EPA /-N-95-002
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
5/31/95
PR NOTICE 95-2 PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
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. §152.46(a)
allows certain registration amendments to be accomplished by notifying the Agency of those
changes before the product is distributed or sold. §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 §152.46.
Recycled/RccyciabSe
Print»d with Soy/CanoJa Ink on paper that
contains at least 50% recycled fiber
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§152.44(b), Application for Amended Registration, requires any modification in the
composition, labeling or packaging of a re stered product to be submitted with an
application for amended registration, with the exception of notifications and non-notifications
under §152.46. §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
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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
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(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
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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.
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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.I.-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)(l) 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
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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
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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;
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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
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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
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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
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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
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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)
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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. SbeTkda Hobgood (703-308-8352).
nsoff, Director
Division
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TABLE A. Registration Changes Described in this PR Notice (Applicable section of this notice is in parenthesis).
TYPE OF
CHANGE
LABEL OR
PACKAGE
Brand Name
Add/Delete
Pests
Add Indoor,
Non-Food
Use Sites
Advisory
Statements
Packaging &
Related
Labeling
Use
Deletions
Storage and
Disposal
Statements
Non-
Mandatory
Bilingual
Labeling
Symbols or
Graphics
Redundant
Statements
Warranty
Statements
NOTIFICATION
Alternate
brand name
(ILA.l.)
(II.A.2.)
Non-Public
Health
Pests Except
Termites
(H.A.3.)
Antimicrobials only
(H.A.4.)
(H.A.5.)
(H.A.6.)
(II.A.7)
Non-English
(H.A.8.)
(II.A.9)
(II. A. 10.)
(n.A.ll.)
NON-
NOTIFICATION
ACCELERATED
REVIEW
AMENDMENT
Primary
brand name
Public
Health
Pests and
Termites
English
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TABLE A. (Continued)
16
TYPE OF
CHANGE
Typos
Package Size and
Net Contents
Non-FEFRA
Related Elements
Name and
Address
Format
PRODUCT
CHEMISTRY
Source of Active
Source of Inert
Nominal
Concentration of
Inert
Certified Limits of
Inert
Proprietary Inerts
Minor
Reformulation
1 ' " _ - ».
NOTIFICATION
Criteria are met.
(n.B.l)
EPA has
asked for
source (II.B.2.a)
OI.B.2.b)
(H.B.2.C)
-1-1- ' i i ...-
NON-
NOTIFICATION
(m.A.)
(m.B.)
(m.c)
(ra.D.)
(m.E).
EPA has not
asked for source
(ILB.2.a)
,.,
ACCELERATED
REVIEW
(IV.)
=========
AMENDMENT
Criteria not met.
(H.B.l)
(H.B.2.d.)
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