FIFRA Scientific Advisory Panel; Open Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

There will be a 4-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Food Quality Protection Act (FQPA) Scientific Advisory Panel (SAP) to review the following sets of scientific issues being considered by the Agency pertaining to: Food allergenicity of Cry9C endotoxin and other non-digestible proteins; Dietary Exposure Evaluation Model (DEEM) Decompositing procedure and software; MaxLIP (Maximum Likelihood Imputation Procedure) Pesticide residue decompositing procedure and software; Dietary Exposure Evaluation Model (DEEM); and consultation on development and use of distributions of pesticide concentrations in drinking water for FQPA assessments.

The meeting is open to the public. Seating at the meeting will be on a first-come basis. Individuals requiring special accommodations at this meeting, including wheelchair access, should contact Laura Morris or Paul Lewis at the address listed under “FOR FURTHER INFORMATION CONTACT” at least 5 business days prior to the meeting so that appropriate arrangements can be made.

DATES:

The meeting will be held on Tuesday, February 29, through Friday, March 3, 2000, from 8:30 a.m. to 5:30 p.m.

ADDRESSES:

Sheraton Crystal City Hotel, 1800 Jefferson Davis Highway, Arlington, VA. The telephone number for the Sheraton hotel is: (703) 486-1111.

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 control number OPP-00641 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Laura Morris or Paul Lewis, Designated Federal Officials, FIFRA SAP (7101C), Office of Science Coordination and Policy, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-6212 or (703) 305-5369; fax number: (703) 605-0656; e-mail address: morris.laura or lewis.paul@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general. 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” 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/.

A meeting agenda and copies of EPA background documents for the meeting will be available early February, 2000. The meeting agenda and EPA primary background documents will be available on the FIFRA SAP web site at http://www.epa.gov/scipoly/sap.

2. In person. The Agency has established an official record for this action under docket control number OPP-00641. 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 (CM 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 (703) 305-5805.

C. How Can I Request to Participate in this Meeting?

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-00641 in the subject line on the first page of your response.Members of the public wishing to submit comments should contact the persons listed under “FOR FURTHER INFORMATION CONTACT” to confirm that the meeting date and the agenda have not been modified or changed.

Interested persons are permitted to file written statements before the meeting. To the extent that time permits, and upon advanced written request to the persons listed under “FOR FURTHER INFORMATION CONTACT”, interested persons may be permitted by the Chair of the FIFRA SAP to present oral statements at the meeting. The request should identify the name of the individual making the presentation, the organization (if any) the individual will represent, and any requirements for audiovisual equipment (e.g., overhead projector, 35 mm projector, chalkboard, etc). There is no limit on the length of written comments for consideration by the Panel, but oral statements before the Panel are limited to approximately 5 minutes. The Agency also urges the public to submit written comments in lieu of oral presentations. Persons wishing to make oral and/or written statements should notify the persons listed under “FOR FURTHER INFORMATION CONTACT” and submit 40 copies of the summary information. The Agency encourages that written statements be submitted before the meeting to provide Panel Members the time necessary to consider and review the comments.

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, Ariel Rios Bldg., 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 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 (703) 305-5805.

3. Electronically. You may submit your comments electronically by e-mail to: “opp-docket@epa.gov,” 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 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP-00641. Electronic comments may also be filed online at many Federal Depository Libraries.

II. Background

A. Purpose of the Meeting?

This 4-day meeting concerns several scientific issues undergoing consideration within the EPA/Office of Pesticide Programs (OPP). The four session topics to be addressed during the 4-day meeting are indicated as follows:

The first session will focus on assessing the potential allergenicity of non-digestible proteins expressed as plant-pesticides. The specific case in question concerns the Cry9C insecticidal protein derived from Bacillus thuringiensis and expressed in field corn. The Agency is asking questions on the use of amino acid homology, the brown Norway rat model for food allergenicity and other subjects with regards to the assessment for potential allergenicity.

The second session will address the decomposition module in the Dietary Exposure Evaluation Model (DEEM) software. In estimating dietary exposure to pesticides, the Agency uses several sources for monitoring data of pesticide residues in foods. These monitoring data, however, are in the form of pesticide residues on composited samples and do not directly represent concentrations of pesticide residues in single food items. For acute dietary exposure estimation, it is the residues in single items of produce that are of interest rather than “average” residues measured in composited samples. The decomposition module in the DEEM software uses a statistical procedure in order to “decomposite” composited monitoring data to estimate residues in single items. The purpose of this presentation is to describe the decomposition component of the software.

The second session will also include a presentation of the MaxLIP (Maximum Likelihood Imputation Procedure) Pesticide residue decompositing procedure and software. For acute dietary exposure estimation, it is the residues in single items of produce that are of interest rather than “average” residues measured in composited samples. The MaxLIP software uses a maximum likelihood estimation procedure in order to “decomposite” composited monitoring data to estimate residues in single items.

The third session will focus on the Dietary Exposure Evaluation Model (DEEM). A major component of assessing the risks of pesticide substances is the estimation of dietary exposure to pesticide residues in foods. The Agency currently uses the DEEM exposure assessment software in conducting its dietary exposure and risk assessment. The purpose of this session is to describe the components and methodologies used by the DEEM software.

The last session is to provide the FIFRA SAP with a progress report on the Agency's efforts to implement the drinking water component of the FQPA aggregate exposure assessment. Aggregate exposure is defined to encompass multiple potential sources of exposure to pesticides and includes exposure from pesticide residues in food, in drinking water and in the home. In order to combine the drinking water component with the population based distribution of pesticide residues on food items in a statistically rigorous manner, the data should be developed with the same general structure. In this way, the Monte Carlo procedure used for the risk assessment for food stuffs can be extended to the drinking water component.

The Agency will outline the basic steps envisioned in developing national, population-weighted distributions of pesticide residues in drinking water and aggregating them with distributions in food. These steps include development of distributions of pesticide drinking water concentration values across surface water/drinking water intake locations, consideration of the impact of treatment by a water utility, and development of methodologies to combine the adjusted distributions with the distribution of pesticide residues on food items. The presentation on development of distributions of drinking water concentrations will describe a process using measured data with a computer modeling/analysis overlay. The details of how the Agency will consider the effects of treatment will be largely addressed in a future FIFRA SAP meeting.

B. Panel Report

Copies of the Panel's report of their recommendations will be available approximately 45 working days after the meeting, and will be posted on the FIFRA SAP web site or may be obtained by contacting the Public Information and Records Integrity Branch at the address or telephone number listed in Unit I.B. of this document.

List of Subjects

• Environmental protection