 2 females and 4 males. In 2002, 12
µg/dL was the highest female BLL and 19 µg/dL was the highest male
BLL.

When comparing the data, DHSS evaluated the children under 72 months who
were tested in 2001 and 2002 more closely. Of the children under 72
months tested in 2001, 33 of the 118 had BLLs of 10 µg/dL or higher
(28%), ranging from 10-31 µg/dL [7]. Comparatively, in 2002, 8 of the
58 children tested had BLLs of 10 µg/dL or higher (14%), ranging from
10-28 µg/dL. The 2002 blood lead numbers indicate an apparent 50%
reduction in the prevalence of elevated BLLs for children tested in 2001
in this age group.

When BLLs for children under 72 months of age residing east of Highway
61/ Commercial Blvd. (the portion of the community closer to the
smelter) were examined exclusively, 30 of the 67 children tested had
BLLs of 10 µg/dL or higher (45%) in 2001[7]. In 2002, 8 of the 46
children tested in this age group had BLLs of 10 µg/dL or higher (17%).
The 2002 blood lead data for the children under 72 months of age
residing in this area show an apparent 62% reduction in the prevalence
of elevated BLLs compared to 2001 data.

  HYPERLINK "http://www.atsdr.cdc.gov/HAC/PHA/herculaneum3/lss_p1.html"
\l "T5#T5"  Table 5  summarizes the comparison of 2001 and 2002 blood
lead data for children under 72 months of age.

Table 5. Summary of Blood Lead Levels for Children under 72 months of
age for Calendar Years 2001 and 2002, reported to DHSS for Zip Code
63048

	2001	2002

Total number of children under 72 months of age blood lead tested.	118
58

Range of BLLs for children tested who were under 72 months of age.
Non-detect*-31 µg/dL	2 µg/dL-28 µg/dL

Average BLL for children tested who were under 72 months of age. 	8.0
µg/dL	6.4 µg/dL

Children under 72 months of age with BLLs of 10 µg/dL or higher. 	33
(28%) of 118 	8 (14%) of 58

Children under 72 months of age residing east of Highway 61/Commercial
Blvd. (the portion of the community closer to the smelter) who were
blood lead tested.	67	46

Children under 72 months of age residing east of Hwy. 61/Commerical
Blvd. with BLLs of 10 µg/dL or higher.	30 (45%) of 67	8 (17%) of 46

* Non-detect = BLLs too low to be detected by laboratory instrument.

Additionally, DHSS reviewed the blood lead data collected from January
1, 2001 though December 31, 2002 with a focus onthe subset ofchildren
under 72 months of age living in Herculaneum who were tested in both
years 2001 and 2002 . A total of 141 different children were tested for
BLL during that time period, 35 of which had serial blood lead
screenings in both 2001 and 2002. Of the 35 children tested in both
years, 31 were located east of Hwy 61/Commercial Blvd. (the portion of
the community closer to the smelter). For those children who have
multiple BLL results for each year, the highest BLL reported in 2001 was
compared to the last BLL reported in 2002. This comparison method was
chosen in order to determine the overall decline in BLLs from the
highest in 2001 to the most recent in 2002. Twenty of the 35 children
tested in both years had BLLs that remained less than 10 µg/dL. Twelve
of these children who had BLLs less than 10 µg/dL in 2001 had a
decrease in BLL in 2002. The remaining 8 of the 20 children who had BLLs
less than 10 µg/dL in both years had BLLs that were either unchanged or
because they were below the various laboratories' reporting limits, DHSS
was unable to verify the change definitively. Nine of the 35 children
with BLLs higher than or equal to 10 µg/dL in 2001 had a decrease to a
BLL of less than 10 µg/dL in 2002. Five children had BLLs higher than
or equal to 10 µg/dL in 2001 and a decreased BLL that was still higher
than or equal to 10 µg/dL in 2002. One child had an increase in BLL
from 2001 to 2002. The blood lead level for this child increased from 11
µg/dL to 25 µg/dL. This child and his/her family have moved away from
Herculaneum. The most recent venus blood lead level for the child,
collected in 2003, has decreased to less than 10 µg/dL.

  HYPERLINK "http://www.atsdr.cdc.gov/HAC/PHA/herculaneum3/lss_p1.html"
\l "T6#T6"  Table 6  contains a summary of these results. A further
breakdown of this data is shown in   HYPERLINK
"http://www.atsdr.cdc.gov/HAC/PHA/herculaneum3/lss_p1.html" \l
"appa#appa"  Appendix A .

Table 6. Summary of Blood Lead Levels for Children under 72 months of
age who were serially tested in both years 2001 and 2002, reported to
DHSS for Zip Code 63048.

