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Pesticide Registration Manual:
Chapter 7 - Notifications and Minor Formulation Amendments

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Current as of March 2011

In this Chapter:

Notifications, Non-Notifications, and Minor Formulation Amendments

This chapter discusses certain minor amendments that can be made to a registered product and do not require the applicant to apply to amend a registration. Such amendments are not subject to the data compensation provisions of FIFRA section 3(c)(1)(F) Exit EPA disclaimer because they do not need to be supported by new data. To emphasize that these applications can only be submitted by the registrant of the product, the applicant is generally referred to as “the registrant” in this chapter.

Some minor changes referred to as “notifications” can be made to a registration, such as changes to a brand name, provided that the Agency is notified before the change is made and before the product is distributed or sold.

“Non-notifications” are changes that can be made to a pesticide label without notifying the Agency (such as the correction of typographical errors).

Although a formulation change may only be accomplished through applying for amended registration, the Agency has developed an accelerated review process for certain “minor formulation amendments” (such as the addition, deletion, or substitution of one or more fragrances, colorants, or other inert ingredients in a formulation).

A notification does not constitute official acceptance of the product label, nor does it guarantee the product’s compliance with regulations. For more detailed information, please refer to PR Notice 98-10 Notifications, Non-Notifications and Minor Formulation Amendments (PDF) (23 pp, 242k).

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Parties Authorized to Submit

Only the registrant or the authorized agent for the company may submit a notification or minor formulation amendment, which must be properly signed and dated. The registrant is also responsible for ensuring that the labeling of any of its distributors or supplementally registered products is in compliance with FIFRA. (Refer to 40 CFR Part 156.) Supplemental distributors, commonly known as sub-registrants, may not submit notifications, nor may registrants submit supplemental distributor labeling for notifications.

Important Note: An applicant or registrant should be aware that knowingly falsifying any part of any application for registration or other information submitted to the Agency is an unlawful act under FIFRA section 12 (a)(2)(M) and 18 USC 1001 and may result in civil or criminal penalties.

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Labeling Notifications

Certain permitted changes to a registration require a notice to EPA but do not require Agency approval. As provided in 40 CFR 152.46(a) (PDF) (1 pp, 143.25 k About PDF) , minor changes that the Agency has determined have no potential to cause unreasonable adverse effects to the environment can be made to a registration, provided that the Agency is notified before the change is made. OPP refers to these changes as “notifications.” As described in 40 CFR 152.46(a), the Agency has issued a notice describing which actions are appropriate as notifications and the procedures to follow. See PR Notice 98-10 (PDF)(23 pp, 242k).

Except for the special procedures for antimicrobials discussed below, it is not necessary to obtain Agency approval of such a change or amendment, and the product may be distributed or sold, as changed, as soon as EPA receives the notification of the change, as long as EPA does not reject the notification. However, to assure the registrants and state regulatory agencies that a notification has been received and reviewed by the Agency, the Agency is attempting to respond in writing to all notifications.

FIFRA, as amended in 1996, specifies slightly different notification requirements for antimicrobial products (FIFRA section 3(c)(9)). For antimicrobial products, registrants must notify the Agency of certain labeling changes at least 60 days prior to distribution or sale of a product bearing the new label. The Agency may disapprove changes within 30 days of their receipt.

Normally, EPA will screen a notification within 30 days of receipt. If EPA determines that the proposed amendment (change) does not qualify as a notification, the Agency will notify the applicant, stating the reason(s) why an application is required for amended registration in lieu of a notification. If the registrant fails to submit an application for amended registration without good cause, and markets the product as if the notification was accepted, the Agency may determine that the registered product is no longer in compliance with the requirements of FIFRA and initiate regulatory action under FIFRA section 6 and/or enforcement actions under FIFRA section 13 (PDF) and section 12 (PDF).

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Permitted Modifications to Registrations through Notification

EPA issued general procedures for notifications in PR Notice 98-10 (PDF) (23 pp, 242k) and a list of changes that may be made through notification. Subsequent PR Notices have modified the original list. As described in PR Notice 98-10, the following registration amendments generally may be accomplished by notification. See PR Notice 98-10 for more descriptions on these categories.

