Pesticide Registration (PR) Notice 95-2:Notifications, Non-Notifications and Minor Formulation Amendments
NOTE: THIS DOCUMENT MAY VARY IN APPEARANCE FROM THE PRINTED
NOTICE. IT HAS BEEN REFORMATTED TO FIT WITHIN THIS SCREEN.
5/31/95
PR NOTICE 95-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS
AND REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION: Persons Responsible for Federal Registration and
Reregistration of Pesticide Products
SUBJECT: Notifications, Non-Notifications and Minor Formulation
Amendments
This Notice describes new policies and procedures effective
immediately which will help streamline and accelerate many
registration amendments. Highlights of this notice include:
expanding the types of labeling and product chemistry amendments
which may be accomplished by notification,
accelerating the review of minor formulation amendments, and
a new certification statement which affirms compliance with this
PR Notice and applicable regulations, and which describes the
consequences of non-compliance.
This PR Notice supersedes PR Notice 88-6 (August 12, 1988)
and the second edition of General Information On Applying For
Registration of Pesticides In The United States (The Blue Book,
Chapter 4. C. and D). This PR Notice also modifies parts of PR
Notices 83-3 and 84-1 (Storage and Disposal Statements), and PR Notice
91-1 (Use Deletions). Table A lists the registration amendments which
may be accomplished by notification, non-notification or accelerated
minor formulation changes as described in this notice.
I. BACKGROUND
On August 12, 1988, the Agency issued PR Notice 88-6 to
implement 40 CFR 152.46, Modifications To Registration Not Requiring
Amended Applications. Section 152.46(a) allows certain registration
amendments to be accomplished by notifying the Agency of those changes
before the product is distributed or sold. Section 152.46(b) allows
other minor changes in labeling or packaging to be made without
notification to the Agency. PR Notice 88-6 described the Agency's
policies and procedures at that time for notifications and non-
notifications under Section 152.46.
Section 152.44(b), Application for Amended Registration,
requires any modification in the composition, labeling or packaging of
a registered product to be submitted with an application for amended
registration, with the exception of notifications and non-
notifications under Section 152.46. Section 152.44(b) provides that
the Agency may waive the requirement for an amendment or permit a
registrant to certify compliance with an Agency requirement instead of
submitting an amendment.
EPA is issuing this notice to allow minor, low risk
registration amendments to be accomplished through notification, non-
notification or as accelerated amendments. EPA believes these
streamlining changes will speed up the process, reduce the waiting
time for registrants and maintain protection to the public health and
the environment.
II. NOTIFICATIONS
The following registration amendments may be accomplished by
notification.
A. Labeling
1. Adding Alternate Brand Names
A registrant may sell a product under one or more alternate
brand names provided he/she notifies the Agency of those names. Each
name must differ from the name of any other of the registrant's
products so as to permit clear identification. Brand names may not be
false or misleading. The addition of alternate brand names for use by
the registrant is not the same as supplemental distribution by a
different company or individual under agreement with the registrant
(see 40 CFR 152.132). Changing the primary brand name of a product
must be done by submitting an application for amendment.
2. Adding or Deleting Pests
A pest that does not pose a threat to public health, except
termites, may be added to the label provided that:
(a) the registrant maintains efficacy data for each pest
added;
(b) the pest occurs on one or more sites on the approved
label;
(c) the pest matches the type of product registered (e.g.,
a fungus may not be added to an insecticidal product); and
(d) the dosage, frequency, concentration or method of
application do not change.
To add public health pests or termites to a label, the
registrant must submit an Application for Amended Registration (EPA
Form 8570-1). Public health pests include, but are not limited to,
mosquitoes, rodents, viruses and bacteria (other than odor-causing).
Microbial pests and claims which are related to public health are
described in OPP's Antimicrobial Program Branch DSS/TSS Sheet #16.
Questions on whether other pests are considered public health related
may be referred to the appropriate branch or PM team. Questions on
termiticide products may be referred to the Insecticide-Rodenticide
Branch.