Individuals	Numbers

Total number of children tested in both 2001 and 2002

31 of the 35 children located east of Hwy 61 & Commercial Blvd 	35

Number of children with blood lead levels always less than 10 µg/dL in
2001 and 2002

12 of the 20 children in this group had a decrease in blood lead level
from 2001 to 2002 	20

Number of children with blood lead levels higher than or equal to 10
µg/dL in 2001 with a decrease to a blood lead level of less than 10
µg/dL in 2002 	9

Number of children with blood lead levels higher than or equal to 10
µg/dL in 2001 with a decreased blood lead level but still higher than
or equal to 10 µg/dL in 2002	5

Children with an increase in blood lead level from 2001 to 2002

One child had a blood lead level higher than 10 µg/dL in 2001 with an
increase in blood lead level in 2002 	1

DISCUSSION

Childhood lead poisoning is a major, but preventable, environmental
health problem. Children are a high-risk group. They are generally
assumed to be at an increased risk of exposure to chemicals in soil
because of their more frequent soil contact and their tendency to ingest
soil, either intentionally or through normal hand-to-mouth behavior.
Exposure to lead in utero, in infancy, and in early childhood may slow
mental development and lower intelligence later in life. The Centers for
Disease Control and Prevention (CDC) recommends that BLLs remain below
10 µg/dL to decrease the likelihood of neurological and learning
problems in children. Other unusually susceptible populations include
the elderly, people with inheritable genetic diseases, alcoholics and
smokers, and people with neurological dysfunction or kidney disease [8,
10].

Recent data from the Second National Report on Human Exposure to
Environmental Chemicals, 1999-2000 (NHANES) conducted by the CDC stated
that the mean children's BLL in the United States is 2.23 µg/dL [11].
Average BLLs in the United States have fallen dramatically since the
1970s. In 1976-1980, the average BLL in children was 15 µg/dL, and in
1991-1994, the average was 2.7 µg/dL [8]. The national prevalence rate,
1999-2000 (NHANES), of BLLs higher than or equal to 10 µg/dL in
children is 2.2% [11].

According to all the blood lead data provided to DHSS, there have been
notable reductions in BLLs in the community from 2001 to 2002. However,
blood lead elevations continue to be documented in this community. The
data provided neither represent a random sample of the community nor
represent the entire community; these BLLs are reflective of physician
selection and/or self-selection. Although there has been an apparent 50
% reduction in the prevalence of elevated BLLs from 2001 to 2002 for
children tested under 72 months of age living in this community, 8 of
the 58 children tested in 2002 (14%) were found to have BLLs of 10
µg/dL or higher. This percentage is still notably higher than the
national prevalence rate of 2.2% [11] and the State of Missouri rate of
5.0% for calendar year 2002 [12].

When BLLs for children residing east of Highway 61/Commercial Blvd. (the
portion of the community closer to the smelter) are examined
exclusively, 8 of the 46 children under 72 months of age tested in 2002
(17%) had BLLs of 10 µg/dL or higher. The 2002 blood lead data for the
children residing in this area show an apparent 62% reduction in the
prevalence of elevated BLLs compared to 2001 data for this age group.
The average BLL in children under 72 months, regardless of proximity to
the smelter, was approximately 8.0 µg/dL for 2001[7]. In 2002, there
has been a reduction in the average BLL to approximately 6.4 µg/dL.
Although there has been a decrease in the average BLL for tested
children of this age group, the average BLL is still notably higher than
the national mean BLL of 2.23 µg/dL [11].

Twenty-six children of 35 tested in both years had decreases in BLL in
2002. Of the 35 children tested in both years, one child had an increase
in BLL from 2001 to 2002.

In 2002, 2 of the 129 children between the ages of 6 and 17 had BLLs of
10 µg/dL or higher (1.5%), compared to 13 of 162 children in 2001 (8%).
A comparison of data from 2001 to 2002 reveals an apparent 81% reduction
in the prevalence of BLLs of 10 µg/dL or higher for children tested in
this age group.

Several factors could be responsible for the apparent reduction in the
prevalence of elevated BLLs in children living in Herculaneum from 2001
to 2002. These factors include the actions taken by the MDNR and EPA to
ensure that the Doe Run Company eliminates or reduces the sources of
exposure; the community's increased awareness of potential pathways of
exposure; modifications of home cleaning methods and changes in hygienic
practices; and the actions taken by DHSS, ATSDR, and the JCHD to
increase childhood lead testing in order to increase awareness of lead
poisoning and its adverse health effects and to provide information
about how to reduce exposures, especially for children. In addition,
some of the children in the area most at risk to lead exposure from the
smelter no longer reside in that area as a result of property buy-outs.

Although there have been notable reductions in the prevalence of
elevated BLLs in children residing in this community, the prevalence of
elevated BLL remains unacceptably high.

Any effects of lead at these levels on the health of children are likely
to be subtle. Therefore, blood lead levels alone are not an indicator of
adverse effects for an individual child. However, in considering
populations (groups of individuals) exposed to lead, adverse health
effects can be seen in groups with elevated blood lead levels [8].
Therefore, it is important that efforts to reduce exposure to lead in
Herculaneum continue.

