Proposed
Rule
on
Conventional
Pesticides
(
40
CFR
Part
158)

May
3­
4,
2005
Holiday
Inn
Rosslyn
1900
N.
Fort
Myer
Drive
Arlington,
VA
22209
Jean
Frane
Senior
Regulatory
Specialist
Office
of
Pesticide
Programs
2
What
Am
I
Going
to
Talk
About?


A
Little
Pre­
History
and
Background

Statutory

Regulatory

Specifics

Applicability
of
part
158

General
provisions

How
to
use
data
tables

Use
pattern
index
(
Appendix
A)


Product
Chemistry
3
The
Proposed
Rule

March
11,
2005
(
70
FR
12275)


90­
day
comment
period

Public
comments
on
or
before
June
9,
2005
4
History
and
Background
Where
did
Data
Requirements
Come
From?
5

President
Nixon
created
the
EPA ..

FDA
USDA
EPA
 .
and
data
requirements
were
without
form
and
void,

and
darkness
was
upon
the
face
of
the
applicant 

 .
In
The
Beginning
6
What
does
the
law
require?


FIFRA
is
a
licensing
statute

"
Unreasonable
adverse
effects"
standard
 
3(
c)(
5)


FFDCA
is
similar
 
individual
tolerance
decisions

"
Reasonable
certainty
of
no
harm"
standard
 
408(
b)


Both
require
submission
of
data
to
demonstrate
standard
is
met.
7
Pre­
EPA
Regulations

Data
requirements
embedded
in
the
statute
 
regulations
mirrored
statutory
language

Regulatory
data
requirements
under
FIFRA
in
1964:

o
 
if
requested
by
the
Director,
a
full
description
of
the
tests
made
and
the
results
thereof
upon
which
the
claims
for
the
economic
poison
are
based ."


Regulatory
data
requirements
under
FFDCA
in
1971:

o
" .
Full
reports
of
investigations
made
with
respect
to
the
safety
of
the
pesticide
chemical
(
These
reports
should
include 
detailed
data
derived
from
appropriate
animal
or
other
biological
experiments ..)"
8
Factoids
About
Pre­
1972
Data
Requirements

1955
­
Certification
of
Usefulness
under
FFDCA

Product
Performance

1965
 
Mrak
Report
(
NAS)


Toxicology
and
Analytical
Methods
under
FFDCA

1970
 
PR
Notice
70­
15

First
Environmental
Fate
Requirements
9
1972

FIFRA
amended
from
consumer
protection
statute
to
risk/
benefit
statute
10
Highlights
of
post­
1972
Data
Evolution

1975
 
Registration
regulations

1978
 
Guidelines
proposed

1975­
82
­
Guideline
development

1981
 
Guidelines
and
regulations
separated

1984
 
Part
158
promulgated

1988
 
Product
Chemistry
upgraded
11
What
types
of
changes
are
proposed?


Newly
imposed
requirement

Newly
codified
requirement

Revision
of
existing
requirement

Potential
elimination
of
requirement
12
Format
Changes

Simplifies
general
provisions
of
subpart
A

Deletes
unnecessary
material

Relocates
material
into
more
appropriate
parts

Creates
new
subparts
by
scientific
discipline

Correspond
to
Guideline
parts
13
Reformat
and
upgrade
structure
Subpart
G:
Product
Performance
Subpart
F:
Toxicology
Subpart
E:
Terrestrial
and
Aquatic
Non­
target
Organisms
Subpart
D
 
Everything
else
Subpart
J
:
Plant
Protection
Subpart
D:
Product
Chemistry
Subpart
C:
Product
Chemistry
Subpart
B
 
How
to
Use
Tables
Subpart
B:
How
to
Use
Data
Tables
Subpart
A
 
General
Provisions
Subpart
A:
General
Provisions
Proposed
Regulation
and
Title
Current
Regulation
and
Title
14
Proposed
Change
to
Subpart
Designations
Subpart
R:
Spray
Drift
Subpart
M:
Microbial
Pesticides
Subpart
P:
Pesticide
Management
and
Disposal
(
Reserved)

Subpart
U:
Applicator
Exposure
Subpart
W:
Antimicrobials
Subpart
L:
Biochemical
Pesticides
Subpart
K:
Post­
Application
Exposure
Subpart
D
­
continued
Proposed
Regulation
and
Title
Current
Regulation
and
Title
15
General
Provisions
 
Subpart
A

Applicability

Definitions

Flexibility

Format
of
Data

CBI

Flagging
Criteria

Waivers

Satisfaction
of
Data
Requirements
16
Applicability
to
Pesticide
Types

Conventional
pesticides
only

Does
not
address

Biochemical,
microbial
pesticides

Antimicrobial
pesticides

Plant­
Incorporated
Protectants
(
PIPs)


Inert
Ingredients

Spray
drift

Product
performance
17
Applicability
to
Actions

Registration
and
Amended
Registration

Reregistration/
DCIs

Tolerances
and
Exemptions

Experimental
Use
Permits
18
CBI

Updates
per:


Statutory
changes
o
Incorporates
FFDCA
CBI
protections
 
408(
i)

o
Now
identical
to
FIFRA
CBI
protections
­
Pre­
tolerance
not
automatically
CBI
­
All
data
submitted
for
tolerance/
exemption
=
FIFRA
data

Class
determinations
o
Extends
class
determination
on
safety
and
efficacy
data
to
all
data
required
by
part
158

Court
cases
have
limited
entitlement
to
protection
o
Section
10(
d)(
1)(
A),(
B),(
C)
data
not
entitled
to
confidentiality
unless
meet
trade
secret
criteria
of
10(
b)
19
CBI
­
continued

Defines
scope
of
"
safety
and
efficacy
information"


Includes
virtually
all
information
submitted
to
Agency
under
part
158

Post­
1988
safety
and
efficacy
data
are
non­
confidential

Requires
upfront
claim
of
CBI
 
not
upfront
substantiation

Unless
claimed
confidential,
EPA
may
release
w/
o
notice

Unless
claimed
confidential,
EPA
may
release
certain
summary
information
w/
o
affirmation
of
multi­
national
status

Procedures
for
CBI
claims
similar
to
current
regulations.


