US Environmental Protection Agency
Office of Pesticide Programs
Pesticide Registration Improvement Renewal Act (PRIA 2)
Fee Category Interpretations
July 9, 2009
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Pesticide Registration Improvement Renewal Act (PRIA 2)
Fee Category Interpretations
Under the Pesticide Registration Improvement Renewal Act of 2007, there are 140 fee categories. Interpretations of these categories are provided in the tables
below, are the same as those on the Fee Determination Decision Tree (link to http://www.epa.gov/pesticides/fees/tool/index.htm) and the PRIA 2 Fee Table (link to
http://www.epa.gov/pesticides/regulating/fees/tool/category-table.html) and describe the Agency's current thinking at this time. To the extent feasible, the Agency
has provided examples of actions that fall within each of the 140 categories. If an applicant has a question regarding the category in which a potential submission
may fall, the applicant may contact one of the Registration Fee Ombudspersons (link to http://www.epa.gov/pesticides/regulating/contacts.htm#product). These
interpretations will be revised based on experience and feedback from applicants.
The 140 fee categories have been separated into three (3) tables for the R (Registration Division), A (Antimicrobial) and B (Biopesticides and Pollution Prevention
Division) fee categories and further separated into application types. The tables provide a crosswalk of the fee code numbers listed in the Congressional Record
and the Federal Register (Published August 5, 2008 (Volume 73, Number 151) Page 45438-45450), the timeframes in which the Agency is to make a decision on
the application and the fee for Fiscal Years (FY) 2009 and 2010.
New Active Ingredient
An active ingredient that is not currently contained as an active ingredient in any registered pesticide product.
New Use (As Defined in 40 CFR 152.3)
New use, when used with respect to a product containing a particular active ingredient, means:
1. Any proposed use pattern that would require the establishment of, the increase in, or the exemption from the requirement of, a tolerance or food
additive regulation under section 408 or 409 of the Federal Food, Drug and Cosmetic Act;
2. Any aquatic, terrestrial, outdoor, or forestry use pattern, if no product containing the active ingredient is currently registered for that use pattern; or
3. Any additional use pattern that would result in a significant increase in the level of exposure, or a change in the route of exposure, to the active
ingredient of man or other organisms.
Experimental Use Permit as Define in 40 CFR 172.2
Any person wishing to accumulate information necessary to register under section 3 of the Act and the regulations thereunder
1. a pesticide not registered with this Agency or
2. a registered pesticide for a use not previously approved in the registration of the pesticide may apply to the Administrator at any time for an
experimental use permit, (b) Pesticides under experimental use permits may not be sold or distributed other than through participants and, if sold
or distributed through participants, may be used only at an application site of a cooperator and in accordance with the terms and conditions of
the experimental use permit.
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Definitions for additional terms used in these interpretations are available in the Fee Determination Decision Tree glossary (link to
http://www.epa.gov/pesticides/fees/tool/resources/glossarv.htm').
Registration Division
EPA
No.
CR
No.
Action
Interpretation
Decision
time
(months)
FY
09
FY
10
FY09/FY10
Registration
Service Fee
($)
Table 1. New Active Ingredients
R010
New Active
Ingredient, Food
use
An application that proposes a food use for an active ingredient that is not currently contained as
an active ingredient in any U.S. registered pesticide product. The use may require the
establishment of or the exemption from the requirement of a tolerance under section 408 of the
FFDCA. The application submission must contain a petition to establish tolerances or
exemption(s) from tolerance for all food/feed commodities covered by the pending registration
application(s). All uses (food and non-food) included in any original application or petition fora
new active ingredient are covered by the base fee for the application in this category if submitted
simultaneously. Some examples of food uses include corn, apples, and aquatic uses involving
potable water, irrigation, or requiring tolerances for fish, or shellfish, pasture, rangeland, home
garden, beehive, livestock, livestock housing, livestock dips, and livestock ear tags.
24
24
542,115
R020
New Active
Ingredient, Food
use; reduced risk
An application that proposes a food use for an active ingredient that is not currently contained as
an active ingredient in any U.S. registered pesticide product. The use may require the
establishment of or the exemption from the requirement of a tolerance under section 408 of the
FFDCA. The application submission must contain a petition to establish tolerances or
exemption(s) from tolerance for all food/feed commodities covered by the pending registration
application(s). All uses (food and non-food) included in any original application or petition for a
new active ingredient are covered by the base fee for the application in this category if submitted
simultaneously. Some examples of food uses include corn, apples, and aquatic uses involving
potable water, irrigation, or requiring tolerances for fish, or shellfish, pasture, rangeland, home
garden, beehive, livestock, livestock housing, livestock dips, and livestock ear tags.
A "reduced risk"(http://www.epa.gov/opprd001/workplan/reducedrisk.html)
submission must accompany the application for registration. The Agency's Reduced Risk
Committee will evaluate the submission and make the determination, based on criteria listed in
PR Notice 97-3 and FIFRA 3(c)(10) (B) (-iv), whether the requested use(s) qualify as "reduced
risk" when compared to currently registered pesticides for the same use(s). The reduced risk
status of any use of a chemical is an initial assessment. Should information warrant, or should
the Agency determine at any time that the data base for the chemical is unacceptable or upon a
more thorough review found to be insufficient to demonstrate that the use/application is reduced
risk, the Agency may reject reduced risk status. In the event that any uses do not qualify as
"reduced risk" by decision of the Reduced Risk Committee, the application will not receive the
reduced risk decision timeframes. The fee category will be changed to the non-reduced risk
category and the action will receive the longer timeframes (e.g. from an R020 New Active
Ingredient, Food Use, "reduced risk" to an R010 New Active Ingredient, Food Use).
18
18
542,115
-------
R030
R040
R050
R060
3
4
5
6
New Active
Ingredient, Food
use; Experimental
Use Permit
application
submitted
simultaneously with
application for
registration;
decision time for
Experimental Use
Permit and
temporary
tolerance same as
#4 (R040)
New Active
Ingredient, Food
use; Experimental
Use Permit
application;
establish temporary
tolerance;
submitted before
application for
registration; credit
$326, 025 toward
new active
ingredient
application that
follows
New Active
Ingredient, Food
use; application
submitted after
Experimental Use
Permit application;
decision time
begins after
Experimental Use
Permit and
temporary
tolerance are
granted
New Active
Ingredient, Non-
food use; outdoor
An Experimental Use Permit (EUP) application and the first application for the same active
ingredient submitted simultaneously for the same food use(s) that is not contained as an active
ingredient in any currently U.S. registered pesticide product. The submission contains both a EUP
request and an application for registration of a pesticide product. The applications propose a food
use. The use may require the establishment of or the exemption from the requirement of a
tolerance under section 408 of the FFDCA. The application submission must contain a petition to
establish tolerances or exemption(s) from tolerance for all food/feed commodities covered by the
pending registration application(s). All uses (food and non-food) included in any original
application or petition for a new active ingredient are covered by the base fee for the application
in this category if submitted simultaneously. Some examples of food uses include corn, apples,
and aquatic uses involving potable water, irrigation, or requiring tolerances for fish, or shellfish,
pasture, rangeland, home garden, beehive, livestock, livestock housing, livestock dips, and
livestock ear tags. The Agency will not accept a certification for crop destruct once the review
clock has started. A change to a crop destruct application would require the applicant to
withdraw their application and start the process application again.
An Experimental Use Permit (EUP) application for food use(s) of an active ingredient that is not
contained as an active ingredient in any currently U.S. registered pesticide product. The
application proposes a food use. The use may require the establishment of or the exemption
from the requirement of a tolerance under section 408 of the FFDCA. The application submission
must contain a petition to establish tolerances or exemption(s) from tolerance for all food/feed
commodities covered by the pending registration application(s). All uses (food and non-food)
included in any original application or petition for a new active ingredient are covered by the base
fee for the application in this category if submitted simultaneously. Some examples of food uses
include corn, apples, and aquatic uses involving potable water, irrigation, or requiring tolerances
for fish, or shellfish, pasture, rangeland, home garden, beehive, livestock, livestock housing,
livestock dips, and livestock ear tags. The Agency will not accept a certification for crop destruct
once the review clock has started. A change to a crop destruct application would require the
applicant to withdraw their application and start the process application again.
An application that proposes a food use for an active ingredient that is not currently contained as
an active ingredient in any U.S. registered pesticide product. The use may require the
establishment of or the exemption from the requirement of a tolerance under section 408 of the
FFDCA. The application submission must contain a petition to establish tolerances or
exemption(s) from tolerance for all food/feed commodities covered by the pending registration
application(s). Data required to support the first application for registration has been previously
reviewed in association with the earlier EUP for the same use(s). All uses (food and non-food)
included in any original application or petition for a new active ingredient are covered by the base
fee for the application in this category if submitted simultaneously. Some examples of food uses
include corn, apples, and aquatic uses involving potable water, irrigation, or requiring tolerances
for fish, or shellfish, pasture, rangeland, home garden, beehive, livestock, livestock housing,
livestock dips, and livestock ear tags.
An application that proposes a non-food use for an active ingredient that is not currently
contained as an active ingredient in any U.S. registered pesticide product. A non-food use
includes a proposed use that is not a food use as described in the food use categories. Outdoor
24
18
14
21
24
18
14
21
599,235
399,525
199,815
376,635
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use means any use that is not indoor as described in the indoor category. All non-food uses
included in the application are covered by the base fee for the application in this category if
submitted simultaneously. Non-food outdoor uses could include treatment of ornamentals in a
shade house and turf uses.
R070 7 New Active
Ingredient, Non-
food use; outdoor;
reduced risk
An application that proposes a non-food use for an active ingredient that is not currently
contained as an active ingredient in any U.S. registered pesticide product. A non-food use
includes a proposed use that is not a food use as described in the food use categories. Outdoor
use means any use that is not indoor as described in the indoor category. All non-food uses
included in the application are covered by the base fee for the application in this category if
submitted simultaneously. Non-food outdoor uses could include treatment of ornamentals in a
shade house and turf uses.
A "reduced risk" (http://www.epa.gov/opprd001/workplan/reducedrisk.html)
submission must accompany the application for registration. The Agency's Reduced Risk
Committee will evaluate the submission and make the determination, based on criteria listed in
PR Notice 97-3 and FIFRA 3(c)(10) (B) (-iv), whether the requested use(s) qualify as "reduced
risk" when compared to currently registered pesticides for the same use(s). The reduced risk
status of any use of a chemical is an initial assessment. Should information warrant, or should
the Agency determine at any time that the data base for the chemical is unacceptable or upon a
more thorough review found to be insufficient to demonstrate that the use/application is reduced
risk, the Agency may reject reduced risk status. In the event that any uses do not qualify as
"reduced risk" by decision of the Reduced Risk Committee, the application will not receive the
reduced risk decision timeframes. The fee category will be changed to the non-reduced risk
category and the action will receive the longer timeframes (e.g. from an R070 New Active
Ingredient, Non- Food Use, "reduced risk" to an R060 New Active Ingredient, Non-Food Use).
16
16
376,635
R080 8 New Active
Ingredient, Non-
food use; outdoor;
Experimental Use
Permit application
submitted
simultaneously with
application for
registration;
decision time for
Experimental Use
Permit same as #9
(R090)
An Experimental Use Permit (EUP) application and the first application for the same active
ingredient submitted simultaneously for the same non-food use(s) that is not contained as an
active ingredient in any currently U.S. registered pesticide product. The submission contains both
a EUP request and an application for registration of a pesticide product. The applications
propose a non-food use. A non-food use includes a proposed use that is not a food use as
described in the food use categories. Outdoor use means any use that is not indoor as described
in the indoor category. All non-food uses included in the application are covered by the base fee
for the application in this category if submitted simultaneously. Non-food outdoor uses could
include treatment of ornamentals in a shade house and turf uses.
21
21
416,640
R090 9 New Active
Ingredient, Non-
food use; outdoor;
Experimental Use
Permit application
submitted before
application for
registration; credit
An Experimental Use Permit (EUP) application for non-food use(s) of an active ingredient that is
not contained as an active ingredient in any currently U.S. registered pesticide product. A non-
food use includes a proposed use that is not a food use as described in the food use categories.
Outdoor use means any use that is not indoor as described in the indoor category. All non-food
uses included in the application are covered by the base fee for the application in this category if
submitted simultaneously. Non-food outdoor uses could include treatment of ornamentals in a
shade house and turf uses.
16
16
279,615
-------
$228,225 toward
new active
ingredient
application that
follows
R100 10 New Active
Ingredient, Non-
food use; outdoor;
submitted after
Experimental Use
Permit application;
decision time
begins after
Experimental Use
Permit is granted
An application that proposes a non-food use for an active ingredient that is not currently
contained as an active ingredient in any U.S. registered pesticide product. A non-food use
includes a proposed use that is not a food use as described in the food use categories. Outdoor
use means any use that is not indoor as described in the indoor category. Data required to
support the first application for registration has been previously reviewed in association with the
earlier EUP for the same use(s). All non-food uses included in the application are covered by the
base fee for the application in this category if submitted simultaneously. Nonfood outdoor uses
could include treatment of ornamentals in a shade house and turf uses.
12
12
137,025
R110 11 New Active
Ingredient, Non-
food use; indoor
An application that proposes a non-food use for an active ingredient that is not currently
contained as an active ingredient in any U.S. registered pesticide product. A non-food use
includes a proposed use that is not a food use as described in the food use categories. Indoor
means that the proposed use is for use inside of manmade structures. All indoor non-food uses
included in the application are covered by the base fee for the application in this category if
submitted simultaneously. Some examples of indoor uses are termiticide structural protection,
and indoor residential treatments (i.e. cockroach treatments). Treatment of ornamentals in a
shade house is classified as outdoor uses and is not covered in this category.
20
20
209,475
R120 12 New Active
Ingredient, Non-
food use; indoor
reduced risk
An application that proposes a non-food use for an active ingredient that is not currently
contained as an active ingredient in any U.S. registered pesticide product. A non-food use
includes a proposed use that is not a food use as described in the food use categories. Indoor
means that the proposed use is for use inside of manmade structures. All indoor non-food uses
included in the application are covered by the base fee for the application in this category if
submitted simultaneously. Some examples of indoor uses are termiticide structural protection and
indoor residential treatments (i.e. cockroach treatments). Treatment of ornamentals in a shade
house is classified as outdoor uses and is not covered in this category.
A "reduced risk" (http://www.epa.gov/opprd001/workplan/reducedrisk.html)
submission must accompany the application for registration. The Agency's Reduced Risk
Committee will evaluate the submission and make the determination, based on criteria listed in
PR Notice 97-3 and FIFRA 3(c)(10) (B) (-iv) , whether the requested use(s) qualify as "reduced
risk" when compared to currently registered pesticides for the same use(s). The reduced risk
status of any use of a chemical is an initial assessment. Should information warrant, or should
the Agency determine at any time that the data base for the chemical is unacceptable or upon a
more thorough review found to be insufficient to demonstrate that the use/application is reduced
risk, the Agency may reject reduced risk status. In the event that any uses do not qualify as
"reduced risk" by decision of the Reduced Risk Committee, the application will not receive the
reduced risk decision timeframes. The fee category will be changed to the non-reduced risk
category and the action will receive the longer timeframes (e.g. from an R120 New Active
Ingredient, Food Use, "reduced risk" to an R110 New Active Ingredient, Food Use).