Brand Names
Addition or Deletion of Pests on the Label

Exceptions: To add claims to a label against a public health pest, termites, or pests on plants subject to quarantine, the registrant may not use notification, but must receive approval to amend the pesticide product registration. Public health pests include, but are not limited to, mosquitoes, cockroaches, fleas, ticks, biting flies, rodents, viruses, and pathogenic bacteria. Refer to PR Notice 2002-1 for list of public health pests (PDF) (32 pp, 22k). Antimicrobial pests and claims that are related to public health are described in OPP's Antimicrobial Division DSS/TSS Sheet #16. Special instructions to add claims for H1N1 can be found on the Guidance for Testing and Labeling Claims against Pandemic 2009 H1N1 Influenza A Virus (Formerly called Swine Flu) web page. Questions about public health pests, termiticides, and products used for plant quarantine may be referred to the appropriate regulatory division that manages those products.

Addition of Indoor, Nonfood Sites for Antimicrobial Products
Changes in Packaging and Related Labeling Statements (except Child Resistant Packaging)
Use Deletions Related to a Data Call-In
Storage and Disposal Statements

Registrants may adopt storage and disposal labeling statements as specified in the following notices without submitting an amendment for approval:

Since PR Notice 98-10, the storage and disposal statements have been revised according to the following PR Notices.

Registrants may continue to adopt labeling statements verbatim from these notices by notification. However, a request for variation in the wording of these statements must be submitted as an amendment.

Use of Symbols and Graphics
Redundant Labeling Statements
Changes in Warranty Statement

Labeling Statements about Product Composition (such as pesticide category, source of ingredient(s), odor or fragrance statements, and water-based statements)

Risk Reduction Statements (such as nonflammability or closed system statements)

Minor Changes to Directions for Use (such as changes in mixing directions that do not affect the dilution ratio or the minimum or maximum use dilutions; addition of tables, charts, or other graphics; addition of similar application methods; and mixing with a fertilizer).

Other Allowable Minor Label Revisions

There are additional minor label changes not described above that may be made by notification, provided they:

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Product Chemistry Notifications

See PR Notice 98-10 for more descriptions on these categories.

Source of Active Ingredients

A registrant may change the source of an active ingredient by notification, provided that the alternate source:

A registrant must submit a Formulator's Exemption (EPA Form 8570-27)(PDF) (2 pp, 104k) 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) (PDF) (1 pp, 143.27 k About PDF) ).

Changes to Active Ingredients That Are Not Allowed by Notification

A registrant may not make the following active ingredient related changes by notification but must submit an application for amendment:

Change in Source of Inert Ingredients

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.

Change in Nominal Concentration of Inert Ingredients

A registrant may change the stated nominal concentration of any inert ingredient by notification, provided that:

Change in the Certified Limits of Inert Ingredients

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 158.350 (PDF) (2 pp, 147.00 k About PDF) or 40 CFR 161.175 (PDF) (2 pp, 158.54 k About PDF) for antimicrobials.

Changes to Inert Ingredients Not Permitted by Notification

EPA does not permit changing proprietary ingredients such as specific solvents or common commodity diluents by notification because they are generally composed of a mixture of ingredients and the registrant does not disclose their composition. Such changes would require the Agency to determine their acceptability based upon information on their composition supplied by the producer.

The Agency also does not permit changing inert ingredients by notification for:

Certified limits of inert ingredients may not be changed via notification for products for which:

Sources for Starting Materials for Integrated Systems Products

An integrated system is a process for producing a pesticide product that: (1) contains any active ingredient derived from a source that is not an EPA-registered product; or (2) contains any active ingredient that was produced or acquired in a manner that does not permit its inspection by the Agency under FIFRA section 9(a) before its use in the process. Refer to 40 CFR 158.300(PDF) (2 pp, 147.00 k About PDF) and for antimicrobials, 40 CFR 161.153(PDF) (2 pp, 146.40 k About PDF) .

A registrant who produces a product by an integrated system and 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 158.325 (PDF) (2 pp, 149.33 k About PDF) and for antimicrobials, 40 CFR 161.160 (PDF) (2 pp, 145.73 k About PDF) .)