Clarifies
CBI
status
of
data
on
pre­
registration/
pre­
tolerance
chemicals

Not
automatically
protected,
must
claim
CBI

Voluntary
agreement
for
CBI
data
sharing
for
joint
review
purposes
20
Flagging
Criteria

What
are
flagging
criteria?


Means
of
prioritizing
reviews
based
upon
hazard
endpoints

Toxicology
criteria
only

Consolidated
11
 
 
7
categories

Eliminates
distinction
between
subchronic
and
chronic
studies

Combines
studies
focused
on
children

Consolidates
specific
NOAEL
study
criteria
into
generic
NOAEL
criteria
21
WAIVERS

Retains
current
provisions
 
no
substantive
changes

Waivers
recognize
that
Part
158
is
"
macro"
in
nature

Expected
data
needs,
based
on
EPA
past
experience
and
practice

Waiver
requests
appropriate
for
unusual
or
specific
products
and
use
patterns

Improved
clarity
and
transparency
of
test
notes
may
reduce
need
for
waiver
requests

Importance
of
pre­
registration
consultation
to
minimize
need
for
waiver
requests

Opportunity
to
seek
in
some
cases
time
extensions
for
data
waivers
that
are
denied
22
How
to
Use
Tables
 
Subpart
B

Expanded
use
categories
 
9
 
 
15

R
versus
CR

Test
substances

Test
notes

Guideline
numbers
for
reference

Experimental
use
permit
requirements
23
Reading
A
Table
­
Example
TABLE:
NONTARGET
PLANT
PROTECTION
DATA
REQUIREMENTS
Use
Pattern
Data
Requirement
Terrestrial
Aquatic
Forestry
and
Residential
Outdoor
Test
substance
Test
Note
No.

Nontarget
Area
Phytotoxicity
­
Tier
I
850.4100
Seedling
emergence
R
R
R
TEP
1,
2,
3
850.4150
Vegetative
vigor
R
R
R
TEP
1,
2,
3,
4
850.4400
850.5400
Aquatic
plant
growth
(
algal
and
aquatic
vascular
plant
toxicity)
R
R
R
TEP
or
TGAI
1
Nontarget
Area
Phytotoxicity
­
Tier
II
850.4225
Seedling
emergence
CR
CR
CR
TEP
1,
3,
5,
6
850.4250
Vegetative
vigor
CR
CR
CR
TEP
1,
3,
4,
5,
6
850.4400
850.5400
Aquatic
plant
growth
(
algal
and
aquatic
vascular
plant
toxicity)
CR
CR
CR
TEP
or
TGAI
1,
7
24
Guidelines
vs
Regulations

Part
158
regulations

Mandatory

Questions
that
must
be
answered

Types
of
data

Parameters
of
the
test
requirement

Guidelines

Non­
mandatory

Acceptable
Test
Protocols,
Methodology
&
Standards

Documentation
and
reporting
of
data

Parameters
of
the
testing
itself
25
How
much
will
this
cost?


Types
of
data
requirement
changes

Newly
codified
requirement
$
28.9
million

Revision
of
existing
requirement
$
21.6
million
­
Total
$
50.5
million

Out
of
the
above
only
$
1.9
are
newly
imposed

Impact
on
small
businesses

1.6%
could
experience
cost
increase
of
 
3%
or
more
of
gross
sales

2.4%
could
experience
cost
increase
of
 
1%
or
more
of
gross
sales
26
How
did
we
calculate
the
cost?


Potential
cost
of
guideline
test

Price
from
laboratories
o
Commercial
laboratories
o
In­
house
laboratories

Average
of
low
and
high
cost
estimates
o
Differences
in
price
charged
by
laboratories

Estimate
of
times
a
particular
test
was
required
o
Scientific
experience
in
Agency

Surrogate
data
or
possible
waiver
27
Product
Chemistry
 
subpart
D

Virtually
nothing
changed

1988
Watershed
Year
for
Product
Chemistry

Re­
inserted
Basic
Chemical
Information
in
Table

Product
Identity
and
Composition
Information

Production/
Formulation
Information

Certification
of
Limits
 
Actives,
Inerts,
Impurities

Enforcement
Method

Clarification
 
avoids
confusion
28
Product
Chemistry
­
continued

Add
UV
Light
Absorption

200­
800
nm
range

Feeds
into
photodegradation

Add
Particle
Size,
Fiber
Length,
Distribution

Feeds
into
spray
drift
analysis

Stability
to
Metals
 
No
Real
Change

R
 
CR

Explodability
 
No
Real
Change

R 
CR

Partition
Coefficient
 
No
Real
Change

CR 
R

Density,
Dissociation
Constant,
Vapor
Pressure

Test
notes
added