A pest may be deleted from the label by notification at any
time.
3. Adding Indoor, Nonfood Sites for Antimicrobial
Products
Indoor, nonfood sites, subsites or substrates may be added to
antimicrobial products provided that:
(a) no additional data (such as efficacy data for public
health pests or termites, groundwater data, ecological effects data,
etc.) are required for the added nonfood sites;
(b) these sites are within an already registered use pattern
category for the product (as specified in 40 CFR Part 158);
(c) exposure is not increased (examples of increased
exposure include adding use in paints to a product registered for
caulking, or adding broadcast treatment to a product registered for
spot treatment);
(d) an agency decision or directive does not explicitly
prohibit addition of nonfood sites to particular products;
(e) the labeling of the technical product from which the end
use product is formulated does not prohibit the proposed site; and
(f) the dosage, concentration, frequency or method of
application do not change.
4. Adding, Revising or Deleting Advisory Statements
Advisory statements (such as those related to use
precautions, efficacy, crop damage and product incompatibility) may be
added or revised provided that the statements:
(a) are not mandatory phrases such as: "do not," "must not"
and "shall not;"
(b) do not negate or detract from the required precautionary
statements or other label statements;
(c) do not trigger efficacy, human health or environmental
concerns;
(d) do not change the dosage, frequency, concentration or
method of application;
(e) are not false or misleading; and
(f) do not negate or conflict with statements made on any
other product label which refers to use of the subject product or
chemical.
Examples of advisory statements include: "This product is not
recommended for use on natural marble surfaces" and "This product
should not be used with products containing X due to risk of explosive
reaction."
Advisory statements may be deleted by notification at any
time.
5. Changes in Packaging and Related Labeling
Statements
Changes in the shape, color or composition of packaging and
in related labeling statements may be done by notification only if all
of the following criteria are met:
(a) the dosage, concentration, frequency or method of
application do not change;
(b) exposure is not likely increased (examples that might
increase exposure include: adding non-water soluble packaging to a
product which is only registered for water-soluble packaging;
protective clothing or equipment required because of the proposed
package change; and new data requirements triggered for increased
exposure);
(c) the product is not subject to child resistant packaging
(CRP), either before or after the proposed change;
(d) the product is not a rodenticide;
(e) no Worker Protection Standard labeling statements are
changed;
(f) the package size is not reduced to the point that the
net contents of the package is smaller than the dosage required by
directions for use;
(g) the package size or other characteristics is not changed
in a way which violates EPA-mandated restrictions imposed on a product
(e.g., size limitations may be imposed on a product to limit its use
to homeowners only); and
(h) no changes are made to "bait stations," "control
stations," "attractant stations" or other packaging that houses the
pesticide during its use.
6. Use Deletions Related to Data Call-In's
Section 6(f) of FIFRA requires EPA to publish a notice of
receipt of a voluntary cancellation of a product or one or more of its
uses in the Federal Register for public comment. If a registrant of
the source(s) of an active ingredient (manufacturing use product--MP)
decides to voluntarily cancel one or more uses in response to a data
call-in, EPA will publish a Federal Register notice announcing the
proposed voluntary cancellation of those uses on the MP and indicate
that such uses will be deleted from all products containing the active
ingredient unless someone responds within the comment period that they
wish to support the continued registration of those uses. After the
comment period closes and no one has requested to support the use(s)
proposed for deletion, end use registrants will be given three
options: support the deleted use(s), request deletion of the use(s) by
notification or voluntarily cancel the product. If deletion of the
use(s) is chosen as a response to a data call-in, the end use
registrant should submit a notification for each product rather than
an amendment as described in PR Notice 91-1. Use deletions for MP
products, or for end use not responding to a data call-in, may only be
submitted as amendments as described in PR Notice 91-1.
7. Storage and Disposal Statements
PR Notices 83-3 and 84-1 permitted registrants to adopt
storage and disposal labeling statements as specified in those notices
without amendment. Registrants may continue to adopt labeling
statements verbatim from those notices by notification. However, a
request for variation in the wording of those statements should be
submitted as an amendment.
