[Federal Register Volume 68, Number 151 (Wednesday, August 6, 2003)]
[Notices]
[Pages 46613-46616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19916]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0152; FRL-7316-8]


Yeast Extract Hydrolysate from Saccharomyces Cerevisiae; Notice 
of Filing a Pesticide Petition to Establish a Tolerance for a Certain 
Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket indentification (ID) number OPP-
2003-0152, must be received on or before September 5, 2003.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Diana M. Horne, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8367; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    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 in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. 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 Copies of This Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2003-0152. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in EPA's Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is

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available for viewing in EPA's electronic public docket. Although not 
all docket materials may be available electronically, you may still 
access any of the publicly available docket materials through the 
docket facility identified in Unit I.B.1. EPA intends to work towards 
providing electronic access to all of the publicly available docket 
materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2003-0152. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID number OPP-2003-0152. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2003-0152.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID number OPP-2003-0152. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is 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 docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket 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.

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

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    7. 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?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodites under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: July 28, 2003.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

Summary of Petition

    The petitioner's summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner and represents the view of the petitioner. 
The petition summary announces the availability of a description of the 
analytical methods available to EPA for the detection and measurement 
of the pesticide chemical residues or an explanation of why no such 
method is needed.

Interregional Research Project Number 4

Morse Enterprises Limited

PP 2E6383

    EPA has received a pesticide petition (PP 2E6383) from 
Interregional Research Project Number 4 (IR-4), Technology Centre of 
New Jersey, Rutgers University, 681 U.S. Highway 1 South, 
North Brunswick, NJ 08902-3390 proposing, pursuant to section 408(d) of 
FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an 
exemption from the requirement of a tolerance for the biochemical 
pesticide yeast extract hydrolysate from Saccharomyces cerevisiae in or 
on all food commodities.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Morse 
Enterprises Limited has submitted the following summary of information, 
data, and arguments in support of their pesticide petition. This 
summary was prepared by Morse Enterprises Limited and EPA has not fully 
evaluated the merits of the pesticide petition. The summary may have 
been edited by EPA if the terminology used was unclear, the summary 
contained extraneous material, or the summary unintentionally made the 
reader conclude that the findings reflected EPA's position and not the 
position of the petitioner.

A. Product Name and Proposed Use Practices

    Yeast extract hydrolysate from Saccharomyces cerevisiae, the active 
ingredient, is mixed with micronutrients to formulate the end use 
product known as KeyPlex 350. KeyPlex 350 is applied at 1 to 3 quarts 
per acre as a foliar spray. Applications are generally repeated at 14 
to 21-day intervals. KeyPlex 350 aids in the prevention of certain 
plant diseases, such as post-bloom fruit drop and greasy spot diseases 
of citrus, and bacterial leaf spot disease of tomatoes.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Yeast 
extract hydrolysate from Saccharomyces cerevisiae is mixed with 
micronutrients to formulate the end use product known as KeyPlex 350. 
KeyPlex 350 contains 0.063% yeast extract hydrolysate from 
Saccharomyces cerevisiae in combination with a micronutrient 
fertilizer. KeyPlex 350 is the end use product. Hereinafter the term 
``yeast extract hydrolysate'' is used to mean yeast extract hydrolysate 
from Saccharomyces cerevisiae.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. This section is not applicable, as this notice 
proposes an exemption from the requirement of a tolerance.
    3. A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. An 
analytical method for residues is not applicable, as this notice 
proposes an exemption from the requirements of a tolerance.

C. Mammalian Toxicological Profile

    1. Acute toxicity. An acute oral toxicity study (OPPTS Harmonized 
Guideline 870.1100) conducted in rats with the end use product KeyPlex 
350 containing 0.063% yeast extract hydrolysate showed that KeyPlex 350 
at 5,000 milligrams/kilogram (mg/kg) is not toxic to rats. Furthermore, 
no test material-related lesions were revealed on the macroscopic 
necropsy examinations conducted at termination of the test.
    2. A primary dermal irritation study. (OPPTS Harmonized Guideline 
870.2500) conducted in rabbits with the end use product KeyPlex 350 
showed that KeyPlex 350 only caused mild or very slight irritation to 
the skin of 1 of 6 rabbits.
    3. A primary eye irritation study. (OPPTS Harmonized Guideline 
870.2400) conducted in rabbits with the end use product KeyPlex 350 
showed that KeyPlex 350 was only moderately irritating. Conjunctiva was 
noticed in all rabbits 1-hour after treatment; all symptoms cleared by 
72 hours post-treatment.
    Yeast extracts are considered generally recognized as safe (GRAS) 
and are approved by the Food and Drug Administration (FDA) as direct 
food additives (21 CFR 184.1983). Yeast extracts are used as a flavor 
improver in hundreds of foods at 0.1% to 2% in the final consumed 
product. The other ingredients in KeyPlex 350 are already approved as 
inert materials or are common fertilizer ingredients.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. The potential dietary exposure of the 
general public to yeast extract hydrolysate residues resulting from the 
use of KeyPlex 350 on food crops is not expected to be significant. The 
public is exposed to yeast extract through its use as a direct food 
additive.
    ii. Drinking water. It is not anticipated that residues of yeast 
extract hydrolysate will occur in drinking water due to its low 
application rate.
    2. Non-dietary exposure. There may be non-dietary exposure to yeast 
extract hydrolysate from non-pesticidal uses of yeast extracts, but 
significantly increased non-dietary exposure and non-occupational 
exposure from yeast extract hydrolysate when used as a pesticide is not 
expected.

E. Cumulative Exposure

    Because of the lack of toxicity of an 0.063% solution of yeast 
extract hydrolysate and because of the fact that yeast extracts are 
already present in the diet at 0.1% to 2% in hundreds of food products, 
no cumulative mode of exposure is expected for yeast hydrolysate and 
other substances having a common mode of action.

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F. Safety Determination

    1. U.S. population. The use of products containing yeast extract 
hydrolysate, which lacks toxicity and is used in such low 
concentrations, is compatible with EPA's objectives to register reduced 
risk pesticides. Based on its lack of toxicity and the fact that yeast 
extracts are already present in the diet, there is reasonable certainty 
that no harm will result from aggregate exposure of the U.S. 
population, including infants and children, to residues of yeast 
extract hydrolysate. This includes all anticipated dietary exposures 
and all other exposures for which there is reliable information. Yeast 
extract hydrolysate is applied at low rates and with its lack of 
toxicity and its history of safe use, it does not pose a safety 
concern.
    2. Infants and children. Based on the lack of toxicity of yeast 
extract hydrolysate, there is a reasonable certainty that no harm to 
children or adults will result from aggregate exposure to yeast 
hydrolysate. Exempting yeast extract hydrolysate from the requirement 
of a tolerance should pose no significant risk to humans.

G. Effects on the Immune and Endocrine Systems

    Yeast extract hydrolysate is a naturally occurring biochemical. To 
date there is no evidence to suggest that yeast extract hydrolysate 
functions in a manner similar to any known hormone, or that it acts as 
an endocrine disruptor.

H. Existing Tolerances

    There are no existing tolerances for yeast extract hydrolysate in 
the United States.

I. International Tolerances

    There are no known approved Codex maximum residue levels 
established for residues of yeast extract hydrolysate.
[FR Doc. 03-19916 Filed 8-5-03; 8:45 am]
BILLING CODE 6560-50-S