[Federal Register Volume 65, Number 24 (Friday, February 4, 2000)]
[Notices]
[Pages 5636-5637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2483]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[OPP-00641; FRL-6490-6]


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 [email protected].

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 Mall2 (CM2), 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

[[Page 5637]]

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, CM2, 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: ``[email protected],'' 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.

    Dated: January 27, 2000.
Steven Galson,
Director, Office of Science Coordination and Policy.
[FR Doc. 00-2483 Filed 2-3-00; 8:45 am]
BILLING CODE 6560-50-F