02-14996. Methodology for Lower Toxicity Pesticide Chemicals; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is soliciting comments on a document entitled “Methodology for Determining the Data Needed and the Types of Assessments Necessary to Make FFDCA Section 408 Safety Determinations for Lower Toxicity Pesticide Chemicals.” Interested parties may request a copy of the Agency's proposed guidance document as set forth in Unit IB of this Notice.

DATES:

Comments, identified by docket ID number OPP-2002-0069, must be received on or before September 11, 2002.

ADDRESSES:

Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP-2002-0069 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Kathryn Boyle, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703-305-6304; fax number: 703-305-0599; 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. This action may, however, be of interest to those persons who are or may be required to conduct testing of chemical substances - under the Federal Food, Drug, and Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 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 applicability of this action to a particular entity, 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 certain other related documents that might be available electronically, 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.epa.gov/​fedrgstr/​.

2. In person. The Agency has established an official record for this action under docket ID number OPP-2002-0069. 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 Hwy., 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-2002-0069 in the subject line on the first page of your response.

1. By mail. Submit your comments to: 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: PIRIB Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 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 in this unit. 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 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket ID number OPP-2002-0069. 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 listed under FOR FURTHER INFORMATION CONTACT.

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 ID 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. What Action is the Agency Taking?

The Agency is announcing the availability of a methodology for assessing the hazards and risks of lower toxicity pesticide chemicals for public comment and review. This paper describes how lower toxicity pesticide chemicals, including inert ingredients, would be evaluated for use in pesticide products. The OPP is the Office within the Environmental Protection Agency (EPA or the Agency) that evaluates pesticide products. OPP's responsibilities (all of which could be affected by the use of this new methodology) include: registration of new active ingredients, reregistration of older active ingredients, reassessment of both tolerances and tolerances exemptions, approval of new inert ingredients, and list reclassification of inert ingredients.

Development of this methodology began as a result of OPP's need to (1) develop a new methodology for assessing inert ingredients to comply with the requirements of the Food Quality Protection Act (FQPA) of 1996 which amended both the FFDCA and the FIFRA, and (2) to improve the efficiency and effectiveness of the inert review process. In many instances, a chemical can be used as an inert ingredient in some pesticide products and as an active ingredient in other pesticide products. Since FFDCA section 408 makes no distinction between active and inert ingredients of a pesticide product, EPA may use this tiered data screening methodology when evaluating any pesticide chemical of apparent low or low/moderate toxicity, regardless of whether it might be characterized as an active or inert ingredient.

At this time, EPA has completed review of two tolerance exemption petitions and over 200 tolerance reassessments for low or low/moderate toxicity chemicals using essentially the process described in this paper. More reviews are underway. Based on these experiences, OPP intends to continue its chemical-by-chemical reviews of pesticide chemicals according to the process described herein for the foreseeable future. However, EPA remains interested in further improvements in the efficiency and reliability of its process, and therefore welcomes comments from interested persons.

After evaluating several alternatives, OPP believes that a screening methodology is the most appropriate way to handle the variety of hazard and exposure issues posed by inert ingredients. This screening methodology will allow OPP to make decisions in a streamlined manner for low or low/moderate toxicity chemical substances. By being able to quickly review and approve the use of these chemical substances, more low or low/moderate toxicity chemical substances will be available for use in pesticide products. OPP will also be able to focus its resources on those chemical substances of potentially higher toxicity requiring in-depth evaluation.

OPP has incorporated elements of a tiered data approach into this methodology. For these lower toxicity chemicals, OPP would use existing information on the hazard potential (both human health and ecological) of a chemical substance as the basis for deciding if additional data are needed to support the use of the chemical. The hazard potential - the toxicity - is the driving force in determining tier placement. Chemical substances that are of low or low/moderate toxicity may be appropriately placed in a lower tier, with fewer data needed to make the safety finding. Chemicals of higher toxicity that can not be appropriately addressed in the lower tiers would be evaluated in a manner substantially similar to that of an active ingredient.

The process described in this paper has three tiers, with the first tier being subdivided into Tiers 1a and 1b. The process begins with a preliminary Tier determination that is based on widely available information on chemical families and categories which includes the hazards associated with these chemicals. Later as the Agency begins to review chemical-specific or surrogate information in the open literature, the preliminary Tier determination may be revised.

The methodology is intended to provide guidance to EPA personnel and decision-makers, and to pesticide registrants. The policies and process described in this methodology are not binding on either EPA or pesticide registrants, and EPA may modify or disregard the process described herein where circumstances warrant and without prior notice. Likewise, pesticide registrants may assert that this process is not appropriate generally or not applicable to a specific pesticide chemical or situation.

III. Questions/Issues for Public Comment

• A significant challenge faced in developing a methodology for a -comprehensive assessment program for chemicals of low or low/moderate --toxicity is determining the most appropriate procedure for evaluating such a diverse group of substances, with a very wide range of ---------physical/chemical characteristics. Does the screening approach as ------described in the methodology paper reflect a workable, logical ---------approach?
• It is likely that a large percentage of inert ingredients are not likely to be of significant toxicological concern. The Agency's ---expectation is that on the order of 50% of inert ingredients would be of low or low/moderate risk. At the same time, EPA must be able to ----identify problematic inert ingredients and then have the resources to take appropriate action to analyze and reduce these risks. Would this methodology give the Agency the necessary flexibility while allowing for an effficient and productive process?
• Several sources for credible, scientifically valid chemical -----information are given in the policy paper. What other possible --------sources of readily available credible, scientifically valid chemical ---information are available?
• The Agency has described, as best possible at this beginning ----stage, the process that would be used to evaluate inert ingredients as -well as the role played by a petitioner for a tolerance or tolerance ---exemption or those seeking to support a chemical during tolerance ------reassessment. What additional information would be helpful to the -----regulated community?

List of Subjects

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

Dated: June 7, 2002.

Marcia E. Mulkey,

Director, Office of Pesticide Programs.