8. Bilingual Labeling
The Agency may require bilingual labeling to protect public
health and the environment [40 CFR 156.10(a)(3)]. When bilingual
labeling is not required by the Agency, registrants may submit by
notification a copy of the foreign language labeling. The foreign
text must be a true and accurate translation of the English text.
Note: Both language versions of the labeling should appear on a
container in their entirety.
9. Use of Symbols and Graphics
Symbols and graphics may be used in conjunction with and in
close proximity to explanatory label text, provided that they do not
substitute for or conflict with label text, and are not false or
misleading (as described in 40 CFR 156.10(a)(5)). Examples include:
arrow diagrams demonstrating how to open product containers.
graphics displaying application patterns such as aerial
application.
pictograms displaying various exposure routes.
pictures of where the product can be used.
pictures of persons wearing appropriate protective clothing.
10. Redundant Labeling Statements
Statements may be combined to remove redundancy anywhere on
the label, provided that statements required by the Agency are not
removed or changed. The revised statements must be consistent with 40
CFR 156.10 and Agency policy.
11. Changes in Warranty Statement
Warranty statements may be revised provided they do not
disclaim the performance or safety of the product when used in
accordance with label directions, and are otherwise consistent with 40
CFR Part 156.
12. Other Revisions
Minor label changes not described in Section II.A.1.-11. and
Section III. which are related to FIFRA may be made by notification,
provided they:
(a) are consistent with 40 CFR Part 156; and
(b) involve no change in the ingredients statement, signal
word, use classification, precautionary statements, statements of
practical treatment (First Aid), physical/chemical/biological
properties, storage and disposal, or directions for use;
and/or
(c) are permitted or required by a PR Notice.
B. Product Chemistry
1. Active Ingredients
A registrant may change the source of an active ingredient by
notification, provided that the alternate source:
(a) is registered for at least the same uses for which the
formulated product is registered; and
(b) is similar to the current source, i.e., meets the
criteria given in 40 CFR 152.43(b)(1) and (2).
A registrant should submit a Formulator's Exemption (EPA Form
8570-27) along with the notification of source change if the new
source is registered for the same uses as the existing source [40 CFR
152.85(c)].
A registrant may not make the following active ingredient
related changes by notification, but must submit an application for
amendment:
A change in the source of an active ingredient which would
result in a change in the amount of any inert ingredient such that it
would fall outside its certified limits. This would be considered an
alternate formulation. Such a change may result in significant
changes in the toxicological or chemical properties of the product.
A change to an unregistered source of an active ingredient.
Addition, deletion, or substitution of an active ingredient
or increase or decrease in the amounts of existing active ingredient
would constitute a new formulation, which requires a separate
registration.
A change in the stated nominal concentration of any active
ingredient or change of certified limits that are not shown on the
previously submitted Confidential Statement of Formula (CSF), EPA Form
8570-4.
If the new source is not registered for the same uses as the
existing source, an amendment for registration must be submitted to
delete unsupported uses from the formulated product, or to support the
additional uses with data.
2. Inert Ingredients
a. Change in Source
If the Agency has required that a registrant identify the
source of an individual inert ingredient, the identity of which is
known to the registrant, the registrant may change the source of that
inert ingredient by notification. However, if the Agency has not
required identification of the source of an inert ingredient, the
registrant may change a source without notification to the Agency.
b. Change in Nominal Concentration
A registrant may change the stated nominal concentration of
any inert ingredient by notification, provided that:
(1) the nominal concentration falls within the certified
limits for that ingredient as listed on the accepted CSF; and
(2) the composition of the ingredient is known to the
registrant.
c. Change in Certified Limits
A registrant may change the certified limits of any inert
ingredient(s) in a formulation by notification, provided that they
fall within the standard certified limits in 40 CFR 158.175(b)(2).