The 2002 data indicate that the average BLL for women between the ages
of 15-44 is approximately 3.6 µg/dL. Comparatively, in 2001 the
approximate average BLL for women in this age group was essentially the
same--3.4 µg/dL [7]. However, in both years, the BLL has been higher
than the national mean of 1.8 µg/dL for this age group [13]. No adverse
health effects would be expected for women at this BLL level.
Nevertheless, lead has been demonstrated to cross the placenta at levels
less than 10 µg/dL and could potentially impact the health of the fetus
[14]. The one female having a BLL of 55 µg/dL in 2001 and 42 µg/dL in
2002 has been advised that should she become pregnant she should alert
her physician to her history of elevated blood lead levels. This
individual was also given guidance on actions that could be taken to
reduce exposure.

Individuals 65 years and older were found to have an approximate mean
BLL of 5.7 µg/dL in 2002, slightly less than the approximate mean BLL
of 5.9 µg/dL in 2001 [7]. However, again, the 2002 mean BLL is higher
than the national mean BLL of 3.3 µg/dL. Six of the 36 people in this
age group that were tested had BLLs of 10 µg/dL; however, no individual
had a BLL of 25 µg/dL or greater. No adverse health effects would be
expected from current BLLs [13]. Still, some past and present
occupational and recreational exposures(e.g., crafts and hobbies)have
been identified for this subgroup that may be contributing to the
elevations.

Child Health Considerations

Children and adults are exposed to lead in many of the same ways. But
children are not small adults. They differ in the behaviors that lead to
their exposures as well as in their susceptibility to toxic effects from
lead exposures. Children are more likely to play outdoors and bring food
into contaminated areas. They are also shorter than adults, so they are
more likely to breathe dust and soil that are close to the ground.
Children are also smaller, resulting in higher doses of chemical
exposure per pound of body weight [10].

Further, children have developing body systems that can sustain
permanent damage if toxic exposures occur during critical growth stages.
Compared to adults, children absorb more of the lead they take into
their bodies, retain more of the lead they take in, and are more
sensitive to its effects [10].

Children may be exposed to lead inside their homes, in and around their
schools, and outside in their yards, playgrounds, and parks. This
community is faced with widespread environmental contamination. Because
children depend on adults for risk identification and management
decisions, it is prudent that further lead exposure be prevented.

CONCLUSIONS

The blood lead data reviewed indicate that exposures have occurred, are
occurring, and are likely to occur in the future and that these
exposures may have an adverse impact on human health. Consequently, this
site has been classified as a public health hazard. Specifically, DHSS
concludes the following:

Fourteen percent (14%) of children living in this community who were
tested in 2002 have blood lead levels known to cause adverse health
effects (BLLs above 10 µg/dL). Seventeen percent (17%) of the children
who were tested in 2002 who reside east of Hwy 61/Commercial Blvd. (the
portion of the community closer to the smelter) have blood lead levels
known to cause adverse health effectson a population level.

Of the females of childbearing age in this community tested for BLLs in
2001 and 2002, one female had BLLs in both years that could cause
adverse health effects to her developing fetus if she became pregnant.

Although there have been sixty-four percent (64%) fewer people blood
lead tested in 2002 compared to 2001, the data seem to indicate that
less lead exposure occurred in 2002 than in 2001. This fact is evidenced
by the apparent decrease in prevalence rates of elevated BLLs among
children tested in 2002 when compared to those tested in 2001 and the
notable number of children with decreased BLLs who were serially tested
in both 2001 and 2002.

RECOMMENDATIONS

EPA and MDNR should continue to ensure that steps are taken by the lead
smelter owners to eliminate/reduce the source(s) of lead exposure as
soon as possible.

The one female of child bearing years who has an elevated blood lead
level should make her physician aware of her history, especially if she
should become pregnant, and take steps to reduce her current exposures
to lead.

EPA and MDNR should continue to conduct environmental sampling to
evaluate all lead exposure pathways for this community.

DHSS and JCHD should continue health education activities for the people
in the community as well as for area health care providers. These
activities should focus on awareness of lead poisoning, its adverse
health effects, and how to reduce exposures and encourage blood lead
testing, especially for children.

A health study should be conducted to evaluate the health impacts of
lead on the community.

When additional information becomes available, DHSS will evaluate it
thoroughly and, if appropriate, update existing assessment documents.
ATSDR and DHSS will respond appropriately to any request for additional
information or action.

PUBLIC HEALTH ACTION PLAN

The Public Health Action Plan (PHAP) for the Herculaneum Lead Smelter
site contains a description of actions to be taken by the Missouri
Department of Health and Senior Services (DHSS), the Agency for Toxic
Substances and Disease Registry (ATSDR), and others. The purpose of the
PHAP is to ensure that this health consultation not only identifies
public health hazards, but also provides an action plan to mitigate and
prevent adverse human health effects resulting from present and/or
future exposure to hazardous substances at or near the site. Implicit in
this plan is a commitment from DHSS and/or ATSDR to follow-up on this
plan to ensure that it is implemented. The public health actions to be
implemented by DHSS, ATSDR, and /or cooperators are as follows:

DHSS/ATSDR will coordinate with the appropriate environmental agencies
to identify environmental sampling that needs to occur so that exposure
pathways can be adequately identified and characterized.