14
14
209,475
-------
R121
R122
R123
R124
R130
13
14
15
16
17
New Active
Ingredient, Non-
food use; indoor;
Experimental Use
Permit application
submitted before
application for
registration; credit
$100, 000 toward
new active
ingredient
application that
follows
Enriched isomer(s)
of registered
mixed-isomer
active ingredient
New Active
Ingredient, Seed
treatment only;
includes non-food
and food uses;
limited uptake into
Raw Agricultural
Commodities
Conditional Ruling
on Preapplication
Study Waivers;
applicant initiated
First Food Use;
Indoor; Food/Food
An Experimental Use Permit (EUP) application for non-food use(s) of an active ingredient that is
not contained as an active ingredient in any currently U.S. registered pesticide product. A non-
food use includes a proposed use that is not a food use as described in the food use categories.
Indoor means that the proposed use is for use inside of manmade structures. All indoor non-food
uses included in the application are covered by the base fee for the application in this category if
submitted simultaneously. Some examples of indoor uses are termiticide structural protection,
and indoor residential treatments (i.e. cockroach treatments). Treatment of ornamentals in a
shade house is classified as outdoor uses and is not covered in this category.
An application that proposes using an enriched isomerof an active ingredient, where such
enriched isomer is not currently contained as an active ingredient in any U.S. registered pesticide
product. This category consists of active ingredients that are a variation on the molecular
structure or composition of a registered product and which will cite at least some of the generic
data conducted with a registered product. All uses (food and non-food) included in the original
application or petition for each new active ingredient are covered by the base fee for the
application in this category if submitted simultaneously.
An application for seed treatment only that proposes a food use or non-food use for an active
ingredient that is not currently contained as an active ingredient in any U.S. registered pesticide
product. All uses (food and non-food) included in the original application or petition for each new
active ingredient are covered by the base fee for the application in this category if submitted
simultaneously. In order for a food crop seed treatment to be considered a nonfood use, data
from a radiotracer study must be available showing no uptake of residues (radioactivity) from
treated seed into the aerial portion of the growing crop and guidance
(http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/860_
Residue_Chemistry_Test_Guidelines/Series/ ) is available. If residues occur in the aerial portion
of the plant, or if there is no data available to make this determination, seed treatments are
considered to be food uses requiring tolerances and fall into a different category.
A pre-application request for an active ingredient, new use, or new product. The request is for
review of each study waiver associated with any of the above pre-applications. The fee for this
category is multiplied by each additional waiver request submitted for review. The study waiver
request must include a written rationale for the study waiver and the identity of the new active
ingredient (chemical structure). The application follows after the Agency has made a ruling on the
study waiver(s). If a study waiver is denied, the application for the new active ingredient, new use
or new product can only be submitted once the study has been conducted and the applicant has
a complete application for registration. The decision on the waiver is conditional upon the review
of the formal registration application and the data accompanying the application. Formal
decisions or formal feedback on study waivers will not be made in meetings such as pre-
registration conferences, Dose Adequacy Response Team meetings (DART), or any other pre-
registration meeting with the Agency.
Table 2. New Uses
An application that proposes the first indoor food use. First food use includes a proposed use of
any U. S. registered active ingredient for which there is no registered "food use". The use may
18
18
18
6
21
18
18
18
6
21
157,500
273,945
407,610
2,184
165,375
-------
Handling
require the establishment of, or the exemption from the requirement of a tolerance under section
408 of the FFDCA. The application submission must contain a petition to establish tolerances or
exemption(s) from tolerance for all food/feed commodities covered by the pending registration
application(s). Indoor means that the proposed use is for use inside of manmade structures. All
indoor food uses included in any original application or petition for the first food use are covered
by the base fee for the application in this category if submitted simultaneously. Some examples
of food uses include use in a food handling and/or processing establishment, use on food crops in
a greenhouse, and aquatic uses involving potable water, irrigation, or requiring tolerances for fish,
or shellfish, home garden, livestock, livestock housing, and livestock dips.
R140 18 Additional food
use; Indoor,
Food/Food
Handling
An application that proposes an additional indoor food use. Additional food use includes a
proposed food use of any U. S. registered active ingredient for which there currently is a
registered food use. The use may require the establishment of the exemption from the
requirement of a tolerance under section 408 of the FFDCA. If residues are reasonably
foreseeable or likely to occur in food or feed or around food, the application submission must
contain a petition to establish tolerances or exemption(s) from tolerance for all food/feed
commodities covered by the pending registration application(s). Increases in exposure such as a
dosage rate increase or different method of application will result in the application being treated
as a new use. Indoor means that the proposed use is for use inside of manmade structures.
Some examples of food uses include use in a food handling and/or processing establishment, use
on food crops in a greenhouse, and aquatic uses involving potable water, irrigation, or requiring
tolerances for fish, or shellfish, home garden, livestock, livestock housing, and livestock dips.
15
15
38,588
R150
19
First Food Use
An application that proposes the first food use. First food use includes a proposed use for any U.
S. registered active ingredient for which there is no registered food use. The use may require the
establishment of, or the exemption from the requirement of a tolerance under section 408 of the
FFDCA. The application submission must contain a petition to establish tolerances or
exemption(s) from tolerance for all food/feed commodities covered by the pending registration
application(s). All uses included in any original application or petition for the first food use are
covered by the base fee for the application in this category if submitted simultaneously. Some
examples of food uses include corn, apples, and aquatic uses involving potable water, irrigation,
or requiring tolerances for fish, or shellfish, pasture, rangeland, home garden, beehive, livestock,
livestock housing, livestock dips, and livestock ear tags. Some examples of unusual outdoor
uses are livestock uses, (i.e. ear tags), livestock dips, and feed through treatments of livestock.
21
21
228,270
R160
20
First Food Use;
Reduced Risk
An application that proposes the first food use. First food use includes a proposed use for any U.
S. registered active ingredient for which there is no registered food use. The use may require the
establishment of, or the exemption from the requirement of a tolerance under section 408 of the
FFDCA. The application submission must contain a petition to establish tolerances or
exemption(s) from tolerance for all food/feed commodities covered by the pending registration
application(s). All food uses included in any original application or petition for the first food use are
covered by the base fee for the application in this category if submitted simultaneously. Some
examples of food uses include corn, apples, and aquatic uses involving potable water, irrigation,
or requiring tolerances for fish, or shellfish, pasture, rangeland, home garden, beehive, livestock,
livestock housing, livestock dips, and livestock ear tags.
A "reduced risk" (http://www.epa.gov/opprd001/workplan/reducedrisk.html)
submission must accompany the application for registration. The Agency's Reduced Risk
Committee will evaluate the submission and make the determination, based on criteria listed in
16
16
228,270
-------
PR Notice 97-3 and FIFRA 3(10) (B) (-iv), whether the requested use(s) qualify as "reduced risk"
when compared to currently registered pesticides for the same use(s). The reduced risk status of
any use of a chemical is an initial assessment. Should information warrant, or should the Agency
determine at any time that the data base for the chemical is unacceptable or upon a more
thorough review found to be insufficient to demonstrate that the use/application is reduced risk,
the Agency may reject reduced risk status. In the event that any uses do not qualify as "reduced
risk" by decision of the Reduced Risk Committee, the application will not receive the reduced risk
decision timeframes. The fee category will be changed to the non-reduced risk category and the
action will receive the longer timeframes (e.g. from an R160 New Use, First Food Use, "reduced
risk" to an R150 New Use, First Food Use).
R170 21 Additional Food
Use
An application that proposes an additional food use. Additional food use includes a proposed
food use for any U. S. registered active ingredient for which there currently is an approved food
use. The use may require the establishment of, or the exemption from the requirement of a
tolerance under section 408 of the FFDCA. The application submission must contain a petition to
establish tolerances or exemption(s) from tolerance for all food/feed commodities covered by the
pending registration application(s). A different pattern of use that significantly changes or
increases exposure such as a dosage rate increase or different method of application will result in
the application being treated as a new use. Some examples of food uses include corn, apples,
and aquatic uses involving potable water, irrigation, or requiring tolerances for fish, or shellfish,
pasture, rangeland, home garden, beehive, livestock, livestock housing, livestock dips, and
livestock ear tags. The fee applies to each additional food use requested up to 5 uses (i.e. the
fee for this category is multiplied by 4 if 4 uses are proposed). If six or more additional food uses
are requested in the application, fee category R190 applies. If a crop group or subgroup is
requested, the fee is based on the number of representative crops in that group or subgroup that
are not currently registered. If all of the representative crops have been registered, then
requesting the crop group will count as one additional use. Some unusual examples of outdoor
uses are livestock uses, (i.e. ear tags), livestock dips, and feed through treatments of livestock.
15
15
57,120
R180 22 Additional Food
Use; Reduced Risk
An application that proposes an additional food use. Additional food use includes a proposed
food use for any U. S. registered active ingredient for which there currently is a registered food
use. The use may require the establishment of, or the exemption from the requirement of a
tolerance under section 408 of the FFDCA. If residues are reasonably foreseeable or likely to
occur in food or feed or around food, the application submission must contain a petition to
establish tolerances or exemption(s) from tolerance for all food/feed commodities covered by the
pending registration application(s). A different pattern of use that significantly changes or
increases exposure such as a dosage rate increase or different method of application will result in
the application being treated as a new use. Some examples of food uses include corn, apples,
and aquatic uses involving potable water, irrigation, or requiring tolerances for fish, or shellfish,
pasture, rangeland, home garden, beehive, livestock, livestock housing, livestock dips, and
livestock ear tags. The fee applies to each additional food use requested up to 5 uses (i.e. the fee
for this category is multiplied by 4 if 4 uses are proposed). If six or more additional food uses are
requested in the application, fee category R200 applies. If a crop group or subgroup is
requested, the fee is based on the number of representative crops in that group or subgroup that
are not currently registered. If all of the representative crops have been registered, then
requesting the crop group will count as one additional use. Some unusual examples of outdoor
uses are livestock uses, (i.e. ear tags), livestock dips, and feed through treatments of livestock.
10
10
57,120
-------
A "reduced risk" (http://www.epa.gov/opprd001/workplan/reducedrisk.html)
submission must accompany the application for registration. The Agency's Reduced Risk
Committee will evaluate the submission and make the determination, based on criteria listed in
PR Notice 97-3 and FIFRA 3( c)(10) (B) (-iv), whether the requested use(s) qualify as "reduced
risk" when compared to currently registered pesticides for the same use(s). In the event that any
uses do not qualify as reduced risk, the application will not receive the reduced risk decision
timeframes. The reduced risk status of any use of a chemical is an initial assessment. Should
information warrant, or should the Agency determine at any time that the data base for the
chemical is unacceptable or upon a more thorough review found to be insufficient to demonstrate
that the use/application is reduced risk, the Agency may reject reduced risk status. In the event
that any uses do not qualify as "reduced risk" by decision of the Reduced Risk Committee, the
application will not receive the reduced risk decision timeframes. The fee category will be
changed to the non-reduced risk category and the action will receive the longer timeframes (e.g.
from an R180 New Use, Additional New Food Use, "reduced risk" to an R170 New Use,
Additional New Food Use).
R190 23 Additional Food
Uses, 6 or more
submitted in one
application
An application that proposes additional food uses. Additional food use includes a proposed food
use for any U. S. registered active ingredient for which there currently is a registered food use.
The use may require the establishment of, or the exemption from the requirement of a tolerance
under section 408 of the FFDCA. The application submission must contain a petition to establish
tolerances or exemption(s) from tolerance for all food/feed commodities covered by the pending
registration application (s). A different pattern of use that significantly changes or increases
exposure such as a dosage rate increase or different method of application will result in the
application being treated as a new use. Some examples of food uses include corn, apples, and
aquatic uses involving potable water, irrigation, or requiring tolerances for fish, or shellfish,
pasture, rangeland, home garden, beehive, livestock, livestock housing, livestock dips, and
livestock ear tags. The application must propose at least (6) specific additional food or feed crops
or 6 or more additional representative commodities for crop subgroups or crop groups. If a crop
group or subgroup is requested, the fee is based on the number of representative crops in that
group or subgroup that are not currently registered. If all of the representative crops have been
registered, then requesting the crop group will count as one additional use.
15
15
342,720
R200 24 Additional Food
Use; 6 or more
submitted in one
application;
Reduced Risk
An application that proposes additional food uses. Additional food use includes a proposed food
use for any U. S. registered active ingredient for which there currently is a registered food use.
The use may require the establishment of, or the exemption from the requirement of a tolerance
under section 408 of the FFDCA. The application submission must contain a petition to establish
tolerances or exemption(s) from tolerance for all food/feed commodities covered by the pending
registration application(s). A different pattern of use that significantly changes or increases
exposure such as a dosage rate increase or different method of application will result in the
application being treated as a new use. Some examples of food uses include corn, apples, and
aquatic uses involving potable water, irrigation, or requiring tolerances for fish, or shellfish,
pasture, rangeland, home garden, beehive, livestock, livestock housing, livestock dips, and
livestock ear tags. The application must propose at least (6) specific additional food or feed crops
or 6 or more additional representative commodities for crop subgroups or crop groups. If a crop
group or subgroup is requested, the fee is based on the number of representative crops in that
group or subgroup that are not currently registered. If all of the representative crops have been
registered, then requesting the crop group will count as one additional use.
10
10
342,720
-------
A "reduced risk" (http://www.epa.gov/opprd001/workplan/reducedrisk.html)
submission must accompany the application for registration. The Agency's Reduced Risk
Committee will evaluate the submission and make the determination, based on criteria listed in
PR Notice 97-3 and FIFRA 3( c)(10) (B) (-iv), whether the requested use(s) qualify as "reduced
risk" when compared to currently registered pesticides for the same use(s). In the event that any
uses do not qualify as reduced risk, the application will not receive the reduced risk decision
timeframes. The reduced risk status of any use of a chemical is an initial assessment. Should
information warrant, or should the Agency determine at any time that the data base for the
chemical is unacceptable or upon a more thorough review found to be insufficient to demonstrate
that the use/application is reduced risk, the Agency may reject reduced risk status. In the event
that any uses do not qualify as "reduced risk" by decision of the Reduced Risk Committee, the
application will not receive the reduced risk decision timeframes. The fee category will be
changed to the non-reduced risk category and the action will receive the longer timeframes (e.g.
from an R200 New Use, Additional Food Uses "reduced risk" to an R190 New Use, Additional
Food Use).
R210 25 Additional food
use; Experimental
Use Permit
application;
establish temporary
tolerance; no credit
toward new use
registration
An Experimental Use Permit (EUP) application for a new food use(s) that includes a proposed
additional food use for any U. S. registered active ingredient that is currently not registered for the
proposed use. The use may require the establishment of or the exemption from the requirement
of a tolerance under section 408 of the FFDCA. The application submission must contain a
petition to establish tolerances or exemption(s) from tolerance for all food/feed commodities
covered by the pending registration application^). Increases in exposure such as a dosage rate
increase or different method of application that will result in a temporary tolerance increase
belong to this category. Some examples of food uses include corn, apples, and aquatic uses
involving potable water, irrigation, or requiring tolerances for fish, or shellfish, pasture, rangeland,
home garden, beehive, livestock, livestock housing, livestock dips, and livestock ear tags. The
Agency will not accept a certification for crop destruct once the review clock has started (the
"clock" or decision review timeframe starts 21 days after the Agency receives the application and
the required fees or approves a fee waiver or fee exemption). A change to a crop destruct
application would require the applicant to withdraw-their application and start the process
application again.
12
12
42,315
R220 26 Additional food
use; Experimental
Use Permit
application; Crop
Destruct Basis; no
credit toward new
use registration
An Experimental Use Permit (EUP) application for a new food use(s) includes a proposed food for
any U. S. registered active ingredient that is currently not registered for the proposed use.
