00-29815. Pesticides; Draft Guidance for Pesticide Registrants on Bee Precautionary Labeling

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 Pesticide Registrants on Bee Precautionary Labeling.” This draft notice provides guidance to registrants and others concerning EPA's policy on bee labeling statements for pesticide products which are toxic to bees, such as honey bees, alfalfa leaf-cutting bees, alkali bees, and other native and non-indigenous pollinating insects that are important to crop production. The purpose of the proposed label changes is to help ensure that pesticide products used outdoors can be used without posing unnecessary risks of bee mortality. EPA believes that these revisions will make the labeling clearer and more easily understood by pesticide users and by regulatory officials who enforce label provisions.

DATES:

Comments, identified by docket control number OPP-00684, must be received on or before January 22, 2001.

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. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-00684 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Jim Roelofs (7506C), Environmental Protection Agency, 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 pesticide registrants, pesticide regulatory officials, beekeepers, pesticide users and to the public in general. Although this action may be of particular interest to those persons who have a specific interest in precautionary labeling to protect bees, 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” “Regulations and Proposed Rules,” 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.access.gpo.gov/​sup_​docs/​.

2. Fax on demand. You may request a faxed copy of the draft PR Notice entitled “Bee Precautionary Labeling Statements,” by using a faxphone to call [phone] and selecting item PR 2000-6133. 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-00684. 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].

C. 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, it is imperative that you identify docket control number OPP-00684 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460.

2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

3. Electronically. You may submit your comments electronically by E-mail to: “[e-mail],” or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1, Suite 8, or ASCII file format. All comments in electronic form must be identified by docket control number OPP-00684. Electronic comments may also be filed online at many Federal Depository Libraries.

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

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA 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 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 the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

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 copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the notice or collection activity.

7. Make sure to submit your comments by the deadline in this notice.

8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. Background

To help determine whether pesticide products used outdoors pose risks of bee mortality, the Agency generally requires acute toxicity data on bees to be submitted with a registration application. See e.g., 40 CFR 158.590(a). Depending on the results of the acute study, EPA may require additional residual toxicity data. EPA pesticide labeling regulations require that “...pesticides toxic to pollinating insects must bear appropriate label cautions.” 40 CFR 156.10(h)(2)(ii)(E). In the 1980s, the Agency published a policy which described a set of standard bee precautionary labeling statements it believed appropriate where results from the bee data indicated toxicity. The most recent version of this policy is found in the 1996 Label Review Manual (USEPA, Office of Prevention, Pesticides and Toxic Substances, Label Review Manual, 2nd Ed. (EPA 737-B-96-001) December, 1996). Under the 1980s policy, where a product displayed extended residual toxicity to bees, the label language EPA believed to be appropriate for precautionary purposes stated: “This product is highly toxic to bees exposed to direct treatment or residues on blooming crops or weeds. Do not apply this product or allow it to drift to blooming crops or weeds if bees are visiting the treatment area.”

Controversy has continued for many years among beekeepers, growers, commercial applicators and State regulators about the adequacy of these statements. For example, many beekeepers believe that the labeling statements are not adequately protective, while many growers believe that the labeling statements are overly restrictive and prevent them from managing pests adequately during the bloom period. State regulators believe that the labeling statements need to be clarified regarding the obligations of applicators with respect to bees.

III. Summary of the Draft PR Notice

A. What Guidance Does the PR Notice Provide?

The PR Notice states EPA's proposed new policy regarding appropriate standard label language to protect bees. This new language would include a specific statement about the length of time in hours or days that the residues of the pesticide product remain a toxic threat to bees. This new proposed labeling statement is based on a study of residual toxicity to bees for a specific product submitted to the Agency, or, in the absence of such a study, it states a default period of toxicity of 24 hours. The proposed label language provides two conditions under which pesticide application would be allowed without limitation to the label-stated period of toxic hazard to bees. The first of these conditions is if the pesticide application method is such that bees will not be exposed even if they are visiting the crop. An example of such a method would be soil incorporation, which would not produce pesticide residues on the foliage, blooms or nectar producing parts of plants, so that bees would not be exposed. The other condition under which use is allowed during the period of toxicity to bees, is when the user actively participates in and meets all the applicable requirements of a state-approved bee protection program.

The Agency believes that label precautions should be supplemented by additional efforts to protect bees, and that state programs are appropriate to this purpose. EPA does not intend to set specific criteria or approve state bee protection programs. The PR Notice recommends that state pesticide regulatory agencies consider a variety of regulatory and non-regulatory measures to include in bee-protection efforts. EPA believes that state agencies are in the best position to understand the localized crop-pesticide combinations and other factors that pose the greatest risks to bees, and can implement appropriate measures to mitigate those risks under varying local and geographic conditions.

B. What Questions/Issues Should You Consider?

Commenters are free to raise any issue, but the following questions are of particular interest to the Agency, and comments on them are invited.

1. Should the precautionary labeling language in the new policy allow for an exception from bee precautions for wide-area public health spray programs? In a number of communications to the Agency, officials involved in public health programs have noted that strict interpretation of the current bee precautionary labeling could prevent effective wide-area pest control in an emergency situation. The Agency's proposed new labeling language could also be very restrictive of wide-area spraying, for example, if a state had no bee protection program, or could not operate the program during an emergency. The suggestion has been made that the label language include a clause to the effect that precautions apply “...except when applications are made to prevent or control a declared public health threat.” The Agency requests comment on whether such an exception on the label is necessary or appropriate, and if it is appropriate, what authority could invoke the exception. Should an exception be applicable to treatments intended to prevent possible disease outbreaks, or limited to significant emergencies like the aftermath of flooding or a proven outbreak of human or animal disease?

2. Should the new policy described in the PR Notice allow a 24 hour period of toxicity statement on labels in the absence of data as a permanent option, or only temporarily until registrants submit residual toxicity data?

3. From the commenter's perspective as a pesticide user, bee keeper, state regulator, or other interested party, would a specific time period of toxicity to bees on the label be more or less useful than the current policy which includes a label prohibition on applications while bees are visiting the treatment area?

4. Is the label condition that pesticides can be applied if the user participates in a state bee protection program likely to encourage bee-protection efforts? From the commenter's perspective, is such a condition more or less useful in achieving bee protection that the current label prohibition against application when bees are visiting the treatment area?

C. What is the Scope of this PR Notice?

The draft PR Notice discussed in this notice is intended to provide guidance to pesticide registrants, EPA personnel, state regulatory personnel, and to the public. As a guidance document, this policy is not binding on either EPA or any outside parties, and EPA may depart from the guidance where circumstances warrant and without prior notice. Registrants and applicants may propose alternatives to the recommended labeling statements described in the Notice and the Agency will assess them for appropriateness on a case-by-case basis. If a product does not meet the requirements of 40 CFR Part 156, the Agency may find the product to be misbranded. As stated above, the Agency believes that the statements outlined in the Notice should reduce the potential for adverse effects to the environment and are “appropriate” within the meaning of 40 CFR 156.10(h)(2)(ii)(E).

EPA 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. 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.

List of Subjects

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

Dated: November 9, 2000.

Marcia Mulkey,

Director, Office of Pesticide Programs