Document ID: EPA-HQ-OPP-2005-0493-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-02-15T05:00Z

Oxytetracycline
Reader's
Guide
1
Reader's
Guide
to
Streptomycin
E­
Docket
#
EPA­
HQ­
OPP­
2005­
0493
EPA
has
created
this
document
to
provide
an
organizational
structure
to
the
Streptomycin
E­
Docket.
The
docket
index
groups
related
documents.
The
Agency
is
providing
this
"
Reader's
Guide"
to
allow
the
reader
to
more
easily
access
and
navigate
the
items
contained
in
the
streptomycin
e­
docket.

Federal
Register
and
Docket
Organizational
Documents:

Docket
Item
1.
Federal
Register
Notice:
Streptomycin
Risk
Assessment(
s),
Notice
of
Availability,
and
Risk
Reduction
Options
(
Phase
3
of
4­
Phase
Process)

This
document
formally
and
publicly
announces
the
streptomycin
risk
assessments
are
available
for
review
on
the
internet
or
at
the
EPA's
Office
of
Pesticides
Programs'
Public
Docket
and
solicits
comments
and
suggestions
on
the
risk
assessments
and
how
to
mitigate
or
address
potential
risks
of
concern.

Docket
Item
2.
Reader's
Guide
to
the
streptomycin
E­
Docket
#
EPA­
HQ­
OPP­
2005­
0493.

This
document.
It
is
designed
to
annotate
all
the
documents
in
the
streptomycin
E­
Docket.

Docket
Item
3.
Meeting
Summary­
Antibiotic
Resistance
Conference
Calls
This
1
page
document
summarizes
two
May
2005
conference
calls
EPA
hosted
with
US
Centers
for
Disease
Control
and
Prevention
(
CDC),
US
Food
and
Drug
Administration
(
FDA),
and
US
Department
of
Agriculture
(
USDA)
to
discuss
the
potential
for
oxytetracycline
and
streptomycin
to
contribute
to
antibiotic
resistance.
The
document
includes
a
list
of
participants,
a
summary
of
topics
discussed,
and,
if
appropriate,
next
steps
and/
or
action
items.

Docket
Item
4.
Meeting
Summary­
EPA/
FDA
Streptomycin
and
Oxytetracycline
Phase
1
Conference
Call
This
2
page
document
summarizes
a
December
2005
conference
call
EPA
hosted
with
FDA
to
discuss
FDA's
comments
on
the
preliminary
(
Phase
1)
streptomycin
and
oxytetracycline
risk
assessments.
The
document
includes
a
list
of
participants,
a
summary
of
topics
discussed,
and,
if
appropriate,
next
steps
and/
or
action
items.
Oxytetracycline
Reader's
Guide
2
Human
Health
Risk
Assessment
Documents
for
Phase
3
Public
Comments
Docket
Item
5.
Meeting­
Summary
­
EPA/
CDC
Streptomycin
and
Oxytetracycline
Phase
1
Conference
Call
This
1
page
document
summarizes
a
November
2005
conference
call
EPA
hosted
with
CDC
to
discuss
CDC's
comments
on
the
preliminary
(
Phase
1)
streptomycin
and
oxytetracycline
risk
assessments.
The
document
includes
a
list
of
participants,
a
summary
of
topics
discussed,
and,
if
appropriate,
next
steps
and/
or
action
items.

Docket
Item
6.
Meeting
Minutes­
Streptomycin
TRED
SMART
Meeting
This
3
page
document
summarizes
a
January
2005
SMART
meeting
EPA
hosted
with
the
streptomycin
technical
registrants,
CDC,
FDA,
and
USDA
to
discuss
use,
usage,
scheduling,
and
other
issues
in
preparation.
The
document
includes
a
list
of
participants,
a
summary
of
topics
discussed,
and,
if
appropriate,
next
steps
and/
or
action
items.

Docket
Item
7.
Tier
I
Estimated
Drinking
Water
Concentrations
of
Streptomycin
and
StreptomycinSulfate
for
use
in
the
Human
Health
Risk
Assessment
as
part
of
the
Tolerance
Reregistration
Eligibility
Decision
(
TRED)

This
41
page
November
2005
document
describes
how
much
streptomycin
may
be
found
in
drinking
water
after
application
in
the
field.

Docket
Item
8.
Streptomycin/
Streptomycin
Sulfate:
Chronic
Dietary
Exposure
Assessment
for
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED)

This
18
page
January
2006
document
reports
the
estimated
dietary
exposure
resulting
from
applications
of
oxytetracycline
to
crops.

Docket
Item
9:
Review
of
Streptomycin
Incident
Reports
This
4
page
August
2005
memorandum
gives
a
summary
of
the
poisoning
incident
data
on
the
active
ingredient
streptomycin.

Docket
Item
10:
Streptomycin
and
Streptomycin
Sulfate
Use
Closure
Memo
This
11
page
March
2005
memorandum
outlines
the
uses
and
application
rates
of
streptomycin
that
were
to
be
used
in
the
preliminary
risk
assessments.
Oxytetracycline
Reader's
Guide
3
Docket
Item
11:
STREPTOMYCIN
SULFATE
(
006310)
and
STREPTOMYCIN
(
006306)
HED
Chapter
of
the
Tolerance
Reassessment
Eligibility
Document
(
TRED)

This
2006
document
reports
the
potential
risk
from
dietary
and
other
exposure
to
oxytetracycline
and
includes
a
qualitative
discussion
of
the
potential
contribution
to
antibiotic
resistance.

Docket
Item
12:
Issues
to
Consider
in
Commenting
on
the
Preliminary
Risk
Assessments
for
Streptomycin
(
Case
Number
0169)
and
Oxytetracycline
(
Case
Number
0655)
in
Support
of
the
2006
TREDs
This
5
page
2006
document
presents
a
brief
background
of
the
steps
taken
in
the
tolerance
reassessment
process
to­
date
and
a
series
of
questions
to
focus
public
comments,
particularly
on
ways
to
reduce
the
likelihood
of
contributing
to
the
development
of
antibiotic
resistant
bacteria
through
the
continued
use
of
streptomycin
and/
or
oxytetracycline.