DHSS/ATSDR will continue to evaluate any additional data that become
available regarding human exposure or contaminants at the site,
including identifying additional exposure pathways and evaluating health
impacts of risk reduction and remediation plans.

DHSS/ATSDR have developed and are implementing a comprehensive health
education plan in this community. Those efforts will continue, and they
will focus on increased childhood lead testing, awareness of lead
poisoning and its adverse health effects, and how to reduce exposures,
especially for children.

JCHD/DHSS/ATSDR will continue to assure case management of children and
other sensitive populations such as women of child bearing age with
elevated BLLs.

DHSS/ATSDR are in the preliminary stages of initiating health study
activities in this community.

PREPARERS OF REPORT

Rachelle Kuster, Missouri Department of Health & Senior Services

Gale Carlson, Missouri Department of Health & Senior Services

Scott Clardy, Missouri Department of Health & Senior Services

CERTIFICATION

This health consultation for the Herculaneum Lead Smelter Site was
prepared by the Missouri Department of Health and Senior Services under
a cooperative agreement with the federal Agency for Toxic Substances and
Disease Registry (ATSDR). It is in accordance with the approved
methodology and procedures at the time the health consultation was
initiated.

Alan G. Parham

Technical Project Officer, SPS, SSAB, DAC

The Division of Health Assessment and Consultation (DHAC), ATSDR, has
reviewed this health consultation and concurs with its findings.

Gail Godfrey

for Richard Gillig

Section Chief, SPS, DHAC, ATSDR

REFERENCES

Missouri Department of Natural Resources, Division of Environmental
Quality, Hazardous Waste Program. Preliminary Assessment: Herculaneum
Lead Smelter Site, Jefferson County, Missouri. 1999 Mar 30.

Agency for Toxic Substances and Disease Registry. Health Consultation
for Herculaneum Lead Smelter Site: Atlanta: US Department of Health and
Human Services; 2001 Jul 13.

Environmental Protection Agency. Transmittal from Bruce Morrison to
Missouri Department of Health and Senior Services, January 8, 2002.

Missouri Department of Natural Resources. Transmittal from David Mosby
to Tony Petruska, Environmental Protection Agency, Sample#A58, November
28, 2001.

Walker P. Herculaneum, Missouri Lead Contamination Health Threat.
Missouri Department of Health and Senior Services; 2001 Sep13.

Agency for Toxic Substances and Disease Registry. Health Consultation on
Exposure Investigation on Herculaneum Lead Smelter Site, Herculaneum,
Missouri. Atlanta: US Department of Health and Human Services; 2001 Sep
14.

Agency for Toxic Substances and Disease Registry. Health Consultation on
Blood Lead Results for 2001 Calendar Year, Herculaneum Lead Smelter
Site, Herculaneum, Missouri. Atlanta: US Department of Health and Human
Services; 2002 Feb 26.

Centers for Disease Control and Prevention. Screening Young Children for
Lead Poisoning: Guidance for State and Local Public Health Officials.
Atlanta, Georgia: US Department of Health and Human Services; 1997 Nov.

Agency for Toxic Substances and Disease Registry. Health Consultation on
Determination if Remedial Actions are Protective of Public Health,
Herculaneum Lead Smelter Site, Herculaneum, Missouri. Atlanta: US
Department of Health and Human Services; 2002 Apr 16.

Agency for Toxic Substances and Disease Registry. Toxicological Profile
for Lead (update). Atlanta: US Department of Health and Human Services;
1999.

Centers for Disease Control and Prevention. Second National Report on
Human Exposure to Environmental Chemicals, NCEH Pub, No. 03-0022. 2003
Jan.

Missouri Department of Health and Senior Services. 2002 Calendar Year
Blood Lead Testing Data, January through December 2002, Children Less
than Six Years of Age; 2003 Jun 4.

Centers for Disease Control and Prevention. Blood Lead Levels--United
States, 1991-1994. Morb Mortal Wkly Rep 1997; 46: 141-6.

Agency for Toxic Substances and Disease Registry. Toxicological Profile
for Lead. Atlanta: US Department of Health and Human Services; 1990.

FIGURES


[Federal Register Volume 84, Number 47 (Monday, March 11, 2019)]
[Notices]
[Pages 8712-8713]
[FR Doc No: 2019-04319]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RD18-7-000]

Commission Information Collection Activities (Ferc-725r); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice of information collection and request for comments.

-----------------------------------------------------------------------

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection FERC-725R (Mandatory Reliability Standards: BAL
Reliability Standards) and submitting the information collection to the
Office of Management and Budget (OMB) for review. Any interested person
may file comments directly with OMB and should address a copy of those
comments to the Commission as explained below. On October 9, 2018, the
Commission published a Notice in the Federal Register in Docket No.
RD18-7-000 requesting public comments. The Commission received no
comments.

DATES: Comments on the collection of information are due April 10,
2019.