Food/feed commodities covered by the pending application(s) must have a certification that all
food/feed treated under the EUP will be destroyed or fed to experimental animals for testing
purposes only. Some examples of food uses include corn, apples, and aquatic uses involving
potable water, irrigation, or requiring tolerances for fish, or shellfish, pasture, rangeland, home
garden, beehive, livestock, livestock housing, livestock dips, and livestock ear tags.
17,136
R230 27 Additional use;
Non-food; Outdoor
An application that proposes a new non-food use. A non-food use includes a proposed use that
is not a food use as described in the food use categories. A different pattern of use that
significantly changes or increases exposure such as a dosage rate increase or different method
of application will result in the application being treated as a new use. Outdoor use means any
use that is not indoor as described in the indoor category. Non-food outdoor uses could include
treatment of ornamentals in a shade house, termiticide use around the perimeter of a house and
turf uses.
15
15
22,827
R240 28 Additional use;
Non-food, Outdoor,
An application that proposes a new non-food use. A non-food use includes a proposed use that
is not a food use as described in the food use categories. A different pattern in a non-food
10
10
22,827
10
-------
Reduced Risk
outdoor use that significantly changes or increases exposure such as a dosage rate increase or
different method of application will result in the application that belongs in this category. Outdoor
use means any use that is not indoor as described in the indoor category. Examples of non-food
outdoor uses are treatment of ornamentals in a shade house, termiticide use around the
perimeter of a house, and turf uses.
A "reduced risk" (http://www.epa.gov/opprd001/workplan/reducedrisk.html)
submission must accompany the application for registration. The Agency's Reduced Risk
Committee will evaluate the submission and make the determination, based on criteria listed in
PR Notice 97-3 and FIFRA 3( c)(10) (B) (-iv), whether the requested use(s) qualify as "reduced
risk" when compared to currently registered pesticides for the same use(s). In the event that any
uses do not qualify as reduced risk, the application will not receive the reduced risk decision
timeframes. The reduced risk status of any use of a chemical is an initial assessment. Should
information warrant, or should the Agency determine at any time that the data base for the
chemical is unacceptable or upon a more thorough review found to be insufficient to demonstrate
that the use/application is reduced risk, the Agency may reject reduced risk status. In the event
that any uses do not qualify as "reduced risk" by decision of the Reduced Risk Committee, the
application will not receive the reduced risk decision timeframes. The fee category will be
changed to the non-reduced risk category and the action will receive the longer timeframes (e.g.
from an R240 New Use, Non- Food Use, "reduced risk" to an R230 New Use, Food Use).
R250 29 Additional Use;
Non-food; Outdoor;
Experimental Use
Permit Application;
no credit toward
new use
registration
An Experimental Use Permit (EUP) application that proposes a new non-food use for any U.S.
registered active ingredient that is currently not registered for the proposed use. A non-food use
includes a proposed use that is not a food use as described in the food use categories. A different
pattern in a non-food outdoor use that significantly changes or increases exposure such as a
dosage rate increase or different method of application will result in the application that belongs in
this category. Outdoor use means any use that is not indoor as described in the indoor category.
Fees will not cover any subsequent application for registration of the new use. Non-food outdoor
uses could include treatment of ornamentals in a shade house, and turf uses.
17,136
R260
30
New Use, Non-
food, Indoor
An application that proposes a new non-food use. A non-food use includes a proposed use that
is not a food use as described in the food use categories. A different pattern in a non-food indoor
use that significantly changes or increases exposure such as a dosage rate increase or different
method of application will result in the application that belongs in this category. The proposed use
is for use inside of manmade structures and is not a food use. Some examples of indoor uses are
termiticides and indoor residential treatments (i.e. cockroach treatments). Treatment of
ornamentals in a shade house is classified as outdoor uses and is not covered in this category.
12
12
11,025
R270
31
New Use, Non-
food, Indoor,
Reduced Risk
An application that proposes a new non-food use. A non-food use includes a proposed use that
is not a food use as described in the food use categories. A different pattern in a non-food indoor
use that significantly changes or increases exposure such as a dosage rate increase or different
method of application will result in the application that belongs in this category. The proposed use
is for use inside of manmade structures and is not a food use. Some examples of indoor uses
are termiticides and indoor residential treatments (i.e. cockroach treatments). Treatment of
ornamentals in a shade house is classified as outdoor uses and is not covered in this category.
A "reduced risk" (http://www.epa.gov/opprd001/workplan/reducedrisk.html)
submission must accompany the application for registration. The Agency's Reduced Risk
Committee will evaluate the submission and make the determination, based on criteria listed in
11,025
11
-------
PR Notice 97-3 and FIFRA 3 (c (10) (B) (-iv), whether the requested use(s) qualify as "reduced
risk" when compared to currently registered pesticides for the same use(s). In the event that any
uses do not qualify as reduced risk, the application will not receive the reduced risk decision
timeframes. The reduced risk status of any use of a chemical is an initial assessment. Should
information warrant, or should the Agency determine at any time that the data base for the
chemical is unacceptable or upon a more thorough review found to be insufficient to demonstrate
that the use/application is reduced risk, the Agency may reject reduced risk status. In the event
that any uses do not qualify as "reduced risk" by decision of the Reduced Risk Committee, the
application will not receive the reduced risk decision timeframes. The fee category will be
changed to the non-reduced risk category and the action will receive the longer timeframes (e.g.
from an R270 New Use, Non-Food Use "reduced risk" to an R260 New Use, Non-Food Use).
R271 32 New use; non-food;
indoor;
Experimental Use
Permit application;
no credit toward
new use
registration
An Experimental Use Permit (EUP) application for a new non-food use(s) includes a proposed
non-food use for any U. S. registered active ingredient that is currently not registered for the
proposed use. A non-food use includes a proposed use that is not a food use as described in the
food use categories. Increases in exposure such as a dosage rate increase or different method
of application will result in the application being treated as a new use. The proposed use is for
use inside of manmade structures and is not a food use. Some examples of indoor uses are
termiticide structural protection and indoor residential treatments (i.e. cockroach treatments).
Treatment of ornamentals in a shade house is classified as outdoor uses and is not covered in
this category.
8,400
R272 33 Review of Study
Protocol; applicant-
initiated; excludes
DART, pre-
registration
conferences, Rapid
Response review,
DNT protocol
review, protocols
needing HSRB
review
An application for approval of each study protocol. Applicant provides a written copy of the
protocol along with any specific questions about the protocol. The fee for this category is
multiplied by each additional protocol submitted for review.
PRIA-2 fees are not applicable for pre-submission or pre-registration conferences or discussions
with the EPA such as Dose Adequacy Response Team (DART), EFED Rapid Response review,
ChemSac review, DNT protocol reviews and HSRB review.
2,184
R273 34 Additional use;
seed treatment;
limited uptake into
Raw Agricultural
Commodities;
includes crops with
established
tolerances (e.g., for
soil or foliar
application);
includes food
and/or non-food
uses
An application that proposes an additional seed treatment use for any U.S. registered
active ingredient for food use or non-food use seed treatment. In order for a seed
treatment to be considered in this category when proposed for seed treatment use on a
food crop, data from a radiotracer study must be available showing no uptake of residues
(radioactivity) from treated seed into the aerial portion of the growing crop and guidance
(http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/860_Residue_Chemistry
_Test_Guidelines/Series/) is available. If residues occur in the aerial portion of the plant, or if
there is no data available to make this determination, seed treatments are considered to be food
uses requiring tolerances and fall into a different category. Examples of food uses are corn,
soybean, and wheat. If a seed treatment use is proposed on ornamental seed or other non-food
use seed treatment then the application would be in this category because it is known, without
consideration of any data, that a tolerance is not required. The fee applies to each seed treatment
use requested up to 5 uses (i.e. the fee for this category is multiplied by 4 if 4 seed uses are
proposed). If a crop group or subgroup is requested, the fee is based on the number of
representative crops in that group or subgroup that are not currently registered. If all of the
12
12
43,575
12
-------
representative crops have been registered, then requesting the crop group will count as one
additional use. If a numerical tolerance needs to be established, the application does not belong
in this category. If six or more seed treatment uses are being proposed, this is not the correct
category (see R274).
R274 35 Additional uses;
seed treatment
only; 6 or more
submitted in one
application; limited
uptake into Raw
Agricultural
Commodities;
includes crops with
established
tolerances (e.g., for
soil or foliar
application);
includes food
and/or non food
uses
An application that proposes an additional seed treatment use for any U.S. registered
active food use or non-food use for an active ingredient that is currently contained as
an active ingredient in any U.S. registered pesticide product. The application must
propose at least (6) specific seed treatment uses or 6 or more representative seeds for
crop subgroups or crop groups. In order for a seed treatment to be considered in this
category when proposed for seed treatment use on a food crop, data from a radiotracer
study must be available showing no uptake of residues (radioactivity) from treated seed
into the aerial portion of the growing crop and guidance
(http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/860_Residue_
Chemistry_Test_Guidelines/Series/) is available. If residues occur in the aerial portion of the
plant, or if there is no data available to make this determination, seed treatments are considered
to be food uses requiring tolerances and fall into a different category. Examples of food uses are
corn, soybean, and wheat. If a seed treatment use is proposed on ornamental seed or other
non-food use seed treatment use, then the application would be in this category because it is
known, without consideration of any data, that a tolerance is not required. If a crop group or
subgroup is requested, the fee is based on the number of representative crops in that group or
subgroup that are not currently registered. If all of the representative crops have been registered,
then requesting the crop group will count as one additional use. If a numerical tolerance needs to
be established, the application does not belong in this category.
12
12
261,450
Table 3. Import and Other Tolerances
R280 36 Establish Import
tolerance
New active
ingredient or first
food use
A petition for an active ingredient that is not currently contained as an active ingredient in any
U.S. registered pesticide product or a petition for the first food use. The petition proposes the
establishment of, or the exemption from the requirement of a tolerance under section 408 of the
FFDCA. The food or feed commodities are imported into the U.S. The applicant is not seeking a
domestic registration for the new active ingredient and no tolerances exist in the U.S. for the
active ingredient. For the first food use, there is a currently U.S. registered non-food use product
and the applicant is not seeking a domestic registration for the proposed food use. All food
tolerances included in the original petition for a new active ingredient or a first food use are
covered by the base fee for that application in this category if submitted simultaneously. Some
examples of food uses include corn, apples, and aquatic uses involving potable water, irrigation,
or requiring tolerances for fish, or shellfish, pasture, rangeland, home garden, beehive, livestock,
livestock housing, livestock dips, and livestock ear tags.
21
21
275,625
R290 37 Establish Import
tolerance
Additional new food
use
A petition application that proposes the establishment of or the exemption from the requirement of
a tolerance under section 408 of the FFDCA for an active ingredient that has a currently approved
U.S. food tolerance. The food or feed commodities are imported into the US. If a crop group or
subgroup is requested, the fee is based on the number of representative crops in that group or
subgroup that are not currently registered. If all of the representative crops have been
established, then requesting the crop group will count as one additional use. The applicant is not
seeking a domestic registration for the additional food use. Some examples of food uses include
corn, apples, and aquatic uses involving potable water, irrigation, or requiring tolerances for fish,
or shellfish, pasture, rangeland, home garden, beehive, livestock, livestock housing, livestock
dips, and livestock ear tags.
15
15
55,125
13
-------
R291
R292
R293
R294
R295
R296
38
39
40
41
42
43
Establish import
tolerances;
additional food
uses; 6 or more
crops submitted in
one petition
Amend an
established
tolerance (e.g.,
decrease or
increase); domestic
or import;
applicant-initiated
Establish
tolerance(s) for
inadvertent
residues in one
crop; applicant-
initiated
Establish
tolerances for
inadvertent
residues; 6 or more
crops submitted in
one application;
applicant-initiated
Establish
tolerances(s) for
residues in one
rotational crop in
response to a
specific rotational
crop application;
applicant-initiated
Establish
tolerances for
residues in
A petition application that proposes the establishment of or the exemption from the requirement of
a tolerance under section 408 of the FFDCA for an active ingredient that has a currently approved
U.S. food tolerance. The food or feed commodities will be imported into the US. The applicant is
not seeking a domestic registration for the additional food use. The petition must propose at least
(6) specific food or feed crops or 6 or more representative commodities for crop subgroups or
crop groups. If a crop group or subgroup is requested, the fee is based on the number of
representative crops in that group or subgroup that are not currently registered. If all of the
representative crops have been established, then requesting the crop group will count as one
additional use
An application and/or a petition request to amend an existing tolerance on domestic or imported
crops. This may be a request to increase or decrease an existing tolerance currently established
under section 408 of the FFDCA. This may be a request to add a representative commodity to an
existing tolerance currently established in order to complete a group or subgroup. The fee for this
category is multiplied by each additional request to amend an existing tolerance.
If a crop group or subgroup is requested, the fee is based on the number of representative crops
in that group or subgroup that are not currently registered. If all of the representative crops have
been registered, then requesting the crop group will count as one additional use. Some examples
of food uses include corn, apples, and aquatic uses involving potable water, irrigation, or requiring
tolerances for fish, or shellfish, pasture, rangeland, home garden, beehive, livestock, livestock
housing, livestock dips, and livestock ear tags.
An application and petition that proposes to establish tolerances for each non-target crop
resulting in inadvertent residues. The active ingredient is currently contained in a pesticide
product registered in the U.S. The fee to establish tolerances for each crop will be multiplied by
the number of crops in the petition (i.e. 5 crops, the fee will be multiplied 5 times the fee for this
category). If a crop group or subgroup is requested, the fee is based on the number of
representative crops in that group or subgroup that are not currently registered. If all of the
representative crops have been registered, then requesting the crop group will count as one
additional use.
An application and petition that proposes to establish tolerances for 6 or more non-target crops
resulting in inadvertent residues. The active ingredient is currently contained in a pesticide
product registered in the U.S. If a crop group or subgroup is requested, the fee is based on the
number of representative crops in that group or subgroup that are not currently registered. If all of
the representative crops have been registered, then requesting the crop group will count as one
additional use.
An application and petition that proposes to establish tolerances for each crop that is rotated and
results in rotational crop residues. The active ingredient is currently contained in a pesticide
product registered in the U.S. The fee to establish tolerances for each crop will be multiplied by
the number of crops in the petition (i.e. 5 crops, the fee will be multiplied 5 times the fee for this
category). If a crop group or subgroup is requested, the fee is based on the number of
representative crops in that group or subgroup that are not currently registered. If all of the
representative crops have been registered, then requesting the crop group will count as one
additional use.
An application and petition that proposes to establish tolerances for 6 or more crops that are
rotated and results in rotational crop residues. The active ingredient is currently contained in a
pesticide product registered in the U.S. If a crop group or subgroup is requested, the fee is based
15
10
12
12
15
15
15
10
12
12
15
15
330,750
39,165
46,200
277,200
57,120
342,720
14
-------
R300
R301
44
45
rotational crops in
response to a
specific rotational
crop petition; 6 or
more crops
submitted in one
application;
applicant-initiated
New product;
identical or
substantially similar
in composition and
use to a registered
product; no data
review or only
product chemistry
data; cite-all data
citation, or
selective data
citation where
applicant owns all
required data, or
applicant submits
specific
authorization letter
from data owner.
Category also
includes 100% re-
package of
registered end use
or manufacturing-
use product that
requires no data
submission nor
data matrix
New product;
identical or
substantially similar
on the number of representative crops in that group or subgroup that are not currently registered.
