Reports and guidance documents; availability, etc.: Pesticide registration; mandatory and advisory labeling statements,

[Federal Register: June 2, 1999 (Volume 64, Number 105)]

[Notices]

[Page 29641-29643]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr02jn99-58]

ENVIRONMENTAL PROTECTION AGENCY

[OPP-00599; FRL-6079-4]

Pesticides; Draft Guidance on Mandatory/Advisory Labeling Statements

AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability.

SUMMARY: The Agency seeks public comment on a draft Pesticide Registration (PR) Notice entitled ``Guidance for Mandatory and Advisory Labeling Statements.'' This draft 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.

DATES: Written comments, identified by docket control number OPP-00599, should be submitted by August 2, 1999.

ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION'' section of this document. To ensure proper receipt by EPA, your comments must identify docket control number OPP-00599 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Environmental Protection Agency (7509C), 401 M St., SW., Washington, DC 20460, telephone number: (703) 305-5448; fax: (703) 305-6920; e-mail address: kempter.carlton@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. Does This Notice Apply to Me?

      You may be potentially affected by this notice if you manufacture or formulate pesticides. Potentially affected categories and entities may include, but are not limited to:

      Examples of Categories

      NAICS

      potentially affected entities

      Pesticide Producers

      32532

      Pesticide manufacturers Pesticide formulators

      This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed could also be affected. If available, the North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this notice affects certain entities. If you have any questions regarding the applicability of this announcement to you, consult the person listed in the ``FOR FURTHER INFORMATION CONTACT'' at the beginnng of this document.

   2. How Can I Get Additional Information or Copies of This Document or Other Documents?

      1. Electronically. You may obtain electronic copies of this document and the draft PR Notice from the EPA Home Page at http:// www.epa.gov/. 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 to receive a faxed copy of this document, as well as supporting information, by using a faxphone to call (202) 401-0527 and selecting item 6120. You may also follow the automated menu.

      3. In person or by phone. If you have any questions or need additional information about this action, you may contact the appropriate technical person identified in the ``FOR FURTHER INFORMATION CONTACT'' at the beginning of this document. In addition, the official record for this document and the draft paper listed in the ``SUMMARY'' at the beginning of this document, including the public versions, has been established under docket control number OPP-00599 (including comments and data submitted electronically as described below). This record not only includes the documents that are physically located in the docket, but also includes all the documents that are referenced in those documents. A public version of this record, including printed, paper versions of any electronic comments, which do not include any information claimed as Confidential Business Information (CBI), is available for inspection in 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 Public Information and Records Integrity Branch telephone number is (703) 305- 5805.

   3. How and to Whom Do I Submit Comments?

      You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, you must identify docket control number OPP-00599 in the subject line on the first page of your response.

      1. By mail. Submit written comments to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.

      2. In person or by courier. Deliver written comments to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.

      3. Electronically. Submit your comments and/or data electronically by e-mail to: opp-docket@epa.gov. Do not submit any information electronically that you consider to be CBI. Submit electronic comments as an ASCII file, avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard computer disks in WordPerfect 5.1/6.1 or ASCII file format. All comments and data in electronic form must be identified by the docket control number. Electronic comments on this notice may also be filed online at many Federal Depository Libraries.

   4. How Should I Handle CBI Information That I Want to Submit to the Agency?

      You may claim information that you submit in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in

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      40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential will be included in the public docket by EPA without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please call the Public Information and Records Integrity Branch telephone number is (703) 305- 5805.

   5. What Should I Consider As I Prepare My Comments for EPA?

      EPA invites you to provide your views on the draft PR Notice. You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide solid technical information and/or data to support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate. 5. Indicate what you support, as well as what you disagree with. 6. Provide specific examples to illustrate your concerns. 7. Make sure to submit your comments by the deadline in this notice. 8. At the beginning of your comments (e.g., as part of the ``Subject'' heading), be sure to properly identify the document you are commenting on. You can do this by providing docket control number OPP- 00599, along with the name, date and Federal Register citation.

2. Background

   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. 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).

3. Summary of Draft PR Notice

   Following is an excerpt from draft PR Notice which summarizes its key points:

   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 to the PR Notice) 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.

4. Questions/Issues for Comment

   While comments are invited on any aspect of the draft PR Notice, EPA is particularly interested in comments on the following questions:

   1. Are the descriptions of mandatory and advisory labeling statements clear and complete? If not, how should they be changed?

   2. Is the basic policy that mandatory and advisory statements should be distinguishable from each other clear and adequate? If not, how can this policy be better expressed?

5. Policies Not Rules

   The draft 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. EPA has stated in this notice that it will make available revised guidance after consideration of public comment. Public comment is not being solicited for the purpose of converting this guidance document into a binding rule. EPA will not be codifying this policy in the Code of Federal Regulations. EPA is soliciting public comment so that it can make fully informed decisions regarding the content of this guidance. The ``revised'' guidance will not be an unalterable document. Once a ``revised'' guidance document is issued, EPA will continue to treat it as guidance, not a rule. Accordingly, on a case-by-case basis EPA will decide whether it is appropriate to depart from the guidance or to modify the overall approach in the guidance. In the course of commenting on this guidance document, EPA would welcome comments that specifically address how the guidance document can be structured so that it provides meaningful guidance without imposing binding requirements.

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6. Contents of Docket

   Documents that are referenced in this notice will be inserted in the docket under the docket control number OPP-00599.

   List of Subjects

   Environmental protection, Administrative practice and procedure, Agricultural commodities, pesticides and pests.

   Dated: May 21, 1999.

   Marcia E. Mulkey, Director, Office of Pesticide Programs.

   [FR Doc. 99-13795Filed6-1-99; 8:45 am]

   BILLING CODE 6560-50-F