ADDRESSES: Comments filed with OMB, identified by OMB Control No. 1902-
0268, should be sent via email to the Office of Information and
Regulatory Affairs<EMAIL_ADDRESS>Attention: Federal Energy
Regulatory Commission Desk Officer.
    A copy of the comments should also be sent to the Commission, in
Docket No. RD18-7-000, by either of the following methods:
     eFiling at Commission's Website: http://www.ferc.gov/docs-filing/efiling.asp
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance, contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-725R, Mandatory Reliability Standards: BAL Reliability
Standards.
    OMB Control No.: 1902-0268.
    Type of Request: Revision to FERC-725R information collection
requirements, as discussed in Docket No. RD18-7-000.
    Abstract: On August 17, 2018, the North American Electric
Reliability Corporation (NERC) filed a petition seeking approval of
proposed Reliability Standard BAL-002-3 (Disturbance Control Standard--
Contingency Reserve for Recovery from a Balancing Contingency Event)
and the retirement of currently-effective Reliability Standard BAL-002-
2. NERC submitted proposed Reliability Standard BAL-002-3 in response
to the Commission's directive in Order No. 835 to develop modifications
to Reliability Standard BAL-002-2, Requirement R1 to require balancing
authorities or reserve sharing groups: (1) To notify the reliability
coordinator of the conditions set forth in Requirement R1, Part 1.3.1
preventing it from complying with the 15-minute ACE recovery period;
and (2) to provide the reliability coordinator with its ACE recovery
plan, including a target recovery time.\1\ The NERC petition states
``the proposed modifications to Reliability Standard BAL-002-3 also
intend to clarify that communication with the reliability coordinator
(RC) should proceed in accordance with Energy Emergency Alert
procedures within the EOP Reliability Standards.\2\ This communication
is performed under the currently-effective Reliability Standard BAL-
002-2 (as part of the operating procedures and processes). The
communications (and related burden) are already covered under FERC-
725R, and the additional information is de minimis. Therefore the
Commission is not modifying the burden estimate for each response and
is submitting this to OMB as a non-material or non-substantive change
to a currently approved collection.
---------------------------------------------------------------------------

    \1\ Disturbance Control Standard--Contingency Reserve for
Recovery from a Balancing Contigency Event Reliability Standard,
Order No. 835, 158 FERC 61,030, at P 37 (2017).
    \2\ NERC Petition at 3.
---------------------------------------------------------------------------

    The Office of Electric Reliability approved the NERC proposal in a
Delegated Order on September 25, 2018.
    Type of Respondents: Balancing authorities and reserve sharing
groups
    Estimate of Annual Burden: \3\ According to the NERC Compliance
Registry as of 8/24/2018, there are 99 balancing authorities in the
United States. The Commission bases individual burden estimates on the
time needed for balancing authorities to develop tools needed to
facilitate reporting that are required in the Reliability Standard. The
communications (and related burden)

are already covered under FERC-725R, so the Commission is not modifying
the burden estimate for each response. However, to reflect normal
fluctuations in industry, we are adjusting the number of respondents
(to 99, rather than 105) for Reliability Standard BAL-002-3, as shown
below.
---------------------------------------------------------------------------

    \3\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of information collection burden, refer to 5
Code of Federal Regulations 1320.3.

                              FERC-725R, Estimate for Reliability Standard BAL-002-3, as Approved in Docket No. RD18-7 4 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 Annual number                                                Total annual burden hours
                                  Number of       of responses   Total number of    Average burden hours &     & total annual cost ($)       Cost per
                                 respondents     per respondent     responses        cost per response ($)            (rounded)           respondent ($)
                                           (1)              (2)  (1) * (2) = (3)  (4).......................  (3) * (4) = (5)..........        (5) / (1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
BA/RSG: \6\ Develop and                     99                1               99  8 \7\ hrs.; $842.32.......  792 hrs.; $83,390........           842.32
 Maintain annually, Operating
 Process and Operating Plans.
BA/RSG\:\ Record Retention...               99                1               99  4 hrs.; $158.72...........  396 hrs.; $15,713........           158.72
                              --------------------------------------------------------------------------------------------------------------------------
    Total....................  ...............  ...............              198  ..........................  1,188 hrs.; $99,103......
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.
---------------------------------------------------------------------------

    \4\ Reliability Standard BAL-002-3 applies to balancing
authorities and reserve sharing groups. However, the burden
associated with the balancing authorities complying with
Requirements R1and R3 is not included in this table because that
burden doesn't change and the Commission already accounted for it
under Commission-approved Reliability Standard BAL-002-1.
    Other components of FERC-725R which are not affected by Docket
No. RD18-7 are not addressed in the table.
    \5\ The estimated hourly cost (wages plus benefits) is based on
Bureau of Labor Statistics (BLS) information (available at http://www.bls.gov/oes/current/naics2_22.htm and, for benefits, https://www.bls.gov/news.release/ecec.nr0.htm).
    The hourly cost (wages plus benefits) for developing and
maintaining operating process and plans is $105.29 and is an average
for an electrical engineer (Occupation code 17-2071, $66.90/hour)
and Legal (Occupation code 23-0000, $ $143.68).
    The hourly cost (wages plus benefits) for record retention is
$39.68 for information and record clerks (Occupation code 43-4199).
    \6\ BA = Balancing Authority; RSG = Reserve Sharing Group.
    \7\ This figure of 8 hours/response is an average of the hourly
burden per response for Years 1-3. Year 1 burden: 12 hours per
response; Years 2-3, each: 6 hours/response. The average annual
burden for Years 1-3 is 8 hours/response (or [12 hours + 6 hours + 6
hours ] / 3).