If all of the representative crops have been registered, then requesting the crop group will count
as one additional use.
Table 4. New Products
An application for registration of an end-use or a manufacturing use pesticide product that is
substantially similar or identical in its uses and/or formulation to products that are currently
registered or differ only in ways that would not significantly increase the risk of unreasonable
adverse effects. The applicant must identify the similar products for all active ingredients in the
proposed product. All applications require the following:
• A data matrix is required with the application.
• Product chemistry data (Group A and B) unless the product is identical (e.g. 100%
repackaged product). In some cases product chemistry data can be satisfied as outlined
in Pesticide Registration Notice 98-1 .
• All inerts must already be approved for the applicable uses in the product.
• The active ingredient listed on the CSF must be an EPA registered product.
• In all cases, the applicant must identify the currently registered similar product for this
category.
• Acute toxicity requirements must be addressed by using: 1) cite-all method or 2)
selective data citation where the applicant owns all required data or; the applicant
submits specific authorization letter from data owner.
The application is not in this category if efficacy, acute toxicity, companion animal safety, and/or
child resistant packaging data are submitted and must be reviewed to support the application.
The application does not fall into this category if it contains a request to waive any of these data.
An application that requires review of cited or submitted data other than product chemistry does
not belong in this fee category.
Substantially similar: Product must have the same active ingredient, in substantially the same
proportion, same chemical composition (solid, liquid, granular), and substantially similar inert
ingredients as the already registered product. In addition, substantially similar means that the
proposed product bears the same use patterns. Adding to or changing existing use patterns
exclude the proposed product from treatment as a substantially similar product. Deleting use
patterns is acceptable.
Identical: Same composition and use patterns as a currently registered end use product.
Manufacturing Use Product: A 100% re-package of a manufacturing use product that requires no
data submission or data matrix is covered by this category.
An application for registration of an end-use pesticide product that is substantially similar or
identical in its uses and/or formulation to products that are currently registered or differ only in
ways that would not significantly increase the risk of unreasonable adverse effects. The applicant
3
4
3
4
1,365
1,638
15
-------
in composition and
use to a registered
product; registered
source of active
ingredient;
selective data
citation only for
data on product
chemistry and/or
acute toxicity
and/or public health
pest efficacy,
where applicant
does not own all
required data and
does not have a
specific
authorization letter
from data owner
must identify the similar products for all active ingredients in the proposed product. All
applications require the following:
• A data matrix is required with the application.
• Product chemistry data (Group A and B) unless the product is identical. In some cases
product chemistry data can be satisfied as outlined in Pesticide Registration Notice 98-1.
• All inerts must already be approved for the applicable uses in the product.
• The active ingredient listed on the CSF must be an EPA registered product.
• In all cases, the applicant must identify the currently registered similar product for this
category.
• Acute toxicity, efficacy, public health pest efficacy, companion animal safety data and/or
child resistant packaging data requirements must be addressed by using: 1) the cite-all
method, or 2) selective data citation where the applicant does not own all required data
and does not have a specific authorization letter from the data owner. If review of data is
needed, this application does not fall within this category.
The application is not in this category if efficacy, acute toxicity, companion animal safety, and/or
child resistant packaging data are submitted and must be reviewed to support the application.
The application does not fall into this category if it contains a request to waive any of these data.
An application that requires review of cited or submitted data other than product chemistry does
not belong in this fee category.
An application proposed as a 100% re-packaged product does not fall within this category (see
category R300).
Substantially similar: Product must have the same active ingredient, in substantially the same
proportion, same chemical composition (solid, liquid, granular), and substantially similar inert
ingredients as the already registered product. In addition, substantially similar means that the
proposed product bears the same use patterns. Adding to or changing existing use patterns
exclude the proposed product from treatment as a substantially similar product. Deleting use
patterns is acceptable.
Identical: Same composition and use patterns as a currently registered end use product.
R310 46 New end-use or
manufacturing-use
product; requires
review of data
package within RD;
includes reviews
and/or waivers of
data for only:
- product chemistry
and/or
- acute toxicity
and/or
-public health pest
efficacy
An application for registration of an end-use or manufacturing use pesticide product that is not
substantially similar or identical in its uses and formulation to products that are currently
registered. All applications require the following:
• A data matrix is required with the application.
• Product chemistry data (Group A and B). In some cases product chemistry data can be
satisfied as outlined in Pesticide Registration Notice 98-1.
• All inerts must already be approved for the applicable uses in the product.
• Acute toxicity, efficacy, public health pest efficacy, companion animal safety data and/or
child resistant packaging data requirements must be addressed by using: 1) the cite-all
method, or 2) selective data citation which includes submitting required data. A rationale
for a waiver or bridging of these data falls within this category.
An application proposed as a 100% re-packaged product does not fall within this category (see
category R300).
4,578
16
-------
R311
R312
49
50
New product;
requires approval
of a new food-use
inert; applicant-
initiated; excludes
approval of
safeners
New product;
requires approval
of new non-food
If an applicant owns the generic data and does not qualify for the formulator's exemption, the
new product application belongs in this category. The application does not fall into this category if
it contains a request to waive generic data or a request to review any generic data.
An application for registration for a new end-use pesticide product containing an active ingredient
that is currently registered for the proposed food uses in the US. The proposed formulation
contains an inert ingredient that has not been approved for use on food use sites (refer to
definition of food use). The applicant requests the inert be granted a tolerance exemption or a
tolerance.
The request for the new inert ingredient's tolerance or tolerance exemption on food sites must
include an application for registration of a new pesticide product. All data (inert and end use
product) and the petition and Notice of Filing (NOF) for the inert ingredient tolerance or tolerance
exemption must be submitted with the application. If a new product registration is not sought,
then the request for food use inert tolerance falls outside of the scope of PRIA.
Approval of a safener does not fall within this category, but falls within the applicable new active
ingredient category.
Data on the new food use inert ingredient: OPP highly recommends the applicant request a
meeting with the Inert Ingredients Assessment Branch (NAB) staff prior to submission under PRIA
to go over data needs. Data to support the inert approval must accompany the application.
Inert ingredients are found in section 180.910 - 960
(http://www.epa.gov/opprd001/inerts/decisiondoc_a2k.html) [Note: A number of exemptions have
expiration dates.]
All applications require the following:
• A data matrix is required with the application.
• Product chemistry data (Group A and B) unless the product is identical. In some cases
product chemistry data can be satisfied as outlined in Pesticide Registration Notice 98-1 .
• All other inert ingredients must already be approved for the applicable uses in the
product.
• Acute toxicity, efficacy, public health pest efficacy, companion animal safety data and/or
child resistant packaging data requirements must be addressed by using: 1) the cite-all
method, or 2) selective data citation which includes submitting the required data. A
rationale for a waiver or bridging of these data falls within this category.
Since this category requires both an application for the product and a petition to approve the inert
ingredient, the entire package must be processed together. If one part of the package fails (i.e.,
inert approval) then the application for the product also fails. A change to the application would
require the applicant to withdraw-their application and petition and start the process application
again.
An application for registration of a new an end-use or manufacturing use pesticide product
containing an active ingredient that is currently registered in the US for the proposed non-food
uses. The proposed formulation contains an inert ingredient that has not been approved for non-
12
6
12
6
16,317
8,715
17
-------
use inert; applicant
initiated
food uses and the applicant requests that the inert be approved for a non-food uses.
The request for the new inert ingredient's use on non-food sites must include an application for
registration of a new pesticide product. All data (inert and end use product) and a request for
approval of the non-food use inert ingredient must be submitted with the application. If a new
product registration is not sought, then the request for non-food use falls outside of the scope of
PRIA.
Approval of a safener does not fall within this category, but falls within the applicable new active
ingredient category.
Data on the new non food inert ingredient: OPP highly recommends the applicant request a
meeting with NAB staff (inertsbranch@epa.gov) prior to product submission under PRIA to go
over data needs. Data to support the inert approval must accompany the application.
All applications require the following:
• A data matrix is required with the application.
• Product chemistry data (Group A and B). In some cases product chemistry data can be
satisfied as outlined in Pesticide Registration Notice 98-1.
• All other inert ingredients must already be approved for the applicable uses in the
product.
• Acute toxicity, efficacy, public health pest efficacy, companion animal safety data and/or
child resistant packaging data requirements must be addressed by using: 1) the cite-all
method, or 2) selective data citation. A rationale for a waiver or bridging of these data
falls within this category.
Since this category requires both an application for the product and inert ingredient information,
the entire package must be processed together. If one part of the package fails (i.e., inert or
product specific data) then the whole category fails. Any change to the application would require
the applicant to withdraw their application and start the process application again.
R313 51 New product;
requires
amendment to
existing inert
tolerance
exemption (e.g.,
adding post-
harvest use);
applicant initiated
An application for registration of a new end-use or manufacturing use pesticide product containing
an active ingredient that is currently registered in the US for the proposed uses. The proposed
formulation contains an inert ingredient that has an exemption from a tolerance and the product's
use will require amending the tolerance exemption of the inert ingredient only. In addition to the
request for a pesticide product registration, the application contains a petition to amend the
existing exemption(s) from a tolerance for all uses covered by the pending registration
application. Appropriate tolerances exist for the active ingredient for the uses proposed in the
application.
The request to amend an inert ingredient's tolerance exemption must include an application for
registration of a new pesticide product. All data (inert and end use product) and the petition and
Notice of Filing (NOF) for the inert ingredient or tolerance exemption must be submitted with the
application. If a new product registration is not sought, then the request for food use inert
tolerance falls outside of the scope of PRIA.
Approval of a safener does not fall within this category, but falls within the applicable new active
10
10
11,991
18
-------
ingredient category.
Inert ingredients are found in section 180.910 - 960
(http://www.epa.gov/opprd001/inerts/decisiondoc_a2k.html) [Note: A number of exemptions have
expiration dates.]
All applications require the following:
• A data matrix is required with the application.
• Product chemistry data (Group A and B). In some cases product chemistry data can be
satisfied as outlined in Pesticide Registration Notice 98-1.
• All other inert ingredients must already be approved for the applicable uses in the
product.
• Acute toxicity, efficacy, public health pest efficacy, companion animal safety data and/or
child resistant packaging data requirements must be addressed by using: 1) the cite-all
method, or 2) selective data citation which includes submitting the required data. A
rationale for a waiver or bridging of these data falls within this category.
Since this category requires both an application for the product and a petition to approve the inert
ingredient, the entire package must be processed together. If one part of the package fails (i.e.,
inert approval) then the application for the product also fails. A change to the application would
require the applicant to withdraw-their application and petition and start the process application
again.
R320 47 New product; new
physical form;
requires data
review in science
divisions
An application for registration of a pesticide product that is not substantially similar or identical in
its uses or formulation to products that are currently registered. A change in the formulation type
or timing of application for the registered physical form that would require residue data
(http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/860_Residue_Chemistry
_Test_Guidelines/Series/), environmental fate data
(http://www.epa.gov/oppefed1/ecorisk_ders/terrestrial_field_dissipation.htm#IC), and/or
ecotoxicity, exposure data, etc., to support the change. For example this includes a change in the
formulation that would change the way a product is applied (i.e. spot-on treatments, controlled
release formulation), a change in the toxicity and/or exposure profile of the product, a pre-mix
product that is not currently registered that requires science review per current guidelines, a
change in the application rates or PHI, animal products with rate depletion data, change in the
formulation, e.g. going from a liquid to a solid, etc.
12
12
11,424
R330 48 New
manufacturing-use
product; registered
active ingredient;
selective data
citation
An application for registration of a manufacturing use pesticide product that is not substantially
similar or identical in its formulation to products that are currently registered for which the
selective data citation is used. New manufacturing use product is any product intended (labeled)
for formulation or repackaging into an end use formulated pesticide product. This product does
not contain directions for use of the product as distributed or sold, or after combination by the
user with other substances.
All applications require the following:
• A data matrix is required with the application.
• Product chemistry data (Group A and B). In some cases product chemistry data can be
satisfied as outlined in Pesticide Registration Notice 98-1.
• All inerts must already be approved for the applicable uses in the product.
12
12
17,136
19
-------
• Acute toxicity, efficacy, public health pest efficacy, companion animal safety data and/or
child resistant packaging data requirements must be addressed by using: 1) selective
data citation. A rationale for a waiver or bridging of these data falls within this category.
An application proposed as a 100% re-packaged product does not fall within this category (see
category R300).
An application for registration of a new product that is a new salt form of an already registered
active ingredient and there are not any currently registered products for this salt form falls into this
category. The Agency will decide on a case-by-case basis if the active ingredient is a new active
ingredient.
R331 52 New product;
repack of identical
registered end-use
product as a
manufacturing-use
product; same
registered uses
only
An application for registration of a manufacturing use pesticide product that is identical in its
formulation and uses to end use products that are currently registered. All applications require
the following:
• A formulator's Exemption statement
• The applicant must identify the registered identical product for this category
• The active ingredient listed on the CSF must be an EPA registered product in order to
satisfy the data requirements for the active ingredient.
If the use pattern for the proposed product differs from the currently registered product, then
additional data are required and the application does not fall within this category (see applicable
new use categories).
2,184
R332 53 New
manufacturing-use
product; registered
active ingredient;
unregistered
source of active
ingredient;
submission of
completely new
generic data
package;
registered uses
only
An application for registration of a manufacturing use pesticide product that is not substantially
similar or identical in its formulation to products that are currently registered. New manufacturing
use product is any product intended (labeled) for formulation or repackaging into an end use
formulated pesticide product. This product does not contain directions for use of the product as
distributed or sold, or after combination by the user with other substances. All applications
require the following:
• A data matrix is required with the application.
• Product chemistry data (Group A and B).
• Acute toxicity data must be addressed by submitting data or using: selective data citation.
A rationale for a waiver or bridging of these data falls within this category.
• The source of the active ingredient is unregistered
• The proposed uses must already be on currently registered products.
• The applicant must cite the similar product with the proposed uses.
• The application contains generic data such as toxicity, environmental fate and/or eco-
toxicity.
24
24
244,650
Table 5. Amendments to Registration
R340 54 Amendment
requiring data
review within RD
(e.g., changes to
precautionary label
statements, or
source changes to
an unregistered
source of active
Modification in the label, formula, or packaging of a registered product which is substantially
similar or is not substantially similar to a currently registered product and which requires the
submission of data or the citation of data by the registrant which requires an analysis by the
Registration Division (RD) only. In all cases the inert ingredients must be already be approved for
the applicable uses in the product. Examples of actions in this category include: formulation
changes to use an unregistered source of active ingredient using the cite-all method of support for
the generic requirements, alternate formulations with data including, 5-batch analysis data, label
changes to Precautionary Statements based on product chemistry and/or acute product toxicity
data; efficacy data; companion animal safety data; child resistant packaging data. Registered
3,444
20
-------
R350
R370
R371
R372
55
56
57
58
ingredient)
Amendment
requiring data
review in science
divisions (e.g.,
changes to REI, or
PPE, or PHI, or use
rate, or number of
applications; or add
aerial application;
or modify GW/SW
advisory statement)
Cancer
reassessment,
applicant-initiated
Amendment to
Experimental Use
Permit; requires
data review/risk
assessment
Refined ecological
and/or endangered
species
assessment;
applicant-initiated
source of active ingredient means that the active ingredient has been issued an EPA Registration
Number (license). EPA-initiated amendment shall not be charged fees. Label amendments
submitted by notification under PR Notices, such as PR Notice 98-10, continue under PR Notice
timelines and are not subject to PRIA fees.