Certified limits may not be changed via notification for products for
which:
(1) the Agency has previously determined that alternative
certified limits will apply; or
(2) the registrant has already changed the nominal
concentration per Section II.B.2.b. above.
d. Inert Changes Not Permitted by
Notification
Changes in proprietary ingredients such as specific solvents
or common commodity diluents, which generally are composed of a
mixture of ingredients and whose composition is not disclosed to the
registrant, require the Agency to determine their acceptability based
upon information on their composition supplied by the producer.
Changes of inerts for: (1) antifoulant paints (because such
changes may affect the release rate of these products) or (2) products
used for the control of vertebrate animals (because odor, taste and
dye are usually crucial to product effectiveness).
Minor formulation changes covered in Section IV. below.
3. Starting Materials for Integrated Systems
Products
A registrant who produces a product by an integrated system
[40 CFR 158.153(g)] which uses an unregistered source of active
ingredient is required to supply the Agency with the sources of the
starting materials for each ingredient (40 CFR 158.153). A registrant
may change the source of his starting materials to other sources if
the change will not result in:
(a) an increase in the upper certified limit of any existing
impurity;
(b) the formation of any new impurity at a level greater
than 0.1 percent by weight of the technical grade active ingredient;
or
(c) the formation of other impurities of toxicological
concern (e.g., dioxins, furans, nitrosamines, arsenicals) above levels
previously permitted by the Agency.
4. Change in Formulation Process
A registrant may modify a formulation process of a product
made by a non-integrated system (a blending or dilution of product
components involving no chemical reaction--distinguished from a
reaction process), provided:
(a) the certified limits of the active and inert ingredients
do not change as a result; and
(b) the physical/chemical/biological characteristics and/or
the effectiveness (efficacy) of the product will not change.
III. NON-NOTIFICATIONS
In accordance with 40 CFR 152.46(b), a registrant may
accomplish the following types of actions without notification to the
Agency:
A. Correcting typographical and printing errors in labeling
as well as changes in grammar and/or phrasing that do not change how
the product will be used (e.g., adding and/or changing prepositions)
provided that the use directions, signal words or requirement for
child-resistant packaging does not change and that the format is
consistent with Agency labeling requirements. Any corrections which
result in changes in use directions, use precautions or the ingredient
statement must be submitted as a notification or an amendment as
described in this PR Notice.
B. Changes in package size and the net contents, except for:
(1) products subject to child-resistant packaging
requirements under 40 CFR Part 157 (either before or after the package
size change);
(2) product subject to other special Agency-mandated size-
related requirements; and
(3) rodenticidal products.
C. Revision, addition or deletion of non-FIFRA related label
elements, such as the following:
Symbols and graphics required by other government agencies
such as the Department of Transportation.
State-required analysis of a fertilizer product.
Lot or batch codes, barcodes or other production identifiers.
Date of manufacture or label approval.
Use of metric units in addition to standard U.S. units for
net contents, dosages and other numeric expressions.
D. Changes in the name or address of the registrant on the
label, except for a change resulting from transfer of ownership, which
requires Agency approval in accordance with 40 CFR 152.135. 40 CFR
Section 152.122 requires, however, that a registrant notify EPA of a
change in its company name, address or designated agent.
E. Redesign of label format that does not modify approved
label text and is consistent with the format requirements of 40 CFR
156.10 and Agency policy. These may include, among other things,
changes in color, type size or style, use of space, configuration or
placement of label elements.
IV. ACCELERATED REVIEW OF MINOR FORMULATION CHANGES
Although a formulation change may only be accomplished
through submission of an application for amended registration, the
Agency has developed an accelerated review for certain minor
formulation amendments. The criteria are listed below, followed by a
description of the review process.
A. Minor Formulation Amendments
Amendments involving the following types of formulation
changes will be considered eligible for accelerated review subject to
these limitations:
1. Addition, deletion or substitution of one or more
colorants in a formulation:
(a) the total percentage of changed colorant does not exceed
1% by weight of the formulation;
(b) the component(s) of the colorant are listed on EPA's
Pesticide Inert Ingredient Lists 3 or 4;
(c) if the product is registered for food use, the colorant
has the appropriate exemption from the requirement of a tolerance
under 40 CFR 180.1001; and
(d) the product is not intended for use on seed.