    Dated: March 5, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-04319 Filed 3-8-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 76 (Thursday, April 22, 2021)]
[Proposed Rules]
[Pages 21231-21233]
[FR Doc No: 2021-08183]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0195; Project Identifier MCAI-2020-00262-R]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

-----------------------------------------------------------------------

SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2014-11-02 for Airbus Helicopters Model SA-365N, SA-365N1, AS-365N2,
and AS 365 N3 helicopters. AD 2014-11-02 requires repetitively
inspecting frame number (No.) 9 for a crack. Since the FAA issued AD
2014-11-02, Airbus Helicopters developed a modification that would
provide an optional terminating action for the repetitive inspections
required by AD 2014-11-02. This proposed AD would retain the
requirements of AD 2014-11-02, provide an optional terminating action
for the repetitive inspections, and reduce the applicability by
excluding certain post-modified helicopters. The actions of this
proposed AD are intended to address an unsafe condition on these
products.

DATES: The FAA must receive comments on this proposed AD by June 7,
2021.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to https://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0195; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this proposed AD, the European Union Aviation Safety Agency (EASA) AD,
any comments received and other information. The street address for
Docket Operations is listed above. Comments will be available in the AD
docket shortly after receipt.
    For service information identified in this proposed rule, contact
Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
https://www.airbus.com/helicopters/services/technical-support.html. You
may view this referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Matt Fuller, AD Program Manager,
General Aviation & Rotorcraft Unit, Airworthiness Products Section,
Operational Safety Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX
76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0195; Project Identifier
MCAI-2020-00262-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Matt
Fuller, AD Program Manager, General Aviation & Rotorcraft Unit,
Airworthiness Products Section, Operational Safety Branch, FAA, 10101
Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Any commentary that the FAA receives which is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Discussion

    The FAA issued AD 2014-11-02, Amendment 39-17852 (79 FR 33050, June
10, 2014) (AD 2014-11-02), for Airbus Helicopters (previously
Eurocopter France) Model SA-365N, SA-365N1, AS-365N2, and AS 365 N3
helicopters. AD 2014-11-02 requires, for helicopters that have a No. 9
frame that has had any repair or alteration made, within 10 hours time-
in-service (TIS) and thereafter at intervals not to exceed 110 hours
TIS, inspections of the left-hand (LH) and right-hand (RH) frame No. 9
for a crack in certain areas using a 10X or higher power magnifying
glass. For all other helicopters, the inspection is required within 110
hours TIS and thereafter in intervals not to exceed 110 hours TIS. If
there is a crack, AD 2014-11-02 requires repairing the frame before
further flight.
    AD 2014-11-02 was prompted by EASA AD 2012-0108-E, dated June 15,
2012 (EASA AD 2012-0108-E), issued by EASA, which is the Technical
Agent for the Member States of the European Union. EASA advises that a
crack was discovered during the ``T'' inspection of an AS365
helicopter. The crack started

at a rivet hole of a doubler that was installed on the frame No. 9 in
accordance with Eurocopter Alert Service Bulletin No. 53.00.42, dated
January 31, 2001. EASA further states that structural alteration of
frame No. 9 by modifications or repairs can result in fatigue crack
initiation under normal operational loads. According to EASA, this
condition, if not corrected, could lead to crack propagation and
failure of frame No. 9, which would adversely affect the structural
integrity of the helicopter. For these reasons, EASA AD 2012-0108-E
requires repetitive inspections of frame No. 9 for a crack in the area
of the doubler or any repair performed in the area of the latch support
and stretcher support.

Actions Since AD 2014-11-02 Was Issued

    Since the FAA issued AD 2014-11-02, Airbus Helicopters introduced
an optional modification (MOD) that would provide terminating action
for the repetitive inspections. Consequently, EASA issued AD 2012-
0108R1, dated September 19, 2019 (EASA AD 2012-0108R1), to supersede
EASA AD 2012-0108-E. EASA AD 2012-0108R1 retains the requirements in
EASA AD 2012-0108-E and introduces the installation of an optional MOD
that calls for replacing the upper section of frame No. 9 with a
reinforced frame.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA of the
unsafe condition described in its AD. The FAA is proposing this AD
after evaluating all known relevant information and determining that an
unsafe condition is likely to exist or develop on other helicopters of
these same type designs.

Differences Between This Proposed AD and the EASA AD

    EASA AD 2012-0108R1 requires contacting Airbus Helicopters for
repair instructions if there is a crack, and the proposed AD does not.
EASA AD 2012-0108R1 applies to Airbus Helicopters Model 365-series
helicopters with a frame No. 9 on which certain doublers or repairs
have been accomplished, whereas this proposed AD would apply to those
model helicopters regardless of if those doublers or repairs have been
accomplished.