Modification in the label of a registered product that is not substantially similar to a currently
registered product and that requires risk analysis by the Agency (i.e. by the Health Effects
Division (HED), the Environmental Fate and Effects Division (EFED), the Biological and Economic
Analysis Division (BEAD), Alternate Risk Integration Assessment Team(ARIA) etc.) to support the
change. Examples of actions in this category include: label changes to Directions for Use
(including REI, PPE, PHI, application rate, application frequency, application timing, addition of
aerial or chemigation application methods consistent with PR Notice 87-1 and 93-2, ground water
or surface water advisory statements, etc. that require risk analysis by EPA. In some cases, the
applicant might not submit new data to support the label amendment, but the Agency would need
a determination of whether the existing database would support a change or modification to the
amended label. EPA-initiated amendment shall not be charged fees. Label amendments
submitted by notification under PR Notices, such as and PR Notice 98-10, continue under PR
Notice timelines and are not subject to PRIA 2 fees.
An application which requests to change the cancer classification.
An application to amend an Experimental Use Permit (EUP) application for the currently
registered uses. The application requires review of the amendment, including data review and/or
new risk assessments for the currently registered uses. If new uses are being proposed, then
the application would not fall within this category.
To be determined and will be published when available.
8
18
6
18
8
18
6
12
1 1 ,424
171,255
8,715
163,065
Antimicrobials Division
A380
59
New Active
Ingredient
Food use, establish
tolerance
exemption
Table 6. New Active Ingredients
An application that proposes a food use for an active ingredient that is not currently contained as
an active ingredient in any U.S. registered pesticide product. The use may require the
establishment of an exemption from the requirement of a tolerance under section 408 of the
Federal Food, Drug, and Cosmetic Act (FFDCA), or an increase in or a food additive regulation or
other clearance under section 409 of the FFDCA. The application may need to include a petition
to establish an exemption from tolerance for all food commodities covered by the pending
registration application(s) or, if residues would not be subject to FFDCA section 408,
documentation of an applicable food additive regulation or other clearance under section 409 of
the FFDCA. Refer to the definition of a "food use" for the uses subject to this category. All uses
(food and non-food) included in any original application or petition for a new active ingredient or a
first food use are covered by the base fee for that application in this category if submitted
simultaneously.
Examples include:
24
24
99,225
21
-------
A390
60
New Active
Ingredient
Food use, establish
tolerance
• Pre- and post-harvest use on crops (other than agricultural fungicides
and aquatic herbicides, which are handled as conventional pesticides)
• Animal drinking water treatment (meat, meat by-products and/or milk
tolerance exemption)
• Process water treatment for post harvest use (field washing of raw
agricultural commodities)
• Treatment of permanent or semi-permanent food contact surfaces
(sanitizers and disinfectants)
• Use of the product in food contact articles, other than food packaging with an
intended ongoing effect in the finished article, including the articles surface or in food
that may contact the article (e.g., conveyor belt-claims to kill bacteria on articles
that come in contact with belt; or a lubricant with claims that the lubricant kills
bacteria
• Treatment of raw agricultural commodities in a food processing facility (FDA
food additive regulation)
• Process water treatment in a food handling facility to control a pest in the water (FDA food
additive regulation)
• Slimicides (FDA food additive regulation) (e.g., pulp and paper board)
• Production of food packaging (FDA food additive regulation)(e.g.,
adhesives, coatings)
• Production of food contact articles other than food packaging (FDA food
additive regulation) (cutting board that contains an antimicrobial as a
preservative)
• Food handling storage establishment premises and equipment (e.g.
eating establishments, meat processing equipment, food handling
equipment)
• Aseptic packaging (FDA food additive regulation)
• Ethanol production (treatment of empty fermentation tank) (check with the
Agency prior to submission of an application)
• Aquatic area application (e.g., lakes, ponds, reservoirs, irrigation systems) (other than
aquatic herbicides which are handled as conventional pesticides)
• Home produce washes (dietary risk assessment required)
• Human drinking water systems (e.g., water purifier units, emergency water
systems, municipal water treatment)
An application that proposes a food use for an active ingredient that is not currently contained as
an active ingredient in any U.S. registered pesticide product. The use may require the
establishment of or the increase in a tolerance under section 408 of the Federal Food, Drug and
Cosmetic Act (FFDCA). If residues are reasonably foreseeable or likely to occur in or around
food, either directly or indirectly, the application may need to include a petition to establish a
tolerance for all food commodities covered by the pending registration application(s). However,
some uses may not require a petition but still be considered under this category. Refer to the
definition of a "food use" for the uses subject to this category. All uses (food and non-food)
included in any original application or petition for a new active ingredient or a first food use are
covered by the base fee for that application in this category if submitted simultaneously.
Examples include:
24
24
165,375
22
-------
A400
A410
61
62
New Active
Ingredient, Non-
food use, outdoor,
FIFRAsec. 2(mm)
uses
New Active
Ingredient
Non-food use,
outdoor, uses other
than FIFRA 2(mm)
• Pre- and post-harvest use on crops (other than agricultural fungicides and aquatic
herbicides, which are handled as conventional pesticides)
• Animal drinking water treatment (meat, meat by-products, and/or milk
tolerance)
• Process water treatment for post harvest use (field washing of raw
agricultural commodities)
• Treatment of permanent or semi-permanent food contact surfaces
(sanitizers and disinfectants)
• Use in the production of food contact articles, other than food
packaging, with an intended ongoing effect in the finished article including the
article's surface or in food that may contact the article (e.g. conveyor belt with
claims to kill bacteria on articles that come in contact with belt)
• Food handling storage establishments premises and equipment (e.g. eating
establishments, meat processing equipment, food handling equipment)
• Ethanol production (treatment of empty fermentation tank)) (check with the
Agency prior to submission of an application)
• Aquatic area application (e.g., lakes, ponds, reservoirs, irrigation systems)(otherthan
aquatic herbicides which are handled as conventional pesticides)
An application that proposes a non-food use for an active ingredient that is not currently
contained as an active ingredient in any U.S. registered pesticide product. A non-food use
includes a proposed use that is not a "food use" as described in the food use categories. Outdoor
use means any use that is not indoor as described in the "indoor category" and that fits the
definition of an antimicrobial found in FIFRA section 2(mm). All non-food, section 2(mm) uses
included in the original application or petition are covered by the base fee for that application in
this category if submitted simultaneously.
Examples include:
• Once through cooling tower treatments
• Aquatic area application (e.g., wastewatertreatment)(otherthan aquatic
herbicides which are handled as conventional pesticides)
• Oil fields (marine)
• Sewage treatment plants (water is treated prior to discharge into the
environment)
An application that proposes a non-food use for an active ingredient that is not currently
contained as an active ingredient in any U.S. registered pesticide product. A non-food use
includes a proposed use that is not a "food use" as described in the food use categories. Outdoor
means any use that is not indoor as described in the "indoor category". Other uses are those
uses not covered by the definition of an antimicrobial found in FIFRA section 2(mm). All non-food
uses included in the original application or petition are covered by the base fee for that application
in this category if submitted simultaneously.
Examples include:
• Wood preservatives
18
21
18
21
82,688
165,375
23
-------
A420
A430
A431
63
64
65
New Active
Ingredient
Non-food use,
indoor, FIFRA sec.
2(mm) uses
New Active
Ingredient, Non-
Food Use Indoor,
uses other than
FIFRA 2(mm) uses
New Active
Ingredient, Non-
food use; indoor;
low-risk and low-
toxicity food-grade
active ingredient(s),
efficacy testing for
public health claims
required under
GLP and following
DIS/TSSorAD-
approved study
protocol
• Antifoulants
• Ballast water
An application that proposes a non-food use for an active ingredient that is not currently
contained as an active ingredient in any U.S. registered pesticide product. A non-food use
includes a proposed use that is not a "food use" as described in the food use categories. The
product is for use inside a manmade structure and fits the definition of an antimicrobial found in
FIFRA section 2(mm). All indoor, non-food, section (2mm) uses included in the original
application or petition are covered by the base fee for that application in this category if submitted
simultaneously.
Examples include:
• Residential use (i.e., carpet sanitizer, hard surface disinfectant)
• Commercial, institutional, industrial premise and equipment (e.g.
offices, hotels, industrial buildings, nursing homes)
• Agricultural premise treatment (e.g., farm structures, buildings and
equipment, animal drinking water)
• Materials Preservatives (e.g., adhesives, coatings, plastic, fabric)
• Industrial processes and water systems treatment (e.g., reverse osmosis
water systems, recirculating cooling tower systems, evaporative condensers)
• Medical premises and equipment (e.g., dental equipment, dental unit
water lines, hospitals)
HVAC
• Swimming pools, spas
• Oil fields (terrestrial)
An application that proposes a non-food use for an active ingredient that is not currently
contained as an active ingredient in any U.S. registered pesticide product. A non-food use
includes a proposed use that is not a "food use" as described in the food use categories. The
product is for use inside a man made structure. Other uses are those not covered by the
definition of an antimicrobial found in FIFRA 2(mm). All indoor non-food uses included in the
original application are covered by the base fee for that application if submitted simultaneously.
Examples include:
• Wood preservative (pressure and non-pressure treatments, e.g., joinery and mill work for
door, window frames)
An application that proposes an indoor non-food use for a low risk/low toxicity food grade active
ingredient that is not currently contained as an active ingredient in any U.S. registered pesticide
product. A non-food use includes a proposed use that is not a "food use" as described in the food
use categories. The product is for use inside a manmade structure. Low risk/low toxicity food
grade active ingredients are those described in PR Notice 2000-6
(www.epa.gov/PR_Notices/pr2000-6.pdf). Other active ingredients proposed as low risk/low
toxicity will be considered on a case-by-case basis. A product making public health claims
require efficacy data be submitted using AOAC, ASTM or OECD protocol. Other approved
potocols are DSS/TSS and those listed on the Antimicrobial Policy & Guidance Documents Web
page. All studies must be completed under GLP.
18
20
12
18
20
12
55,125
82,688
57,750
24
-------
A440
66
New Use,
First Food Use,
establish tolerance
exemption
Table 7. New Uses
An application that proposes the first food use. First food use includes a proposed use for any
U.S. registered active ingredient for which there is no registered "food use". The use may require
an exemption from the requirement of a tolerance under section 408 of the Federal Food, Drug
and Cosmetic Act (FFDCA) or a food additive regulation or other clearance under section 409 of
the FFDCA. If residues are reasonably foreseeable or likely to occur in or around food, either
directly or indirectly, and the risks from all foreseeable residues are minimal, the application
submission may need to include a petition to establish an exemption for tolerance for all food
commodities covered by the pending registration application or if residues would not be subject to
FFDCA section 408, documentation of an applicable food additive regulation or other clearance
under section 409 of the FFDCA. Refer to the definition of a "food use" for the uses subject to
this category. All uses (food and non-food) included in any original application or petition for a first
food use and to establish tolerance exemptions are covered by the base fee for that application in
this category if submitted simultaneously.
Examples include:
• Pre- and post-harvest use on crops (other than agricultural fungicides
and aquatic herbicides, which are handled as conventional pesticides)
• Animal drinking water treatment (meat, meat by-products and/or
milk tolerance exemption)
• Process water treatment for post harvest use (field washing of raw
agricultural commodities
• Treatment of permanent or semi-permanent food contact surfaces
(sanitizers and disinfectants).
• Use of the product in food contact articles, other than food packaging with an
intended ongoing effect in the finished article, including the articles surface or in food
that may contact the article (e.g., conveyor belt - claims to kill bacteria on articles
that come in contact with belt)
• Treatment of raw agricultural commodities in a food processing facility (FDA
food additive regulation)
• Process water treatment in a food handling facility to control a pest in the water (FDA
food additive regulation)
• Production of food packaging (FDA food additive regulation) (e.g. adhesives,
coatings)
• Production of food contact articles other than food packaging (FDA food
additive regulation) (conveyor belt, cutting board that contains an antimicrobial as a
preservative)
• Slimicides (FDA food additive regulation) (e.g., pulp and paper board)
• Production of food packaging (FDA food additive regulation) (e.g
adhesives, coatings)
• Food handling storage establishments premises and equipment (e.g.
eating establishments, meat processing equipment, food handling
equipment)
• Aseptic packaging (FDA food additive regulation)
• Ethanol production (treatment of empty fermentation tank) (check with the
Agency prior to submission of an application)
21
21
27,563
25
-------
Aquatic area application (e.g., lakes, ponds, reservoirs, irrigation systems)(otherthan
aquatic herbicides which are handled as conventional pesticides)
Home produce washes (dietary risk assessment required)
Human drinking water systems (e.g., water purifier units, emergency water
systems, municipal water treatment)
A450
67
New use
First food use,
establish tolerance
An application that proposes the first food use. First food use includes a proposed use of any
U.S. registered active ingredient for which there is no registered "food use". The use may require
the establishment of an exemption from the requirement of a tolerance under section 408 of the
Federal Food, Drug, and Cosmetic Act (FFDCA), or an increase in or a food additive regulation or
other clearance under section 409 of the FFDCA. The application may need to include a petition
to establish an exemption from tolerance for all food commodities covered by the pending
registration application(s) or, if residues would not be subject to FFDCA section 408,
documentation of an applicable food additive regulation or other clearance under section 409 of
the FFDCA. Refer to the definition of a "food use" for the uses subject to this category. All uses
(food and non-food) included in any original application or petition for a first food use are covered
by the base fee for that application in this category if submitted simultaneously.
Examples include:
• Pre- and post-harvest use on crops (other than agricultural fungicides and aquatic
herbicides, which are handled as conventional pesticides).
• Animal drinking water treatment
• Process water treatment for post harvest use (field washing of raw
agricultural commodities)
• Treatment of permanent or semi-permanent food contact surfaces
(sanitizers). In some cases this will include a disinfectant use
• Use in the product of food contact articles, other than food packaging with an
intended ongoing effect in the finished article, including the articles surface or in food
that may contact the article (e.g., conveyor belt: claims to kill bacteria on articles
that come in contact with belt)
• Food handling storage establishment premises and equipment (e.g.
eating establishments, meat processing equipment, food handling
equipment)
• Ethanol production (treatment of empty fermentation tank)(check with the
Agency prior to the submission of an application)
• Aquatic area application (e.g., lakes, ponds, reservoirs, irrigation systems)(otherthan
aquatic herbicides which are handled as conventional pesticides)
21
21
82,688
A460 68 New use, additional
food use; establish
tolerance
exemption
An application that proposes an additional food use. Additional food use includes a proposed
food use of any U. S. registered active ingredient for which there currently is an approved food
use. The use may require the establishment of an exemption from the requirement of a tolerance
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), or an increase in or a
food additive regulation or other clearance under section 409 of the FFDCA. The application may
need to include a petition to establish an exemption from tolerance for all food commodities
covered by the pending registration application(s) or, if residues would not be subject to FFDCA
section 408, documentation of an applicable food additive regulation or other clearance under
section 409 of the FFDCA. Refer to the definition of a "food use" for the uses subject to this
category. A different pattern of use that significantly changes or increases exposure such as a
15
15
11,025
26
-------
A470
69
New use, additional
food use, establish
tolerance
dosage rate increase or different method of application will result in the application being treated
as a new use.
The fee applies to each additional food use requested in the application.
Examples of the uses in this category include:
• Pre- and post-harvest use on crops (other than agricultural fungicides and
aquatic herbicides, which are handled as conventional pesticides).
