Document ID: EPA-HQ-OPP-2005-0492-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-02-15T05:00Z

Oxytetracycline
Reader's
Guide
1
Reader's
Guide
to
Oxytetracycline
E­
Docket
#
EPA­
HQ­
OPP­
2005­
0492
EPA
has
created
this
document
to
provide
an
organizational
structure
to
the
Oxytetracycline
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
oxytetracycline
e­
docket.

Federal
Register
and
Docket
Organizational
Documents:

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

This
document
formally
and
publicly
announces
the
oxytetracycline
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
oxytetracycline
E­
Docket
#
EPA­
HQ
OPP­
2005­
0492.

This
document.
It
is
designed
to
annotate
all
the
documents
in
the
oxytetracycline
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
Oxytetracycline
TRED
SMART
Meeting
This
3
page
document
summarizes
a
January
2005
SMART
meeting
EPA
hosted
with
the
oxytetracycline
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
Drinking
Water
Exposure
Assessment
of
Oxytetracycline
Supporting
the
Reassessment
Under
FQPA
of
Pear
and
Peach
&
Nectarine
Use
Patterns
and
the
Assessment
of
the
New
Use
Pattern,
Apple
This
16
page
October
2005
document
describes
how
much
oxytetracycline
may
be
found
in
drinking
water
after
application
in
the
field.

Docket
Item
8.
Oxytetracycline
TRED.
Summary
of
Product
Chemistry
and
Residue
Data.

This
38
page
September
2005
document
reports
on
the
fate
and
metabolic
pathways
of
oxytetracycline
and
describes
how
much
oxytetracycline
is
likely
to
remain
in
food
after
use
over
time.

Docket
Item
9:
Oxytetracycline
Use
Closure
Memo,
Case
No.
0655
This
11
page
March
2005
memorandum
outlines
the
uses
and
application
rates
of
oxytetracycline
that
were
to
be
used
in
the
preliminary
risk
assessments.

Docket
Item
10:
Oxytetracycline
Chronic
Dietary
Exposure
Assessment
for
the
Tolerance
Reregistration
Eligibility
Decision
(
TRED)
Dietary
Assessment
Oxytetracycline
Reader's
Guide
3
This
2006
document
reports
the
estimated
dietary
exposure
resulting
from
applications
of
oxytetracycline
to
crops.

Docket
Item
11:
Oxytetracycline:
HED
Chapter
of
the
Tolerance
Reregistration
Eligibility
Decision
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.