Related Service Information Under 1 CFR Part 51

    Airbus Helicopters has co-published as one document Emergency Alert
Service Bulletin (EASB) No. 05.00.63, Revision 2, dated December 20,
2018 (EASB 05.00.63 Rev 2), for Model AS365-series helicopters and EASB
No. 05.00.30, Revision 2, dated December 20, 2018 (EASB 05.00.30 Rev
2), for non-FAA type certificated Model AS565-series helicopters. EASB
05.00.63 Rev 2 would be incorporated by reference in this proposed AD;
EASB 05.00.30 Rev 2 would not.
    EASB 05.00.63 Rev 2 applies to helicopters with a frame No. 9 that
has not been modified by MOD 07 53C17, 07 53D21, 07 53D22, or 07 53D02,
and that has had doublers installed or repairs performed in accordance
with certain service instructions. EASB 05.00.63 Rev 2 describes
procedures for inspecting the frame No. 9 for a crack and specifies
contacting Airbus Helicopters for further procedures if there is a
crack.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Other Related Service Information

    Airbus Helicopter has also issued Service Bulletin No. AS365-
53.00.57, Revision 0, dated December 20, 2018 (SB AS365-53.00.57), for
Model AS365-series helicopters. SB AS365-53.00.57 specifies replacing
the upper section of the No. 9 frame with a reinforced version as an
option to terminate the visual inspections specified in EASB 05.00.63
Rev 2.
    The FAA also reviewed Eurocopter EASB No. 05.00.63, Revision 1,
dated June 18, 2012 (EASB 05.00.63 Rev 1). EASB 05.00.63 Rev 1
specifies the same procedures as EASB 05.00.63 Rev 2; however, EASB
05.00.63 Rev 2 excludes helicopters with certain MODs installed from
its effectivity.

Proposed AD Requirements

    This proposed AD would continue to require, for helicopters that
have a No. 9 frame that has had any repair or alteration made, within
10 hours TIS after the effective date of this AD and every 110 hours
TIS thereafter, inspecting the LH and RH frame No. 9 for a crack in the
areas of the latch support and stretcher support with a 10X or higher
power magnifying glass. For all other helicopters, this proposed AD
would require this inspection within 110 hours TIS after the effective
date of this AD and thereafter at intervals not to exceed 110 hours
TIS. If there is a crack, the proposed AD would also continue to
require, before further flight, repairing the crack. This proposed AD
would also provide an optional terminating action for the repetitive
inspections that would consists of installing Eurocopter MOD 53C17 or
MOD 53D02, or Airbus Helicopters MOD 07 53D21 or MOD 07 53D22, as
applicable to your helicopter.

Costs of Compliance

    The FAA estimates that this proposed AD would affect 33 helicopters
of U.S. Registry. The FAA estimates that operators may incur the
following costs in order to comply with this AD. At an average labor
rate of $85 per hour, inspecting the LH and RH frame No. 9 would
require about 3 work-hours, for a cost per helicopter of $255 and a
total cost to U.S. operators of $8,415 per inspection cycle. Repairing
a cracked frame No. 9 would require about 20 work-hours, and required
parts would cost about $15,000, for a cost per helicopter of $16,700.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866,

    2. Will not affect intrastate aviation in Alaska, and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2014-11-02, Amendment 39-17852
(79 FR 33050, June 10, 2014); and
0
b. Adding the following new AD:

Airbus Helicopters: Docket No. FAA-2021-0195; Project Identifier
MCAI-2020-00262-R.

(a) Applicability

    This airworthiness directive (AD) applies to Airbus Helicopters
Model SA-365N, SA-365N1, AS-365N2, and AS-365-N3 helicopters,
certificated in any category, except helicopters with Eurocopter
modification (MOD) 53C17 or MOD 53D02, or Airbus Helicopters MOD 07
53D21 or MOD 07 53D22, installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as a crack in frame number
(No.) 9, which if not detected and corrected, could result in
failure of frame No. 9, loss of structural integrity, and subsequent
loss of control of the helicopter.

(c) Affected ADs

    This AD replaces AD 2014-11-02, Amendment 39-17852 (79 FR 33050,
June 10, 2014).

(d) Comments Due Date

    The FAA must receive comments by June 7, 2021.

(e) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(f) Required Actions

    (1) For helicopters that have any repair or alteration to the
frame No. 9, within 10 hours time-in-service (TIS) after the
effective date of this AD and thereafter at intervals not to exceed
110 hours TIS, using a 10X or higher power magnifying glass, inspect
the left-hand (LH) and right-hand (RH) frame No. 9 for a crack in
the area of the latch support and stretcher support, as depicted in
Figure 1 of Airbus Helicopters Emergency Alert Service Bulletin No.
05.00.63, Revision 2, dated December 20, 2018 (EASB 05.00.63).
    (2) For all other helicopters, within 110 hours TIS after the
effective date of this AD and thereafter at intervals not to exceed
110 hours TIS, perform the inspection in paragraph (f)(1) of this
AD.
    (3) If there is a crack, before further flight, repair the frame
No. 9. Repairing a frame is not terminating action for the
repetitive inspections required by paragraphs (f)(1) and (2) of this
AD.
    (4) As an optional terminating action for the repetitive
inspections required by paragraphs (f)(1) and (2) of this AD,
replace the upper section of frame No. 9 with a reinforced frame,
Eurocopter MOD 53C17 or MOD 53D02, or Airbus Helicopters MOD 07
53D21 or MOD 07 53D22.

