[Federal Register Volume 69, Number 18 (Wednesday, January 28, 2004)]
[Notices]
[Pages 4151-4154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1242]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0404; FRL-7339-2]


Harpin Protein; 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 ID number OPP-2003-0404, must be 
received on or before February 27, 2004.

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 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:
     Crop production (NAICS code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticde manufacturing (NAICS code 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-2003-0404. 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

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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 the EPA 
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 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 on 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-2003-0404. 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-2003-0404. 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-2003-0404.
    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-2003-0404. 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

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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.
    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 commodities 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: January 12, 2004.
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 EDEN Bioscience Corporation, 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.

 EDEN Bioscience Corporation

 PP 3F6765

     EPA has received a pesticide petition (3F6765) from EDEN 
Bioscience Corporation, 3830 Monte Villa Parkway, Bothell, WA 98021-
6942, proposing pursuant to section 408(d) of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180, 
to establish an amendment of the existing tolerance exemption for the 
biochemical pesticide harpin protein on all raw agricultural 
commodities. Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as 
amended, EDEN Bioscience Corporation has submitted the following 
summary of information, data, and arguments in support of their 
pesticide petition. This summary was prepared by the EDEN Bioscience 
Corporation; 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.
     In the Federal Register of September 9, 1999 (64 FR 49010) (FRL-
6095-9), EPA issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a(d), announcing the filing of a pesticide tolerance petition 
(PP 9F6027) by the EDEN Bioscience Corporation. This notice included a 
summary of the petition prepared by the petitioner and this summary 
contained conclusions and arguments to support its conclusion that the 
petition complied with the Food Quality Protection Act (FQPA) of 1996. 
This petition requested that 40 CFR part 180 be amended by establishing 
an exemption from the requirement of a tolerance for the biochemical 
pesticide harpin protein in or on all food crops. The final rule 
exempted the biochemical harpin from the requirement of a tolerance on 
food commodities when applied/used in agricultural fields and 
greenhouses for the management of plant diseases, the significant 
improvement in growth and yields, and the suppression of certain 
insects and other pests. EPA published a final rule establishing a 
tolerance exemption in the Federal Register of May 3, 2000 (65 FR 
25660) (FRL-6497-4), amending 40 CFR 180.1204. Research on other harpin 
proteins that are similar to this active ingredient indicates that many 
of these proteins also exhibit activities of commercial value in crop 
production. Because 40 CFR 180.1204 does not specify the scope of 
harpin proteins that are exempt, EDEN proposes to clarify this 
exemption by specifying the criteria a protein must meet in order to be 
subject to the exemption.

A. Product Name and Proposed Use Practices

     All products containing harpin protein(s) that meet the 
specifications proposed in this exemption. Products containing harpin 
protein are used to enhance plant growth, quality, and yield, to 
improve overall plant health, and to aid in pest management.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Harpin 
proteins share several identifying characteristics. Harpin proteins are 
less than 100 kilo Dalton (kD) in size. They are acidic proteins, with 
Daltons an iso-electric point (pI) of less than 7.0. They are comprised 
of at least 10% of the amino acid glycine and contain no more than one 
cystine amino acid residue. Harpin proteins elicit the hypersensitive 
response (HR). HR is characterized as rapid, localized cell death in 
plant tissue after infiltration of harpin into the intercellular spaces 
of plant leaves. Harpin proteins possess a common secondary structure 
consisting of alpha and beta units that form an HR domain. They are 
readily degraded by proteinase, and are heat stable, meaning that they 
retain HR activity when heated to 65 oC for 20 minutes.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. No residues of harpin protein are expected to 
occur at the time of harvest because harpin protein is rapidly degraded 
by environmental factors such microbial digestion and ultraviolet (UV) 
irradiation. For example, studies demonstrate that harpin is degraded 
within minutes by SubtilisinA, a microbial enzyme that

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occurs commonly in the environment. In fact, this mode of rapid 
degradation in the environment is one of the proposed criteria for 
including a harpin protein in the exemption from the requirement of a 
tolerance. Specifically, the proposed criterion is ``no protein 
fragments >3.5 kD after 15 minutes degradation with SubtilisinA.'' 
Residue studies submitted to support the existing exemption from 
tolerance demonstrate that harpin protein is not detectable at the time 
of harvest. In these studies, no harpin protein residues could be 
detected in samples taken immediately after harpin protein was applied 
at the maximum application rate. Because there is no detectable residue 
at harvest, an analytical method is not relevant.
    3. A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. No 
analytical method to detect and measure residues of harpin protein is 
needed because harpin protein poses no hazard to humans. Results of 
mammalian toxicology studies conducted at the limit dose indicate no 
observed adverse effects associated with harpin protein. Moreover, no 
residues of harpin protein are expected to occur at the time of harvest 
because harpin protein is rapidly degraded by environmental factors 
such as microbial digestion and UV irradiation.