2. Addition, deletion or substitution of one or more
fragrances in a formulation:
(a) the total percentage of changed, added or deleted
fragrance does not exceed 1% by weight of the formulation;
(b) information on the composition of the fragrance has been
provided to the Agency by the fragrance manufacturer or registrant;
(c) the fragrance has been determined to be acceptable for
such use by the Agency at the proposed concentration or the
component(s) of the fragrance are listed on EPA's Pesticide Inert
Ingredient Lists 3 or 4; and
(d) if the product is registered for food use, the fragrance
components are exempt from the requirement of a tolerance under 40 CFR
180.1001.
(e) the product is not intended for use in baits or
repellents.
3. Addition, deletion or substitution of one or
more inert ingredients (other than fragrances or dyes) in a
formulation:
(a) the nominal concentration of active ingredient does not
change;
(b) the change does not invalidate any product-specific data
submitted in support of the initial registration which causes
additional data to be required;
(c) the identity of any proposed substitute inert ingredient
is known by the registrant and is listed on EPA's Pesticide Inert
Ingredient Lists 3 or 4;
(d) if the product is registered for food use, the inert
ingredient is considered to be exempt from the requirement of a
tolerance under 40 CFR 180.1001;
(e) any change is for inert ingredients used for the same
purpose in the formulation (e.g., carrier, emulsifier, surfactant);
and
(f) the product is not intended for use in public health
antimicrobial products, baits or repellents.
Applications for accelerated review of the above kinds of
amendments should not be submitted if the proposed reformulation will:
(1) change the product's acute toxicity category or
physical/chemical characteristics necessitating label modifications;
or
(2) affect the product's efficacy so that supporting data
are required (such as for vertebrate control products, tin-based
antifoulant paints, food-contact sanitizing solutions subject to
regulation under 21 CFR 178.1010, and liquid or aerosol
insecticides intended for household use).
B. Review Process
If a registrant believes that an amendment meets the criteria
above, he/she should identify it as such on the application for
amended registration with a statement such as "Minor Formulation
Amendment per PR Notice 95-2 ." The submission should be addressed to
the Product Manager and contain:
1. an application (EPA Form 8570-1),
2. one (1) copy of the CSF for the existing
formulation,
3. two (2) copies of the CSF of the proposed
formulation, and
4. any supporting information such as MSDS sheets on
the added inert ingredient(s).
The PM will make every effort to prepare an appropriate
response to the registrant either accepting or rejecting the amendment
within 45 days of receipt of application.
V. PROCEDURES FOR NOTIFICATIONS
A. Notifications
1. Notification Submission
For each product a notification should be submitted with a
completed Application for Registration (EPA Form 8570-1). A photocopy
of the EPA application form is acceptable; an original form is not
needed. The application should bear the following statements:
"Notification of (insert type of change, such as 'Alternate
Brand Name') per PR Notice (insert number)."
"This notification is consistent with the provisions of PR
Notice 95-2 and EPA regulations at 40 CFR 152.46, and no other changes
have been made to the labeling or the confidential statement of
formula of this product. I understand that it is a violation of 18
U.S.C. Sec. 1001 to willfully make any false statement to EPA. I
further understand that if this notification is not consistent with
the terms of PR Notice 95-2 and 40 CFR 152.46, this product may be in
violation of FIFRA and I may be subject to enforcement action and
penalties under sections 12 and 14 of FIFRA."
2. Labeling
For each notification involving labeling changes, one (1)
copy of the labeling must be submitted with the changes clearly marked
so that they can be photocopied.
3. Confidential Statement of Formula (CSF)
Two (2) original and signed CSFs must be submitted for either
a notification or an amendment involving a CSF change. In addition,
a Formulator's Exemption form (EPA Form 8570-27) should be submitted
for any change in the identity or source of active ingredients.
4. Signature
Each notification should be signed by the registrant or
authorized agent and include that person's current address and
telephone number.
