US EPA Draft Pesticide Registration (PR) Notice: May 21, 1999

EPA is seeking public comment on this draft Pesticide Registration (PR) Notice. This notice provides guidance to the registrant for improving the clarity of labeling statements in order to avoid confusing directions and precautions and to prevent the misuse of pesticides. Comments are welcome until August 2, 1999. Federal Register Notice Vol. 64, No. 105, Pages 29641-29643 provides details on how to submit comments.

Fax-On-Demand
Fax Number: (202) 401-0527
Item: 6120

Draft 5/21/99
Pesticide Registration (PR) Notice 99-

Notice to Manufacturers, Producers, Formulators and Registrants of Pesticides

Attention:	Persons Responsible for Registration and Reregistration of Pesticide Products
Subject:	Guidance for Mandatory and Advisory Labeling Statements

This notice provides guidance to the registrant for improving the clarity of labeling statements in order to avoid confusing directions and precautions and to prevent the misuse of pesticides. The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) section 2(ee) defines "to use any registered pesticide in a manner inconsistent with its labeling" (misuse) as use of "...any registered pesticide in a manner not permitted by the labeling...," and goes on to list a number of exceptions to the term. Use includes storage, transportation, handling, pre-application activities, mixing and loading, worker notification and worker protection, application, post-application activities and disposal.

I. Guidance on Mandatory and Advisory Labeling Statements

Statements on the pesticide labeling may be interpreted by users different from what the registrant or EPA intended when the labeling was accepted. If EPA believes that misuse has occurred, a court may have to decide whether a product's labeling statements are clear enough for the user to understand how to lawfully use the product. Pesticide labeling needs to clearly identify what is required of the user to handle and apply a pesticide safely. The Agency is engaged in numerous efforts to improve labels in general (e.g., the Consumer Labeling Initiative), as well as specific areas of the labeling of pesticide products (e.g., bee precautionary labeling and pesticide drift labeling).

Mandatory statements, which commonly use imperative verbs such as "must" or "shall," either require action or prohibit the user from taking certain action. Advisory statements simply provide information, either in support of the mandatory statements or about the product in general. To ensure that the intent of each labeling statement is clear, mandatory statements need to be clearly distinguishable from advisory statements.

Currently, labeling provisions are enforced by taking into consideration all the information presented on the label and reading advisory statements in the context of the entire label. Problems can arise when advisory statements are either vague or ambiguous in meaning, or are inconsistent with other labeling. In the past, advisory statements have commonly used suggestive verbs such as "should," "may" or "recommend" to help the user achieve the directed behavior, but sometimes these statements can be unclear as to whether they are mandatory or advisory. In a recent misuse enforcement action, for example, the person charged with the violation argued that advisory statements misled him into taking action which was inconsistent with the mandatory statements.

The Agency seeks to improve mandatory and advisory labeling statements by providing guidance (see Appendix) on how they can best be written. This guidance consists of two steps. First, mandatory statements are generally written in imperative or directive terms (such as "shall," "must," "do this," "do not") so that a typical user will understand that these statements direct the user to take or avoid certain actions. Second, advisory statements are best written in descriptive or nondirective terms to support the mandatory statements or provide information. Suggestive terms such as "should," "may" or "recommend" may be confusing or ambiguous, or potentially conflict with mandatory labeling statements; thus, they are to be avoided whenever possible. EPA realizes that the use of descriptive terms for advisory statements is not appropriate for every situation and that there are times where it may be necessary to use "should," "may," "recommend" or similar words. However, in most cases it is best to state advisory labeling statements in straightforward, descriptive language.

II. How to Change Labels

Registrants should follow the guidance above and in the Appendix whenever submitting new or revised labeling to EPA for registration or reregistration. Registrants of new or existing products should draft their product labels to be consistent with the guidance, and submit them for acceptance as follows:

Registrants may modify or add mandatory or advisory labeling statements for currently registered products only by submitting an application for amended registration. This application should include the following items: a completed EPA application form 8570-1, five copies of the draft label, and a description on the application, such as, "Amended in accordance with PR Notice 99- ."
Registrants may no longer add or change advisory labeling statements to existing products by notification as previously permitted by PR Notices 95-2 and 98-10. This PR Notice supersedes those PR Notices concerning advisory statements.
Applicants for registration of new products should follow the guidance in this notice when drafting labeling to be submitted with an application.