C. Mammalian Toxicological Profile

     Products containing harpin proteins exhibit little or no mammalian 
toxicity. To qualify for exemption, a harpin protein must exhibit a rat 
acute oral toxicity lethal dose (LD50) of greater than 5,000 
mg product/kg body weight Toxicity Category IV. The source(s) of 
genetic material that encode the harpin protein(s) is limited to 
bacterial plant pathogens that are not known to be pathogenic to 
mammals. Harpin proteins must be readily degraded by a proteinase that 
is representative of environmental conditions. Specifically, there must 
be no protein fragments of a size greater than 3.5 kD after 15 minutes 
degradation with SubtilisinA, a proteinase that is common and 
widespread in the environment. Further, harpin proteins have a nontoxic 
mode of action; they activate the treated plant's own growth and 
defense systems. EDEN Bioscience Corporation has concluded that harpin 
proteins pose no unique or additional risk to children or infants, and 
proposes an exemption from the requirement of a tolerance for all 
harpin proteins that meet the following specifications:
    1. Consists of a protein <100 kD in size that is acidic pI <7.0, 
glycine rich >10% and contains no more than one cystine residue.
    2. The source(s) of genetic material encoding the protein are 
bacterial plant pathogens that are not known to be mammalian pathogens.
    3. Elicits the hypersensitive response (HR) which is characterized 
as rapid, localized cell death in plant tissue after infiltration of 
harpin into the intercellular spaces of plant leaves.
    4. Possesses a common secondary structure consisting of alpha and 
beta units that form an HR domain.
    5. Is heat stable (retains HR activity when heated to 65 
oC for 20 minutes).
    6. Is readily degraded by a proteinase representative of 
environmental conditions (no protein fragments >3.5 kDa after 15 
minutes degradation with SubtilisinA).
    7. Exhibits a rat acute oral toxicity LD50 of >5,000 mg 
product/kg body weight.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Because harpin proteins are rapidly 
degraded in the environment by common proteinases, UV irradiation, and 
oxidizing agents, no active ingredient residues are detectable, using 
available methods, on treated crops even immediately after application. 
Dietary exposure to harpin via consumption of treated food or feed is 
negligible, if any at all.
    ii. Drinking water. Harpin proteins readily degraded by common 
proteinases and UV irradiation, and are highly sensitive to very small 
amounts of chlorine or similar oxidizing agents as contained in many 
municipal water systems. Therefore, residues of harpin are unlikely to 
occur in drinking water or food, given its rapid degradation in soil 
and water.
    2. Non-dietary exposure. The company believes that the potential 
for non-dietary exposure to the general population including infants 
and children is unlikely as the proposed use sites are primarily 
commercial, agricultural and horticultural settings and that non-
dietary exposures would not be expected to pose any quantifiable risks 
due to lack of residues of toxicological concern. Increased nondietary 
exposure of harpin via home and garden use, etc., is not considered 
likely because of the typically low use rates and volumes, and the lack 
of persistence of the active ingredient in the environment.

E. Cumulative Exposure

     Consideration of a common mode of toxicity is not appropriate, 
given that there is no indication of mammalian toxicity of harpin 
protein and no information that indicates that toxic effects would be 
cumulative with any other compounds. Moreover, harpin proteins do not 
exhibit a toxic mode of action in its target pests or diseases.

F. Safety Determination

    1. U.S. population. Harpin's lack of toxicity is demonstrated by 
the results of acute toxicity testing in mammals in which harpin causes 
no adverse effects when dosed orally at the limit dose for the study. 
Thus, the aggregate exposure to harpin over a lifetime should pose 
negligible risks to human health.
    2. Infants and children. Based on the lack of toxicity and low 
exposure, there is a reasonable certainty that no harm to infants, 
children, or adults will result from aggregate exposure to harpin 
residues. Exempting harpin proteins that meet the specified criteria 
from the requirement of a tolerance should pose no significant risk to 
humans or the environment.

G. Effects on the Immune and Endocrine Systems

     EDEN Bioscience Corporation has no information to suggest that 
harpin proteins will adversely affect the immune or endocrine systems.

H. Existing Tolerances

     An existing exemption from tolerance has been established for 
harpin protein in the United States, 40 CFR 180.1204.

I. International Tolerances

     EDEN Bioscience Corporation is not aware of any tolerances, 
exemptions from tolerance or maximum residue levels issued for harpin 
protein outside of the United States.
[FR Doc. 04-1242 Filed 1-27-04; 8:45 am]
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