Registrants may change the source of the starting materials to other sources by notification if the integrated system product is:

Changes to the Formulation Process for Non-Integrated Systems

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:

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Submitting Notifications

Application Form: 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. In order for the application to be processed, include the following statements on the application:

Labeling: For each notification involving labeling changes, one copy of the labeling must be submitted with the changes clearly marked so that they can be photocopied.

Confidential Statement of Formula (CSF): Two 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) must be submitted for any change in the identity or source of active ingredients.

Signature: Each notification must be signed by the registrant or authorized agent and include that person's current address and telephone number.

Address: Notifications should be sent to the address listed in Chapter 21.

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In accordance with 40 CFR 152.46(b) (PDF) (1 pp, 143.25 k About PDF) and PR Notice 98-10 (PDF) (2 pp, 48k), a registrant may make certain changes to its pesticide label without notifying the Agency. See PR Notice 98-10 for more descriptions on these categories.

Typographical and Printing Errors
Changes in Package Size and Net Contents
Revision, Addition, or Deletion of Non-FIFRA Related Label Elements
Transfer of Ownership
Changes in the Name or Address of the Registrant on the Label
Redesign of Label Format
Nonpesticidal Characteristics

The following are examples of nonpesticidal characteristics statement changes allowed by non-notifications:

Statement of Practical Treatment

The heading “First Aid” may be substituted for “Statement of Practical Treatment” without notification to the Agency.

Product Packaging

The Agency allows the addition of “Recycled Content” claims to the pesticide label without prior notification. A statement about the recycled content of pesticide packaging itself may be made in accordance with guidance from the Federal Trade Commission.

Bilingual Labeling

A registrant may provide bilingual labeling on any product without notification to the Agency. EPA may require bilingual language as well. Refer to 40 CFR 156.10(a)(3) (PDF) (6 pp, 162.65 k About PDF) . The foreign text must be a true and accurate translation of the English text.

Important Note: Foreign text may be used on all or part of the labeling.

Recycling of Containers

The Agency allows certain types of statements regarding the recycling of containers to be added to the label without prior notification. Refer to 40 CFR Part 156, Subpart H Container Labeling 156.140, 156.144, 156.146 and 156.156 for appropriate statements.

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Minor Formulation Amendments

Although a formulation change may only be accomplished through submission of an application for amended registration, the Agency has developed an accelerated review process for certain minor formulation amendments.

The criteria for accelerated review are listed below, followed by a description of the review process.

Criteria for Accelerated Review

Amendments involving the following types of formulation changes will be considered eligible for accelerated review subject to the following limitations:

Addition, deletion, or substitution of one or more colorants in a formulation:
Addition, deletion, or substitution of one or more fragrances in a formulation:
Addition, deletion, or substitution of one or more inert ingredients (other than fragrances or dyes) in a formulation:

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Grounds for Denying Accelerated Review

Applications for the above kinds of amendments will not be considered for accelerated review if:

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Submitting Minor Formulation Amendments

If a registrant believes that an amendment meets the criteria above, he/she should highlight this on the application for amended registration with a statement such as “Minor Formulation Amendment per PR Notice 98-10.” The submission should be addressed to the appropriate regulatory division’s Product Manager/Team Leader and to the address listed in Chapter 21 and include:

EPA will make every effort to prepare an appropriate response to the registrant either accepting or rejecting the amendment within 45 days of receipt of the application except when confirmatory data are submitted. Additional time is required for review of such data.

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Final Printed Labeling

After acceptance of a new product registration, labeling amendment or labeling notification, final printed labeling must be submitted before the product is sold or distributed. Two copies of the final printed labeling that incorporate any labeling changes required by the acceptance letter and/or notification must be submitted.

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Contacts for Additional Information

Any questions or need for additional information regarding notifications should be directed to the appropriate Product Manager assigned the product in question. Refer to Chapter 21 for a listing of Product Branches.

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References Cited in Chapter 7

Refer to Chapter 19 for information on the source of these documents.

Code of Federal Regulation, Title 40

Federal Insecticide, Fungicide, and Rodenticide Act (PDF), as amended by the Food Quality Protection Act of August 3, 1996

Pesticide Registration Notices

Label Review Manual

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