(g) Special Flight Permits

    Special flight permits to a repair facility may be issued
provided that the flight does not exceed 10 hours TIS, any crack
does not exceed a maximum crack length of 80 mm, and no passengers
are onboard.

(h) Credit for Previous Actions

    You may take credit for the actions required by paragraphs
(f)(1) and (2) of this AD if you performed them before the effective
date of this AD using Eurocopter Emergency Alert Service Bulletin
No. 05.00.63, Revision 1, dated June 18, 2012.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch
office, send it to the attention of the person identified in
paragraph (j)(1) of this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    (1) For more information about this AD, contact Matthew Fuller,
AD Program Manager, General Aviation & Rotorcraft Unit,
Airworthiness Products Section, Operational Safety Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-
5110; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or
at https://www.airbus.com/helicopters/services/technical-support.html. You may view this referenced service information at
the FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information
on the availability of this material at the FAA, call (817) 222-
5110.
    (3) The subject of this AD is addressed in European Union
Aviation Safety Agency (EASA) AD 2012-0108R1, dated September 19,
2019. You may view the EASA AD on the internet at https://www.regulations.gov in Docket No. FAA-2021-0195.

(k) Subject

    Joint Aircraft Service Component (JASC) Code: 5300: Fuselage
Structure.

    Issued on March 19, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-08183 Filed 4-21-21; 8:45 am]
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[Federal Register Volume 80, Number 169 (Tuesday, September 1, 2015)]
[Notices]
[Pages 52773-52774]
[FR Doc No: 2015-21609]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4220-DR; Docket ID FEMA-2015-0002]

West Virginia; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice amends the notice of a major disaster declaration
for State of West Virginia (FEMA-4220-DR), dated May 18, 2015, and
related determinations.

DATES: Effective Date: August 5, 2015.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Regis L.
Phelan, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of Kari Suzann Cowie as
Federal Coordinating Officer for this disaster.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance

(Presidentially Declared Disasters); 97.039, Hazard Mitigation
Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2015-21609 Filed 8-31-15; 8:45 am]
BILLING CODE 9111-23P


[Federal Register: February 10, 2009 (Volume 74, Number 26)]
[Rules and Regulations]
[Page 6541-6542]
[DOCID:fr10fe09-4]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2008-N-0039]

Oral Dosage Form New Animal Drugs; Ivermectin Paste

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect

approval of a supplemental abbreviated new animal drug application
(ANADA) filed by IVX Animal Health, Inc. The supplemental ANADA
provides for use of ivermectin oral paste for the treatment and control
of additional species of gastrointestinal parasites in horses.

DATES: This rule is effective February 10, 2009.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV 104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200-286
that provides for oral use of PHOENECTIN (ivermectin) Paste 1.87
percent for the treatment and control of additional species of
gastrointestinal parasites in horses. The supplemental ANADA is
approved as of December 18, 2008, and the regulations are amended in 21
CFR 520.1192 to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subject in 21 CFR Part 520

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. In Sec.  520.1192, remove paragraphs (b)(3), (e)(1)(ii)(A), and
(e)(1)(ii)(B); and revise paragraphs (b)(1), (b)(2), and (e)(1)(ii) to
read as follows:

Sec.  520.1192  Ivermectin paste.

* * * * *
    (b) * * *
    (1) No. 050604 for use of a 1.87 percent paste as in (e)(1) of this
section and a 0.153 percent paste for use as in paragraph (e)(2) of
this section.
    (2) Nos. 051311, 054925, 059130, and 061623 for use of a 1.87
percent paste for use as in paragraph (e)(1) of this section.
* * * * *
    (e) * * *
    (1) * * *
    (ii) Indications for use. For treatment and control of Large
Strongyles (adults): Strongylus vulgaris (also early forms in blood
vessels), S. edentatus (also tissue stages), S. equinus,
Triodontophorus spp. including T. brevicauda and T. serratus, and
Craterostomum acuticaudatum; Small Strongyles (adults, including those
resistant to some benzimidazole class compounds): Coronocyclus spp.
including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp.
including C. catinatum and C. pateratum, Cylicocyclus spp. including C.
insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus,
Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C.
goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum;
Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth-
stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-
stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus
axei; Large mouth Stomach Worms (adults): Habronema muscae; Bots (oral
and gastric stages): Gasterophilus spp. including G. intestinalis and
G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus
arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri;
Summer Sores caused by Habronema and Draschia spp. cutaneous third-
stage larvae; Dermatitis caused by neck threadworm microfilariae,
Onchocerca sp.
* * * * *

    Dated: February 3, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E9-2749 Filed 2-9-09; 8:45 am]

BILLING CODE 4160-01-S