00-12379. Pesticides; Guidance for Pesticide Registrants on Mandatory and Advisory Labeling Statements

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of availability.

SUMMARY:

The Agency has issued Pesticide Registration (PR) Notice 2000-5 entitled “Guidance for Mandatory and Advisory Labeling Statements.” This PR 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.

FOR FURTHER INFORMATION CONTACT:

Jeff Kempter, (7505C), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general. Although this action may be of particular interest to those persons who are required to register pesticides. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document and the PR Notice from the Office of Pesticide Programs' Home Page at http://www.epa.gov/​pesticides. You can also go directly to the listings from the EPA Internet Home Page at http://www.epa.gov. To access this document, on the Home Page select “Laws and Regulations” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr.

2. Fax-on-demand. You may request a faxed copy of the Pesticide Registration (PR) Notice entitled “Guidance for Mandatory and Advisory Labeling Statements,” by using a faxphone to call [phone] and selecting item 6128. Also, you may select item 6129 for the paper entitled “Responses to Public Comments on Draft PR Notice on Mandatory/Advisory Labeling.” You may also follow the automated menu.

3. In person. The Agency has established an official record for this action under docket control number OPP-00599B. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

II. What Guidance Does this PR Notice Provide?

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 the term “to use any registered pesticide in a manner inconsistent with its labeling” (i.e., misuse) as use of “. . . any registered pesticide in a manner not permitted by the labeling . . . .” For purposes of this notice, the term “use” includes storage, transportation, handling, pre-application activities, mixing and loading, worker notification and worker protection, application, post- application activities and disposal. Registrants are not required to submit applications in response to this notice, however, EPA will review applications in light of the guidance presented here and seek to clarify labeling statements that are unclear or ambiguous. Finally, 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 the use of notification for adding or modifying advisory statements.

III. Guidance on Mandatory and Advisory Labeling Statements

Statements on the pesticide labeling may be interpreted by users differently from what the registrant or EPA intended when the labeling was accepted. If EPA believes that misuse has occurred, an administrative law judge or 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 pesticide product labels in general (e.g., the Consumer Labeling Initiative), as well as in specific areas of the labeling (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 generally 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 of the information presented on the label and by 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 mandatory labeling statements. In the past, advisory statements have commonly used suggestive verbs such as “should,” “may,” or “recommend” to encourage the user to achieve the directed behavior, but often 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.

Advisory language using terms such as “should,” “may,” and “recommend” can create ambiguities as to the intent of the direction or precaution. Too often, common everyday speech using the word “should” creeps into mandatory label statements where the imperative tense is needed to communicate that certain action is required. Another problem is contradictory headings and statements. A set of mandatory directions preceded by an advisory heading such as “Use Recommendations” potentially conflicts as to the nature of the intended action. Lastly, the use of words such as “should” in advisory language can mistakenly imply that an unaccepted use is permissible. For example, the direction “you should remove all food articles prior to use” on a product that is not registered for any food uses could be mistakenly read to suggest that it is not mandatory to remove all food from the area to be treated.

The Agency seeks to improve mandatory and advisory labeling statements by providing guidance on how they can best be written. 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, and that failure to follow these instructions is a misuse of the product. Advisory statements are generally 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. 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 craft advisory labeling statements in straightforward, descriptive language.

The PR Notice was developed from a draft document by the same title that was released for public comment on June 2, 1999 (64 FR 29641) (FRL-6079-4). The Agency received comments from various organizations. Each of the commenters offered recommendations for improving the document. All comments were extensively evaluated and considered by the Agency. This revised version embodies some of the recommendations of the commenters. A summary of the public comments, as well as the Agency's response to the comments, is being made available as described in Units I.B.1. and I.B.2.

IV. Why is a PR Notice Guidance and Not a Rule?

The PR Notice discussed in this notice is intended to provide guidance to EPA personnel and decision-makers, and to the public. As a guidance document and not a rule, this policy is not binding on either EPA or any outside parties. Although this guidance document provides a starting point for EPA decisions, EPA will depart from this policy where the facts or circumstances warrant. In such cases, EPA will explain why a different course was taken. Similarly, outside parties remain free to assert that this policy is not appropriate for a specific pesticide or that the specific circumstances demonstrate that this policy should be abandoned.

List of Subjects

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Pesticides and pests

Dated: May 10, 2000.

Marcia E. Mulkey,

Director, Office of Pesticide Programs.