Because of the importance of maintaining a clear distinction between mandatory and advisory statements, and of making these statements as clear as possible to pesticide users, EPA will review all new or changed mandatory and advisory labeling statements through the amendment process, except for those statements permitted by other PR Notices.

Registrants should submit applications for new products and amendment as follows:

U.S. Postal Service Deliveries
The following official mailing address should be used for all correspondence or data submissions sent to OPP by mail:
Document Processing Desk (AMEND) or (APPL), as applicable
Office of Pesticide Programs (7504C)
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460-0001

Personal/Courier Service Deliveries
The following address should be used for all correspondence or data submissions that are hand-carried or sent by courier service Monday through Friday, from 8:00 AM to 4:30 PM, excluding Federal holidays:
Document Processing Desk (AMEND) or (APPL), as applicable
Office of Pesticide Programs (7504C)
U.S. Environmental Protection Agency
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, Virginia 22202

III. For Further Information

If you have questions, contact the Labeling Team (703-308-9071), the appropriate Product Manager (Registration Division and Antimicrobial Division) or Regulatory Action Leader (Biopesticides and Pollution Prevention Division) for your product.

Marcia E. Mulkey, Director
Ofice of Pesticide Programs

Appendix to PR Notice 99- : Guidance for Writing Clear Labeling

A. Mandatory Statements

Mandatory statements generally relate to the actions that are necessary to ensure the appropriate and efficacious use of the pesticide and to prevent the occurrence of unreasonable adverse effects. Mandatory statements include directions for use and precautions that direct the user to take or avoid specific actions. The directions and precautions specify where, when and how a pesticide is to be applied. When specifying action, mandatory statements are written in imperative or directive sentences (e.g., "Wash application equipment...," "Do not use ...," "Users must...," "Apply to corn at a maximum rate of one to two pounds per acre 30 days prior to harvest."

The following directions and precautions are further examples of mandatory statements.

"Keep Out of Reach of Children."
"Wear chemical resistant gloves."
"If swallowed, call a doctor."
"Do not induce vomiting."
"Do not apply directly to water."
"Do not apply within 66 feet of wells."
"Keep away from heat, sparks and open flame."
"Do not enter into treated areas for 12 hours."
"Apply immediately after mixing."
"Do not apply when wind speed exceeds 15 mph."

B. Advisory Statements

The registrant may request that certain product information be included on the labeling in addition to what is required as long as the information is not false or misleading. This information is considered advisory labeling and advises the user about product characteristics and various techniques for enhancing the use of the product. Advisory statements have traditionally used words such as "should," "may," "suggest" or "recommend" and are not always distinguishable from statements that direct action by the user. Advisory statements using descriptive or nondirective terms enable the user to more clearly distinguish advisory statements from mandatory statements which direct the user to take specific actions.

The following examples illustrate how an advisory statement that uses words such as "should," "may" or "recommend" can be rewritten using descriptive terms. Below is a list of sample, hypothetical advisory statements under different label categories. Each category includes:

a. A typical label advisory statement that uses terms such as "should," "may" or "recommend" and
b. The rewritten statement using descriptive terms. [designated as "preferred"]

The best advisory statements describe the recommended action and the reason it is recommended. The following "b." statements are examples only; other descriptive statements can also accomplish the same purpose.

Precautionary Statements

1. a. Latex gloves are recommended.

b. Latex gloves provide the best protection. [preferred]

2. a. Sensitized persons should avoid further contact with and reuse of contaminated clothing.

b. Contacting or reusing contaminated clothing can cause skin reactions in sensitized persons. [preferred]

Physical and Chemical Hazards

1. a. It is preferable to open containers of aluminum phosphide products in open air as under certain conditions they may flash upon opening. Containers may also be opened near a fan or other appropriate ventilation which will rapidly exhaust contaminated air.

b. Opening aluminum phosphide containers outdoors or indoors near a fan or other ventilation assures that the gas will be rapidly dispersed or evacuated if the product flashes upon opening. [preferred]

Directions for Use

Mixing

1. a. Tank mixtures should always be applied immediately after preparation. If for any reason this is not possible, assure that sufficient agitation has been provided to re-mix all products and check for complete resuspension prior to application.

