[Federal Register Volume 68, Number 90 (Friday, May 9, 2003)]
[Notices]
[Pages 25026-25029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11478]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0162; FRL-7306-3]


Rhamnolipid Biosurfactant; 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-2003-0162, must be 
received on or before June 9, 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: Denise Greenway, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8263; 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 identification (ID) number OPP-2003-0162. 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 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 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

[[Page 25027]]

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-2003-0162. 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-2003-0162. 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-2003-0162.
    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-2003-0162. 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.
    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: April 29, 2003.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

Summary of Petition

    The petitioner 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.

Jeneil Biosurfactant Company

PP 1F6288

    EPA has received a pesticide petition 1F6288 from Jeneil 
Biosurfactant Company, 400 N. Dekora Woods Boulevard, Saukville, 
Wisconsin 53080, proposing pursuant to section 408(d) of

[[Page 25028]]

the Federal Food, Drug, and Cosmetic Act (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 rhamnolipid biosurfactant in 
or on all food commodities.
    Pursuant to section 408(d)(2)(A)(I) of the FFDCA, as amended, 
Jeneil Biosurfactant Company has submitted the following summary of 
information, data, and arguments in support of their pesticide 
petition. This summary was prepared by Jeneil Biosurfactant Company, 
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

    Rhamnolipid biosurfactant is intended for the prevention and 
control of plant pathogenic fungi on horticultural and agricultural 
crops. Fungal diseases are often spread by zoospores that are 
transported from one plant to another and from field to field. 
Rhamnolipid biosurfactant kills zoospores that cause fungal disease, on 
contact. Target pests are any zoosporic plant pathogenic microorganisms 
including the following genera: Plasmodiophora, Polymyxa, Spongospora, 
Physoderma, Olpidium, Synchytrium, Rhizophydium, Achlya, Aphanomyces, 
Albugo, Peronopythora, Pachymetra, Pythium, Phytophthora, 
Trachysphaera, Basidiophora, Peronosclerospora, Plasmopara, 
Pseudoperonospora, Sclerophthora, and Sclerospora. End-use formulations 
of rhamnolipid biosurfactant are applied through conventional equipment 
as a spray, fog, drench or seed soak to the point of saturation, and 
can also be incorporated into nutrient solutions for hydroponic plants 
and vegetables. The product will be diluted with water and applied to 
growing plants and agricultural commodities at a rate of 70 to 100 
parts per million (ppm). One end-use formulation, Zonix Biofungicide 
(8.5% active ingredient), is proposed at this time.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. 
Rhamnolipid biosurfactant, CAS number: 147858-26-2; CAS name: Decanoic 
acid, 3-[[6-deoxy-2-O-(6-deoxy-[alpha]-L-mannopyranosyl)-[alpha]-L- 
mannopyranosyl]oxy]-, 1-(carboxymethyl)octyl ester, mixture with 1-
(carboxymethyl)octyl 3-[(6-deoxy-[alpha]-L-
mannopyranosyl)oxy]decanoate. The basic composition of the active 
ingredient consists of a well-known carbohydrate (rhamnose sugar) and 
fatty acid (hydroxydecanoic acid). The active ingredient is a mixture 
of two types of rhamnolipid molecules, R1 (RLL) and R2 (RRLL) at a 
ratio of R2:R1 = 0.7 - 2.0. Chemical name of the rhamnolipid molecules 
is as follows: Molecule 1 (defined as R1 or RLL): Decanoic acid, 3-[(6-
deoxy-[alpha]-L-mannopyranosyl) oxy]-, 1-(carboxymethyl) octyl ester; 
and molecule 2 (defined as R2 or RRLL): Decanoic acid, 3-[[6-deoxy-2-O-
(6-deoxy-[alpha]-L-mannopyranosyl)-[alpha]-L-mannopyranosyl] oxy]-, 1-
(carboxymethyl) octyl ester.
    Rhamnolipid biosurfactant, in particular, causes the lysis of 
zoospores of plant pathogens. Zoospores, the unicellular, motile spore 
stage in the life cycle of plant pathogens, are vulnerable to 
rhamnolipid biosurfactants due to the fact that the membrane-bound 
spore lacks a protective cell wall. The rhamnolipid destroys the 
permeability of the plasma membrane and results in the loss of motility 
and rapid lysis of the zoospore. Rhamnolipid biosurfactants are 
effective against all zoosporic plant pathogens, such as downy mildews, 
Pythium and Phytophthora.
    Biosurfactants are produced by a variety of microorganisms and have 
been shown to play a role in enhancing bioavailability and 
biodegradation of petroleum hydrocarbons, in the attachment and 
detachment of bacteria to surfaces, and in complexing metals 
efficiently. Biosurfactants have application in cosmetics, personal 
care products, detergents, textile processing, agricultural crop 
protection products, metal treatment and processing, leather 
processing, hard surface cleaning, electronics component cleaning, pulp 
and paper processing, paint formulation, hydrocarbon recovery, oil tank 
cleaning and oil sludge remediation.
    Rhamnolipids are comprised of extra-cellular natural substances 
(glycolipids) produced during a controlled aerobic fermentation process 
utilizing a strain of the bacterium pseudomonas aeruginosa. 
Rhamnolipids are recovered from the process by centrifugation, 
extraction, and subsequent purification. No bacteria are present in the 
manufactured product and the production processes are strict in quality 
control to assure no live organisms exist. Purified rhamnolipids can be 
quantified by weight and rhamnose determination.
    2. 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. It is not expected 
that, when used as proposed, rhamnolipid biosurfactant would result in 
residues that are of toxicological concern.