5. EPA Mailing Address
All correspondence concerning notification actions should be
addressed and mailed to:
Document Processing Desk (NOTIF) or (AMEND) (as applicable)
Office of Pesticide Programs (7504C)
U.S. Environmental Protection Agency
401 M Street S.W.
Washington, D.C. 20460-0001
6. EPA Delivery Address
The official delivery address used for notification actions
hand-carried or courier delivered Monday through Friday, 8:00 AM to
4:30 PM, excluding Federal holidays is:
Document Processing Desk (NOTIF) or (AMEND) (as applicable)
Office of Pesticide Programs (7504C)
U.S. Environmental Protection Agency
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
7. EPA Processing of Notifications
EPA will screen all notifications to determine whether they
meet the criteria in this PR Notice or other notices. If a
notification is determined not to qualify for notification, EPA will
inform the registrant via letter that the submission does not qualify
and is being sent to the RD PM team for processing as an application
for amended registration. EPA will attempt to screen each
notification within 30 days of receipt.
B. Pending Applications
If a registrant has an application for amended registration
pending with the Agency which qualifies for notification pursuant to
this Notice, the registrant should: (1) send a letter to the PM
requesting that the application for amended registration be withdrawn
and (2) submit a notification to one of the addresses above. The
Agency will then process the notification in lieu of the application
for amended registration.
C. Distribution and Sale
When amendment of a registration is permissible by
notification, the notification must be received by the Agency before
the registrant may distribute or sell the product. Final printed
labeling must be also be submitted to the Agency before a product, as
modified, may be sold or distributed [PR Notice 82-2 and 40 CFR
156.10(a)(6)]. For notifications, one (1) copy of the final printed
labeling is required per product, either with or separate from the
notification. For all other amendments, two (2) copies of the final
printed labeling are required. A product distributed or sold before
a notification and final printed labeling are received is in violation
of FIFRA.
VII. COMPLIANCE
Notifications and non-notifications should comply with Agency
regulations and policy. Notifications and non-notifications which are
not in compliance may be subject to enforcement action under FIFRA
sections 12 and 14. The Agency will audit notifications to assure
that the process is working properly and that such submissions are in
compliance.
VIII. ADDITIONAL INFORMATION
If you have questions about this notice, call Ms. Sherada
Hobgood (703-308-8352).
/signed by Stephen L. Johnson/
Stephen L. Johnson, Director
Registration Division
TABLE A. Registration Changes Described in this PR Notice
(Applicable section of this notice is in parenthesis).
TYPE OF ACCELERATED
CHANGE NOTIFICATION NON-NOTIFICATION REVIEW AMENDMENT
LABEL OR
PACKAGE
Brand Alternate Primary
Name brand name brand name
(II.A.1.)
Add/Delete (II.A.2.) Public
Pests Non-Public Health
Health Pests and
Pests Except Termites
Termites
Add Indoor, (II.A.3.)
Non-Food Antimicrobials
Use Sites only
Advisory
Statements (II.A.4.)
Packaging
& Related
Labeling (II.A.5.)
Use
Deletions (II.A.6.)
Storage and
Disposal
Statements (II.A.7)
Non- Non-English English
Mandatory (II.A.8.)
Bilingual
Labeling
Symbols or
Graphics (II.A.9)
Redundant
Statements (II.A.10.)
Warranty
Statements (II.A.11.)
Typos (III.A.)
Package Size
and Net Contents (III.B.)
Non-FIFRA
Related Elements (III.C)
Name and
Address (III.D.)
Format (III.E.)
PRODUCT CHEMISTRY
Source of Criteria are met. Criteria
Active (II.B.1) not met.
(II.B.1)
Source of EPA has EPA has
Inert asked for asked for
source (II.B.2.a) source (II.B.2.a)
Nominal
Concentration
ofInert (II.B.2.b)
Certified
Limits of
Inert (II.B.2.c)
Proprietary
Inerts (II.B.2.d.)
Minor
Reformulation (IV.)
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