b. Applying the product immediately after preparation assures that it is in suspension. If application is delayed, agitation to re-mix the products and checking for resuspension ensures the mixture is properly blended before application. [preferred]

Application

1. a. Factors such as depth to the drain system and soil type and degree of compaction should be taken into account in determining the depth of treatment.

b. The depth of treatment depends on the depth of the drain system, soil type, and degree of soil compaction. [preferred]

2. a. The dilution should be applied to the trench and mixed with the soil as it is replaced in the trench.

b. Mixing the replacement soil with the dilution in the trench forms a protective barrier. [preferred]

3. a. It may be necessary to treat along one side of interior partition walls if there are cracks in the slab, plumbing entry points, existing termite infestations, or other conditions which would make treatment appropriate.

b. Treatment along one side of interior partition walls where there are cracks in the slab, plumbing entry points, existing termite infestations, or evidence of other means of access prevents further infestation.

4. a. Rotary hoeing is recommended for preemergence applications which do not receive adequate rainfall or sprinkler irrigation to wet the top 2 inches of soil or depth of germinating weeds within about 10 days after application.

b. Rotary hoeing assists soil incorporation, if there is inadequate rainfall or sprinkler irrigation does not wet the top 2 inches of soil or depth of germinating weeds within 10 days of a preemergence application. [preferred]

5. a. The spray mixture should be directed to the soil around base of the cotton plants. Care should be taken to prevent the spray from striking the cotton leaves as injury will occur. The use of leaf lifters or shields on application equipment is recommended to avoid spraying the cotton foliage.

b. Injury will occur if spray strikes the cotton leaves. Directing the spray mixture around the base of the cotton plants and using leaf lifters and shields on application equipment will help minimize foliage contact. [preferred]

Cleaning

1. a. It is recommended that the sprayer be thoroughly cleaned by flushing with a detergent solution at the end of each work day when any emulsifiable oil, oil concentrate, or other emulsifiable formulation has been used either alone or in tank mix combinations with other pesticide formulations, even if no obvious problems have been encountered. This precaution will ensure a clean sprayer and continued trouble-free operation.

b. Flushing the sprayer with detergent solution at the end of each work day when an emulsifiable oil, oil concentrate, or other emulsifiable formulation has been used alone or in tank mix combinations ensures a clean sprayer and trouble-free operation. [preferred]

1.	a. Latex gloves are recommended. b. Latex gloves provide the best protection. [preferred]
2.	a. Sensitized persons should avoid further contact with and reuse of contaminated clothing. b. Contacting or reusing contaminated clothing can cause skin reactions in sensitized persons. [preferred]

1.	a. Factors such as depth to the drain system and soil type and degree of compaction should be taken into account in determining the depth of treatment. b. The depth of treatment depends on the depth of the drain system, soil type, and degree of soil compaction. [preferred]
2.	a. The dilution should be applied to the trench and mixed with the soil as it is replaced in the trench. b. Mixing the replacement soil with the dilution in the trench forms a protective barrier. [preferred]
3.	a. It may be necessary to treat along one side of interior partition walls if there are cracks in the slab, plumbing entry points, existing termite infestations, or other conditions which would make treatment appropriate. b. Treatment along one side of interior partition walls where there are cracks in the slab, plumbing entry points, existing termite infestations, or evidence of other means of access prevents further infestation.
4.	a. Rotary hoeing is recommended for preemergence applications which do not receive adequate rainfall or sprinkler irrigation to wet the top 2 inches of soil or depth of germinating weeds within about 10 days after application. b. Rotary hoeing assists soil incorporation, if there is inadequate rainfall or sprinkler irrigation does not wet the top 2 inches of soil or depth of germinating weeds within 10 days of a preemergence application. [preferred]
5.	a. The spray mixture should be directed to the soil around base of the cotton plants. Care should be taken to prevent the spray from striking the cotton leaves as injury will occur. The use of leaf lifters or shields on application equipment is recommended to avoid spraying the cotton foliage. b. Injury will occur if spray strikes the cotton leaves. Directing the spray mixture around the base of the cotton plants and using leaf lifters and shields on application equipment will help minimize foliage contact. [preferred]