• Animal drinking water treatment (meat, meat by-products and/or milk
tolerance exemption)
• Process water treatment for post harvest use (field washing of raw
agricultural commodities)
• Treatment of permanent or semi-permanent food contact surfaces
(sanitizers and disinfectants)
• Use in the product of food contact articles, other than food packaging with an
intended ongoing effect in the finished article, including the articles surface or in food that may
contact the article (conveyor belt - claims to kill bacteria that on articles that come in contact
with belt)
• Treatment of raw agricultural commodities in a food processing facility (FDA
food additive regulation)
• Process water treatment in a food handling facility to control a pest in the water
(FDA food additive regulation-EPA dietary risk assessment)
• Production of food contact articles other than food packaging (FDA food
additive regulation) (conveyor belt, cutting board that contains an
antimicrobial as a preservative)
• Slimicides (FDA food additive regulation) (e.g., pulp and paper board)
• Production of food packaging (FDA food additive regulation)(e.g,, adhesives,
coatings)
• Food handling storage establishment premises and equipment (e.g. eating
establishments, meat processing equipment, food handling equipment)
• Aseptic packaging (FDA food additive regulation)
• Ethanol production (treatment of empty fermentation tank) (check with the Agency
prior to submission of any application)
• Aquatic area application (e.g., lakes, ponds, reservoirs, irrigation systems)(otherthan aquatic
herbicides which are handled as conventional pesticides)
• Home produce washes (dietary risk assessment required)
• Human drinking water systems (e.g., water purifier units, emergency water
systems, municipal water treatment)
An application that proposes a food use. Additional food use includes a proposed food use of any
U. S. registered active ingredient for which there currently is an approved food use. The use may
require the establishment of a tolerance, the increase in, or modification of a tolerance under
section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA). The application may need to
include a petition to establish a tolerance for all food commodities covered by the pending
application(s). Refer to the definition of a "food use" for the uses subject to this category. A
different pattern of use that significantly changes or increases exposure such as a dosage rate
increase or different method of application will result in the application being treated as a new
15
15
27,563
27
-------
A480
A490
70
71
New use,
Additional use,
non-food, outdoor
FIFRAsec. 2(mm)
uses
New use, additional
use, non-food,
outdoor, other uses
use.
The fee applies to each additional new food use requested in the application.
Examples include:
• Pre and post harvest use on crops (other than agricultural fungicides and
aquatic herbicides, which are handled as conventional pesticides)
• Animal drinking water treatment
• Process water treatment for post harvest use (field washing of raw
agricultural commodities)
• Treatment of permanent or semi-permanent food contact surfaces
(sanitizers and disinfectants).
• Use in the product of food contact articles, other than food packaging
• with an intended ongoing effect in the finished article, including the articles
surface or in food that may contact the article)
• Food handling storage establishment premises and equipment (e.g. eating
establishments, meat processing equipment, food handling equipment)
• Ethanol production (treatment of empty fermentation tank) (check with the Agency
prior to submission of an application)
• Aquatic area application (e.g., lakes, ponds, reservoirs, irrigation systems)(otherthan
aquatic herbicides which are handled as conventional pesticides)
An application that proposes a non-food use for an active ingredient with a current EPA
registration. A non-food use includes a proposed use that is not a "food use" as described in the
food use categories. Outdoor use means any use that is not indoor as described in the "indoor
category" and that fits the definition of an antimicrobial found in FIFRA section 2(mm). The fee
applies to each new non-food use requested. A different pattern of use that significantly changes
or increases exposure such as a dosage rate increase or different method of application will result
in the application being treated as a new use.
Examples include:
• Once through cooling tower
• Aquatic area application (other than aquatic herbicides which are handled as conventional
pesticides)
• Oil fields (marine)
• Sewage/wastewater treatment plants (water is treated prior to discharge into the
environment)
• Any of the above use patterns that would result in a significant increase in the level of
exposure (increase in dosage rate, or a change in the route of exposure fog vs. spray), to
the active ingredient of man or other organisms.
An application that proposes a non-food use for an active ingredient with a current EPA
registration. The fee applies to each non-food use in this category requested in the application.
A non-food use includes a proposed use that is not a "food use" as described in the food use
categories. Outdoor means any use that is not indoor as described in the "indoor category".
Other uses are those uses not covered by the definition of an antimicrobial found in FIFRA
section 2(mm). A different pattern of use that significantly changes or increases exposure such
as a dosage rate increase or different method of application will result in the application being
9
15
9
15
16,538
27,563
28
-------
treated as a new use.
Examples include:
• Wood preservatives
• Antifoulants
• Ballast water
• Any of the above use patterns that would result in a significant increase in the level
of exposure (increase in dosage rate, or a change in the route of exposure (fog vs. spray),
to the active ingredient of man or other organisms.
A500 72 New use, additional
use, non-food,
indoor FIFRA sec.
2(mm) uses
An application that proposes a non-food use for an active ingredient with a current EPA
registration. The fee applies to each non-food use in this category requested in the application. A
non-food use includes a proposed use that is not a "food use" as described in the food use
categories. The product is for use inside a manmade structure or is a low exposure use pattern
that requires minimal ecological and/or environmental fate data (see examples below) and that
fits the definition of an antimicrobial found in FIFRA section 2(mm). A different pattern of use that
significantly changes or increases exposure such as a dosage rate increase or different method
of application will result in the application being treated as a new use.
Examples include:
• Residential use (i.e., carpet sanitizer, hard surface disinfectant)
• Commercial, institutional, industrial premise and equipment (e.g.
offices, hotels, industrial buildings, nursing homes)
• Agricultural premise treatment (e.g., farm structures, buildings and
equipment, animal drinking water equipment)
• Materials Preservatives (e.g., adhesives, coatings, plastic, fabric)
• Swimming pool, spa
• Industrial processes and water systems treatment (e.g., reverse osmosis water
systems, re-circulating cooling tower systems, evaporative condensers)
• Medical premises and equipment (e.g., dental equipment, dental unit
water lines, hospitals)
HVAC
11,025
Oil field (terrestrial)
Any of the above use patterns that would result in a significant increase in the
of exposure (increase in dosage rate, or a change in the route of exposure
spray), to the active ingredient of man or other organisms.
level
(fog vs.
A510 73 New use, additional
use, non-food,
indoor, other than
FIFRA 2(mm) uses
An application that proposes a non-food use for an active ingredient with a current EPA
registration. The fee applies to each non-food use in this category requested in the application. A
non-food use includes a proposed use that is not a "food use" as described in the food use
categories. The product is for use inside a manmade structure. Other uses are those uses not
covered by the definition of an antimicrobial found in FIFRA 2(mm). A different pattern of use that
significantly changes or increases exposure such as a dosage rate increase or different method
of application will result in the application being treated as a new use.
Examples include:
12
12
11,025
29
-------
Wood preservative, pressure and non-pressure treatments (e.g., joinery and mill work for
door, window frames)
Any significant increase in exposure requiring science review (increase in dosage rate,
different method of application (fog vs. spray) will be treated as a new use
A520
74
Experimental Use
Permit application
An experimental use permit is a tool that allows an unregistered pesticide to be used, or a
registered pesticide to be used for an off-label use, under controlled, field or actual use conditions
so that data required to support a FIFRA section 3 registration can be developed (e.g., data
necessary to evaluate efficacy and potential for safe use or adverse effects on humans and the
environment such as a swimming pool use). If residues are reasonably foreseeable or likely to
occur, the application submission must contain one of the following: (i) evidence of applicable
FFDCA tolerances, exemptions, or clearances; (ii) a petition to establish a tolerance(s) or
exemption(s) for all food commodities; (iii) certification that all food or feed derived from the
experimental use will be destroyed, fed only to experimental animals for testing purposes, or
disposed of in a manner that precludes its consumption as food or feed and presents no
unreasonable adverse effects on the environment.
5,513
A521 75 Review of public
health efficacy
study protocol
within AD; per AD
Internal Guidance
for the Efficacy
Protocol Review
Process; Applicant
initiated; Tier 1
An application that requires the review of a modified protocol where only minor changes are made
to an existing efficacy method (e.g. AOAC International, ASTM, AATCC, or an AD approved
method described in A431). The study design for a Tier 1 protocol will be reviewed and approved
within AD. A draft label with proposed directions for use and use claims must accompany the
application. Examples of minor changes include: varied test conditions (e.g., contact time, use of
different hard surface carrier types [porcelain penicylinders vs. stainless steel penicylinders],
modification of standard method to support additional microorganisms [e.g., Germicidal Spray
Products test for spore-formers], and changes to support alternate application types [e.g., foams].
A pre-registration meeting is recommended prior to submission of the protocol. The Agency will
make every effort during this meeting to determine if the protocol is Tier 1. If during further
review, the Agency determines that a Tier I protocol should be elevated to Tier 2 status, the
applicant will receive notification prior to this change. Protocol review and approval must be
completed before efficacy data is generated using the approved protocol and an application for
registration is submitted to AD.
2,100
A522 76 Review of public
health efficacy
study protocol
outside AD by
members of AD
Efficacy Protocol
Review Expert
Panel; Applicant
initiated; Tier 2
An application that requires the review of a new public health efficacy protocol, or a major change
to an existing efficacy method (e.g. AOAC International, ASTM, AATCC, or an AD approved
method described in A431). Applies to study design that requires review by external members
of an AD Efficacy Protocol Review Expert Panel. A draft label with proposed directions for use
and use claims must accompany the application, along with proposed performance measures.
Examples of major protocol changes would include surrogate consideration, field test component,
air sanitizers, simulated or in-use testing, changes in growth conditions [e.g., shaking vs. static for
TB testing] and novel protocols for products with label claims that don't meet the conventional
sterilant/disinfectant/sanitizer standards (e.g., treated materials). A pre-registration meeting is
recommended prior to submission of the protocol. The Agency will make every effort during this
meeting to determine if the protocol is Tier 2. Protocol review and approval must be completed
before efficacy data is generated using the approved protocol and an application for registration is
submitted to AD.
15
12
10,500
Table 8. New Products and Amendments
A530
77
New product,
An application for registration of an end-use or a manufacturing use pesticide product that is
1,103
30
-------
identical or
substantially similar
in composition and
use to a registered
product; no data
review or only
product chemistry
data; cite all data
citation or selective
data citation where
applicant owns all
required data; or
applicant submits
specific
authorization letter
from data owner.
Category also
includes 100% re-
package of
registered end-use
or manufacturing
use product that
requires no data
submission nor
data matrix.
substantially similar, identical in its uses and formulation or that differ only in ways that would not
significantly increase the risk of unreasonable adverse effects on the environment to products that
are currently registered. The applicant must identify the similar products for all active ingredients
in the proposed product. All applications require the following:
• A data matrix is required with the application if it is not a 100% re-packaged product.
• Product chemistry data (Group A and B) unless the product is identical (e.g. 100%
repackaged product).
• The active ingredient listed on the CSF must be an EPA registered product.
• In all cases, the registrant must identify the registered similar product for this category.
• Acute toxicity requirements must be addressed by using:
1) the cite-all method
2) selective data citation where the applicant owns all required data, or
3) applicant submits specific authorization letter from the data owner.
The application is not in this category if efficacy, acute toxicity, companion animal safety, and/or
child resistant packaging data are submitted and must be reviewed to support the application.
The application does not fall into this category if it contains a request to waive any of these data.
An application that requires review of cited or submitted data other than product chemistry does
not belong in this fee category. If the use pattern on the TGAI differs from the proposed products,
then additional data are required and the application does not fall within this category.
Substantially similar: Product must have the same active ingredient, in substantially the same
proportion, same chemical composition (solid, liquid, granular), and substantially similar inert
ingredients as the already registered product. In addition, substantially similar means that the
product bears the same use patterns or fewer. Adding to or changing existing use patterns
excludes the product from treatment as a substantially similar product. Substantially similar use
patterns for public health products are limited to identical organisms on both products. For non-
public health products substantially similar use patterns-are limited to identical organisms on both
products.
Deleting use patterns is acceptable
Identical products: Same composition and use patterns as an already registered end-use
product.
Manufacturing Use Product: A 100% re-package of a manufacturing use product that requires
no data submission nor data matrix is covered by this category.
Unregistered: The Agency has not issued an EPA Registration Number (license) for the source
material.
A531 78 New product;
identical or
substantially similar
in composition and
use to a registered
product; registered
An application for registration of an end-use pesticide product that is substantially similar or
identical in its uses and/or formulation to products that are currently registered or differ only in
ways that would not significantly increase the risk of unreasonable adverse effects. The applicant
must identify the similar products for all active ingredients in the proposed product. All
applications require the following:
• A data matrix is required with the application.
1,575
-------
A532
85
source of active
ingredient;
selective data
citation only for
data on product
chemistry and/or
acute toxicity
and/or public health
pest efficacy,
where the applicant
does not own all
required data and
does not have a
specific
authorization letter
from data owner.
New product;
identical or
substantially similar
in composition and
use to a registered
product; registered
active ingredient;
unregistered
source of active
ingredient; cite-all
data citation except
for product
chemistry; product
chemistry data
submitted.
• Product chemistry data (Group A and B) unless the product is identical. In
some cases product chemistry data can be satisfied as outlined in PR
Notice 98-1 .
• All inerts must be already approved for the applicable uses in the product.
• The source of the active ingredient must be currently registered (licensed)
with the Agency.
• In all cases, the applicant must identify the currently registered similar
product for this category.
• Acute toxicity, efficacy, public health pest efficacy, and/or child resistant
packaging data requirement must be addressed by using: 1) the cite-all
method, or 2) selective data citation where the applicant does not own all
required data and does not have a specific authorization letter from the data
owner. If a review of data other than product chemistry is needed, the
application does not fall into this category.
The application does not fall into this category if efficacy, acute toxicity, companion animal safety,
and/or child resistant packaging data are submitted and must be reviewed to support the
application. The application does not fall into this category if it contains a request to waive any of
these data. An application that requires review of cited or submitted data other than product
chemistry does not belong in this fee category.
If the use pattern on the TGAI differs from the proposed products, then additional data are
required and the application does not fall within this category.
Substantially similar: Product must have the same active ingredient, in substantially the same
proportion, same chemical composition (solid, liquid, granular) and substantially similar inert
ingredients as the already registered product. In addition, substantially similar means that the
proposed product bears the same use patterns. Adding to or changing existing use patterns
excludes the proposed product from treatment as a substantially similar product. Deleting use
patterns is acceptable.
Identical: Same composition and use patterns as a currently registered end use product.
An application for registration of an end-use pesticide or manufacturing use product that is
substantially similar or identical in its uses and/or formulation to products that are currently
registered or differ only in ways that would not significantly increase the risk of unreasonable
adverse effects. All applications require the following:
• Product chemistry data (Group A and B) on the end-use product as well as the
unregistered source of active ingredient.
• The cite-all method must be used to satisfy the generic data requirements.
• Acute toxicity requirements must be addressed by using the cite-all method.
• In all cases, the applicant must identify the currently registered similar
product for this category.
The application is not this category if efficacy, acute toxicity, companion animal safety, and/or
child resistant packaging data are submitted and must be reviewed to support the application.
The application does not fall into this category if it contains a request to waive any of these data.
4
4
4,410
32
-------
A540
A550
A560
79
80
81
New end use
product; FIFRA §
2(mm) uses only
New end use
product, uses other
than FIFRA sec.
2(mm); non-FQPA
product
New manufacturing
use product,
registered active
ingredient,
selective data
citation
An application that requires review of cited or submitted data other than product chemistry does
not belong in this fee category. If the use pattern on the TGAI differs from the proposed product,
then additional data are required and the application does not fall within this category.