C. Mammalian Toxicological Profile

    Rhamnolipid biosurfactant has been evaluated for toxicity through 
oral, dermal, inhalation and eye routes of exposure. Studies indicate 
the end-use product is Toxicity Category I for eye irritation (diluted 
end-use product is Toxicity Category IV for eye irritation), and 
Toxicity Category IV for all other routes of exposure. Studies resulted 
in an acute oral lethal dose (LD50) >5,000 milligrams/
kilogram (mg/kg), acute dermal LD50 >5,000 mg/kg, acute 
inhalation lethal concentration (LC50) 2.05 mg/L, primary 
eye irritation severe at 9.5% active ingredient and slight at 1.0% 
active ingredient, and primary skin irritation minimal.
    A waiver has been requested for dermal sensitization based on the 
fact that the active ingredient is not toxic or irritating dermally, 
and a lack of reported effects by users of the surfactant in a variety 
of products. Rhamnolipid biosurfactants have been marketed for over 3 
years as an emulsifier, dispersant and wetting agent. Since its 
discovery, no incidents of hypersensitivity have been reported by 
researchers, manufacturers or users. A waiver has been requested for 
genotoxicity based on the fact that rhamnolipid biosurfactant is not 
related to any known mutagen and does not belong to a chemical class of 
compounds containing known mutagens. The rhamnolipid molecules are 
simply glycolipids composed of a rhamnose sugar ring and a fatty acid 
tail. Individually these molecules are not considered toxic or 
mutagenic. Rhamnose is a comparatively rare sugar listed by FDA as a 
food additive. Fatty acids are ubiquitous in animals and plants, and 
are the major source of energy in the body. Consequently the breakdown 
products of rhamnolipids are of little toxicological concern. A waiver 
has been requested for 90-day oral toxicity, teratogenicity and 
immunotoxicity based on the physical mode of action of the product, the 
demonstrated lack of oral, dermal and inhalation toxicity, and the 
innocuous nature of the potential breakdown products of rhamnolipid 
biosurfactants. The mode of action of rhamnolipid biosurfactants is a 
physical action on the plant pathogen rather than a specific

[[Page 25029]]

toxic action. Rhamnolipid biosurfactant is virtually non-toxic to rats 
as demonstrated in the acute oral, dermal and inhalation studies 
submitted. The lack of mammalian toxicity supports the position that 
the physical action of rhamnolipid biosurfactants is a physical 
interaction with the zoospore membrane rather than a specific toxic 
mechanism that might be of concern. The chemical structures of the 
rhamnolipids suggest that there is little potential for chronic 
toxicity, teratogenicity or immunotoxicity in animals or humans as a 
result of exposure. The rhamnolipid molecules are simply glycolipids 
composed of a rhamnose sugar ring and a fatty acid tail. Individually 
these molecules are not considered toxic.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Dietary exposure from use of 
rhamnolipid biosurfactant, as proposed, is minimal. The use of 
rhamnolipid biosurfactant involves low levels of active ingredient 
applied to growing plants prior to harvest. Residues of rhamnolipid 
biosurfactant are not expected to be of toxicological concern. The 
rhamnolipid molecules are simply glycolipids composed of a rhamnose 
sugar ring and a fatty acid tail. Individually these molecules are not 
considered toxic.
    ii. Drinking water. Similarly, exposure to humans from residues of 
rhamnolipid biosurfactant in consumed drinking water would be unlikely. 
Rhamnolipid biosurfactant is a naturally occurring extra-cellular 
substance that is produced by a microorganism known to exist in plant 
habitats; it is not known to grow or thrive in aquatic environments. 
Potential exposure to surface water would be negligible and exposure to 
drinking water (well or ground water) would be impossible to measure.
    2. Non-dietary exposure. The potential for non-dietary exposure to 
the general population, including infants and children, is unlikely as 
the proposed use sites are agricultural settings. However, non-dietary 
exposures would not be expected to pose any quantifiable risk due to a 
lack of residues of toxicological concern. Personal protective 
equipment mitigates the potential for exposure to applicators and 
handlers of the proposed products, when used in agricultural settings.

E. Cumulative Exposure

    It is not expected that, when used as proposed, rhamnolipid 
biosurfactant would result in residues that are of toxicological 
concern. The rhamnolipid molecules are simply glycolipids composed of a 
rhamnose sugar ring and a fatty acid tail. Individually these molecules 
are not considered toxic.

F. Safety Determination

    1. U.S. population. Acute toxicity studies have shown that 
rhamnolipid biosurfactant is not toxic, but is irritating via ocular 
exposure. Residues of rhamnolipid biosurfactant are not expected to be 
of toxicological concern. The rhamnolipid molecules are simply 
glycolipids composed of a rhamnose sugar ring and a fatty acid tail. 
Individually these molecules are not considered toxic. There is a 
reasonable certainty of no harm to the general U.S. population from 
exposure to this active ingredient.
    2. Infants and children. As mentioned above, residues of 
rhamnolipid biosurfactant are not expected to be of toxicological 
concern. There is a reasonable certainty of no harm for infants and 
children from exposure to rhamnolipid biosurfactant from the proposed 
uses.

G. Effects on the Immune and Endocrine Systems

    To date there is no evidence to suggest that rhamnolipid 
biosurfactant functions in a manner similar to any known hormone, or 
that it acts as an endocrine disrupter.

H. Existing Tolerances

    There is no U.S. EPA tolerance for rhamnolipid biosurfactant.

I. International Tolerances

    A Codex Alimentarium Commission Maximum Residue Level is not 
required for rhamnolipid biosurfactant.
[FR Doc. 03-11478 Filed 5-8-03; 8:45 am]
BILLING CODE 6560-50-S