Substantially similar: Product must have the same active ingredient, in substantially the same
proportion, same chemical composition (solid, liquid, granular) and substantially similar inert
ingredients as the already registered product. In addition, substantially similar means that the
proposed product bears the same use patterns. Adding to or changing existing use patterns
excludes the proposed product from treatment as a substantially similar product. Deleting use
patterns is acceptable.
Identical: Same composition and use patterns as a currently registered end use product.
An application for registration of a pesticide product that is not substantially similar or identical in
its uses or formulation to products that are currently registered. All applications require the
following:
• A data matrix is required with the application.
• Product chemistry data (Group A and B) unless the product is identical. In
some cases product chemistry data can be satisfied as outlined in PR
Notice 98-1 .
• All inerts must be already approved for the applicable uses in the product.
• Acute toxicity, efficacy, public health pest efficacy, companion animal safety data
and/or child resistant packaging data requirements must be addressed by using
: 1) the cite-all method, or 2) selective data citation which includes submitting
the required data. A rationale for a waiver of these data falls within this category.
A different pattern of use that significantly changes or increases exposure such as a dosage rate
increase or different method of application will result in the application being treated as a new
use.
An application for registration of a pesticide product that is not substantially similar or identical in
its uses or formulation to products that are currently registered. These applications require
product chemistry data (Group A and Group B), acute toxicity data (addressing all 6 endpoints),
and possibly leaching data. Examples include:
• Wood preservatives
• Antifoulants
• Ballast water
• Any of the above use patterns that would result in a significant increase in the level
of exposure (increase in dosage rate, or a change in the route of exposure (fog vs. spray),
to the active ingredient of man or other organisms.
An application for registration of a manufacturing use pesticide product that is substantially similar
or identical in its formulation to products that are currently registered. New Manufacturing use
product is any product intended (labeled) for formulation or repackaging into an end use
formulated pesticide product. This product does not contain directions for use of the product as
distributed or sold, or after combination by the user with other substances.
All applications require the following:
4
6
12
4
6
12
4,410
4,410
16,538
33
-------
A570
A571
A572
82
83
84
Label Amendment
requiring data
submission
Cancer
reassessment;
applicant initiated
Refined ecological
risk and/or
endangered
species
assessment;
applicant initiated.
• A data matrix is required with the application.
• Product chemistry data (Group A and B) are required. In some cases, product
chemistry data can be satisfied as outlined in Pesticide Registration Notice 98-1 .
• All inert ingredients must be approved for the applicable uses in the product.
An application proposed as a 100% re-packaged product does not fall within this category.
An application for registration of a new product that is a salt of an already registered active
ingredient and there are not any currently registered products for this salt. The Agency will
decide on a case-by-case basis whether an ingredient should be classified as a new active
ingredient.
An application for amended registration which requires review of data. This includes chemistry,
toxicology, efficacy or other science review. Examples include:
• Any submission that includes efficacy data or that requires an efficacy
review.
• Signal word changes/review of acute toxicity data
• New active ingredient (ai) sources - change from one unregistered
source to another or change from a registered source to an unregistered source
• Any submission requesting a CRP exemption
• Any formula change that requires efficacy data, including confirmatory data.
Routine formula changes are not PRIA actions. Routine formula changes are
those which do not require data to support the change such as a new fragrance, dye
or other addition or modification to the inert ingredients in the formula.
• Antifoulant product formula changes which require a release rate study to be
submitted
• Any application that is significantly inconsistent with an applicable RED. For
example, disagreement with a batching designation.
NOTE: Any significant increase in exposure requiring science review (increase in dosage rate,
different method of application (fog vs. spray) will be treated as a new use.
An application in which a request is made to change the cancer classification.
To be determined. Will be posted when available.
4
18
18
4
18
12
3,308
82,688
78,750
Biopesticides and Pollution Prevention Division
B580
86
New active
ingredient; food
Table 9. Microbial and Biochemical Pesticides; New Products and Amendments
A new microbial or biochemical pesticide active ingredient. The use requires the applicant submit
a petition to establish a tolerance under section 408 of the Federal Food, Drug and Cosmetic Act
18
18
44,100
34
-------
B590
B600
B610
B620
B621
B630
B631
B640
87
88
89
90
91
92
93
94
use; establish
tolerance
New active
ingredient; food
use; establish
tolerance
exemption
New active
ingredient; non-
food use
Food Use;
Experimental Use
Permit application;
establish temporary
tolerance
exemption
Non-Food Use;
Experimental Use
Permit application
Extend or amend
Experimental Use
Permit
First food use;
establish tolerance
exemption
Amend established
tolerance
exemption
First food use;
(FFDCA). A tolerance is the maximum residue level permitted for a pesticide active ingredient in
or on food or animal feed, in accordance with FFDCA.
All uses (food and/or non-food) included in any original application or petition for a new active
ingredient or a first food uses that otherwise satisfy the conditions for the category are covered by
the base fee for that application.
An application for a product containing a new microbial or biochemical pesticide active ingredient.
The proposed use meets the definition of a food use, requires that the applicant submit data to
enable the Agency to conduct a dietary exposure assessment and may require that the applicant
submit a petition for an exemption from the requirement of a tolerance for the active ingredient.
All uses (food and non-food) included in any original application or tolerance exemption petition
for a new active ingredient are covered by the base fee for the application in this category if
submitted simultaneously.
An application for a product containing a new microbial or biochemical pesticide active ingredient,
with uses that do not fall under the definition of a food use.
All non-food uses included in any original application or petition for a new active ingredient are
covered by the base fee for the application in this category if submitted simultaneously.
An application for an Experimental Use Permit for a microbial or biochemical pesticide, where the
proposed use meets the definition of a food use and requires that the applicant submit data to
enable the Agency to conduct a dietary exposure assessment. The proposed use may require
that the applicant submit a petition for an exemption from the requirement of a tolerance for the
active ingredient. If required, the temporary tolerance exemption is established for an appropriate
period of time to allow the harvested commodity to enter the food or feed supply during the
experimental period.
An application for an Experimental Use Permit for a microbial or biochemical pesticide, with uses
that do not fall under the definition of a food use, or with an agreement to destroy or use only for
experimental purposes any crops treated during the experimental program.
An application to amend an existing Experimental Use Permit for a microbial or biochemical
pesticide. Amendments could include but are not limited to changing the uses, use sites, and/or
acreage tested, and/or extending the length of time for completion of the experimental program.
If a tolerance or tolerance exemption needs to be amended in connection with this action, you
must add the cost of a petition (see B631 or B641 , below, as appropriate).
An application for registration of a new use for a microbial or biochemical pesticide, where the
proposed first food use meets the definition of a food use, requires that the applicant submit data
to enable the Agency to conduct a dietary exposure assessment and may require that the
applicant submit a petition for an exemption from the requirement of a tolerance for the active
ingredient.
A petition to amend an existing tolerance exemption for a microbial or biochemical pesticide
active ingredient where the proposed use meets the definition of a food use and requires that the
applicant submit data to enable the Agency to conduct a dietary exposure assessment and that
the applicant submit a petition for an exemption from the requirement of a tolerance for the active
ingredient. This category includes amendments to temporary tolerance exemptions and other
time-limited tolerance exemptions. In addition to the petition, there may be an application to
amend an existing registered product or experimental use permit.
An application for registration of a new use for a microbial or biochemical pesticide where there is
16
12
9
6
6
12
9
18
16
12
9
6
6
12
9
18
27,563
16,538
11,025
5,513
4,410
11,025
11,025
16,538
35
-------
establish tolerance
a reasonable expectation or certainty that residues of the active ingredient could occur in human
food, animal feed, or in livestock from the proposed use. The first food use requires the applicant
submit a petition to establish a tolerance for the active ingredient for the proposed use, and to
submit data to demonstrate that dietary exposures to residues of the active ingredient at the
tolerance level meet the FFDCA standard of reasonable certainty of no harm.
All uses included in any original application or petition for a first food use that otherwise satisfy the
conditions for the category are covered by the base fee for that application.
B641 95 Amend established
tolerance (e.g.,
decrease or
increase)
A petition to amend an established tolerance for a microbial or biochemical pesticide, with
supporting data to demonstrate that dietary exposures to residues of the active ingredient at the
tolerance level meet the FFDCA standard of reasonable certainty of no harm. This category
includes amendments to temporary tolerances, such as those established in connection with an
experimental use permit. In addition to the petition, there may be an application to register a
product, or to amend an existing registered product or experimental use permit.
12
12
11,025
B650
96
New use; non-food
An application for registration of a new use fora microbial or biochemical pesticide, with uses that
do not fall under the definition of a food use. This category also includes a change in use pattern
such that the exposure to humans and the environment could be significantly increased (e.g.,
additional routes of exposure) and therefore must be evaluated for increased risks.
5,513
B660 97 New product;
identical or
substantially similar
in composition and
use to a registered
product; no data
review or only
product chemistry
data; cite-all data
citation, or
selective data
citation where
applicant owns all
required data, or
applicant submits
specific
authorization letter
from data owner.
Category also
includes 100% re-
package of
registered end-use
or manufacturing-
use product that
requires no data
submission or data
matrix.
An application for registration of an end-use or a manufacturing use microbial or biochemical
pesticide product that is substantially similar, identical in its uses and formulation, or that differs
only in ways that would not significantly increase the risk of unreasonable adverse effects on the
environment to products that are currently registered. The applicant must identify the similar
registered products for all active ingredients in the proposed product. All applications require the
following:
1,103
• A data matrix is required with the application if it is not a 100% re-packaged product.
• Product chemistry data (Group A and B) unless the product is identical (e.g., 100%
repackaged product). In some cases, product chemistry data can be satisfied as
outlined in Pesticide Registration Notice 98-1.
• The active ingredient(s) must be currently registered and the CSF must include its EPA
Registration Number(s).
• In all cases, the registrant must identify the registered similar product for this category.
• Acute toxicity requirements must be addressed by using:
1)The cite-all method
2) Selective data citation where the applicant owns all required data, or
3) Applicant submits specific authorization letter from the data owner
The application is not in this category if efficacy, acute toxicity, companion animal safety, and/or
child resistant packaging data are submitted and must be reviewed to support the application.
The application does not fall into this category if it contains a request to waive any of these data.
An application that requires review of cited or submitted data other than product chemistry does
not belong in this fee category. If the use pattern on the TGAI differs from the proposed products,
then additional data are required and the application does not fall within this category.
Substantially similar: Product must have the same active ingredient, in substantially the same
proportion, same chemical composition (solid, liquid, granular), and substantially similar inert
36
-------
B670
B671
98
99
New product;
registered source
of active ingredient;
all Tier I data for
product chemistry,
toxicology, non-
target organisms,
and product
performance must
be addressed with
product specific
data or with
request for data
waivers supported
by scientific
rationales.
New product; food
use; unregistered
source of active
ingredient; requires
amendment of
established
tolerance or
tolerance
exemption; all Tier I
data requirements
for product
chemistry,
toxicology, non-
target organisms,
and product
performance must
be addressed with
product-specific
data or with
requests for data
waivers supported
ingredients as the already registered product. In addition, substantially similar means that the
proposed product bears the same use pattern. Adding to or changing existing use patterns
excludes the proposed product from treatment as a substantially similar product. Deleting use
patterns is acceptable.
Identical: Same composition and use patterns as a currently registered end-use product.
Manufacturing Use Product: A 100% re-package of a manufacturing use product that requires
no data submission or data matrix is covered by this category.
An application for registration of a microbial or biochemical pesticide product that is not
substantially similar or identical in its uses and/or formulation to products that are currently
registered. These applications require product specific chemistry data, acute toxicity data and
other Tier I mammalian and non-target toxicity data as determined by the general use patterns for
the product. When public health pests are claimed, efficacy (product performance) data for the
product must be submitted. Formulator's exemption for the data requirements can be claimed
when the source of the TGAI is registered by another pesticide registrant. If the registered source
of the active ingredient is owned by the current applicant, Formulator's exemption is not
applicable. The data used to support the registered source is instead referenced on the
applicant's data matrix. This category is not for a new use.
An application for registration of a microbial or biochemical pesticide product that is not
substantially similar or identical in its uses and/or formulation to products that are currently
registered. These applications require product specific chemistry data, acute toxicity data and
other Tier I mammalian and non-target toxicity data as determined by the general use patterns for
the product. When public health pests are claimed, efficacy (product performance) data for the
product must be submitted. This category includes products containing an active ingredient(s)
that requires a change in, or establishment of, a tolerance or tolerance exemption, and in those
situations there must be a petition to establish or amend an existing tolerance or tolerance
exemption for the active ingredient.
6
16
6
16
4,410
11,025
37
-------
by scientific
rationales.
B672 100 New product; non-
food use or food
use having
established
tolerance or
tolerance
exemption;
unregistered
source of active
ingredient; no data
compensation
issues; all Tier I
data requirements
for product
chemistry,
toxicology, non-
target organisms,
and product
performance must
be addressed with
product-specific
data or with
request for data
waivers supported
by scientific
rationales.
An application for registration of a microbial or biochemical pesticide product that is not
substantially similar or identical in its uses and/or formulation to products that are currently
registered. These applications require product specific chemistry data, acute toxicity data and
other Tier I mammalian and non-target toxicity data as determined by the general use patterns for
the product. When public health pests are claimed, efficacy (product performance) data for the
product must be submitted. This category does not include products containing an active
ingredient(s) that requires a change in, or establishment of, a tolerance or tolerance exemption or
require the Agency to conduct a dietary risk assessment.
12
12
7,875
B680 101 Label amendment
requiring data
submission
An application to amend a registration is in this category when it contains data to support a
change in the label (such as use patterns, use site changes) or to add an alternate formulation, or
change the basic formulation of a currently registered product. These data include but are not
limited to: toxicity data, product chemistry data, manufacturing process, non-target toxicity data,
efficacy/product performance, child-resistant packaging data, and data to support a new pattern
of use (e.g., increased application rate, different application methods) that changes the potential
for human and/or environmental risks or exposure.
EPA-initiated amendments shall not be charged fees. Label amendments submitted by
notification under PR Notices., such as PR Notice 95-2 and PR Notice 98-10, continue under PR
Notice timelines and are not subject to PRIA fees.
4,410
B681 102 Label amendment;
unregistered
source of active
ingredient;
supporting data
require scientific
review
An application to amend a registration is in this category when it contains data to support a
change in the label (such as use patterns, use site changes) or to add an alternate formulation or
change the basic formulation of a currently registered product. These data include but are not
limited to: toxicity data, non-target toxicity data, efficacy/product performance, child-resistant
packaging data, additional (unregistered) sources of the active ingredient with supporting
chemistry data, manufacturing process, efficacy (if public health pests are claimed), and data to
support a pattern of use (e.g., increased application rate, different application methods) that
5,250
38
-------
B682
B690
B700
B701
B710
103
104
105
106
107
Protocol review;
applicant-initiated;
excludes time for
HSRB review (pre-
application)
New active
ingredient; food or
non-food use
Experimental Use
Permit application;
new active
ingredient or new
use
Extend or amend
Experimental Use
Permit
New product;
identical or
substantially similar
in composition and
use to a registered
product; no data
review or only
product chemistry
data; cite-all data
citation, or
selective data
citation where
applicant owns all
required data, or
applicant submits
specific
authorization letter
from data owner.
Category also
includes 100% re-
package of
registered end-use
or manufacturing-
use product that
requires no data
changes the potential for human and/or environmental risks or exposure.
An applicant-initiated request to review a study protocol to address a data requirement prior to
submission of an application to register a product (or amend a currently registered product). If the
study protocol is for a product performance study involving human test subjects (such as
mosquito repellents and other products designed to protect humans from public health pests), it
must be reviewed by the Human Studies Review Board (HSRB) before the registrant conducts
the study. Protocols reviewed by the HSRB are not included in this fee category.
Table 10. Straight Chain Lepidopteran Pheromones (SCLPS)
An application for a product containing a new active ingredient SCLP which either has no food
uses or if there is a food use, is anticipated to meet the existing tolerance exemption for SCLPs.
All uses (food and/or non-food) included in any original application or petition for a first food use
that otherwise satisfy the conditions for the category are covered by the base fee.
An application for an experimental use permit where the SCLP fits within the existing tolerance
exemption for SCLPs, or with an agreement to destroy, or use only for experimental purposes,
any crops treated during the experimental program.
An application to amend an existing Experimental Use Permit for a SCLP product, which could
include (but is not limited to): changing the uses, use sites, and/or acreage tested, and/or
extending the length of time for completion of the experimental program.
An application for registration of a SCLP product that is substantially similar or identical in its uses
and formulation to products that are currently registered, or differ from a currently registered
product only in ways that would not significantly increase the risk of unreasonable adverse effects
to humans or the environment. In all cases, the applicant must identify the similar registered
product.
Identical products are identical to another registered product and bear identical use patterns.
For an identical (1 00% repackaging or repack) of a registered SCLP product, the data
requirements are satisfied by the registered identical product. The Confidential Statement of
Formula (CSF) of the proposed product must indicate the product is a 100% repack of the
previously registered product.
Substantially similar products must contain the same active ingredient, in substantially the same
proportion. They must have the same physical state (solid, liquid, granular), and contain
substantially similar other (inert) ingredients. The proposed product must have the same use
patterns.
Identical/substantially similar products may have fewer uses, but all of its uses must have been
approved for the claimed similar product. Adding or changing the use patterns (other than
removal of uses) excludes the product from treatment as a substantially similar product.
If the new product is a simple dilution of, or differs only by a minor change in inert ingredients
from the registered product, some minor product chemistry may be required. Any cited data must
have been previously reviewed and accepted by the Agency.
3
6
6
3
3
3
6
6
3
3
2,100
2,205
1,103
1,103
1,103
39
-------
B720
B721
B722
B730
B740
B750
108
109
110
111
112
113
submission or data
matrix.
New product;
registered source
of active ingredient;
all Tier 1 data for
product chemistry,
toxicology, non-
target organisms,
and product
performance must
be addressed with
product specific
data or with
request for data
waivers supported
by scientific
rationales
New product;
unregistered
source of active
ingredient
New use and/or
amendment to
tolerance or
tolerance
exemption
Label amendment
requiring data
submission
Experimental Use
Permit application;
registered active
ingredient; non-
food/feed or crop
destruct basis; no
SAP review
required
Experimental Use
A new product is not substantially similar to a registered product if an unregistered source of
TGAI material is used to formulate the new product, or if new data, scientific literature, and/or
waivers are submitted to satisfy the data requirements for the new product.
An application for a new product for an existing SCLP active ingredient that includes data to
support the registration.
An application for a new product for a registered SCLP active ingredient; the source of the active
ingredient used in the product is not registered.
An application for a new use for a registered SCLP active ingredient that is not covered by the
SCLP tolerance exemption. A petition to amend the established tolerance exemption for SCLPs,
with supporting data to demonstrate that dietary exposures to residues of the active ingredient
meet the FFDCA safety standard, i.e., there is a reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue, must accompany the application.
An application to amend an existing registration containing an SCLP active ingredient. The
application contains for Agency review data that is submitted to support a change to the
formulation and/or data that is necessary to support a product labeling change (e.g., use pattern,
use sites, etc.)
EPA-initiated amendments shall not be charged fees. Label amendments submitted by
notification under PR Notices, such as PR Notice 95-2 and PR Notice 98-10, continue under PR
Notice timelines and are not subject to PRIA fees.
Table 11. Plant Incorporated Protectants (PIPS)
An application for an EUP using a registered PIP active ingredient, without food or feed uses, or
with an agreement to destroy, or use only for experimental purposes, any crops treated during the
experimental program. No issue(s) raised that would require a SAP.
Example: transfer existing PIP trait by traditional breeding, such as from field corn to sweet corn.
An application for an EUP to allow a registered PIP active ingredient to be used under controlled,
4
6
6
4
6
9
4
6
6
4
6
9
1,103
2,310
2,310
1,103
82,688
110,250
40
-------
B760
B761
B770
114
115
116
Permit application;
registered active
ingredient;
establish temporary
tolerance or
tolerance
exemption; no SAP
review required
Experimental Use
Permit application;
new active
ingredient; non-
food/feed or crop
destruct basis; SAP
review required;
credit $78,750
toward new active
ingredient
application that
follows
Experimental Use
Permit application;
new active
ingredient; non-
food/feed or crop
destruct; no SAP
review required;
credit $78,750
toward new active
ingredient
application that
follows
Experimental Use
Permit application;
new active
ingredient;
establish temporary
tolerance or
tolerance
exemption; SAP
review required;
credit $105, 000
toward new active
ingredient
application that
field or actual use conditions so that the data required to support a federal registration can be
developed to evaluate the PIP's efficacy and potential for adverse effects on human health and
the environment. A temporary tolerance or exemption is set for an appropriate period of time to
allow the harvest of any treated food or feed commodities during the experimental period. No
issue(s) raised that would require a SAP.
Example: transfer existing PIP trait by traditional breeding, such as from field corn to sweet corn.
An application for an EUP using a new PIP active ingredient without food or feed uses, or with an
agreement to destroy, or use only for experimental purposes, any crops treated during the
experimental program. The new PIP active ingredient raises issue(s) which require a SAP.
An application for an EUP using a new PIP active ingredient with no food or feed uses, or with an
agreement to destroy, or use only for experimental purposes, any crops treated during the
experimental program. No issue(s) raised that would require a SAP.
An application for an EUP to allow a new PIP active ingredient to be used under controlled, field
or actual use conditions so that data required to support a federal registration can be developed
to evaluate its efficacy and potential for adverse effects on humans and the environment. A
temporary tolerance or exemption will be established for an appropriate period of time to allow the
harvest of any treated food or feed commodities during the experimental period. The new PIP
raises issue(s) that require a SAP review.
12
7
15
12
7
15
137,813
82,688
165,375
41
-------
B771
B772
B773
B860
117
118
119
120
follows
Experimental Use
Permit application;
new active
ingredient;
establish temporary
tolerance or
tolerance
exemption; no SAP
review required;
credit $105, 000
toward new active
ingredient
application that
follows
Amend or extend
existing
Experimental Use
Permit; minor
changes to
experimental
design; established
temporary
tolerance or
tolerance
exemption is
unaffected
Amend or extend
Experimental Use
Permit; minor
changes to
experimental
design; extend
established
temporary
tolerance or
tolerance
exemption
Amend
Experimental Use
Permit; first food
use or major
revision of
experimental
design.
An application for an EUP to allow a new PIP active ingredient to be used under controlled, field
or actual use conditions so that data required for a federal registration can be developed to
evaluate its efficacy and potential for adverse effects on humans and the environment.
A temporary tolerance or exemption will be established for an appropriate period of time to allow
the harvest of any treated food or feed commodities during the experimental period.
The new PIP raises no issue(s) that require a SAP review.
An amendment making minor changes to or extend the test period of an existing PIP EUP
registration.
An amendment making minor changes to or to extend the test period of an existing PIP EUP; an
extension of an existing temporary tolerance/tolerance exemption is needed.
An amendment to expand, extend or modify a PIP EUP. A tolerance or tolerance exemption must
be established for the first food use of the active ingredient in the product. A petition to establish a
tolerance or exemption from the requirement of a tolerance with supporting data must accompany
an application for the first food use.
10
3
5
6
10
3
5
6
110,250
11,025
27,563
11,025
42
-------
B780
B790
B800
B810
B820
B840
121
122
123
124
125
126
New active
ingredient; non-
food/feed; no SAP
review required
New active
ingredient; non-
food/feed; SAP
review required
New active
ingredient;
establish
permanent
tolerance or
tolerance
exemption based
on temporary
tolerance or
tolerance
exemption; no SAP
review required
New active
ingredient;
establish
permanent
tolerance or
tolerance
exemption based
on temporary
tolerance or
tolerance
exemption; SAP
review required
New active
ingredient;
establish tolerance
or tolerance
exemption; no SAP
review required.
New active
ingredient;
establish tolerance
or tolerance
exemption; SAP
An application for a new PIP active ingredient for a non-food/feed use. No issue(s) identified that
warrant a SAP.
May be either a registration for seed increase or a full commercial registration. If a seed increase
registration is granted first, full commercial registration is obtained using B890.
An application for a new PIP active ingredient for a non-food/feed use with issue(s) identified that
warrant a SAP.
May be either a registration for seed increase or a full commercial registration. If a seed increase
registration is granted first, full commercial registration is obtained using B890.
An application for a new PIP active ingredient for a food/feed use. A temporary tolerance or
temporary exemption from a tolerance already exists to support an EUP for the active ingredient.
A permanent tolerance or tolerance exemption is needed for registration. A petition to establish a
tolerance or exemption from the requirement of a tolerance with supporting data must accompany
the application. No issue(s) identified that warrant a SAP.
May be either a registration for seed increase or a full commercial registration. If a seed increase
registration is granted first, full commercial registration is obtained using B890.
An application for a new PIP active ingredient for a food/feed use. A temporary tolerance or a
temporary exemption from a tolerance already exists to support an EUP for the active ingredient.
A permanent tolerance or tolerance exemption is needed for registration. A petition to establish a
tolerance or exemption from the requirement of a tolerance with supporting data must accompany
the application. Issue(s) identified that warrant a SAP.
May be either a registration for seed increase or a full commercial registration. If a seed increase
registration is granted first, full commercial registration is obtained using B890.
An application for a new PIP active ingredient for a food/feed use. A tolerance or an exemption
from a tolerance must be established. No previous temporary tolerance or tolerance exemption
has been established. A petition to establish a tolerance or exemption from the requirement of a
tolerance with supporting data must accompany the application. No issue(s) identified that
warrant a SAP.
May be either a registration for seed increase or a full commercial registration. If a seed increase
registration is granted first, full commercial registration is obtained using B890.
An application for a new PIP active ingredient for a food/feed use. A tolerance or an exemption
from a tolerance must be established. No previous temporary tolerance or temporary tolerance
exemption has been established. A petition to establish a tolerance or exemption from the
requirement of a tolerance with supporting data must accompany the application. Issue(s)
identified that warrant a SAP.
12
18
12
18
15
21
12
18
12
18
15
21
137,813
192,938
220,500
275,625
275,625
330,750
43
-------
B830
B850
B851
B852
B870
B880
127
128
129
130
131
132
review required.
New active
ingredient;
Experimental use
Permit application
submitted
simultaneously;
establish tolerance
or tolerance
exemption; no SAP
review required
New active
ingredient;
Experimental Use
Permit requested
simultaneously;
establish tolerance
or tolerance
exemption; SAP
review required.
New active
ingredient; different
genetic event of a
previously
approved active
ingredient; same
crop; no tolerance
action required; no
SAP review
required.
New active
ingredient; different
genetic event of a
previously
approved active
ingredient; same
crop; no tolerance
action required;
SAP review
required.
New Use
New Product; no
SAP review
May be either a registration for seed increase or a full commercial registration. If a seed increase
registration is granted first, full commercial registration is obtained using B890.
An application for a new PIP active ingredient for a food/feed use. An EUP application
accompanies the registration application. A tolerance or an exemption from a tolerance must be
established. A petition to establish a tolerance or exemption from the requirement of a tolerance
with supporting data must accompany the application. No issue(s) identified that warrant a SAP.
May be either a registration for seed increase or a full commercial registration. If a seed increase
registration is granted first, full commercial registration is obtained using B890.
An application for a new PIP active ingredient for a food/feed use. An EUP application
accompanies the registration application. A tolerance or an exemption from a tolerance must be
established. A petition to establish a tolerance or exemption from the requirement of a tolerance
with supporting data must accompany the application. Issue(s) identified that warrant a SAP.
May be either a registration for seed increase or a full commercial registration. If a seed increase
registration is granted first, full commercial registration is obtained using B890.
An application for a new PIP active ingredient for a food/feed use that differs from a similar active
ingredient that is registered due to its origination from a different genetic event. The new PIP
active ingredient and the proposed use is already covered under an existing tolerance or
tolerance exemption. No issue(s) identified that warrant a SAP.
An application for a new PIP active ingredient for a food/feed use that differs from a similar active
ingredient that is registered due to its origination from a different genetic event. The new PIP
active ingredient and the proposed use is already covered under an existing tolerance or
tolerance exemption. Issue(s) identified that warrant a SAP.
An application to amend a registered PIP product to add a new use site.
Example: transfer existing PIP trait by traditional breeding, such as from field corn to sweet corn.
An application fora new PIP product containing a previously registered active ingredient that is in
an existing registered product. No issue(s) identified that require a SAP review.
15
21
9
9
9
9
15
21
9
9
9
9
330,750
385,875
110,250
165,375
33,075
27,563
44
-------
B881
B890
B891
B900
B901
B902
B903
B904
133
134
135
136
137
138
139
140
required.
New product; SAP
review required.
Amendment; seed
production to
commercial
registration; no
SAP review
required
Amendment; seed
production to
commercial
registration; SAP
review required
Amendment
(except #B890); No
SAP review
required; (e.g., new
IRM requirements
that are applicant
initiated; or
amending a
conditional
registration to
extend the
registration
expiration date with
additional data
submitted)
Amendment
(except #B890);
SAP review
required
PIP Protocol
Review
Inert ingredient
tolerance
exemption; e.g. a
marker such as
NPT II, reviewed in
BPPD
Import tolerance or
Example: Stacking PIP traits within a crop using traditional breeding techniques.
An application for a new PIP product containing a previously registered active ingredient that is in
an existing registered product. Issue(s) identified that requires a SAP review.
Example: Stacking PIP traits within a crop using traditional breeding techniques.
An application to amend a registered PIP product that only allows for seed production to allow for
commercial registration. No issue(s) identified that require a SAP review.
An application to amend a registered PIP product that only allows for seed production to allow for
commercial registration. Issue(s) identified that require a SAP review.
An application to amend a registered PIP product - except as described in B870, B890 and B891 .
No issue(s) identified that require a SAP review.
EPA-initiated amendments shall not be charged fees. Label amendments submitted by
notification under PR Notices such as PR Notice 95-2 and PR Notice 98-10, continue under PR
Notice timelines and are not subject to PRIA fees.
An application to amend a registered PIP product, except as defined in B870, B890 and B891 .
Issue(s) identified that require an SAP review.
EPA-initiated amendments shall not be charged fees. Label amendments submitted by
notification under PR Notices such as PR Notice 95-2 and PR Notice 98-10, continue under PR
Notice timelines and are not subject to PRIA fees.
An applicant-initiated request for Agency review of the proposed description of the study(ies) that
will be performed to support the registration of a PIP
A petition to establish a tolerance or an exemption from tolerance for a PIP inert ingredient (for
example, a marker protein).
A petition to establish a tolerance or tolerance exemption for foods imported into the United
15
9
15
6
12
3
6
9
15
9
15
6
12
3
6
9
82,688
55,125
110,250
11,025
66,150
5,513
55,125
110,250
45
-------
tolerance
exemption;
processed
commodities/food
only
States that contain PIP active ingredients.
46
------- |